Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

AMENDED AND RESTATED COLLABORATION AND LICENSE AGREEMENT

This Amended and Restated Collaboration and License Agreement (the

“Agreement”) is entered into as of December 17, 2025 (the “Restatement Date”), by and

between Exelixis, Inc., a Delaware company having an address at 1851 Harbor Bay Parkway,

Alameda, CA 94502, USA (“Exelixis”) and Ipsen Pharma SAS, a French corporation having an

address at 70 rue Balard, 75015 Paris, France (“Licensee”). Exelixis and Licensee may be

referred to herein individually as a “Party” or collectively as the “Parties”.

Recitals

Whereas, Exelixis, a biopharmaceutical company, is developing its proprietary

compound known as cabozantinib for the treatment of cancer, and owns or controls certain

patents, know-how and other intellectual property relating to such compound;

Whereas, Licensee, a fully-integrated pharmaceutical company, possesses substantial

resources and expertise in the development and commercialization of pharmaceutical products;

and

Whereas, Exelixis and Licensee are parties to that certain Collaboration and License

Agreement dated February 29, 2016 (the “Effective Date”), as subsequently amended by the

First Amendment dated effective December 20, 2016, Second Amendment dated effective

September 14, 2017, Third Amendment dated effective October 26, 2017, Fourth Amendment

dated effective October 11, 2022 (the “Fourth Amendment Effective Date”), and Fifth

Amendment dated effective August 24, 2023 (the “Fifth Amendment Effective Date”)

(collectively, the “Original Agreement”) under which the Parties have been collaborating on the

development and commercialization of cabozantinib;

Whereas, the Parties wish to amend and restate the Original Agreement in accordance

with Section 17.2 thereof to incorporate the amendments, all under the terms and conditions

hereof.

Agreement

Now, Therefore, in consideration of the foregoing premises and the mutual covenants

contained herein, and for other good and valuable consideration, the receipt and sufficiency of

which are hereby acknowledged, Exelixis and Licensee hereby agree to amend and restate the

Original Agreement as of the Restatement Date, so that it reads in its entirety as follows:

1.Definitions

1.1“Additional Markets” means [ * ].

1.2“Affiliate” means, with respect to any party, any entity that, directly or indirectly

through one or more intermediaries, controls, is controlled by or is under common control with

such party, but for only so long as such control exists. As used in this Section 1.2, “control”

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

means (a) to possess, directly or indirectly, the power to direct the management or policies of an

entity, whether through ownership of voting securities, by contract relating to voting rights or

corporate governance; or (b) direct or indirect beneficial ownership of more than fifty percent

(50%) (or such lesser percentage which is the maximum allowed to be owned by a foreign

corporation in a particular jurisdiction) of the voting share capital or other equity interest in such

entity.

1.3“Applicable Laws” means the applicable provisions of any and all national,

supranational, regional, state and local laws, treaties, statutes, rules, regulations, administrative

codes, guidance, ordinances, judgments, decrees, directives, injunctions, orders, permits

(including MAAs) of or from any court, Regulatory Authority or governmental agency or

authority having jurisdiction over or related to the subject item.

1.4“Calendar Quarter” means each respective period of three (3) consecutive

months ending on March 31, June 30, September 30, and December 31.

1.5“Calendar Year” means each respective period of twelve (12) consecutive

months ending on December 31.

1.6 “Clinical Trial” or “Clinical Trials” means Phase 1 Clinical Trial, Phase 2

Clinical Trial, Phase 3 Clinical Trial or Phase 4 Clinical Trial as the context dictates.

1.7“cGCP” shall mean the current clinical practice as set out in (i) ICH Harmonized

Guidance on current Good Clinical Practice (CPMP/ICH/135/95), (ii) US Code of Federal

Regulations, Title 21, Chapters 50, 54, 56, 58, 210, 211 and 312, as may be amended from time

to time, (iii) EU Directive 2001/20/EC and related guidelines, and (iv) the equivalent law or

regulation in any other applicable jurisdiction in the Territory.

1.8“cGLP” shall mean current good laboratory practice standards promulgated or

endorsed by the FDA, as defined in U.S. 21 C.F.R. Part 58 (or such other comparable regulatory

standards in jurisdictions outside the U.S.), as they may be updated from time to time.

1.9“cGMP” shall mean the current minimum standards for methods to be used in,

and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a

drug as specified by applicable laws of the relevant countries at the time of manufacturing

conducted in accordance with this Agreement, defined under (i) 21 C.F.R. Part 210 and 211, (ii)

Directive 2003/94/EC, (iii) Volume 4, Rules Governing Medicinal Products in the EU, Part I and

II, in each case, as amended from time to time, and (iv) equivalent law or regulations in any other

applicable jurisdiction in the Territory.

1.10“Cometriq” means that certain pharmaceutical product containing the Compound

in capsule formulation and known as Cometriq®, which has been developed and commercialized

by Exelixis as of the Effective Date for the treatment of progressive, metastatic medullary

thyroid cancer (MTC).

1.11“Commercialization” means the conduct of all activities undertaken before and

after Regulatory Approval relating to the promotion, sales, marketing, medical support, and

distribution (including importing, exporting, transporting, customs clearance, warehousing,

invoicing, handling and delivering Products to customers) of Products in the Field in or outside

of the Licensee Territory, including sales force efforts, detailing, advertising, market research,

market access (including price and reimbursement activities), medical education and information

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

services, publication, scientific and medical affairs; advisory and collaborative activities with

opinion leaders and professional societies including symposia, marketing, sales force training,

and sales (including receiving, accepting and filling Product orders) and distribution.

“Commercialize” and “Commercializing” have correlative meanings.

1.12“Commercially Reasonable Efforts” means, with respect to a Party and its

obligations under this Agreement, those commercially reasonable efforts and resources

consistent with the usual practices of a similarly situated company for the development and

commercialization of a pharmaceutical product originating from its own research and

development department without a royalty obligation to others, which is at a similar stage of

research, development or commercialization, taking into account that product’s profile of

efficacy and safety; proprietary position, including patent and regulatory exclusivity; regulatory

status, including anticipated or approved labeling and anticipated or approved post-approval

requirements; present and future market and commercial potential, including competitive market

conditions (but not taking into account any payment owed to the other Party under this

Agreement), and all other relevant factors, including technical, legal, scientific and/or medical

factors. Commercially Reasonable Efforts requires that a Party: (i) at a minimum establish a

plan to achieve objectives and assign specific responsibilities for the achievement of that plan

and (ii) make and implement decisions and allocate resources designed to advance progress with

respect to such objectives.

1.13“Committee” means the JSC, JDC, JCC or any subcommittee established by the

JSC, as applicable.

1.14“Competing Product” means any product or compound, other than the

Compound and Products: (a) for which the mechanism of action includes modulation of the

kinase activities of cMET, VEGFR2, Ret or any combination of these targets; and (b) which

directly binds and modulates the activity of: (i) VEGFR2; (ii) cMET; and/or (iii) Ret, [ * ].

1.15“Compound” means cabozantinib, having the chemical structure set forth in

Exhibit A, including [ * ].

1.16“Confidentiality Agreement” means that certain Confidential Disclosure

Agreement between Exelixis and Licensee dated as of February 10, 2015.

1.17“Confidential Information” means all Know-How and other proprietary

scientific, marketing, financial or commercial information or data that is generated by or on

behalf of a Party or its Affiliates or which one Party or any of its Affiliates has supplied or

otherwise made available to the other Party or its Affiliates, whether made available orally, in

writing, or in electronic form, including information comprising or relating to concepts,

discoveries, inventions, data, designs or formulae in relation to this Agreement; provided that all

Exelixis Technology will be deemed Exelixis’ Confidential Information, all Licensee

Technology will be deemed Licensee’s Confidential Information, and all Joint Inventions and

Joint Patents will be deemed both Parties’ Confidential Information.

1.18“Control” or “Controlled” means, with respect to any Know-How, Patents or

other intellectual property rights, the legal authority or right (whether by ownership, license or

otherwise but without taking into account any rights granted by one Party to the other Party

pursuant to this Agreement) of a Party to grant access, a license or a sublicense of or under such

Know-How, Patents or other intellectual property rights to another Party, or to otherwise disclose

proprietary or trade secret information to such other Party, without breaching the terms of any

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

agreement with a Third Party, or misappropriating the proprietary or trade secret information of a

Third Party.

1.19“Cost of Goods” means, with respect to any Compound or Product, the fully

burdened cost to manufacture such Compound or Product, which means: (a) in the case of [ * ];

and (b) in the case of [ * ]. Actual unit costs shall consist of [ * ]. Direct material costs shall

include the [ * ]. Direct labor costs shall include the cost of: [ * ]. [ * ].

1.20“Data” means any and all scientific, technical, test, marketing or sales data

pertaining to any Product that is generated by or on behalf of Exelixis, Licensee, their respective

Affiliates and Sublicensees, including research data, clinical pharmacology data, pre-clinical

data, clinical data, clinical study reports or submissions made in association with an IND or

MAA with respect to any Product.

1.21“Development” means all development activities for the Compound and Product

(whether alone or for use together, or in combination, with another active agent or

pharmaceutical product as a combination product or combination therapy) that are directed to

obtaining Regulatory Approval(s) of the Product and lifecycle management of the Product in any

country in the world, including all non-clinical, preclinical and clinical testing and studies of the

Product; toxicology, pharmacokinetic and pharmacological studies; statistical analyses; assay

development; protocol design and development; the preparation, filing and prosecution of any

MAA for the Product; development activities directed to label expansion and/or obtaining

Regulatory Approval for one or more additional indications following initial Regulatory

Approval; development activities conducted after receipt of Regulatory Approval, including

Phase 4 Clinical Trials; and all regulatory affairs related to any of the foregoing. “Develop” and

“Developing” have correlative meanings.

1.22“Development Costs” means the costs incurred by a Party or for its account,

during the Term and pursuant to this Agreement, that are specifically directed (or reasonably

allocable) to the Development of a Product. The Development Costs shall include amounts that

a Party pays to Third Parties involved in the Development of a Product (at cost, and excluding

any Third Party Royalties), and all internal costs (calculated on an FTE basis at the then-current

FTE Rate) and out-of-pocket costs incurred by or on account of a Party in performing

Development in accordance with the GDP.

1.23“Drug Master File” means any (a) drug master files filed with the FDA with

respect to the Product, (b) active substance master file (ASMF) filed with the EMA, and (c)

equivalent filing in other countries in the Licensee Territory.

1.24“EMA” means the European Medicines Agency or its successor.

1.25“EU” means the European Economic Area and Switzerland.

1.26“Executive Officers” the Chief Executive Officer of Exelixis and the Chief

Executive Officer of Licensee.

1.27“Exelixis Know-How” means all Know-How that Exelixis Controls as of the

Effective Date or during the Term, including any Joint Inventions, that is necessary or reasonably

useful for the Development, use, importation, offer for sale or sale of any Compound or Product

in the Field in the Licensee Territory. The Exelixis Know-How includes the Exelixis Data.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

1.28“Exelixis Patents” means all Patents in the Licensee Territory that Exelixis

Controls as of the Effective Date or during the Term (including any Joint Patents) that would be

infringed, absent a license or other right to practice granted under such Patents, by the

Development, use, importation, offer for sale or sale of any Compound or Product in the Field in

the Licensee Territory (considering patent applications to be issued with the then-pending claims

and considering Joint Patents as if owned solely by Exelixis), but excluding those Patents set

forth in Exhibit B-2. The Exelixis Patents existing as of the Restatement Date are set forth in

Exhibit B-1.

1.29“Exelixis [ * ]” means the [ * ] in Exhibit F.

1.30“Exelixis Technology” means the Exelixis Know-How and the Exelixis Patents,

including Exelixis’ interest in the Joint Inventions and Joint Patents.

1.31“Exelixis Territory” means the U.S. and Japan.

1.32“Expanded Access Program” means the administration of the Product to named

individuals who do not meet the clinical trial enrollment criteria either outside of a clinical trial

or after the completion of a clinical trial. Expanded Access Programs are also known as named

patient programs, named patient supply, and temporary authorization for use.

1.33“Export Control Laws” means all applicable U.S. laws and regulations relating

to (a) sanctions and embargoes imposed by the Office of Foreign Assets Control of the U.S.

Department of Treasury or (b) the export or re-export of commodities, technologies, or services,

including the Export Administration Act of 1979, 24 U.S.C. §§ 2401-2420, the International

Emergency Economic Powers Act, 50 U.S.C. §§ 1701-1706, the Trading with the Enemy Act, 50

U.S.C. §§ 1 et. seq., the Arms Export Control Act, 22 U.S.C. §§ 2778 and 2779, and the

International Boycott Provisions of Section 999 of the U.S. Internal Revenue Code of 1986 (as

amended).

1.34“FCPA” means the U.S. Foreign Corrupt Practices Act (15 U.S.C. Section

78dd-1, et. seq.), as amended.

1.35“FDA” means the U.S. Food and Drug Administration or its successor.

1.36“Field” means all indications and uses in humans and animals.

1.37“First Commercial Sale” means, on a Product-by-Product and country-by-

country basis, the earlier of (i) the First Commercial RCC Sale or (ii) first sale by Licensee or

any of its Affiliates or Sublicensees to a Third Party for end use of Cometriq for the MTC

indication in a given country in the Licensee Territory after Regulatory Approval has been

granted with respect to such Product in such country.

1.38“First Commercial RCC Sale” means, on a Product-by-Product and country-by-

country basis, the first sale by Licensee or any of its Affiliates or Sublicensees to a Third Party

for end use of a Product in a given country in the Licensee Territory after Regulatory Approval

has been granted with respect to such Product in such country for the first indication approved by

the relevant Regulatory Authority in the treatment of RCC (e.g., 2nd line therapy for RCC).

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

1.39“FTE” means the equivalent of full-time individual’s work, performed by one or

more individuals, in an Exelixis fiscal year (which fiscal year is, in most years, 52 weeks exactly

consisting of [ * ] working hours [ * ].

1.40“FTE Rate” means an initial rate of (a) with respect to Exelixis’ personnel, [ * ]

per FTE per 52-week Exelixis Fiscal Year and (b) with respect to Licensee’s personnel, [ * ],

which rate shall apply through December 31, 2016. Thereafter, the FTE Rate shall be changed

annually on a Calendar Year basis to reflect any year-to-year percentage increase or decrease (as

the case may be) (i) with respect to Exelixis, in the Consumer Price Index for All Urban

Consumers for the U.S., as published by the U.S. Department of Labor, Bureau of Labor

Statistics (“CPI”), and (ii) with respect to Licensee, in the French consumer price index as

published by the French National Institute of Statistics and Economic Studies (“INSEE”)

available at insee.fr (both changes based on the change in the CPI from the most recent

applicable index available as of the Effective Date to the most recent applicable index available

as of the date of the calculation of such revised FTE Rate). [ * ] The Parties acknowledge that

the FTE Rate calculated in accordance with Section 1.39 with respect to all Development Costs

shall be effective as from [ * ].

1.41“Future Exelixis Licensee” means any licensee or Sublicensee of Exelixis (other

than Licensee) to which a license or a sublicense with respect to Products is granted by Exelixis

for all or any portion of the Exelixis Territory (e.g., the U.S., Canada and/or Japan) or will be

granted after the Effective Date.

1.42“Generic Product” means, with respect to a Product in a particular regulatory

jurisdiction, any pharmaceutical product that (a) contains the same active pharmaceutical

ingredient(s) as such Product; (b) is approved by the Regulatory Authority in such country as a

substitutable generic for such Product (for an indication for which such Product obtained

Regulatory Approval from the applicable Regulatory Authority in such jurisdiction) on an

expedited or abbreviated basis based on bioequivalence or interchangeability with the Product;

and (c) is sold in such jurisdiction by a Third Party that is not a Sublicensee and did not purchase

such product in a chain of distribution that included any of Exelixis, Licensee, or their respective

Affiliates, licensees, or sublicensees.

1.43“Governmental Authority” means any national, international, federal, state,

provincial or local government, or political subdivision thereof, or any multinational organization

or any authority, agency or commission entitled to exercise any administrative, executive,

judicial, legislative, police, regulatory or taxing authority or power, any court or tribunal (or any

department, bureau or division thereof, or any governmental arbitrator or arbitral body).

1.44“HCC” means hepatocellular carcinoma.

1.45“Health Canada” means the federal department of the government of Canada

having the authority to regulate the sale of medicinal or pharmaceutical products, or any

successor agency thereof.

1.46“ICH” means the International Conference on Harmonization (of Technical

Requirements for Registration of Pharmaceuticals for Human Use).

1.47“IND” means an investigational new drug application or equivalent application

filed with the applicable Regulatory Authority, which application is required to commence

human clinical trials in the applicable country.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

1.48“Initiation” means, with respect to a Clinical Trial, the first dosing of the first

human subject in such Clinical Trial.

1.49“Inventions” means all inventions, whether or not patentable, discovered, made,

conceived, or reduced to practice, in the course of activities contemplated by this Agreement.

1.50“Know-How” means all technical information, know-how and data, including

inventions, discoveries, trade secrets, specifications, instructions, processes, formulae,

compositions of matter, cells, cell lines, assays, animal models and other physical, biological, or

chemical materials, expertise and other technology applicable to, development, registration, use

or marketing or to methods of assaying or testing them, and including all biological, chemical,

pharmacological, biochemical, toxicological, pharmaceutical, physical and analytical, safety,

nonclinical and clinical data, regulatory documents, data and filings, instructions, processes,

formulae, expertise and information, relevant to the research, development, use, importation,

offering for sale or sale of, or which may be useful in studying, testing, developing, Products.

Know-How excludes Patents and manufacturing know-how of Compound or Product.

1.51“Licensee Know-How” means all Know-How that Licensee or its Affiliate

Controls as of the Effective Date or during the Term, including any Joint Inventions, that is [ * ]

for the research, Development, manufacture, use, importation, offer for sale or sale of any

Compound or Product in the Field. The Licensee Know-How includes the Licensee Data.

1.52 “Licensee Patents” means all Patents that Licensee or its Affiliate Controls as of

the Effective Date or during the Term (including any Joint Patents) that would be infringed,

absent a license or other right to practice granted under such Patents, by the research,

Development, manufacture, use, importation, offer for sale or sale of any Compound or Product

(considering patent applications to be issued with the then-pending claims and considering Joint

Patents as if owned solely by Licensee or its Affiliate).

1.53“Licensee Technology” means the Licensee Know-How and the Licensee

Patents, including Licensee’s interest in the Joint Inventions and Joint Patents.

1.54“Licensee Territory” means the world outside the Exelixis Territory.

1.55“MAA” means a marketing authorization application or equivalent application,

and all amendments and supplements thereto, filed with the applicable Regulatory Authority in

any country or jurisdiction. For clarity, MAA does not include any application for Pricing and

Reimbursement Approval.

1.56“MAA Approval” means approval of an MAA by the applicable Regulatory

Authority for marketing and sale of a Product in the applicable country or jurisdiction, but

excluding any pricing and/or reimbursement approval.

1.57“Major Market Countries” means [ * ].

1.58“Medical Affairs” or “Medical Affairs Activities” means activities designed to

ensure or improve appropriate medical use of, conduct medical education of, or further research

regarding, the Product, including by way of example: (a) activities of medical scientific liaisons

who, among their other functions, may: (i) conduct service based medical activities including

providing input and assistance with consultancy meetings, proposing investigators for clinical

trials sponsored or co-sponsored by a Party or Affiliate, and providing input in the design of such

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

trials and other research related activities; and/or (ii) deliver non-promotional communications

and conduct non-promotional activities; (b) grants to support continuing medical education,

symposia, or Third Party research related to the Product; (c) development, publication and

dissemination of publications relating to the Products; (d) medical information services provided

in response to inquiries communicated via sales representatives or received by letter, phone call

or email; (e) conducting advisory board meetings, international advisory board activities or other

consultant programs, including the engagement of key opinion leaders and health care

professional in individual or group advisory and consulting arrangements; and (f) the evaluation

of applications submitted to Licensee for support of investigator-initiated trials.

1.59“MTC” means medullary thyroid cancer.

1.60“Net Sales” means, with respect to any Product, the gross amounts invoiced for

sales or other dispositions of such Product by or on behalf of Licensee and its Affiliates and

Sublicensees to Third Parties, less the following deductions to the extent included in the gross

invoiced sales price for such Product or otherwise directly paid or incurred by Licensee or its

Affiliates or Sublicensees, as applicable, with respect to the sale or other disposition of such

Product:

(a)normal and customary trade and quantity discounts actually allowed and

properly taken directly with respect to sales of such Product (provided that such discounts are not

applied disproportionately to such Product when compared to the other products of Licensee or

its Affiliate or Sublicensee, as applicable);

(b)credits or allowances given or made for rejection or return of previously

sold Products or for retroactive price reductions and billing errors;

(c)rebates and chargeback payments granted to managed health care

organizations, pharmacy benefit managers (or equivalents thereof), national, state/provincial,

local, and other governments, their agencies and purchasers and reimbursors, or to trade

customers;

(d)[ * ] costs of freight, carrier insurance, and other transportation charges

directly related to the distribution of such Product. [ * ]; and

(e)taxes, duties or other governmental charges (including any tax such as a

value added or similar tax, other than any taxes based on income) directly levied on or measured

by the billing amount for such Product, as adjusted for rebates and refunds.

Upon any sale or other disposition of any Product that should be included within Net

Sales for any consideration other than exclusively monetary consideration on bona fide arms’-

length terms, then for purposes of calculating Net Sales under this Agreement, such Product shall

be deemed to be sold exclusively for money at the average sales price of the relevant Product in

arm’s length transactions during the applicable reporting period generally achieved for such

Product in the country in which such sale or other disposition occurred when such Product is sold

alone and not with other products (average sales price to be measured as the aggregate Product

Net Sales divided by the aggregate number of units sold in such country).

In no event will any particular amount identified above be deducted more than once in

calculating Net Sales. Sales of a Product between Licensee and its Affiliates or Sublicensees for

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

resale shall be excluded from the computation of Net Sales, but the subsequent resale of such

Product to a Third Party shall be included within the computation of Net Sales.

The supply of Product as samples, for use in non-clinical or clinical trials, or for use in

any test or studies reasonably necessary to comply with any applicable laws, rules, or regulations

or as is otherwise normal and customary in the industry shall not be included in the computation

of Net Sales, so long as Licensee, its Affiliates, and Sublicensees do not receive payment for

such Product in excess of the Cost of Goods of such Product.

1.61 “NSCLC” means non-small cell lung cancer.

1.62“Patents” means (a) all patents, certificates of invention, applications for

certificates of invention, priority patent filings and patent applications, and (b) any renewals,

divisions, continuations (in whole or in part), or requests for continued examination of any of

such patents, certificates of invention and patent applications, and any all patents or certificates

of invention issuing thereon, and any and all reissues, reexaminations, extensions, supplementary

protection certificates, divisions, renewals, substitutions, confirmations, registrations,

revalidations, revisions, and additions of or to any of the foregoing.

1.63“Phase 1 Clinical Trial” means a clinical trial in any country conducted in a

small number of human volunteers designed or intended to establish an initial safety profile,

pharmacodynamics, or pharmacokinetics of a Product. For clarity, a Phase 1 Clinical Trial may

include studies conducted in oncology patients.

1.64“Phase 2 Clinical Trial” means a clinical trial of a Product in human patients in

any country to determine initial efficacy and safety and dose range finding. A Phase 2 Clinical

Trial is typically conducted before embarking on a Phase 3 Clinical Trial, but may be

registrational.

1.65“Phase 3 Clinical Trial” means a pivotal clinical trial of a Product in human

patients in any country with a defined dose or a set of defined doses of a Product designed to

ascertain efficacy and safety of such Product for the purpose of submitting applications for

Regulatory Approval to the competent Regulatory Authorities.

1.66“Phase 4 Clinical Trial” means a product support clinical trial of a Product that

is commenced after receipt of MAA Approval in the country where such trial is conducted.

Phase 4 Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic

studies, post-marketing surveillance trials, and any such trials conducted as part of an Expanded

Access Program.

1.67 “Pricing and Reimbursement Approval” means, with respect to a Product, the

approval, agreement, determination or decision of any Governmental Authority establishing the

price or level of reimbursement for such Product, as required in a given country or jurisdiction

prior to sale of such Product in such jurisdiction.

1.68“Product” means any pharmaceutical product containing the Compound as an

active ingredient, in any form, presentations, dosage or formulation, including but not limited to

Cometriq. For purposes of this Agreement, all formulations of single-agent Product containing

the Compound shall be considered the same Product, and all formulations of combination

product, if any, containing the same set of active agents shall be considered the same Product.

10.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

1.69“Public Official or Entity” means (a) any officer, employee (including

physicians, hospital administrators, or other healthcare professionals), agent, representative,

department, agency, de facto official, representative, corporate entity, instrumentality or

subdivision of any government, military or international organization, including any ministry or

department of health or any state-owned or affiliated company or hospital, or (b) any candidate

for political office, any political party or any official of a political party.

1.70“RCC” means renal cell carcinoma.

1.71“Region” means, individually and collectively, the following regions: [ * ].

1.72“Regulatory Approval” means any and all approvals (including MAA Approval,

and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits,

notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for

the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for

sale, sale or other commercialization of a Product in any country or jurisdiction.

1.73“Regulatory Authority” means any Governmental Authority that has

responsibility in its applicable jurisdiction over the testing, development, manufacture, use,

storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other

commercialization of pharmaceutical products in a given jurisdiction, including the FDA, the

EMA and Health Canada or other foreign equivalent. For countries where governmental

approval is required for pricing or reimbursement for a pharmaceutical product to be reimbursed

by national health insurance (or its local equivalent), Regulatory Authority shall also include any

Governmental Authority whose review or approval of pricing or reimbursement of such product

is required.

1.74“Regulatory Exclusivity” means any exclusive marketing rights or data

exclusivity rights conferred by any Regulatory Authority with respect to a Product other than

patents, including, without limitation, rights conferred in the U.S. under the Hatch-Waxman Act

or the FDA Modernization Act of 1997 (including pediatric exclusivity), or rights similar thereto

outside the U.S., such as Directive 2001/83/EC (as amended) in the EU.

1.75“Regulatory Filing” means all applications, filings, submissions, approvals,

licenses, registrations, permits, notifications and authorizations (or waivers) with respect to the

testing, Development, manufacture or Commercialization of any Product made to or received

from any Regulatory Authority in a given country, including any INDs and MAAs.

1.76“Safety Data” means Data related solely to any adverse drug experiences and

serious adverse drug experience as such information is reportable to Regulatory Authorities.

Safety Data also includes “adverse events”, “adverse drug reactions” and “unexpected adverse

drug reactions” as defined in the ICH Harmonised Tripartite Guideline for Clinical Safety Data

Management: Definitions and Standards for Expedited Reporting.

1.77“SEC” means the U.S. Securities and Exchange Commission, or any successor

entity or its foreign equivalent such as the French Autorités des Marchés Financiers or

otherwise, as applicable.

1.78“Sponsor” means the Party that takes the ultimate responsibility for the initiation,

performance and management of, including financing or arranging the financing for, the

appropriate Clinical Trial.

11.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

1.79“Stockout Period” means a period during which Licensee, as a result of failure of

Exelixis to supply Product, has no commercial inventory available to supply the market in the

Licensee Territory. Inventory stockouts arising from Licensee’s failure to maintain the [ * ]

safety stock in accordance with the Supply Agreement shall not give rise to a Stockout Period.

1.80“Sublicensee” means a Third Party to whom Licensee grants a sublicense to

Develop, use, import, promote, offer for sale or sell any Product in the Field in the Licensee

Territory, beyond the mere right to purchase Products from Licensee and its Affiliates, and

excluding wholesalers, full-service distributors that do not promote the sale of the Product, and

other similar physical distributors. In no event shall Exelixis or any of its Affiliates be deemed a

Sublicensee.

1.81“Third Party” means any entity other than Exelixis or Licensee or an Affiliate of

Exelixis or Licensee.

1.82“Tier 1 Additional Indication” means RCC (1st line), HCC (1st line), [ * ].

1.83“Tier 2 Additional Indication” means any line of therapy for [ * ].

1.84“Top 5 EU” means the United Kingdom, Germany, France, Spain, and Italy.

1.85“U.S.” means the United States of America, including its territories and

possessions (including Puerto Rico).

1.86“Valid Claim” means (a) a claim of an issued and unexpired patent that has not

been revoked or held unenforceable, unpatentable or invalid by a decision of a court or other

governmental agency of competent jurisdiction that is not appealable or has not been appealed

within the time allowed for appeal, and that has not been abandoned, disclaimed, denied or

admitted to be invalid or unenforceable through reissue, re-examination or disclaimer or

otherwise, or (b) a claim of a pending patent application that has not been cancelled, withdrawn

or abandoned or finally rejected by an administrative agency action from which no appeal can be

taken and that has not been pending for more than [ * ].

1.87Additional Definitions. The following table identifies the location of definitions set

forth in various Sections of the Agreement:


Defined Terms	Section
Acquisition Transaction	17.8(b)
Alliance Manager	3.9
Allowable Increases	4.5(b)
Auditor	10.4
Beneficial Party	9.2(d)
Canada Studies	4.15
Change of Control	2.8(c)
Claim	13.3
Commercialization Plan	6.2
Competing Program	2.8(a)

12.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.


Defined Terms	Section
Compound Invention	11.1(b)(i)
Development Budget	4.2
Disputed Matter	16.2
Divest	2.8(c)
EU LOE Event	5.5(a)(iii)(B)
Excess Funds	4.5(a)
Exelixis Fiscal Year	1.38
Exelixis Data	11.1(a)
Exelixis Entity	17.8(a)(i)(1)
Exelixis Indemnitee	13.2
Exelixis Only Development Work	4.5(e)
First LOE Event	5.5(a)(iii)(C)
Generic Entry	5.5(a)(iii)(A)
Global Development Plan or GDP	4.2
Indemnitee	13.3
Indemnitor	13.3
Independent Work	4.3
Independent Work Cost	9.2(b)
Initial Committed Studies	4.5(a)
Injunctive Relief	16.3(b)
Licensee Data	11.1(a)
Licensee Indemnitee	13.1
Licensee Only Development Work	4.5(e)
Joint Commercialization Committee or JDC	3.3
Joint Development Committee or JDC	3.2
Joint Steering Committee or JSC	3.1
Joint Inventions	11.1(b)(ii)
Joint Patents	11.1(b)(ii)
Losses	13.1
Loss of Exclusivity	5.5(a)(iii)(A)
Materials	4.14
PV Contribution Fee	5.5(a)(ii)
PV Costs	5.5(a)(i)
Pharmacovigilance Agreement	5.5
Previously Achieved Commercial Milestone	9.4(b)(ii)
Previously Achieved Commercial Milestone for Canada	9.4(b)(iii)

13.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.


Defined Terms	Section
Product Infringement	11.3(a)
Product Marks	11.6(a)
Promotional Materials	6.4(c)
Recall	5.9
Regulatory Meeting	5.4
Royalty Term	9.5(b)
Sales Forecast	6.3(c)
Second LOE Event	5.5(a)(iii)(C)
Sobi	5.2
Sobi Agreement	8.1
Sole Inventions	11.1(b)(ii)
Standstill Period	17.8(a)
Sunshine Reporting Laws	5.10
Supply Agreement	7.1
Supply Contacts	3.10
Term	15.1(a)
TMC	5.2
U.S. LOE Event	5.5(a)(iii)(B)
Withholding Tax Action	10.3(c)

2.Grant of Licenses

2.1Licenses Granted to Licensee. Subject to the terms and conditions of this

Agreement (including Section 8.1), Exelixis hereby grants to Licensee, during the Term:

(a)an exclusive (even as to Exelixis, except as expressly set forth herein),

royalty-bearing license, with the right to grant sublicenses solely as provided in Section 2.2,

under the Exelixis Technology to use, sell, offer for sale, import and otherwise Commercialize

(but not to make or have made) the Products in the Field and in the Licensee Territory; and

(b)a non-exclusive license, with the right to grant sublicenses solely as

provided in Section 2.2, under the Exelixis Technology to Develop (but not to make or have

made) the Products on a worldwide basis under the GDP, and to use the Products for that

purpose. Exelixis agrees not to grant any further license to Develop the Products except to

Future Exelixis Licensees.

2.2Sublicenses. Licensee shall have the right to grant sublicenses under the licenses

granted in Section 2.1:

(a)to an Affiliate of Licensee without Exelixis’ express prior written consent

and without providing any written notice to Exelixis, provided that such sublicense will

terminate if such sublicensee no longer qualifies as an Affiliate of Licensee.

14.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(b)to any Third Party distributor identified on Exhibit C attached hereto

(which list of approved distributors shall be agreed upon by the Parties within thirty (30) days

following the Effective Date) without Exelixis’ express prior written consent, provided that

Licensee does not have an Affiliate that is then engaged in selling pharmaceutical products in

such sublicensed territory.

(c)to any Third Party distributor not listed in Exhibit C without Exelixis’

express prior written consent, provided that (i) Licensee does not have an Affiliate that is then

engaged in selling pharmaceutical products in such sublicensed territory; (ii) Licensee has

conducted a reasonable investigation of such Third Party and believes that such Third Party is

qualified and competent, and such Third Party annually certifies its compliance with, and

actually complies with, Applicable Laws and other applicable requirements, (iii) such Third

Party is then engaged in the promotion and commercialization of oncology products, and (iv)

Licensee is then using such Third Party for distribution of pharmaceutical products other than

Products; and provided further that Licensee notifies Exelixis in writing [ * ] days’ in advance of

granting such sublicense specifying (x) the name of such Third Party and the country(ies) such

sublicense will cover, and (y) that Licensee has met the conditions set forth in (ii) – (iv). If

Exelixis believes Licensee should not grant such sublicense to such Third Party, it may direct

such concern and any documentation supporting such concern to the JSC for discussion.

(d)to a Third Party other than as set forth in (b) and (c) with Exelixis’ express

prior written consent.

(e)All sublicenses granted under the licenses granted in Section 2.1 shall be in writing and

shall be subject to, and consistent with, the terms and conditions of this Agreement and shall

provide that any such Sublicensee (for clarity, including any distributor) shall not further

sublicense except with the consent of Licensee and Exelixis. Licensee shall ensure that each

agreement with a Sublicensee grants Exelixis all rights with respect to Data, Inventions and

Regulatory Filings made or generated by such Sublicensee as if such Data, Inventions and

Regulatory Filings were made or generated by Licensee. Licensee shall be responsible for the

compliance of its Affiliates, Sublicensees (for clarity, including any distributors), and

subcontractors with the terms and conditions of this Agreement. Licensee shall provide written

notice to Exelixis of each sublicense granted to a Third Party hereunder, specifying the name of

the Sublicensee, the territory, and the duration of the sublicense.

Licensee agrees that in countries where it is not Commercializing Products through its Affiliates,

it will only contract with Third Party distributors who satisfy the conditions of paragraphs (b),

(c), or (d) above, whether or not a sublicense of rights hereunder is actually required.

2.3Reserved Rights. Exelixis hereby expressly reserves:

(a)the right under Exelixis Technology to exercise its rights and perform its

obligations under this Agreement, whether directly or through one or more licensees or

subcontractors, including the right to Develop the Compound and Products in the Licensee

Territory under the GDP; and

(b)subject to Section 2.8, all rights to practice, and to grant licenses under,

the Exelixis Technology outside of the scope of the licenses granted in Section 2.1, including the

exclusive right to make and have made the Compound and Products anywhere in the world, and

15.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

the exclusive rights to practice the Exelixis Patents and Exelixis Know-How with respect to

compounds and products other than Compound and Products.

2.4Licenses Granted to Exelixis. Subject to the terms and conditions of this

Agreement, Licensee hereby grants to Exelixis:

(a)an exclusive (even as to Licensee, except as expressly set forth herein),

royalty-free, fully paid-up license, with the right to sublicense (provided that any such

sublicensee may only grant a further sublicense at two tiers), under the Licensee Technology to

use, sell, offer for sale, import and otherwise Commercialize the Products in the Field in the

Exelixis Territory;

(b)a co-exclusive, royalty-free, fully paid-up license, with the right to

sublicense (provided that any such sublicensee may only grant a further sublicense at two tiers),

under the Licensee Technology to Develop the Compound and Products on a worldwide basis

under the GDP; and

(c)an exclusive (even as to Licensee), royalty-free, fully paid-up license, with

the right to sublicense (provided that any such sublicensee may only grant a further sublicense at

two tiers), under the Licensee Technology to make and have made the Compound and Products

anywhere in the world.

(d)Sublicenses: Exelixis shall have the right to grant sublicenses under the

licenses granted in Section 2.4

A.without Licensee’s consent and without providing any

written notice to Licensee if such sublicense is granted to an Affiliate; and

B.without Licensee’s prior written consent, provided however

that a written notice is sent to Licensee for Licensee’s information if such sublicense is granted

to Third Parties to manufacture the Product and provided further that such Third Party is

qualified and certified to manufacture the Product in such country in accordance with Applicable

Laws and other applicable requirements.

2.5No Implied Licenses; Negative Covenant. Except as set forth in this

Agreement, neither Party shall acquire any license or other intellectual property interest, by

implication or otherwise, under or to any Patents, Know-How or other intellectual property

owned or controlled by the other Party. Neither Party shall, nor shall it permit any of its

Affiliates or sublicensees to, practice any Patents or Know-How licensed to it by the other Party

outside the scope of the licenses granted to it under this Agreement.

2.6Disclosure of Know-How. For as long as the Parties are conducting

Development activities under the GDP, Exelixis shall, without additional compensation, disclose

and make available to Licensee, in electronic form where, all Exelixis Know-How that comes

into existence after the Effective Date and that was not previously provided to Licensee,

promptly after the development, making, conception or reduction to practice of such Exelixis

Know-How. For as long as the Parties are conducting Development activities under the GDP,

Licensee shall and shall cause its Affiliates to, without additional compensation, disclose and

make available to Exelixis, in electronic form where possible, any Licensee Know-How not

previously provided to Exelixis, and promptly after the earlier of the development, making,

conception or reduction to practice of such Licensee Know-How. The JDC and JCC shall each

16.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

establish a mechanism for the reciprocal disclosure of Know-How within its respective area of

responsibility.

2.7Third Party Licenses.

(a)If Exelixis enters into any agreement with a Third Party after the Effective

Date that includes a license from such Third Party to Exelixis under any Know-How or Patents

that are necessary or reasonably useful to Develop, use, sell, offer for sale or import the Products

in the Field and in the Licensee Territory, then Exelixis shall notify Licensee, identifying the

relevant Know-How or Patents, by providing Licensee with the substantive terms of the

applicable Third Party license agreement to Licensee, to the extent applicable to the rights that

would be sublicensed to Licensee, which Exelixis hereby agrees to do. Such Know-How and

Patents, to the extent falling within the definition of Exelixis Technology, will be sublicensed to

Licensee if Licensee provides Exelixis with written notice in which (i) Licensee consents to

adding such Patents and Know-How to the definition of Exelixis Technology, (ii) Exelixis and

Licensee, acting reasonably in good faith, agree on the terms and conditions of the payments that

would be owed under such license agreement as a result of Exelixis’ granting a sublicense to

Licensee or Licensee’s practice thereunder, including Licensee’s and its Affiliates’ and

Sublicensees’ Development, use, sale, offer for sale and importation of the Compound and

Products in the Field and in the Licensee Territory, and a reasonable allocation of all other

payments under such license agreement, and to make all payments when due and provide all

reports required under such license agreement; and (iii) Licensee acknowledges in writing that its

sublicense under such license agreement is subject to the terms and conditions of such license

agreement.

(b)Licensee shall promptly notify Exelixis if it becomes aware of any Third

Party Know-How or Patents that are necessary or reasonably useful to Develop, make, have

made, use, sell, offer for sale or import the Compound and Products in the Field, and shall give

Exelixis the first right to negotiate and obtain a license from such Third Party under such Know-

How or Patents. Except with the prior written consent of the other Party, neither Party shall

obtain a license to Third Party Patents or Know-How that is necessary or reasonably useful to

Develop, make, have made, use, sell, offer for sale or import the Products, for use with the

Products in the other Party’s territory, unless it obtains the right to sublicense such rights to the

other Party.

2.8Exclusivity.

(a)Subject to Section 2.8(c) below, for the period starting from the Effective

Date and for ten (10) years following the first Regulatory Approval of the Product in the first

indication other than MTC, neither Party (nor any of its Affiliates) shall, directly or indirectly

(including through a Third Party), commercialize any Competing Product for therapeutic or

prophylactic use (a “Competing Program”).

(b)Subject to Section 2.8(c) below, for the period starting from the Effective

Date and for five (5) years following the first Regulatory Approval of the Product in the first

indication other than MTC, neither Party (nor any of its Affiliates) shall, directly or indirectly

(including through a Third Party) develop any Competing Program [ * ].

(c)In the event that a Third Party becomes an assignee of this Agreement, or

an Affiliate of a Party after the Effective Date through merger, acquisition, consolidation or other

17.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

similar transaction, and such Third Party, as of the closing date of such transaction, is engaged in

the conduct of a Competing Program:

(i)if such transaction constitutes a Change of Control of [ * ], [ * ]

shall have the right to terminate the Agreement as provided herein. [ * ] shall have [ * ]

following the announcement of such transaction to give written notice to [ * ] of its intent to

terminate the Agreement, such termination to be effective [ * ] after receipt of notice of

termination (but only after completion of the transaction with such entity having a Competing

Product) unless [ * ] notifies [ * ] within [ * ] of receipt of the notice of termination of its

decision to (a) Divest any such Competing Product to a Third Party, (b) discontinue the

Competing Program, or (c) acting reasonably and in good faith agree with [ * ] and such assignee

or new Affiliate to find a mutually acceptable agreement whereby they can, on compliance with

Applicable Laws, jointly exploit such Competing Product together with the Product. Such

disposition shall be completed within [ * ] of completion of any such sale or Change of Control

transaction. During the [ * ], such assignee or new Affiliate (as the case may be) shall have the

right to continue the Competing Program and such continuation shall not constitute a breach of

such Party’s exclusivity obligations set forth above; provided that such assignee or new Affiliate

(as the case may be) conducts the Competing Program independently of the activities of this

Agreement and does not use any [ * ] in the conduct of the Competing Program. In the event this

Agreement is terminated in accordance with the foregoing, neither Party shall [ * ];

(ii)if such transaction constitutes a Change of Control of [ * ], then

such assignee or new Affiliate shall continue to Develop and Commercialize the Product using a

level of Commercially Reasonable Efforts that assumes the Competing Program was not

acquired and shall, within [ * ] after the closing of such Change of Control transaction: (a) Divest

the Competing Program to a Third Party, or (b) discontinue the Competing Program. During the

[ * ] period, such assignee or new Affiliate (as the case may be) shall continue to fulfill its

obligations under this Agreement in all respects, shall conduct Competing Program activities

independently of the activities pursuant to this Agreement and shall not use any [ * ] in the

conduct of the Competing Program;

(iii)if such transaction does not constitute a Change of Control of such

Party, then such Party and its new Affiliate shall have [ * ] from the closing date of such

transaction to wind down or complete the Divesture of the Competing Program; during this

period, the Party’s conduct of the Competing Program shall not deemed a breach of the

exclusivity obligations set forth above, provided that the Party continues to fulfill its obligations

under this Agreement in all respects, conducts its Competing Program activities independently of

the activities pursuant to this Agreement and does not use: (A) any [ * ] or (B) [ * ], in each case

in the conduct of such Competing Program. For clarity, if such Party completely winds down the

Competing Program within the [ * ] time period, it shall be allowed to divest the Competing

Program later, provided that it does not restart the Competing Program.

As used in this Section 2.8(c), “Change of Control” means, with respect to a Party: (1) a

merger, reorganization or consolidation involving such Party in which the voting securities of

such Party outstanding immediately prior thereto cease to represent at least fifty percent (50%) of

the combined voting power of the surviving entity immediately after such merger, reorganization

or consolidation; or (2) a person or entity, or group of persons or entities acting in concert,

acquire more than fifty percent (50%) of the voting equity securities or management control of

such Party; and “Divest” means the sale or transfer of rights to the Competing Program to a

18.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Third Party without receiving a continuing share of profit, royalty payment or other economic

interest in the success of such Competing Program.

(d)During the Term of this Agreement, neither Party (nor any of its

Affiliates) shall, directly or indirectly (including through a Third Party), commercialize the

Product or any Generic Product of any Product in the other party’s territory.

(e)To enforce the Parties’ respective obligations set forth in this Section

2.8(e), to the extent permitted by Applicable Law, neither Party shall, and shall ensure that its

respective Affiliates, permitted Sublicensees, and Third Party distributors will not, either directly

or indirectly, advertise, promote, or market Products, including via the Internet, to any Third

Party or place of business, residence, or shipping address in the other Party’s territory for the

duration of the Royalty Term. The foregoing shall restrict either Party, to the extent permitted by

Applicable Law, from engaging in any form of direct or indirect solicitation, advertisement, or

promotion in the other Party’s territory. Each Party shall promptly, without any right to

remuneration or compensation, forward to the other Party all inquiries regarding the Product by

persons or entities whose place of business, residence, or shipping address is in the other Party’s

territory.

(f)Licensee will [ * ]. In the event that Exelixis or Licensee [ * ], Licensee

shall [ * ].

3.Governance

3.1Joint Steering Committee. As of the Effective Date, the Parties have established

a joint steering committee (the “Joint Steering Committee” or the “JSC”), composed of an

equal number of up to [ * ] senior officers of each Party, to oversee and guide the strategic

direction of the collaboration of the Parties under this Agreement. The JSC shall act as a joint

consultative body and to the extent expressly provided herein, a joint decision-making body.

The JSC shall in particular:

(a)provide a forum for discussion of the Development and

Commercialization of the Compound and Products in the Licensee Territory and the Exelixis

Territory;

(b)review and approve the global strategy for the Development of the Product

worldwide and review and approve any proposed amendments to the GDP, including

corresponding budgets, following recommendation by the JDC;

(c)review and approve the Commercialization Plans for the Licensee

Territory, including proposed amendments, following recommendation by the JCC;

(d)review and approve Sales Forecasts (and corrective plans, if any)

submitted by Licensee pursuant to Section 6.3(c), following recommendation by the JCC;

(e)review the manufacturing and supply strategy, supply performance and

Cost of Goods, including periodic review of worldwide order forecasts for the Product to avoid

supply shortage and unfavorable treatment of Licensee’s supply requirements disproportionate to

those of Exelixis and Future Exelixis Licensees on the basis of their respective volumes;

19.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(f)review and approve any recommendations of the JCC not to launch (or to

significantly delay the launch of) a Product in a particular country of the Licensee Territory;

(g)review and approve coordinated activities under global brand strategies for

the Products in each of the Parties’ territories, following recommendation by the JCC;

(h)approve decisions of the JDC, JCC and any other joint subcommittee

established by JSC, including appointment of memberships, membership changes, and resolving

any disputed matter submitted to it by such Committees;

(i)establish additional joint subcommittees as it deems necessary or advisable

to further the purpose of this Agreement, including approving establishment and membership of

subcommittees if proposed by the JDC or JCC; and

(j)perform such other functions as appropriate to further the purposes of this

Agreement, as expressly set forth in this Agreement or allocated to it by the Parties’ written

agreement, including providing financial oversight of the activities conducted pursuant to this

Agreement.

For clarity, any information sharing of Commercialization matters regarding the Exelixis

Territory shall be for solely for purposes of the coordination of the Parties’ activities, and

Exelixis shall retain all decision making authority with respect to such matters without requiring

any approvals except as expressly provided in Sections 14.4 and 14.5.

3.2Joint Development Committee. As of the Effective Date, the Parties have

established a joint Development, Medical Affairs, and regulatory committee (the “Joint

Development Committee” or the “JDC”), composed of up to [ * ] representatives of each Party,

to monitor and coordinate the Development of, and Medical Affairs Activities connected with,

the Compound and Products at the operational level. Each JDC representative shall have

knowledge and expertise in the clinical development of products similar to the Products. The

JDC shall in particular:

(a)report to the JSC on all significant Development activities, including

implementation of the GDP, and on the activities of the JDC;

(b)coordinate and monitor the Development activities of the Parties under the

GDP and oversee implementation of the GDP;

(c)provide a forum for and facilitate communications between the Parties

with respect to the Development of Products in the Licensee Territory and the Exelixis Territory,

including sharing of Development information and Data in accordance with Section 4.7(a);

(d)elaborate, review and approve clinical trial protocols, including

investigator-initiated and cooperative group clinical trial plans and protocols, and statistical

analysis plans for Clinical Trials (and any amendments thereto) in the Exelixis and Licensee

Territories and monitor the progress of the clinical studies;

(e)define areas of permissible scientific and medical inquiry and parameters

for Phase 4 Clinical Trials in the Exelixis and Licensee Territories;

20.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(f)review Data resulting from Phase 1/1b/2 Clinical Trials against go/no-go

criteria in the GDP to determine progression to a Phase 3 Clinical Trial;

(g)review Data resulting from Phase 3 Clinical Trials against go/no-go

criteria in the GDP to determine progression to submission of Regulatory Filing;

(h)prepare amendments to the GDP (including the Development Budget) and

submit such amendments to the JSC for approval;

(i)monitor and coordinate all regulatory actions worldwide, communications

and submissions for the Compound and Products under the GDP and pharmacovigilance and

safety matters worldwide;

(j)establish joint working groups (such clinical, regulatory and safety) as it

deems necessary or appropriate to oversee the day-to-day management of different aspects of the

Development work under the GDP;

(k)oversee and coordinate the Medical Affairs Activities for the Product in all

indications, which shall be subject to a Medical Affairs portion of the GDP and may be

coordinated through a Medical Affairs working group established and overseen by the JDC;

(l)oversee and coordinate decisions related to research or Development of

new indications, characterization and Development of bio-markers (if any), which may be

coordinated through a Medical Affairs working group established and overseen by the JDC;

(m)review activities related to pharmaceutical development, Phase 3 Clinical

Trial active ingredient and drug product new campaigns (i.e., chemical process scale-up/

optimization (if needed) and micronization process study, manufacturing, QC testing and release

of GMP batches of active ingredient and drug product as needed for Phase 3 Clinical Trial, in

particular, review and approval of the protocols on manufacturing, micronization, scale-up plan

and process optimization);

(n)maintain and review the “Company Core Data Sheet”, which shall cover

material relating to safety, indications, dosing, pharmacology and other information concerning

the Product including Company Core Safety Information;

(o)coordinate the supply of the Compound and Products to Licensee for

Development use;

(p)oversee and facilitate the Parties’ communications and activities with

respect to publications under Section 14.4;

(q)establish and supervise the global publication strategy with respect to the

Compound and Products;

(r)perform such other functions as may be appropriate to further the purposes

of this Agreement with respect to the Development of Products, including endeavoring to resolve

any disputes between the Parties arising from the deliberations of the JDC, or as otherwise

directed by the JSC.

21.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

3.3Joint Commercialization Committee. As of the Effective Date, the Parties have

established a joint commercialization committee (the “Joint Commercialization Committee” or

the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the

Commercialization of Products at the operational level. Each JCC representative shall have

knowledge and expertise in the commercialization of products similar to Products. The JCC

shall in particular:

(a)report to the JSC on all significant Commercialization activities in the

Licensee Territory, including implementation of the Commercialization Plan, and on the

activities of the JCC;

(b)review, discuss and approve the Commercialization Plans and related

activities with respect to the Commercialization of Products in the Licensee Territory;

(c)provide a forum for and facilitate communications and coordination

between the Parties with respect to the Commercialization of Products in the Licensee Territory

and the Exelixis Territory;

(d)on an annual basis, review and approve Licensee’s Sales Forecast prepared

pursuant to Section 6.3(c) as well as any corrective plans submitted thereunder;

(e)review and approve any recommendation by Licensee not to launch (or to

significantly delay the launch of) any Product in any country of the Licensee Territory;

(f)review and discuss the major findings of Licensee’s market research with

respect to any Product in the Licensee Territory;

(g)provide input to the JDC on the global publication strategy with respect to

the Products and implement such strategy under supervision of the JDC once it has been

established;

(h)review and oversee the branding and product positioning strategy for

Products in the Licensee Territory;

(i)establish pricing corridors for Products in the Licensee Territory for the

purpose of reimbursement and potential international pricing reference by relevant Regulatory

Authorities;

(j)define and coordinate medical messaging worldwide with respect to the

Products;

(k)oversee and facilitate the Parties’ communications and activities with

respect to publications under Section 14.4;

(l)design a global brand strategy for the Licensee Territory (e.g., a four-year

brand plan, resource plan, etc.) and submit such strategy to the JSC for review and approval;

(m)discuss and coordinate the manufacture and supply of the Products to

Licensee for Commercial use; and

22.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(n)perform such other functions as may be appropriate to further the purposes

of this Agreement with respect to the Commercialization of Products, including endeavoring to

resolve any disputes between the Parties arising from the deliberations of the JCC, or as

otherwise directed by the JSC.

3.4Executive Committee. Each Party shall designate an appropriate senior

executive officer of Exelixis and/or Licensee (e.g., CEO or members of each Party’s executive

committee) to meet once a year to discuss strategic issues and other issues that either Party

deems important to maintain a successful partnership and collaboration.

3.5Committee Membership and Meetings.

(a)Committee Members. Each Committee representative shall have

appropriate knowledge and expertise and sufficient seniority within the applicable Party to make

decisions arising within the scope of the applicable Committee’s responsibilities. Each Party

may replace its representatives on any Committee on written notice to the other Party, but each

Party shall strive to maintain continuity in the representation of its Committee members. The

[ * ]. [ * ]. The chairperson shall prepare and circulate agendas to Committee members at least

seven (7) days before each Committee meeting and shall direct the preparation of reasonably

detailed minutes for each Committee meeting, which shall be approved by the chairperson and

circulated to Committee members within thirty (30) days of such meeting. The initial members

of each of the JSC, JCC and JDC shall be determined by the Parties promptly following the

Effective Date.

(b)Meetings. Each Committee shall hold meetings at such times as it elects

to do so, but in no event shall meetings of the JDC and JCC be held less frequently than once

every [ * ], and meetings of the JSC once every [ * ], during the [ * ] following the Effective

Date and then the Parties may decide to reduce the frequency of the Committee meetings. The

first JSC meeting, first JDC meeting, and first JCC meeting shall be held within [ * ] after the

Effective Date, at which meetings the dates for the first calendar year shall be set. Meetings of

any Committee may be held in person, or by audio or video teleconference; provided that unless

otherwise agreed by both Parties at least [ * ] meetings per year shall be held in person during the

first [ * ] following the Effective Date, and, for the subsequent years of the Term, at least one (1)

meeting per year of each Committee shall be held in person. In-person Committees shall be held

at locations alternately selected by the Parties. Each Party shall be responsible for all of its own

expenses of participating in any Committee meetings. No action taken at any meeting of a

Committee shall be effective unless at least one (1) representative of each Party is participating.

In addition, upon written notice to the other Party, either Party may request that a special ad hoc

meeting of the JSC be convened for the purpose of resolving any disputes in connection with, or

for the purpose of reviewing or making a decision pertaining to any material subject-matter

within the scope of the JSC, the review or resolution of which cannot be reasonably postponed

until the following scheduled JSC meeting. Such ad hoc meeting shall be convened at such time

as may be mutually agreed by the Parties, but no later than [ * ] following the notification date of

request that such meeting be held.

(c)Non-Member Attendance. Each Party may from time to time invite a

reasonable number of participants, in addition to its representatives, to attend the Committee

meetings in a non-voting capacity; provided that if either Party intends to have any Third Party

(including any consultant) attend such a meeting, such Party shall provide reasonable prior

written notice to the other Party and obtain the other Party’s approval for such Third Party to

attend such meeting, which approval shall not be unreasonably withheld or delayed. Such Party

23.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

shall ensure that such Third Party is bound by written confidentiality and non-use obligations

consistent with the terms of this Agreement.

3.6Decision-Making.

(a)All decisions of each Committee shall be made by unanimous vote, with

each Party’s representatives collectively having one (1) vote. If after reasonable discussion and

good faith consideration of each Party’s view on a particular matter before a Committee, the

representatives of the Parties cannot reach an agreement as to such matter within [ * ] after such

matter was brought to such Committee for resolution, then, except as provided in Section 3.6(c),

if such disagreement arose within the JDC or JCC, it shall be referred to the JSC for resolution.

If the JSC cannot resolve such matter within [ * ], or if the disagreement first arose within the

JSC, then either Party at any time may refer such issue to the Executive Officers for resolution.

(b)If the Executive Officers cannot resolve such matter within [ * ] after such

matter has been referred to them, then:

(i)Exelixis shall have the final decision making authority, which shall

be exercised in its reasonable discretion, with respect to Development matters, except for:

A.the addition of [ * ], the cost of which would be [ * ]; and,

B.any material modification to a [ * ]; for the purpose of this

clause, “material modification” means any material changes to the agreed upon [ * ].

(ii)Licensee shall have the final decision making authority, which

shall be exercised in its reasonable discretion, with respect to (1) Commercialization in the

Licensee Territory, except with respect to the decision [ * ] a particular Product in a country, (2)

Medical Affairs in the Licensee Territory, and (3) regulatory matters in the Licensee Territory

that do not affect the Exelixis Territory; provided that Licensee’s decision shall be consistent

with the terms and conditions of this Agreement, including without limitation Section 6.4(b)

regarding pricing, and Section 6.3(c) regarding sales forecasts.

(iii)Neither Party shall have the final decision making authority with

respect to the matters in Sections 3.6(b)(i)(1) and 3.6(b)(i)(2) or with respect to the decision not

to [ * ] a particular Product in a particular country [ * ], and the status quo shall persist with

respect to such matter if the Parties are unable to agree.

(c)Notwithstanding Section 3.6(a), [ * ] representative shall have the deciding

vote on all tactical [ * ] matters for the Products [ * ], and such matter shall not be subject to

escalation to [ * ]; provided that such decision does not directly affect [ * ] and such decision

shall be consistent with the terms and conditions of this Agreement.

3.7Limitations on Authority. Each Committee shall have only such powers as are

expressly assigned to it in this Agreement, and such powers shall be subject to the terms and

conditions of this Agreement. Without limiting the generality of the foregoing, no Committee

will have the power to amend this Agreement, and no decision of a Committee may be in

contravention of any terms and conditions of this Agreement.

3.8Discontinuation of Committees. The activities to be performed by each

Committee shall solely relate to governance under this Agreement, and are not intended to be or

24.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

involve the delivery of services. Each Committee shall continue to exist until the first to occur

of: (a) the Parties mutually agree to disband such Committee; or (b) Exelixis provides written

notice to Licensee of its intention to disband and no longer participate in such Committee. Once

the Parties mutually agree or Exelixis has provided written notice to disband such Committee,

such Committee shall have no further obligations under this Agreement and, thereafter, each

Party shall designate a contact person for the exchange of information under this Agreement or

such exchange of information shall be made through Alliance Managers, and decisions of such

Committee shall be decisions as between the Parties, subject to the other terms and conditions of

this Agreement.

3.9Alliance Managers. Promptly after the Effective Date, each Party shall appoint

an individual who shall be an employee of such Party having appropriate qualification and

experience to act as the alliance manager for such Party (the “Alliance Manager”). Each

Alliance Manager shall be responsible for coordinating and managing processes and interfacing

between the Parties on a day-to-day basis throughout the Term. The Alliance Manager will

ensure communication to the JSC of all relevant matters raised at the JDC, the JCC and at any

joint subcommittees and project teams. Each Alliance Manager shall be permitted to attend

meetings of the JSC and other Committees as appropriate as non-voting participants. The

Alliance Managers shall be the primary contact for the Parties regarding the activities

contemplated by this Agreement and shall facilitate all such activities hereunder. Each Party

may replace its Alliance Manager with an alternative representative at any time with prior

written notice to the other Party. Any Alliance Manager may designate a substitute to

temporarily perform the functions of that Alliance Manager. Each Alliance Manager shall be

charged with creating and maintaining a collaborative work environment within the JSC and its

subcommittees. Each Party shall bear its own costs of its Alliance Manager, which costs shall be

excluded from the Parties’ respective Development and manufacturing costs.

3.10Supply Contacts. Each Party shall designate one (1) qualified and experienced

supply chain professional to serve as that Party's primary supply contact regarding the supply of

Compound and Products within this Agreement (“Supply Contacts”) and under the direction of

the JCC. Each Party may replace its Supply Contact with an alternative representative at any

time with prior written notice to the other Party. Supply Contacts shall be responsible for

facilitating information exchange and discussion between the Parties regarding the supply of

Compound and Products under this Agreement. [ * ]. Each Party shall bear its own costs of its

Supply Contact, which costs shall be excluded from the Parties’ respective Development and

Cost of Goods.

4.Development

4.1Overview. Subject to the terms and conditions of this Agreement, the Parties will

collaborate with respect to the Development of the Compound and Products and share the Data

resulting from such collaboration to facilitate the Development of the Compound and Products

throughout the Licensee Territory and the Exelixis Territory.

4.2Development Plan. The Development of the Compound and Products under this

Agreement (including the development of the Compound and any Product as a combination

product or combination therapy with another product and/or therapy), including Independent

Work and Licensee Only Development Work, shall be conducted only pursuant to a

comprehensive written global Development plan (the “Global Development Plan” or “GDP”),

which shall be incorporated by reference as part of this Agreement. The GDP shall set forth the

timeline and details (including line of therapy, tumor type, primary endpoints, approximate

25.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

patient size, combination agents and comparator agents) of all preclinical and clinical

Development activities to be conducted by the Parties as necessary to generate Data sufficient to

meet the common requirements of both the EMA and FDA for MAA Approval of the Compound

and Products for RCC, HCC, and other indications agreed upon by the Parties. The GDP may

also include any other Development activities approved by the JSC, including parameters for

permissible scientific inquiry in Phase 4 Clinical Trials. The GDP will include Clinical Trials

that the Parties are committed to conducting (unless modification is required by a Regulatory

Authority or any local or regional IRB/ethics committee, or is reasonably necessary to protect

patient safety) as well as Clinical Trials that will be decided by the JDC and JSC based on Data

and results obtained after the Effective Date and the Parties’ review of the future competitive

landscape. The GDP shall include a coordinated Development and regulatory strategy, including

the Parties’ respective roles in the Development of the registration dossier and Regulatory Filings

for the Products and the countries in which Development of the Products will occur. The GDP

shall also set forth the detailed budget of the anticipated costs for such Development activities

(the “Development Budget”) on a study-by-study or Clinical Trial-by-Clinical Trial basis. As

of the Effective Date, the Parties have agreed upon an initial GDP and Development Budget,

attached to this Agreement as Exhibit D. If the terms of the GDP contradict, or create

inconsistencies or ambiguities with, the terms of this Agreement, then the terms of this

Agreement shall govern. From time to time during the Term (at least on [ * ] basis), the JDC

shall prepare updates and amendments, as appropriate, to the then-current GDP, including

budgets, and shall submit such updates and amendments to the JSC for review and approval

before such updates and amendments are adopted. If upon the determination by the JDC as

reviewed and approved by the JSC, any pre-clinical, or Clinical Trials not included in the GDP

(i) are required in order to obtain and/or maintain MAA Approval for a Product in the EU and in

one or all the countries of the Exelixis Territory, or (ii) are otherwise recommended by the EMA

or the FDA in the EU and in one or all of the countries of the Exelixis Territory, then the JDC

shall review and recommend and the JSC shall review and approve an amendment to the GDP

reflecting such additional studies, including associated budget. The costs of such additional

studies shall be borne by the Parties as provided in Section 4.5(a).

4.3Independent Work. If either Party is interested in pursuing additional

Development work on a Product (the “Developing Party”) for the benefit of the Exelixis

Territory (in the case of Exelixis) or the Licensee Territory (in the case of Licensee) beyond what

is set forth in the then current GDP, then such Party shall provide the other Party with a written

detailed plan and budget for such additional work (the “Proposal”). Within [ * ] of receipt of the

Proposal, the JDC or delegated team shall meet to review the Proposal and to permit the other

Party (“Non-Developing Party”) an opportunity to ask questions and request additional

information from the Developing Party related to the Proposal, including whether such Proposal

is reasonably likely to have a material and adverse effect on the Product in the Non-Developing

Party’s territory. The Parties acknowledge that it is their intent to collaborate in good faith to

establish a similar review and approval process with any Future Exelixis Licensee. No additional

Development work shall proceed without the approval of the JSC, and following each such

approval such additional Development work and corresponding budget shall be incorporated into

the GDP by the JDC (the “Newly-Proposed Development”). For any Newly-Proposed

Development work, the Non-Developing Party that did not propose such work originally may

elect, at its discretion, to share the Development Costs with respect to such Development work

under Section 9.2(b). If the Non-Developing Party does not decide to pursue the Newly-

Proposed Development work jointly with the Developing Party or does not share the

Development Costs with respect to such Development work, in which event such Development

work shall be deemed “Independent Work” and the Developing Party may pursue such work in

the Field in its respective territory and the Development Costs with respect thereto shall be

26.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

deemed Independent Work Costs and subject to Sections 4.5(d) and 9.2(b). Notwithstanding the

foregoing, following the approval of the Independent Work by the JSC, the Party proposing the

Independent Work may conduct such Independent Work, provided that: (A) it shall do so in

accordance with the amended GDP; (B) such Independent Work shall be conducted under the

oversight of the JDC and the JSC; and (C) neither Party shall conduct Independent Work in a

manner that would have a material adverse effect on the Products in either Party’s territory.

4.4Annual Update to Development Budget. The JDC shall discuss and agree upon

the subsequent year’s Development Budget on an annual basis no later than November 1 of each

year. The JDC shall report any significant changes in the annual budgets to the JSC for approval

at the next scheduled JSC meeting.

4.5Development Cost.

(a)Committed Studies As Of The Effective Date (Current Budget).

Except as set forth in Section 4.5(b) below, Exelixis shall bear one hundred percent (100%) of all

Development Costs for the first [ * ] dollars ($[ * ]) of Development Costs for all Clinical Trials

that are committed studies in the GDP [ * ] as of the Effective Date (“Initial Committed

Studies”). Thereafter, except as set forth in Section 4.5(b) below, (i) Exelixis shall bear sixty-

five percent (65%) and Licensee shall bear thirty-five percent (35%) of all Development Costs

for such Clinical Trials [ * ] until the aggregate Development Costs of such Clinical Trials equals

[ * ] dollars ($[ * ]), and (ii) if aggregate Development Costs for such Clinical Trials [ * ] exceed

[ * ] dollars ($[ * ]), Exelixis shall bear [ * ] percent ([ * ]%) and Licensee shall bear [ * ] percent

([ * ]%) of all remaining Development Costs for such Clinical Trials. For Clinical Trials that

become committed studies in the GDP after the Effective Date, Exelixis shall bear sixty-five

percent (65%) and Licensee shall bear thirty-five percent (35%) of all Development Costs of

such Clinical Trials. If Exelixis completes the Initial Committed Studies for an amount less than

[ * ] dollars ($[ * ]), any amount not spent (“Excess Funds”) shall be credited against the Parties’

respective share of Clinical Trials that become committed studies in the GDP after the Effective

Date. Without limiting the foregoing, if any [ * ].

(b)Allowable Increases. Separate from the cost allocation provided for in

Section 4.5(a), Exelixis shall bear sixty-five percent (65%) and Licensee shall bear thirty-five

percent (35%) of all Allowable Increases in Development Costs for all Clinical Trials that are

committed studies in the GDP as of the Effective Date. “Allowable Increases” are defined as

increased Development Costs resulting from (i) changes in study design after the Effective Date

that are approved by the JDC and JSC [ * ] (up to the amount of a mutually-agreed budget

increase), (ii) changes in regulatory requirements arising after the Effective Date (including

changes required or recommended by Regulatory Authorities, but excluding changes required or

recommended specifically by a Regulatory Authority of the Exelixis Territory solely for the

benefit of the Exelixis Territory), and (iii) extensions in the duration of Clinical Trials resulting

from a lower than anticipated rate of clinical events or higher rates of survival.

(c)Expanded Access Program 214. Exelixis shall bear the first [ * ] dollars

($[ * ]) of Development Costs (excluding the costs of Licensee FTEs and other internal costs of

Licensee) associated with Expanded Access Program 214. Licensee shall bear one hundred

percent (100%) of its internal costs of such program, inclusive of its FTEs, as well as one

hundred percent (100%) of all Development Costs of such program in excess of the [ * ] dollars

($[ * ]) borne by Exelixis. If such program is completed for an amount of Development Costs

less than [ * ] dollars ($[ * ]), no financial adjustment shall be made.

27.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(d)Independent Work Cost. Notwithstanding Section 4.5(a), the Party

conducting the Independent Work approved by the JSC under Section 4.3 shall be solely

responsible for the Development Costs with respect to such Independent Work, subject to

Section 9.2(c).

(e)Country-Specific Development Work. Notwithstanding Section 4.5(a),

each Party shall be solely responsible for all Development Costs with respect to Development

activities that are exclusively for the benefit of the countries within such Party’s Territory,

including: (i) any and all country-specific activities (e.g., a Japan only trial for Exelixis or China

only trial and Canada Studies for Licensee, Expanded Access Programs); (ii) all Phase 4 Clinical

Trials solely benefiting such Party’s territory; (iii) any and all Development activities required

for any pricing and/or reimbursement approvals in such Party’s territory (but are not required for

the MAA Approval in such territory). The Development work set forth in this Section 4.5(e)

pertaining to Licensee shall be deemed the “Licensee Only Development Work” and the

Development work set forth in this Section 4.5(e) pertaining to Exelixis shall be deemed the

“Exelixis Only Development Work.” All planned and in-process Licensee Only Development

Work and Exelixis Only Development Work shall be included in and conducted in accordance

with the GDP, to be performed reasonably and subject to the oversight of the JDC and the JSC.

4.6Development Responsibilities. The JDC shall reasonably allocate Development

responsibilities of the Compound and Products under the GDP between the Parties and such

allocation shall be set forth in the GDP, provided that: (a) Exelixis shall be the Sponsor and have

the operational responsibility for all Development work under the GDP that is ongoing as of the

Effective Date; (b) each Party shall have the operational responsibility for its own Independent

Work; and (c) Licensee shall be the Sponsor and have the operational responsibility for the

Licensee Only Development Work and Exelixis shall be the Sponsor and have the operational

responsibility for the Exelixis Only Development Work.

4.7Data Exchange and Use.

(a)General. In addition to its adverse event and Safety Data reporting

obligations pursuant to Section 5.5, each Party shall promptly provide the other Party with (i)

[ * ] status reports on trial recruitment and other metrics consistent with the performing Party’s

internal reporting for clinical studies and Development activities, provided however that in case

of unexpected events that may have any impact on safety and recruitment, each Party shall

inform the other Party within forty-eight (48) hours from knowledge of the occurrence of such

event; (ii) supporting documentation (e.g. protocols, CRFs, analysis plans, etc.); (iii) preliminary

and final Data, and interim, preliminary and final results and reports; and (iv) output from

advisory committees and investigator meetings, any and all such documentation generated by

each Party (including by any Sublicensee or any Future Exelixis Licensee) from its Development

activities under this Agreement as such documentation could reasonably be deemed to affect the

Development or Commercialization activities of the Product in each Party’s territory. As time

may be of the essence, each Party shall collaborate in good faith in the exchange of any such

Data set forth in this Section within [ * ] of receipt. The Parties shall cooperate on a secure

website to facilitate the sharing of reports, Data and other information on a routine basis. Except

as set forth in Section 4.7(b) below, each Party shall have the right to use and reference, without

additional consideration, any and all Data generated by or on behalf of the other Party (including

by any Sublicensee or any Future Exelixis Licensee) under this Agreement for obtaining and

maintaining Regulatory Approval for the Products and otherwise Commercializing the Products

in its territory in accordance with the terms of this Agreement. For clarity, this Section 4.7(a)

28.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

shall apply to all Development under the GDP, including Independent Work (but subject to

Section 4.7(b) below), Exelixis Only Development Work and Licensee Only Development

Work. Notwithstanding the foregoing, should either Party fail to obtain such use and reference

rights from any Sublicensee or Future Exelixis Licensee, such Party shall not have the right to

grant use and access or rights to such Sublicensee or Future Exelixis Licensee to any

documentation listed in this Section 4.7(a) generated by or on behalf of the other Party.

(b)Independent Work. Notwithstanding the foregoing, the Party receiving

Data resulting from the other Party’s Independent Work shall have the right to use such Data

only to the extent reasonably necessary for the receiving Party to comply with its regulatory

reporting and compliance obligations, including safety reporting obligations, but shall not have

the right to use such Data to support its own Development, Regulatory Approval or

Commercialization except pursuant to Section 9.2(c).

4.8Diligence. Each Party shall use Commercially Reasonable Efforts to perform the

Development activities assigned to such Party under and in accordance with the GDP. Unless

otherwise agreed by the Parties, Exelixis shall be the Sponsor and be responsible for conducting

all Clinical Trials that are required to obtain MAA Approvals by both the EMA and FDA for

RCC, HCC, NSCLC, and other indications in the GDP. In addition, Licensee shall also use

Commercially Reasonable Efforts to Develop Licensee Only Development Work and any

Licensee Independent Work, file MAAs and seek and maintain Regulatory Approval (including

Pricing and Reimbursement Approval, as applicable) for the Products throughout the Licensee

Territory.

4.9Compliance. Each Party shall Develop the Compound and Products in

compliance with all Applicable Laws, including good scientific and clinical practices under the

Applicable Laws of the country in which such activities are conducted.

4.10Development Records. Each Party shall maintain complete, current and accurate

records of all Development activities conducted by it hereunder, and all data and other

information resulting from such activities. Such records shall fully and properly reflect all work

done and results achieved in the performance of the Development activities in good scientific

manner appropriate for regulatory and patent purposes. Each Party shall document all non-

clinical studies and Clinical Trials in formal written study reports according to Applicable Laws

and national and international guidelines (e.g., ICH, cGCP, cGLP, and cGMP).

4.11Development Reports. At [ * ] JDC meeting, each Party shall provide the JDC

with regular reports detailing its Development activities for the Products under this Agreement,

and the results of such activities. In addition, after the completion of any Clinical Trial or other

study of the Products, the Party responsible for the conduct of such Clinical Trial or study shall

promptly provide the other Party (but in no event more than [ * ] following receipt) with a data

package consisting of, at a minimum, tables, lists and figures, as well as any other Data specified

in the GDP or otherwise agreed by the Parties. The Parties shall discuss the status, progress and

results of each Party’s Development activities under this Agreement at such JDC meetings.

4.12Use of Subcontractors. Each Party may perform its Development activities

under this Agreement through one or more subcontractors, provided that (a) such Party will

remain responsible for the work allocated to, and payment to, such subcontractors to the same

extent it would if it had done such work itself; (b) each subcontractor undertakes in writing

obligations of confidentiality and non-use regarding Confidential Information that are

substantially the same as those undertaken by the Parties pursuant to Article 14, and (c) each

29.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

subcontractor agrees in writing to assign all intellectual property developed in the course of

performing any such work to such Party (or, in the event such assignment is not feasible, a

license to such intellectual property with the right to sublicense to such other Party). The Parties

may also subcontract work on terms other than those set forth in this Section 4.12 with the prior

approval of the JDC.

4.13[This Section has been intentionally omitted.]

4.14Materials Transfer. In order to facilitate the Development activities

contemplated by this Agreement, either Party may provide to the other Party certain biological

materials or chemical compounds Controlled by the supplying Party (collectively, “Materials”)

for use by the other Party in furtherance of such Development activities. Except as otherwise

provided for under this Agreement, all such Materials delivered to the other Party will remain the

sole property of the supplying Party, will be used only in furtherance of the Development

activities conducted in accordance with this Agreement, will not be used or delivered to or for

the benefit of any Third Party, except to subcontractors, without the prior written consent of the

supplying Party, and will be used in compliance with all Applicable Laws. The Materials

supplied under this Agreement must be used with prudence and appropriate caution in any

experimental work because not all of their characteristics may be known. Except as expressly set

forth in this Agreement, THE MATERIALS ARE PROVIDED “AS IS” AND WITHOUT ANY

REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING WITHOUT

LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS

FOR ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT THE USE OF THE

MATERIALS WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER

PROPRIETARY RIGHTS OF ANY THIRD PARTY.

4.15Canada Studies. If any Regulatory Authority in Canada requires one or more

additional studies to support any MAA submitted by Licensee for the Product in Canada that are

exclusively for the benefit of Canada (the “Canada Studies”), such studies shall be deemed

Licensee Only Development Work and subject to Licensee’s applicable obligations set forth

herein including, without limitation, those obligations set forth in Sections 4.2, 4.5(e), 4.6, 4.7(a),

and 4.8. In accordance with Section 3.2(h), the JDC shall prepare an amendment(s) to the GDP

with respect to any Canada Studies and submit such amendment(s) to the JSC for approval.

Exelixis shall, as may be required to enable Licensee to be the Sponsor of the Canada Studies, be

subject to Exelixis’ applicable obligations set forth in Section 5.1(b). Exelixis shall have the

right to use the Data of the Canada Studies generated by Licensee to support its own

Development, Regulatory Approval or Commercialization in the Exelixis Territory subject to

Section 9.2(b).

5.Regulatory Activities

5.1Regulatory Responsibilities.

(a)General.

(i)The GDP shall set forth the regulatory strategy for seeking

Regulatory Approval for the Compound and Products by the appropriate Regulatory Authorities

in the Licensee Territory and Exelixis Territory. The GDP shall also specify which Party shall

apply for and hold Regulatory Filings in each country with respect to the conduct of

Development activities; provided that if any Canada Studies are included in the GDP, the GDP

shall specify that Licensee shall apply for and hold Regulatory Filings in Canada. Subject to the

30.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

direction and oversight of the JDC, each Party shall be responsible for implementing such

regulatory strategy in its territory. Except as otherwise provided herein or required by

Applicable Law, each Party shall be responsible for the preparation and submission of any and

all Product registrations and marketing approvals in its territory and shall own and hold all such

Regulatory Filings (including Regulatory Approvals), and neither Party shall submit any

application for Product registration or marketing approval in the other Party’s territory.

(ii)Each Party shall be responsible for the cost and expense of all

regulatory activities in its territory.

(iii)Licensee acknowledges that Exelixis may be required to

communicate with Regulatory Authorities in the Licensee Territory as a result of Development

and manufacturing activities in such territory. Exelixis shall notify Licensee as soon as

reasonably possible of such communication with Regulatory Authorities and seek to incorporate

input from Licensee in preparation for such communication. Exelixis shall then keep Licensee

informed of any such communications.

(b)Transfer of Regulatory Filings. Except as set forth in Section 5.2,

Exelixis shall, in each case as may be required to enable Licensee to submit and file Regulatory

Filings and obtain MAA Approvals for Products in the Licensee Territory:

(i)transfer to Licensee all Regulatory Approvals and Regulatory

Filings submitted to any Regulatory Authority in the Licensee Territory for the Compound and

Products that are in Exelixis’ name and Controlled by Exelixis, other than INDs relating to

Clinical Trials conducted and sponsored by Exelixis pursuant to the GDP;

(ii)to the extent that such transfer is not permitted under Applicable

Laws, Exelixis shall provide to Licensee a right of reference or use to such Regulatory Approvals

and Regulatory Filings. Exelixis shall provide appropriate notification of Licensee’s access and

reference rights to the applicable Regulatory Authorities (including, to the extent applicable, an

informed consent letter under Article 10c of Directive 2001/83/EC as amended), at the expense

of Licensee seeking such right of reference. For the purposes of this Agreement, “right of

reference” shall mean the “right of reference or use” as defined in 21 C.F.R. §314.3(b) and any

equivalent regulation outside the US, including Article 10c of Directive 2001/83/EC, as each

may be amended from time to time;

(iii)provide to Licensee copies in electronic form of all Regulatory

Approvals and Regulatory Filings submitted to any Regulatory Authority in the Licensee

Territory including those related to CMC, manufacturing and product development, validation

and manufacturing for the Compound and Products that are in Exelixis’ name and Controlled by

Exelixis, regulatory dossiers in Exelixis’ possession or Control, and the Drug Master File; and

(iv)to the extent any variations to the chemistry, manufacturing, and

controls (“CMC”) section of the Regulatory Filing are required to conform with a variation that

is initiated by Exelixis at its sole discretion, Exelixis shall reimburse Licensee for all associated

fees that are paid by Licensee in filing such variations; provided that, for variations required to

comply with Applicable Laws or any requirement of a Regulatory Authority, (a) Exelixis shall

remain responsible for submissions and associated fees for all CMC variations originally

attributable to a Regulatory Authority in the Exelixis Territory, and (b) Licensee shall be

responsible for submissions and associated fees for all CMC variations originally attributable to a

Regulatory Authority in the Licensee Territory.

31.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

5.2Existing Arrangements. The Parties acknowledge that as of the Effective Date,

Exelixis; its regulatory agent, TMC Pharma Services (“TMC”); and its authorized distributor,

Swedish Orphan Biovitrum AB (“Sobi”), hold certain Regulatory Filings, licenses, and MAA

Approvals related to Cometriq for MTC in the EU. Exelixis, and Exelixis on behalf of TMC and

Sobi, will ensure that Exelixis, TMC and Sobi will transfer Regulatory Filings, licenses, and

MAA Approvals for Cometriq for MTC to Licensee in accordance with Article 8. In addition,

Exelixis holds certain EMA Regulatory Filings, including the EMA MAA filing, for the Product

in RCC. As set forth in Section 5.1(b), the Parties shall cooperate to be ready to transfer and

assign these EMA Regulatory Filings to Licensee and Exelixis shall notify the EMA promptly

after the Effective Date that Licensee shall be the Marketing Authorization Holder as from the

date of the transfer of the MAA. The Parties agree to work toward the transfer of MAA holder

status to Licensee by [ * ]. Until the MAA transfer is accepted by the EMA, Exelixis shall be

responsible for preparing and filing the MAA for the Product in RCC.

5.3Regulatory Information Sharing. Each Party shall, upon the other Party’s

reasonable request, promptly provide the other Party (but in no event more than [ * ]) with copies

of any Regulatory Filings prepared (including any drafts), submitted or received by such Party in

the U.S. and the Licensee Territory pertaining to the Compound and Products, and such other

Party shall have the right to review and comment on drafts of such Regulatory Filings, provided

that such review and comment shall not delay the submission of any Regulatory Filings. The

sharing of Regulatory Filings shall, as applicable, be the following communications/

correspondence with the Regulatory Authority: (i) summary of contact reports either Party

receives concerning substantive conversations or substantive meetings in its respective territory

with the FDA, EMA, CFDA and PMDA with respect to the Product or if contacts with those

Regulatory Authorities are made orally, to be reduced in writing, (ii) documents related to

regulatory milestones and dates (e.g., submission, validations, agency review questions, CHMP

opinion and FDA complete response letter and their equivalent), (iii) IND annual reports and

cover letters of all agency submissions relating to the Compound or any Product. If any

Regulatory Filing to be provided under this Section 5.3 was originally created in a language

other than the English language, then at the receiving Party’s request and to the extent already

existing and readily available, the providing Party shall provide an English translation along with

the original document to the receiving Party. The Parties acknowledge that it is their intent to

collaborate in good faith in the exchange of such Regulatory communications including with any

Sublicensee or Future Exelixis Licensee. Each of Licensee and Exelixis shall use Commercially

Reasonable Efforts to grant the other Party access and rights to use any such communications

with any Regulatory Authority generated by or on behalf of any Sublicensee or Future Exelixis

Licensee, respectively. Should either Party fail to obtain such access and rights from any

Sublicensee or Future Exelixis Licensee, such Party shall not have the right to grant access or

rights to such Sublicensee or Future Exelixis Licensee to any such communications with any

Regulatory Authority generated by or on behalf of the other Party.

5.4Meetings with Regulatory Authorities. On a current and ongoing basis, each

Party shall provide the other Party with a list and schedule of any in-person meeting or material

teleconference with the Regulatory Authorities (or related advisory committees) in the Licensee

Territory planned for the next Calendar Quarter that relates to the Development of the

Compound and Products under the GDP in the Licensee Territory (each, a “Regulatory

Meeting”). In addition, each Party shall notify the other Party as soon as reasonably possible if

such Party becomes aware of any additional Regulatory Meetings that become scheduled for

such Calendar Quarter and will keep the other Party informed of any significant interface or

communication with any Regulatory Authority which might affect efforts to obtain Regulatory

Approval for the Product. Licensee shall be solely responsible for any communications with the

32.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Regulatory Authorities occurring or required in connection with performing its regulatory

responsibilities set forth in this Article 5 with respect to the Product in the Licensee Territory,

and Exelixis shall have the right to provide input in preparation for all Regulatory Meetings and,

with the consent of Licensee, not to be unreasonably withheld, the right, but not the obligation, to

have its representatives attend (but, unless otherwise requested by the other Party, not participate

in) the Regulatory Meetings. Licensee shall have these same rights with respect to any such

Regulatory Meetings before such Regulatory Filings are transferred to Licensee under Sections

5.1(b) and 5.2.

(a)Regulatory Inspections. Licensee shall permit the Regulatory

Authority(ies) in the Exelixis Territory to conduct inspections of Licensee, its Affiliates, and

acting reasonably and in good faith of Sublicensees or subcontractors (including Clinical Trial

sites) relating to the Development of the Product under the GDP, and shall ensure that such

Affiliates, and acting reasonably and on good faith, such Sublicensees and subcontractors permit

such inspections. In addition, Licensee shall promptly notify Exelixis of any such inspection and

shall supply Exelixis with all information pertinent thereto. Licensee shall use Commercially

Reasonable Efforts to allow an Exelixis representative to attend any such inspection with the

presence of Licensee. Exelixis shall permit the Regulatory Authority(ies) in the Licensee

Territory to conduct inspections of Exelixis, its Affiliates, and acting reasonably and in good

faith of Sublicensees or subcontractors (including Clinical Trial sites) relating to the

Development of the Product under the GDP for the Licensee Territory, and shall ensure that such

Affiliates, and acting reasonably and on good faith, such Sublicensees and subcontractors permit

such inspections. In addition, Exelixis shall promptly notify Licensee of any such inspection and

shall supply Licensee with all information pertinent thereto. Exelixis shall use Commercially

Reasonable Efforts to allow a Licensee representative to attend any such inspection with the

presence of Exelixis.

5.5Adverse Event Reporting; Pharmacovigilance Agreement. Within sixty (60)

days after the Effective Date, but in any case prior to transfer of the marketing authorization, the

Parties shall enter into a pharmacovigilance agreement setting forth the worldwide

pharmacovigilance procedures for the Parties with respect to the Products, such as Safety Data

sharing, adverse events reporting and safety signal and risk management (the

“Pharmacovigilance Agreement”), which agreement shall be amended by the Parties [ * ] to

comply with any changes in Applicable Laws or any guidance received from Regulatory

Authorities. Such procedures shall be in accordance with, and enable the Parties to fulfill, local

and national regulatory reporting obligations under Applicable Laws (including to the extent

applicable, those obligations contained in ICH guidelines, E2A, E2B, E2C, E2D and E2F) to

monitor the patients’ safety. Exelixis has established and shall continue to hold at its costs and

expenses the global safety database for the Products, and shall maintain such global safety

database for so long as such Product is under Development and/or Commercialization by the

Parties. The Parties will collaboratively agree on data cut points for periodic aggregate safety

reports and Exelixis will author such reports; the Parties will jointly review and approve such

reports before submission to worldwide Regulatory Authorities as required. The Parties

acknowledge that the Parties amended the Pharmacovigilance Agreement to address the

modification to the Parties’ respective territories as outlined in the First Amendment.

(a)Parties’ Respective Contributions to PV Costs.

33.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(i)From the Effective Date through [ * ], Exelixis shall bear one

hundred percent (100%) of the cost and expense for establishing and maintaining such global

database and the preparation of periodic aggregate safety reports (“PV Costs”).

(ii)For the [ * ] commencing on [ * ], Licensee shall pay Exelixis, as a

contribution towards the PV Costs, an amount equal to [ * ] (the “PV Contribution Fee”), in the

manner set forth in clauses (A) and (B) immediately below, which amount shall not be subject in

any respect to audit or renegotiation.

A.Within [ * ] of the Fourth Amendment Effective Date, Licensee

shall pay Exelixis the previously invoiced and outstanding PV

Costs for the Calendar Quarters ending [ * ], which aggregate

amount shall equal [ * ].

B.Licensee shall pay Exelixis an amount equal to [ * ] within [ * ]

of receipt of the invoice for such amount.

(iii)For each Calendar Quarter commencing on [ * ] through the end of

the Calendar Quarter in which the First LOE Event (as defined below) occurs, Licensee shall pay

Exelixis an amount equal to [ * ] within [ * ] of the end of such quarter, which amount shall be

invoiced and shall not be subject in any respect to audit or renegotiation; provided, however, that

in consideration of the entry into this Agreement as of the Restatement Date, for each Calendar

Year commencing on [ * ], the PV Contribution Fee shall be reduced to [ * ]. LOE Event, U.S.

LOE Event, EU LOE Event, First LOE Event and Second LOE Event shall be defined as

follows:

A.Loss of exclusivity (“LOE”) occurs at the earliest of (i) the

latest of expiration of the last-to-expire Valid Claim of the

Exelixis Patents or Licensee Patents covering the Product in

either the US or the EU, as applicable, [ * ] and (ii) the first

time there is a Generic Entry with respect to such Product [ * ].

For purposes of this definition, “Generic Entry” means, with

respect to a particular Product, that one or more Generic

Products to such Product [ * ].

B.There are two separate LOE Events based on the following

Territories: the U.S. (“U.S. LOE Event”), and the EU (“EU

LOE Event”).

C.The earliest to occur of either the U.S. LOE Event or the EU

LOE Event is the “First LOE Event.” The latest to occur of

either the U.S. LOE Event or the EU LOE Event is the

“Second LOE Event.”

(iv)For each Calendar Quarter following the First LOE Event through

the end of the Calendar Quarter in which the Second LOE Event occurs, Licensee shall pay

Exelixis an amount equal to [ * ] within [ * ] of the end of such quarter, which amount shall be

[ * ] at the end of [ * ] Calendar Quarters, which shall be invoiced and shall not be subject in any

respect to audit or renegotiation. For the sake of clarity, by way of example, after the occurrence

of the First LOE Event, Licensee pays Exelixis [ * ] for [ * ] Calendar Quarters, then [ * ] for

34.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

[ * ] Calendar Quarters, and so on until the end of the Calendar Quarter in which the Second

LOE Event occurs.

(v)Further, for the sake of clarity, Licensee shall have no obligation to

pay Exelixis [ * ] under this Section 5.5(a) for any Calendar Quarter from, and after, the end of

the Calendar Quarter in which the Second LOE Event occurs.

(b)Exelixis will ensure that each Party and any Future Exelixis Licensee are

able to access the data, if necessary indirectly, from the global safety database in order to meet

legal and regulatory obligations. The Parties agree that Exelixis shall not transfer the

responsibility or holding of the global safety database to any CRO, sublicensee, Future Exelixis

Licensee or any Third Party without Licensee’s prior written consent and approval, which shall

not be unreasonably withheld, conditioned or delayed if such transferee (and its Affiliates) is a

pharmaceutical company of comparable size as Licensee and agrees to grant Licensee access and

other rights to the global safety database substantially equivalent to those granted by Exelixis

under the Pharmacovigilance Agreement. The use by Exelixis of a CRO, sublicensee, Future

Exelixis Licensee shall be at Exelixis’ sole cost and expenses.

(c)The JDC shall establish a joint safety subcommittee which shall have the

role and responsibility of reviewing and maintaining up to date the Pharmacovigilance

Agreement. As per the applicable Pharmacovigilance Agreement each Party shall be primarily

responsible for reporting quality complaints, adverse events and Safety Data related to the

Products to any Regulatory Authorities and responding to safety issues and to all requests of

Regulatory Authorities related to the Products under any MAA or Regulatory Approval for the

Product held by such Party and filed with such Regulatory Authorities, in each case at its own

cost. Each Party agrees to comply with its respective obligations under the Pharmacovigilance

Agreement and to cause its Affiliates, licensees and sublicensees to comply with such

obligations.

5.6No Harmful Actions. If a Party believes that the other Party is taking or intends

to take any action with respect to a Product that could reasonably be expected to have a material

adverse impact upon the regulatory status of such Product in the first Party’s territory, then such

Party may bring the matter to the attention of the JDC and the Parties shall discuss in good faith

to resolve such concern.

5.7Notification of Threatened Action. Each Party shall notify the other Party

within [ * ] of any information it receives regarding any threatened or pending action, inspection

or communication by any Regulatory Authority, which may affect the safety or efficacy claims

of any Product or the continued Development or Commercialization of any Product. Upon

receipt of such information, the Parties shall promptly consult with each other in an effort to

arrive at a mutually acceptable procedure for taking appropriate action.

5.8Right of Reference to Regulatory Materials. Each Party hereby grants to the

other Party the right of reference to all Regulatory Filings pertaining to the Compound and

Products submitted by or on behalf of such Party. The receiving Party may use such right of

reference solely for the purpose of seeking, obtaining and maintaining Regulatory Approval of

the Products for use in its territory in accordance with this Agreement. Notwithstanding the

foregoing, the receiving Party may use such right of reference to any Regulatory Filings based on

Data resulting from the other Party’s Independent Work only to comply with its safety reporting

obligations, unless the receiving Party pays the other Party for such work pursuant to Section

9.2(c).

35.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

5.9Recalls. In the event that a recall, withdrawal or correction (including the

dissemination of relevant information) of any Product in a Party’s territory is required by a

Regulatory Authority of competent jurisdiction, or if any Regulatory Authority requires or

advises either Party or such Party’s Affiliates or Sublicensees to distribute a “Dear Doctor” letter

or its equivalent regarding use of such Product in a Party’s territory or if a recall, withdraw or

correction of a Product in its territory is deemed advisable by such Party in its sole discretion,

such Party shall so notify the other Party no later than [ * ] in advance of the earlier of (i)

initiation of a recall, withdrawal or correction; or (ii) the submission of plans for such an action

to a Regulatory Authority. Any such recall, withdrawal, correction, or dissemination of

information (e.g., “Dear Doctor” letter) shall be referred to herein as a “Recall”. Promptly after

being notified of a Recall, each Party shall provide the other Party with such assistance in

connection with such Recall as may be reasonably requested by such other Party. All costs and

expenses in connection with a Recall in a Party’s territory shall be paid by such Party, including

without limitation the costs and expenses related to the dissemination of relevant information.

Each Party shall handle exclusively the organization and implementation of all Recalls of

Products in its territory. Notwithstanding the foregoing, any Recall related to the manufacture

and supply of the Product by Exelixis to Licensee shall be governed by the terms and conditions

of the Supply Agreement.

5.10Sunshine Reporting Laws. Each Party acknowledges that the other Party may

be subject to federal, state, local and international laws, regulations and rules related to the

tracking and reporting of payments and transfers of value provided to health care professionals,

health care organizations, and other relevant individuals and entities (collectively, “Sunshine

Reporting Laws”), and agrees to provide the other Party with all information regarding such

payments or transfers of value by such Party as necessary for such other Party to comply in a

timely manner with its reporting obligations under the Sunshine Reporting Law.

6.Commercialization

6.1General. Subject to the terms and conditions of this Article 6 (including Section

6.7), Licensee shall have the sole and exclusive responsibility, at its own expense, for all aspects

of the Commercialization of the Products in the Licensee Territory, including: (a) developing and

executing a commercial launch and pre-launch plan, (b) negotiating with applicable

Governmental Authorities and other payors regarding the price and reimbursement status of the

Products; (c) marketing and promotion; (d) booking sales and distribution and performance of

related services; (e) handling all aspects of order processing, invoicing and collection, inventory

and receivables; (f) providing customer support, including handling medical queries, and

performing other related functions; and (g) conforming its practices and procedures to

Applicable Laws relating to the promotion, sales and marketing, access, and distribution of the

Products.

6.2Commercialization Plan. As soon as practical after the Effective Date, Licensee

shall prepare and present to the JCC a Commercialization plan for Products in the Licensee

Territory, including a reasonably detailed description and an anticipated timeline for Licensee’s

significant Commercialization activities for the Products for the next [ * ] commencing with the

[ * ] (the “Commercialization Plan”). Taking into consideration the requirements of Section

6.3(c), the Commercialization Plan shall include such information on a country-by-country basis

for each of the Major Market Countries. Licensee shall update and amend the

Commercialization Plan annually starting in November 2017 and each subsequent November,

shall present such updates and amendments to the JCC for review and discussion. Without

limiting the provisions of this Section 6.2, through the JCC, Licensee shall consult with and

36.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

provide updates to Exelixis ([ * ]) regarding the commercial strategy and Commercialization of

Products in the Licensee Territory. Subject to the provisions of this Agreement and compliance

with the Commercialization Plan, Licensee shall have full Control and authority with respect to

the day-to-day Commercialization of the Products and implementation of the Commercialization

Plan.

6.3 Diligence.

(a)General. During the Term, Licensee shall use Commercially Reasonable

Efforts to Commercialize the Products for all indications that have received or will receive

Regulatory Approval throughout the Licensee Territory. In addition, and without limitation of

the foregoing, Licensee shall, as soon as possible following each MAA Approval(s), subject to

Section 6.4(b), launch the Product for such indication and obtain all necessary Price and

Reimbursement Approvals at least in [ * ] (subject to the business judgment to delay or not to

launch a particular Product in a particular country of the EU because of adverse pricing or other

business considerations). In the event that Licensee recommends not to launch a particular

Product in a particular country of the Licensee Territory, or to deliberately defer such launch, it

shall advise the JCC at the next meeting of such Committee and provide a reasonably detailed

rationale for such determination. Thereafter, Licensee shall utilize Commercially Reasonable

Efforts in the ongoing support for the Product in each such country. Licensee shall report to the

JCC its efforts in each of these countries at least [ * ] at meetings of the JCC [ * ].

(b)Additional Markets. Promptly after the Effective Date, Licensee shall

commence preparation of a reasonably detailed Commercialization plan, sales forecast, and

launch timing for Commercialization of the Product, using Commercially Reasonable Efforts, in

the Additional Markets. On or before December 31, 2016, Licensee shall present to the JCC

such reasonably detailed Commercialization plan, sales forecast, and launch timing for

Commercialization of the Product, using Commercially Reasonable Efforts, in the Additional

Markets. Such report shall specifically assess the opportunity and plans for [ * ].

(c)Minimum Commercial Performance. In addition to the foregoing

general commitments, and subject to Section 6.3(e), for each Calendar Year for [ * ] full

Calendar Years commencing [ * ], Licensee shall prepare a commercially reasonable forecast of

commercial sales of Product in the Licensee Territory (“Sales Forecast”) and submit the Sales

Forecast to the JCC with sufficient time for the JCC to review and finalize such Sales Forecast

by [ * ] of the year immediately preceding the year covered in such Sales Forecast. The Sales

Forecast shall be based upon the same market share trajectory as the Product achieved in the U.S.

for the same time period following Regulatory Approval (including Pricing and Reimbursement

Approval, if required) for each indication, as may be modified on the basis of other relevant

commercial considerations, including other comparable product experience in Europe compared

to the U.S. For the first [ * ] Calendar Years following [ * ], Sales Forecasts will be used solely

for management purposes and have no effect under this Agreement. If in any Calendar Year

during the remaining [ * ] Calendar Years (the “Minimum Commercial Performance Period”)

Net Sales realized in the Licensee Territory are less than [ * ] percent ([ * ]%) of forecasted sales

for such year, then Licensee shall submit a corrective plan to the JCC for review and approval for

the next Calendar Year in order to achieve forecasted sales and such corrective plan shall be

incorporated into the Commercialization Plan. If, for a second Calendar Year during the

Minimum Commercial Performance Period, Net Sales realized are again less than [ * ] percent

([ * ]%) of forecasted sales then:

37.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(i) if Licensee failed to execute the corrective plan submitted to the

JCC, it shall be considered a material breach giving rise to Exelixis’ right to terminate this

Agreement pursuant to Section 15.2;

(ii)if Licensee did execute the corrective plan submitted to the JCC,

but still failed to achieve at least [ * ] percent ([ * ]%) of forecasted sales, then Licensee must

submit a new corrective plan to the JCC; and

(iii)if during the Minimum Commercial Performance Period, Licensee

fails to achieve at least [ * ] percent ([ * ]%) of forecasted sales in [ * ] of the [ * ] Calendar

Years during the Minimum Commercial Performance Period, it shall be considered a material

breach after the [ * ] of such Calendar Years giving rise to Exelixis’ right to terminate this

Agreement pursuant to Section 15.2.

(d)Minimum Commercial Performance Compensation. If in any

Calendar Year during the Minimum Commercial Performance Period Net Sales realized in the

Licensee Territory are less than [ * ] percent ([ * ]%) of forecasted sales for such year, then

Licensee shall owe to Exelixis the Minimum Commercial Performance Compensation in respect

of such year, to be paid within [ * ] of the end of the relevant Calendar Year. For the purposes of

this Agreement, the “Minimum Commercial Performance Compensation” shall be equal to

the royalty payments due on the difference between [ * ] percent ([ * ]%) of the forecasted sales

for the applicable Calendar Year and the Net Sales realized during the applicable Calendar Year.

(e)Minimum Commercial Performance Relief. In the event of conditions

that give rise to a Stockout Period, Licensee shall be relieved of the obligation to meet minimum

commercial performance obligations pursuant to Section 6.3(c) for the Calendar Year in which

such Stockout Period occurs.

(f)Commercial Updates. Licensee shall update the JCC on a [ * ] basis

regarding its Commercialization activities with respect to the Products in the Licensee Territory.

Each such update shall be in a form to be agreed by the JCC and shall summarize Licensee’s, its

Affiliates’ and Sublicensees’ significant Commercialization activities with respect to the

Products in the Licensee Territory, and shall contain at least such information at such level of

detail reasonably required by Exelixis to determine Licensee’s compliance with its diligence

obligations set forth herein. Such updates shall include, on a [ * ] basis, Licensee’s sales

activities, marketing activities and Medical Affairs Activities. In addition, if Licensee is then

working under a corrective plan under Section 6.3(c), such updates shall also include the budget

and actual cost and expense (including FTE levels) for such activities in [ * ] for the current year

and previous year.

6.4Coordination of Commercialization Activities.

(a)Generally. The Parties recognize that their collaboration may benefit

from the coordination of certain activities in support of the Commercialization of the Products in

both the Licensee Territory and the Exelixis Territory. As such, the Parties, through the JCC,

shall develop and coordinate Commercialization strategies for the Product (e.g., for branding and

messaging, international congresses, advisory boards), and the Parties shall conduct

Commercialization activities for the Product in their respective territories consistent with such

global strategy. The foregoing shall not be construed as requiring Exelixis to seek Licensee’s

consent in connection with the establishment and/or implementation of any sales, marketing, or

medical affairs practices in the Exelixis Territory.

38.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(b)Pricing. Licensee shall keep Exelixis timely informed on the status of any

application for Pricing and Reimbursement Approval or material updates to an existing Pricing

and Reimbursement Approval in the Licensee Territory, including any discussion with a

Regulatory Authority with respect thereto. Licensee shall have the right to determine the price of

the Product sold in the Licensee Territory [ * ]. [ * ]. In the event the Pricing and

Reimbursement Approvals in a given country of the Licensee Territory [ * ], Licensee shall have

no obligation to launch the Product in such country. Licensee and its Affiliates and Sublicensees

shall not sell any Product in combination with, as part of a bundle with, or as a combination

therapy with other products, or offer packaged arrangements to customers that include a Product,

in such a manner as to disproportionately discount the selling price of the Product [ * ]. For

clarification, should Licensee derive direct economic benefit from the sale of another

pharmaceutical product that is approved to be used in combination with Product, [ * ].

(c)Sharing of Promotional Materials. Licensee shall, at its own expense,

prepare, develop, produce or otherwise obtain, and utilize sales, promotional, advertising,

marketing, website, educational and training materials (the “Promotional Materials”) to support

its Commercialization activities in the Licensee Territory. The Parties shall share samples of

Promotional Materials (including English translation, if available) with respect to the

Commercialization of the Products with one another. Additional materials, including medical

education and medical information, sales force and sales force training materials, will be made

available to the other Party upon request.

(d)Commercialization in Exelixis Territory. Subject to the terms and

conditions of this Agreement (including Section 6.7), Exelixis shall have the exclusive right to

Commercialize the Product in the Exelixis Territory at its own cost and expense, with or without

Third Party(ies).

6.5Detailing and Promotion. Licensee shall not engage any contract sales

organization to conduct sales activities for the Product in the Licensee Territory without written

JCC approval, nor shall Licensee use the same sales force to promote the Product and a separate

product that is indicated for the same indication without written JCC approval.

6.6Medical Affairs Activities.

(a)Coordination of Global Medical Affairs Activities. Commencing with

transfer of the RCC MAA to Licensee, but subject to the final sentence of this Section 6.6(a),

Licensee shall lead and conduct all Medical Affairs Activities for the Product in the Licensee

Territory in accordance with the medical affairs portion of the GDP. From such date, Licensee

shall be responsible for Medical Affairs Activities in the Licensee Territory, provided however,

that Exelixis shall have the right, but not the obligation, to also conduct Medical Affairs

Activities in the Licensee Territory in global support of the Product consistent with the medical

affairs portion of the GDP and in coordination with Licensee. Exelixis will not undertake

Medical Affairs Activities in the Licensee Territory without prior coordination with Licensee.

(b)Advisory Panels. To the extent practicable, each Party shall give the

other Party written notice at least [ * ] in advance of any major market or international level

advisory panel meetings with key opinion leaders with respect to the Commercialization of the

Products in the Licensee Territory and the Exelixis Territory that are held, sponsored or attended

by either Party or its Affiliate or sublicensee, and each Party shall have the right to attend and

participate in such meetings.

39.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

6.7Diversion. Each Party hereby covenants and agrees that it and its Affiliates shall

not, and it shall contractually obligate (and use Commercially Reasonable Efforts to enforce such

contractual obligation) its sublicensees not to, directly or indirectly, promote, market, distribute,

import, sell or have sold any Product, including via the Internet or mail order, to any Third Party

or to any address or Internet Protocol address or the like in the other Party’s territory. Neither

Party shall engage, nor permit its Affiliates and sublicensees to engage, in any advertising or

promotional activities relating to any Product for use directed primarily to customers or other

buyers or users of such Product located in any country or jurisdiction in the other Party’s

territory, or solicit orders from any prospective purchaser located in any country or jurisdiction in

the other Party’s territory. If a Party or its Affiliates or sublicensees receives any order for a

Product for use from a prospective purchaser located in a country or jurisdiction in the other

Party’s territory, such Party shall immediately refer that order to such other Party and shall not

accept any such orders. Neither Party shall, nor permit its Affiliates and sublicensees to, deliver

or tender (or cause to be delivered or tendered) any Product for use in the other Party’s territory.

7.Manufacture and Supply.

7.1Manufacture and Supply. Exelixis will manufacture and supply, itself and/or

through a Third Party contract manufacturer, all Compound and Products for use in the

Development and Commercialization of the Products under this Agreement. All Products

supplied by Exelixis to Licensee shall be at a price equal to [ * ]. It is anticipated that Exelixis

will supply commercial Product to Licensee in final, labeled packaged form. Exelixis shall be

responsible for packaging and labeling for all countries in the Licensee Territory. The Cost of

Goods of the Compound and Products used in the Development work under the GDP shall be

included in the Development Cost and shared by the Parties in accordance with Sections 4.5 and

9.2. Exelixis shall source such Product supply for both Parties either from a facility owned by

Exelixis or from a reputable, qualified and certified Third Party and, in the event Licensee is

responsible for conducting any Clinical Studies pursuant to Section 4.3, 4.5(d) or 4.5(e), Exelixis

shall provide such supply to Licensee for such Clinical Studies in accordance with the GDP.

Within two (2) months of the Effective Date, the Parties shall enter into a Supply Agreement for

the manufacture and supply of the Compound and Products to Licensee (the “Supply

Agreement”). The Parties acknowledge that the Parties amended the Supply Agreement to

address the modification to the Parties’ respective territories as outlined in the First Amendment

and added [ * ] reports from the tracking system as set forth in Section 2.8(f) detailing the

distribution and sale of product supplied for Canada.

8.Transition of EU Regulatory and Commercialization Operation.

8.1Termination of Sobi Agreement. Licensee acknowledges that as of the

Effective Date, Exelixis has entered into an Amended and Restated Commercialization

Agreement with Swedish Orphan Biovitrum AB (“Sobi”) for the distribution of the Product in

the EU in MTC, effective January 1, 2015 (the “Sobi Agreement”). No later than March 4,

2016, Exelixis shall exercise its right to terminate the Sobi Agreement and Exelixis shall bear the

cost of any resulting termination payment to Sobi under Section 8.3(g) of the Sobi Agreement.

Prior to the effective date of the termination of the Sobi Agreement, Licensee acknowledges and

agrees that the licenses granted by Exelixis to Licensee hereunder are subject to the rights

granted by Exelixis to Sobi under the Sobi agreement. Exelixis shall ensure that a meeting be

held with Sobi and Licensee within sixty (60) days of the Effective Date to achieve a smooth

transition from Sobi to Licensee for the distribution of the Product in MTC in the EU. Exelixis

agrees, if necessary, to enforce the obligations of the Sobi Agreement as against Sobi to provide

40.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

for a smooth transition of commercial responsibility for the distribution of the Product in the EU

in MTC as contemplated by the Sobi Agreement.

8.2Transfer of Regulatory Filings. As soon as practicable, but no later than [ * ],

the Parties shall cooperate to transfer the EMA MAA filing from TMC for Cometriq in MTC to

Licensee, including Marketing Authorization Holder status (including commitments and

obligations listed in the MAA, and Exelixis shall ensure with TMC that such transfer shall occur,

except that Exelixis shall complete the EMA post-marketing commitment of Study XL184-401,

with the costs of such study to be shared in accordance with Section 4.5), and the Pediatric

Investigation Plan, provided that Licensee shall be responsible for all Regulatory Filings and

interactions with the EMA with respect to such studies and Regulatory Filings, maintaining

Orphan Drug Status, and all further EMA requirements with respect to such studies and

Regulatory Filings. Without limiting the foregoing, such transfer efforts shall include (a)

providing supporting documentation, responding to requests by applicable Regulatory

Authorities and other reasonable efforts in connection with the MAA Approvals, (b) preparing

and filing Regulatory Filings in countries of the Licensee Territory where Sobi and/or TMC has

not as of the Effective Date filed Regulatory Filings and it is or it becomes commercially

reasonable to do so. Licensee’s rights and obligations as a regulatory sponsor with respect to

each particular Regulatory Filing under Article 5 shall commence upon the completion of such

transfer.

8.3Transition of Commercial Responsibilities for Cometriq. Licensee and

Exelixis acknowledge and agree that Licensee shall assume the rights and responsibilities for the

Commercialization of Cometriq in the EU concurrent with the effective date of the termination

of the Sobi Agreement. Consistent with Section 8.2, the Parties shall cooperate to effectuate the

transfer of such rights and responsibilities to Licensee in a manner that minimizes any delay or

interruption of the Commercialization of Cometriq in the EU.

9.Financial Provisions

9.1Upfront Payment. Licensee shall make a one-time, non-refundable, non-

creditable upfront payment to Exelixis of two hundred million dollars ($200,000,000) within five

(5) business days after the Effective Date. In consideration of the expanded license rights

granted by Exelixis to Licensee to include Canada as part of the Licensee Territory, by virtue of

the First Amendment, Licensee shall make a one-time, non-refundable, non-creditable payment

to Exelixis of ten million dollars ($10,000,000) within five (5) days after execution of First

Amendment.

9.2Sharing/Reimbursements of Development Costs and PV Costs.

(a)Future Development Costs. No later than [ * ] after the beginning of

each Calendar Quarter during which a Party will perform any Development activity (other than

the Independent Work and Licensee Only Development Work) in such Calendar Quarter

pursuant to the GDP, such Party shall submit to the other Party a statement setting forth the

Development Costs incurred, including the other Party’s share (calculated in accordance with

Section 4.5) of (i) estimated Development Costs for the then current quarter; (ii) variances from

prior invoiced estimates and actual Development Costs; and (iii) Development Costs incurred by

or on account of such Party in the past quarter not previously invoiced. Such invoice shall

include a reasonably detailed report for such Development Costs, including supporting

documents. To the extent provided in Section 4.5, the other Party shall pay the amount invoiced

within [ * ] after the receipt of the invoice, subject to the other Party’s right to audit the invoicing

41.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Party’s records and books related to such costs as provided in Section 10.4. For clarity, making

such a payment does not preempt the paying Party’s audit rights under Section 10.4, which

remain in full force and effect. If both Parties will perform Development activities under the

GDP in such Calendar Quarter, the Parties shall consolidate the payments for such Calendar

Quarter into a single payment from one Party to the other Party.

(b)Independent Work. Except as set forth below in this Section 9.2(b), each

Party shall bear all the internal (calculated on an FTE basis using the then current FTE Rate) and

out-of-pocket costs and expenses incurred by or on account of such Party in performing its own

Independent Work (the “Independent Work Costs”). After the completion of such Independent

Work, such Party shall provide the other Party with a report of such Independent Work Costs. If

a Party desires to submit any portion of the Data resulting from any Independent Work

conducted by the other Party and related Regulatory Filings generated by the other Party to

support Regulatory Approval in its territory, then such Party shall notify the other Party in

writing at any time upon the completion of such Independent Work. Within [ * ] after its receipt

of such notice, the Party conducting or having conducted such Independent Work shall submit to

the other Party a reasonably detailed invoice setting forth [ * ] ([ * ]%) of the Independent Work

Costs that would have been incurred by or on account of such other Party in connection with the

generation of such Data under Section 9.2(b) as if such Independent Work Costs were

Development Costs. If the Party seeking to use such Data decides to use such Data to support

Regulatory Approval in its territory, then such Party shall notify the other Party in writing and

pay the amount invoiced within [ * ] after the receipt of such invoice, subject to such Party’s

right to audit the invoicing Party’s records and books related to such costs as provided in Section

10.4. For clarity, making such a payment does not preempt the paying Party’s audit rights under

Section 10.4, which remain in full force and effect.

(c)Internal Development Cost. Each Party shall record and calculate its

internal Development Costs on an FTE basis at the FTE Rate.

(d)Development Cost for Products in Combination. If any Product is

Developed under this Agreement in combination with a Party’s proprietary product (the

“Beneficial Party”), either as a combination product or combination therapy, then such

Development work shall be conducted in accordance with the GDP and the Development Costs

with respect to such Development shall be included in the Development Budget, provided that

only [ * ] percent ([ * ]%) of the Development Cost with respect to such Development shall be

subject to the Parties’ cost sharing under Section 9.2(b) and the Beneficial Party shall be solely

responsible for the other [ * ] percent ([ * ]%) of the Development Costs.

9.3Development Milestone Payments.

(a)Development Milestones. Subject to the remainder of this Section 9.3,

Licensee shall pay to Exelixis the non-refundable, non-creditable payment set forth in the table

below upon the achievement of the applicable milestone event (whether by or on behalf of

Licensee, Exelixis, or their Affiliates, licensee(s) of Exelixis or Sublicensees):

42.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.


Milestone Event	Milestone Payments
Milestone Event	For RCC (2nd line)	For HCC (2nd line)	Tier 1 Additional Indication	Tier 2 Additional Indication
Milestone #1: Initiation of first Phase 3 Clinical Trial	n.a.	n.a.	$20 million	$[ * ]
Milestone #2: First MAA filing with the EMA	n.a	$ 10 million	$25 million	$[ * ]
Milestone #3: First MAA Approval by EMA	$60 million	$40 million	$50 million	$[ * ]
TOTAL	$60 million	$50 million	$95 million	$[ * ]

(i)For RCC (2nd line) and for HCC (2nd line), each milestone payment

shall be paid once for the applicable events described above for each different applicable

Product.

(ii)For Tier 1 Additional Indications and Tier 2 Additional

Indications, each milestone payment shall be paid once for the applicable milestone events

described above for a total payment of [ * ] for up to [ * ]. For clarity, such milestone payments

may be earned if [ * ]. In the event that any indication [ * ].

(iii) Milestone #1 shall be deemed achieved and payable, if not already

achieved, upon achievement of any of Milestone #2 and/or Milestone #3 for the same indication.

(iv)Milestone #2 shall be deemed achieved and payable, if not already

achieved, upon achievement of Milestone #3 for the same indication.

(b)Notice and Payment. Each Party shall notify the other Party in writing

within [ * ] after the achievement of any milestone set forth in this Section 9.3 by such Party, its

Affiliates, or its Sublicensees. Licensee shall pay to Exelixis the applicable development

milestone payments within [ * ] after the delivery or receipt of such notice. Notwithstanding the

foregoing sentence, Licensee shall pay to Exelixis the Milestone #2 payment (First MAA filing

with the EMA) for the Tier 1 Additional Indication ($25,000,000) either within [ * ] after the

delivery or receipt of notice, or on [ * ], whichever is later.

43.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(c)Development Milestones Specific to Canada. Subject to the remainder

of this Section 9.3(c), Licensee shall pay to Exelixis the non-refundable, non-creditable payment

set forth in the table below upon the achievement of the applicable milestone event (whether by

or on behalf of Licensee, Exelixis, or their Affiliates, licensee(s) of Exelixis or Sublicensees):


Milestone Event	Milestone Payment
Milestone A: MAA Approval by Health Canada (i.e., receipt of a “Notice of Compliance”) for a Product for RCC (2nd line)	$5,000,000
Milestone B: MAA Approval by Health Canada for a Product for RCC (1st line)	$3,000,000*
Milestone C: MAA Approval by Health Canada (i.e., receipt of a “Notice of Compliance”) for a Product for HCC (2nd line)	$2,000,000
Milestone D: MAA Approval by Health Canada (i.e., receipt of a “Notice of Compliance”) for a Product for the first indication other than RCC or HCC	$[ * ]
Milestone E: MAA Approval by Health Canada (i.e., receipt of a “Notice of Compliance”) for a Product for the second indication other than RCC or HCC	$[ * ]

(i)*With respect to a Product, if Licensee achieves Milestone A, and

as part of such Milestone A, RCC (1st line) is also included in the claims section of the approved

label of Milestone A and allows Licensee to promote the Product for use in RCC (1st line), then

Licensee shall pay Exelixis the milestone payment corresponding to Milestone B in addition to

the milestone amount owed for achievement of Milestone A. For clarity, in no event shall

Licensee be obligated to pay to Exelixis more than a total of $8,000,000 for the achievement of

Milestones A and B with respect to any one Product.

(ii)Subject to Section 9.3(c)(i), each milestone payment shall be paid

once for the applicable events described above for each different applicable Product.

9.4Commercial Milestones Payments.

(a)EU Launch Milestones. Licensee shall pay to Exelixis the non-

refundable, non-creditable payment set forth in the table below upon the achievement of the

applicable milestone event (whether by or on behalf of Licensee, its Affiliates, or Sublicensees):

44.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.


EU Launch Milestones	Milestone Payments
First commercial sale of a Product in any country in the Top 5 EU	$10 million
First commercial sale of a Product in any second country in the Top 5 EU	$10 million

(b)Net Sales Milestones.

(i)The Parties acknowledge that the Net Sales shall be calculated in

accordance with Section 1.60 with respect to all sales for the Products in the Licensee Territory

made on or after [ * ]. In the event of overpayment or underpayment by Licensee of royalties to

Exelixis on the Net Sales of the Products sold in the Licensee Territory for the Calendar Years

[ * ] due to change in subparagraph (d) of Section 1.60, the Parties hereby agree that any

remaining balance due by or owed to Licensee shall be debited or credited to Licensee, as

applicable pursuant to payment terms to be mutually agreed by the Parties in writing.

(ii)Net Sales Milestones for Licensee Territory Excluding Canada.

Licensee shall pay to Exelixis the one-time, non-refundable, non-creditable payments set forth in

the table below when the aggregated Net Sales of all Products in the Licensee Territory, but

excluding the Net Sales of all Products in Canada, in any period of four (4) consecutive Calendar

Quarters first reach the values indicated in the table below. Once one of the values indicated in

the table below is first reached and the corresponding milestone payment is paid by Licensee

under this Section 9.4(b)(ii) (the “Previously Achieved Commercial Milestone”), the period of

four (4) consecutive Calendar Quarters to be applied to determine the reaching of a subsequent

Net Sales amount in the table below shall only start at the Calendar Quarter immediately

following the fourth (4th) Calendar Quarter which served as the period to determine the reaching

of the Net Sales amount triggering the Previously Achieved Commercial Milestone. For the

avoidance of doubt, each payment in this Section 9.4(b)(ii) shall be payable once only, regardless

of the number of times such milestone is subsequently achieved.


Aggregate Net Sales of all Products in the Licensee Territory Excluding Canada in Any 4 Consecutive Calendar Quarters	Milestone Payments
Equal or exceed$100 million	$25 million
Equal or exceed$250 million	$50 million
Equal or exceed $400 million	$100 million
Equal or exceed $600 million	$150 million
Equal or exceed $[ * ]	$[ * ]

(iii)Net Sales Milestones for Canada. Licensee shall pay to Exelixis

the one-time, non-refundable, non-creditable payments set forth in the table below when the

45.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

aggregated Net Sales of all Products in Canada in any period of four (4) consecutive Calendar

Quarters first reach the values indicated in the table below. Once one of the values indicated in

the table below is first reached and the corresponding milestone payment is paid by Licensee

under this Section 9.4(b)(iii) (the “Previously Achieved Commercial Milestone for Canada”),

the period of four (4) consecutive Calendar Quarters to be applied to determine the reaching of a

subsequent Net Sales amount in the table below shall only start at the Calendar Quarter

immediately following the fourth (4th) Calendar Quarter which served as the period to determine

the reaching of the Net Sales amount triggering the Previously Achieved Commercial Milestone

for Canada. For the avoidance of doubt, each payment in this Section 9.4(b)(iii) shall be payable

once only, regardless of the number of times such milestone is subsequently achieved. For

clarity, the amounts set forth in this Section 9.4(b)(iii) refer to Canadian dollars.


Aggregate Net Sales of all Products in Canada in Any 4 Consecutive Calendar Quarters	Milestone Payments
Equal or exceedCAD$30 million	CAD$3 million
Equal or exceedCAD$[ * ]	CAD$[ * ]
Equal or exceed CAD$[ * ]	CAD$[ * ]

(c)Notice and Payment.

(i)Licensee shall notify Exelixis in writing within [ * ] after the

achievement of any EU launch milestone set forth in Section 9.4(a) above by Licensee, its

Affiliates or its Sublicensees. Licensee shall pay to Exelixis the applicable EU launch milestone

payments within [ * ] after the delivery or receipt of such notice.

(ii)As part of the report in Section 10.1, Licensee shall provide written

notice to Exelixis if (1) the aggregated Net Sales of all Products in the Licensee Territory, but

excluding the Net Sales of all Products in Canada, in any four (4) consecutive Calendar Quarters

first reach the values set forth in Section 9.4(b)(ii), or (2) the aggregated Net Sales of all Products

in Canada in any four (4) consecutive Calendar Quarters first reach the values set forth in Section

9.4(b)(iii), and Licensee shall pay to Exelixis the corresponding Net Sales milestone payment

within [ * ] after the end of the Calendar Quarter.

9.5Royalty Payments.

(a)Royalty Rate.

(i)Royalty Rate for Licensee Territory Excluding Canada.

Subject to the other terms of this Section 9.5, during the Royalty Term, Licensee shall make

quarterly non-refundable, non-creditable royalty payments to Exelixis on the annual Net Sales of

all Products sold in the Licensee Territory, but excluding the annual Net Sales of all Products

sold in Canada, at the applicable rate set forth below:

46.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.


Annual Net Sales of all Products in the Licensee Territory Excluding Canada	Royalty Rate
Portion less than or equal to $[ * ]	22%
Portion greater than $[ * ] and less than or equal to $[ * ]	[ * ]%
Portion greater than $[ * ]	26%

(ii)Royalty Rate for Canada. Subject to the other terms of this

Section 9.5, during the Royalty Term, Licensee shall make quarterly non-refundable, non-

creditable royalty payments to Exelixis on the annual Net Sales of all Products sold in Canada at

the applicable rate set forth below:


Annual Net Sales of all Products in Canada	Royalty Rate
Portion less than or equal to CAD$30 million	22%
Portion greater than CAD$30 million and less than or equal to CAD$[ * ]	[ * ]%
Portion greater than CAD$[ * ]	26%

For clarity, the annual Net Sales amounts set forth in this Section 9.5(a)(ii) refer to

Canadian dollars.

(b)Royalty Term. Royalties shall be paid on a Product-by-Product and

country-by-country basis in the Licensee Territory from the First Commercial Sale of such

Product in such country by or on behalf of Licensee, its Affiliates or Sublicensees, until the latest

of (i) expiration of the last-to-expire Valid Claim of the Exelixis Patents and Licensee Patents

covering such Product in such country, including its composition, method of manufacture or

method of use, each covering the Product as Commercialized; (ii) the expiration of any

Regulatory Exclusivity covering such Product in such country; or (iii) ten (10) years after the

First Commercial Sale of such Product in such country for the first indication to obtain

Regulatory Approval in the Licensee Territory other than MTC (the “Royalty Term”).

(c)Royalty Reductions

(i)If one or more Generic Products to a Product is sold in any country

in the Licensee Territory during the Royalty Term for such Product in such country, and [ * ], the

royalty rates provided in Section 9.5(a) for such Product shall be reduced in such country by [ * ]

percent ([ * ]%) [ * ].

47.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(ii)If it is [ * ] for Licensee to obtain a license from a Third Party

under any Patent in a particular country in the Licensee Territory in order to sell a Product in

such country and Licensee obtains such a license, Licensee may deduct, from the royalty

payment that would otherwise have been due pursuant to Section 9.5(a) with respect to Net Sales

of such Product in such country in a particular Calendar Quarter, an amount equal to [ * ] percent

([ * ]%) of the royalties paid by Licensee to such Third Party pursuant to such license on account

of the sale of such Product in such country during such Calendar Quarter.

(iii)If the Applicable Laws (including legal doctrine) in a particular

country or jurisdiction requires a royalty reduction after the expiration of the relevant patents,

and the Royalty Term for a particular Product in such country or jurisdiction extends beyond the

time period set forth in Section 9.5(b)(i), then the royalty rates provided in Section 9.5(a) shall be

reduced by [ * ] percent ([ * ]%) for such Product in such country (e.g., a reduction from [ * ]%

to [ * ]%) during the remainder of the Royalty Term that extends beyond the time period set forth

in Section 9.5(b)(i) unless and until the royalty reduction set forth in Section 9.5(c)(i) becomes

applicable. For the same period of time, if neither Exelixis nor Licensee has [ * ] in such

country, such royalty reduction shall be [ * ] percent ([ * ]%) instead of [ * ] percent ([ * ]%).

(iv)If [ * ] any and all approvals (including pricing and reimbursement

approval, if applicable), licenses, registrations, permits, notifications, and authorizations (or

waivers) of any Regulatory Authority that are necessary for the promotion, marketing,

distribution, offer for sale, sale, or other commercialization [ * ] (“Approval”) in any country in

the Licensee Territory [ * ], and such Approval [ * ], and [ * ], then, [ * ] the royalty rates

provided in Section 9.5(a) for such Product shall be reduced in such country by [ * ] percent

([ * ]%) for the remainder of the Royalty Term for such Product in such country. For clarity,

[ * ]for the purposes of this Section 9.5(c)(iv). Further, if the Approval is [ * ], then the royalty

reduction will only apply [ * ]; and, where [ * ], the Parties will discuss in good faith to promptly

agree upon a reasonable method for [ * ] for the purpose of calculating the royalty reduction

pursuant to this Section 9.5(c)(iv).

(v)Notwithstanding the foregoing, during any Calendar Quarter in the

Royalty Term for a Product in a country, the operation of clause 9.5(c)(i), 9.5(c)(ii), 9.5(c)(iii),

and 9.5(c)(iv) above, individually or in combination, shall not reduce by more than [ * ] percent

([ * ]%) the royalties that would otherwise have been due under Section 9.5(a) with respect to

Net Sales of such Product in such country during such Calendar Quarter.

(d)Basis of Payment. This Section 9.5 is intended to provide for royalty

payments to Exelixis equal to the percentages of Net Sales set forth in this Section 9.5 for the

entire duration of the Royalty Term. In establishing this payment structure, Licensee recognizes

and acknowledges the substantial value of the various actions and investments that Exelixis has

taken and will undertake under this Agreement, as well as the fact that the value of the license

granted hereunder resides substantially in the Know-How. Therefore, Licensee agrees that the

royalty payments set forth above are appropriate for the entire duration of such payment

obligation. The Parties have agreed to the payment structure set forth herein as a convenient and

fair mechanism for both Parties to be compensated for the value of their actions and investments

under this Agreement.

(e)Launch Period Adjustment. For the first fifty million dollars

($50,000,000) of cumulative Net Sales, Licensee shall make quarterly non-refundable, non-

creditable royalty payments to Exelixis on the Net Sales of all Products sold in the Licensee

Territory at the rate of two percent (2%) rather than at the rate set forth in Section 9.5(a). For the

48.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

first one hundred million dollars ($100,000,000) of cumulative Net Sales immediately following

the initial fifty million dollars ($50,000,000) of cumulative Net Sales, Licensee shall make

quarterly non-refundable, non-creditable royalty payments to Exelixis on the Net Sales of all

Products sold in the Licensee Territory at the rate of twelve percent (12%) rather than at the rate

set forth in Section 9.5(a). Thereafter, the royalty rate for all Net Sales shall be at the applicable

rate set forth in Section 9.5(a).

(f)Stockout Holiday. In the event of conditions that give rise to a Stockout

Period, Licensee shall be relieved of the obligation to pay royalties pursuant to Section 9.5(a) on

Net Sales occurring for a period of time, commencing with the first commercial sale following

the end of the Stockout Period, equal in duration to the Stockout Period.

9.6Exelixis Payments to Third Party. Exelixis shall be solely responsible for all

payments, including royalties and milestone payments, due with respect to Compound and

Products pursuant to any Third Party agreement that Exelixis entered into prior to or as of the

Effective Date, including any obligations surviving the termination of the Product Development

and Commercialization Agreement between [ * ], as set forth in such Collaboration Agreement.

9.7Supply Payments. Licensee shall pay Exelixis for Compound and Product

Exelixis supplies to Licensee an amount equal to [ * ], all as provided in the Supply Agreement.

10.Payment; Records; Audits

10.1Payment; Reports. Royalty payments due by Licensee to Exelixis under Section

9.5 shall be calculated and reported for each Calendar Quarter. All royalty payments due under

Section 9.5 shall be paid within [ * ] after the end of each Calendar Quarter and shall be

accompanied by a report setting forth, on a country-by-country basis, Net Sales of the Products

by Licensee and its Affiliates and Sublicensees in the Licensee Territory in sufficient detail to

permit confirmation of the accuracy of the royalty payment made, including, for each country,

the number of Products sold, the gross sales and Net Sales of Products, including the deductions

from gross sales to arrive at Net Sales, the royalties payable, the method used to calculate the

royalties, the exchange rates used, any adjustments to royalties in accordance with Section 9.5,

and whether any commercial milestone under Section 9.4 has been achieved. Promptly after the

Effective Date, the Parties will agree on the form of royalty report. Licensee shall submit a

single report for all Net Sales during the Calendar Quarter, including all Licensee’s, Affiliates’

and Sublicensees’ Net Sales but shall separately identify the Net Sales and other information

applicable to each entity.

10.2Exchange Rate; Manner and Place of Payment. Except as provided in

Sections 9.4(b)(iii) and 9.5(a)(ii), all references to dollars and “$” herein shall refer to U.S.

dollars. All payments hereunder shall be payable in U.S. dollars. When conversion of Net Sales

from any currency other than U.S. dollars is required, such conversion shall be at the exchange

rate [ * ]. All payments owed under this Agreement shall be made by wire transfer in

immediately available funds to a bank and account designated in writing by Exelixis, unless

otherwise specified in writing by Exelixis.

10.3Taxes.

(a)Taxes on Income. Each Party shall be solely responsible for the payment

of all taxes imposed on its share of income arising directly or indirectly from the activities of the

Parties under this Agreement.

49.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(b)Tax Cooperation. The Parties agree to cooperate with one another and

use reasonable efforts to avoid or reduce tax withholding or similar obligations in respect of the

milestone payments, milestone payments and other payments made by Licensee to Exelixis

under this Agreement. To the extent Licensee is required by Applicable Laws to deduct and

withhold taxes on any payment to Exelixis, Licensee shall pay the amounts of such taxes to the

proper Governmental Authority in a timely manner and promptly transmit to Exelixis an official

tax certificate or other evidence of such payment sufficient to enable Exelixis to claim such

payment of taxes. Exelixis shall provide Licensee any tax forms that may be reasonably

necessary in order for Licensee to not withhold tax or to withhold tax at a reduced rate under an

applicable bilateral income tax treaty, to the extent legally able to do so. Exelixis shall use

reasonable efforts to provide any such tax forms to Licensee in advance of the due date.

Licensee shall provide Exelixis with reasonable assistance to enable the recovery, as permitted

by Applicable Laws, of withholding taxes or similar obligations resulting from payments made

under this Agreement, such recovery to be for the benefit of Exelixis. Licensee shall have the

right to deduct any such tax, levy or charge actually paid from payment due to Exelixis. Each

Party agrees to assist the other Party in claiming exemption from such deductions or

withholdings under double taxation or similar agreement or treaty from time to time in force and

in minimizing the amount required to be so withheld or deducted.

(c)Taxes Resulting From Licensee’s Action. Licensee represents and

warrants that, as of the Effective Date, Licensee is not required by Applicable Law to deduct or

withhold taxes on the upfront payment, milestone payments, royalty payments, and other

payments payable to Exelixis under this Agreement. If a Party takes any action of its own

discretion (not required by a Regulatory Authority), including any assignment, sublicense,

change of place of incorporation, or failure to comply with Applicable Laws or filing or record

retention requirements, which results in a withholding or deduction obligation (“Withholding

Tax Action”), then such Party shall pay the sum associated with such Withholding Tax Action.

For clarity, if Licensee undertakes a Withholding Tax Action, then the sum payable by Licensee

(in respect of which such deduction or withholding is required to be made) shall be increased to

the extent necessary to ensure that Exelixis receives a sum equal to the sum which it would have

received had no such Withholding Tax Action occurred. Otherwise, the sum payable by

Licensee (in respect of which such deduction or withholding is required to be made) shall be

made to Exelixis after deduction of the amount required to be so withheld or deducted. If a

change in Applicable Laws results in a withholding or deduction obligation absent either Party

taking a Withholding Tax Action, then the amount of such withholding or deduction obligation

shall be paid by Licensee to the applicable Governmental Authority on behalf of Exelixis,

provided that Licensee shall assist Exelixis in minimizing or recovering such withholding or

deduction obligation. The Parties shall use commercially reasonable efforts to invoke the

application of any applicable bilateral income tax treaty that would reduce or eliminate otherwise

applicable taxes with respect to payments payable pursuant to this Agreement.

10.4Records; Audit. Each Party shall maintain complete and accurate records in

sufficient detail in relation to this Agreement to permit the other Party to confirm the accuracy of

the amount of Development Costs and the Cost of Goods to be reimbursed or shared,

achievement of commercial milestones, the amount of royalty and other payments under this

Agreement. Each Party will keep such books and records for at least [ * ] following the Calendar

Year to which they pertain. Upon reasonable prior notice, such records shall be inspected during

regular business hours at such place or places where such records are customarily kept by an

independent certified public accountant (the “Auditor”) selected by the auditing Party and

reasonably acceptable to the audited Party for the sole purpose of verifying for the auditing Party

the accuracy of the financial reports furnished by the audited Party pursuant to this Agreement or

50.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

of any payments made, or required to be made, by or to the audited Party pursuant to this

Agreement. Before beginning its audit, the Auditor shall execute an undertaking acceptable to

each Party by which the Auditor agrees to keep confidential all information reviewed during the

audit. Such audits may occur no more often than once each Calendar Year and not more

frequently than once with respect to records covering any specific period of time. Each Party

shall only be entitled to audit the books and records from the [ * ] Calendar Years prior to the

Calendar Year in which the audit request is made. Such auditor shall not disclose the audited

Party’s Confidential Information to the auditing Party, except to the extent such disclosure is

necessary to verify the accuracy of the financial reports furnished by the audited Party or the

amount of payments to or by the audited Party under this Agreement. In the event that the final

result of the inspection reveals an undisputed underpayment or overpayment, the underpaid or

overpaid amount shall be settled within [ * ] after the Auditor’s report. The auditing Party shall

bear the full cost of such audit unless such audit reveals an overpayment to, or an underpayment

by, the audited Party that resulted from a discrepancy in the financial report provided by the

audited Party for the audited period, which underpayment or overpayment was more than [ * ]

percent ([ * ]%) of the amount set forth in such report, in which case the audited Party shall

reimburse the auditing Party for the costs for such audit. With respect more specifically to the

Development Costs to be paid or shared pursuant to Section 9.2, in addition to the right of

inspection and audit by an Auditor, the Party making the payment (the “Payor”) shall have the

right at its expense to review any records of out-of-pocket costs and expenses incurred by the

Party requesting the payment (the “Payee”) and time-keeping logs of Payee sufficient to justify

the work-time spent by each FTE of the Payee as well as the books of the Payee upon reasonable

notice sent by Payor to Payee and during regular business hours. For clarity, making such a

payment does not preempt the paying Party’s audit rights under this Section 10.4, which remain

in full force and effect. Payee’s FTE’s work-time shall be appropriately allocated between the

other product and the Product for purpose of calculating the internal costs specifically dedicated

to the Product.

10.5Late Payments. In the event that any payment due under this Agreement is not

paid when due in accordance with the applicable provisions of this Agreement, the payment shall

accrue interest from the date due at the [ * ] interest rate of [ * ] percent ([ * ]%) [ * ]; provided,

however, that in no event shall such rate exceed the maximum legal annual interest rate. The

payment of such interest shall not limit the Party entitled to receive payment from exercising any

other rights it may have as a consequence of the lateness of any payment.

11.Intellectual Property

11.1Ownership.

(a)Data. All Data generated in connection with any Development or

Commercial activities with respect to any Product conducted by or on behalf of Exelixis and its

Affiliates and licensees (other than Licensee) (the “Exelixis Data”) shall be the sole and

exclusive property of Exelixis or its Affiliates or licensees, as applicable. All Data generated in

connection with any Development or Commercial activities with respect to any Product

conducted by or on behalf of Licensee or its Affiliates or Sublicensees (the “Licensee Data”)

shall be the sole and exclusive property of Licensee or of its Affiliates or Sublicensees, as

applicable. For clarity, each Party shall have access and right to use and reference the other

Party’s Data as and to the extent set forth in this Agreement.

(b)Inventions. Inventorship of any Inventions will be determined in

accordance with the standards of inventorship and conception under U.S. patent laws. The

51.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Parties will work together to resolve any issues regarding inventorship or ownership of

Inventions. Ownership of Inventions will be allocated as follows:

(i)Exelixis will solely own all data, Inventions, and Patents claiming

such Inventions that relate to the composition, manufacture or use of any Compound, or any

improvement of any such composition, manufacture or use (each, a “Compound Invention”).

All Compound Inventions will be included in the Exelixis Know-How, and Patents in the

Licensee Territory claiming such Inventions will be included in the Exelixis Patents. To the

extent any Compound Invention is made by Licensee, whether solely or jointly with Exelixis,

Licensee shall, and hereby does, transfer and assign to Exelixis, without additional consideration,

all of its interest in such Compound Invention.

(ii)Except for Compound Inventions, each Party shall solely own any

Inventions made solely by its and its Affiliates’ employees, agents, or independent contractors

(“Sole Inventions”), and the Parties shall jointly own any Inventions that are made jointly by

employees, agents, or independent contractors of one Party and its Affiliates together with

employees, agents, or independent contractors of the other Party and its Affiliates (“Joint

Inventions”). All Patents claiming patentable Joint Inventions shall be referred to herein as

“Joint Patents.” Except to the extent either Party is restricted by the licenses granted to the

other Party under this Agreement, each Party shall be entitled to practice, license, assign and

otherwise exploit its interest under the Joint Inventions and Joint Patents without the duty of

accounting or seeking consent from the other Party.

11.2Patent Prosecution and Maintenance.

(a)Exelixis Patents.

(i)Subject to this Section 11.2(a), Exelixis shall have the sole right,

but not the obligation, to control the preparation, filing, prosecution and maintenance (including

any interferences, reissue proceedings, reexaminations, inter partes review, patent term

extensions, applications for supplementary protection certificates, oppositions, invalidation

proceedings and defense of validity or enforceability challenges) of the Exelixis Patents (other

than Joint Patents) worldwide, using counsel of its own choice in the Exelixis Territory and

counsel mutually agreed to by the Parties in the Licensee Territory. Licensee shall reimburse

Exelixis for all costs and expenses incurred with respect to the preparation, filing, prosecution

and maintenance of Exelixis Patents in the Licensee Territory after the Effective Date, within

[ * ] from the date of invoice for such costs and expenses provided by Exelixis. In the event that

Licensee does not reimburse Exelixis for such costs and expenses for any Exelixis Patent or

notifies Exelixis in writing that it elects to cease reimbursing Exelixis for such costs and

expenses for any Exelixis Patent, such Patent shall cease to be an Exelixis Patent and shall no

longer be subject to the licenses and other rights granted by Exelixis to Licensee under this

Agreement. Exelixis shall keep Licensee informed of material progress with regard to the

preparation, filing, prosecution and maintenance of Exelixis Patents in the Licensee Territory,

sufficiently in advance for Licensee to be able to review any material documents, including

content, timing and jurisdiction of the filing of such Exelixis Patents in the Licensee Territory,

and Exelixis shall consult with, and consider in good faith the requests and suggestions of,

Licensee with respect to strategies for filing, prosecuting and defending, if any, Exelixis Patents

in the Licensee Territory.

(ii)In the event that Exelixis desires to abandon or cease prosecution

or maintenance of any Exelixis Patent in any country in the Licensee Territory, Exelixis shall

52.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

provide reasonable prior written notice to Licensee of such intention to abandon (which notice

shall, to the extent possible, be given no later than [ * ] prior to the next deadline for any action

that must be taken with respect to any such Exelixis Patent in the relevant patent office). In such

case, upon Licensee’s written election provided no later than [ * ] after such notice from

Exelixis, Exelixis shall continue prosecution and maintenance of such Exelixis Patent at

Licensee’s direction and expense. If Licensee does not provide such election within [ * ] after

such notice from Exelixis, Exelixis may, in its sole discretion, continue prosecution and

maintenance of such Exelixis Patent or discontinue prosecution and maintenance of such

Exelixis Patent.

(b)Licensee Patents.

(i)Subject to this Section 11.2(b), Licensee shall have the first right,

but not the obligation, to control the preparation, filing, prosecution and maintenance (including

any interferences, reissue proceedings, reexaminations, patent term extensions, applications for

supplementary protection certificates, oppositions, invalidation proceedings and defense of

validity or enforceability challenges) of all Licensee Patents (other than Joint Patents)

worldwide, at its sole cost and expense and by counsel of its own choice in the Licensee

Territory and by counsel mutually agreed to by the Parties in the Exelixis Territory. Licensee

shall keep Exelixis informed of the status of filing, prosecution, maintenance and defense, if any,

of the Licensee Patents, and Licensee shall consult with, and consider in good faith the requests

and suggestions of, Exelixis with respect to strategies for filing, prosecuting and defending, if

any, Licensee Patents.

(ii)In the event that Licensee desires to abandon or cease prosecution

or maintenance of any Licensee Patent, Licensee shall provide reasonable prior written notice to

Exelixis of such intention to abandon (which notice shall, to the extent possible, be given no later

than [ * ] prior to the next deadline for any action that must be taken with respect to any such

Licensee Patent in the relevant patent office). In such case, upon Exelixis’ written election

provided no later than [ * ] after such notice from Licensee, Exelixis shall have the right to

assume prosecution and maintenance of such Licensee Patent at Exelixis’ expense and Licensee

shall assign to Exelixis all of its rights, title and interest in and to such Licensee Patent. If

Exelixis does not provide such election within [ * ] after such notice from Licensee, Licensee

may, in its sole discretion, continue prosecution and maintenance of such Licensee Patent or

discontinue prosecution and maintenance of such Licensee Patent.

(c)Joint Patents.

(i)Subject to this Section 11.2(c), Exelixis shall have the first right,

but not the obligation, to prepare, file, prosecute and maintain (including any interferences,

reissue proceedings, reexaminations, patent term extensions, applications for supplementary

protection certificates, oppositions, invalidation proceedings and defense of validity or

enforceability challenges) Joint Patents using a patent counsel selected by Exelixis in the

Exelixis Territory and counsel mutually agreed to by the Parties in the Licensee Territory.

Licensee shall reimburse Exelixis for all costs and expenses incurred with respect to the

preparation, filing, prosecution and maintenance of Joint Patents in the Licensee Territory, within

[ * ] from the date of invoice for such costs and expenses provided by Exelixis. In the event that

Licensee does not reimburse Exelixis for such costs and expense for any Joint Patent or notifies

Exelixis in writing that it elects to cease reimbursing Exelixis for such costs and expense for any

Joint Patent, Licensee shall execute such documents and perform such acts, at Licensee’s

expense, as may be reasonably necessary to effect an assignment of Licensee’s entire right, title,

53.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

and interest in and to such Joint Patent to Exelixis, and such Patent shall cease to be either a Joint

Patent or a Exelixis Patent and shall no longer be subject to the licenses and other rights granted

by Exelixis to Licensee under this Agreement. Exelixis shall keep Licensee informed of material

progress with regard to the preparation, filing, prosecution, maintenance and defense, if any of

Joint Patents, including content, timing and jurisdiction of the filing of such Joint Patents, and

Exelixis shall consult with, and consider in good faith the requests and suggestions of, Licensee

with respect to filing, prosecuting and defending, if any, Joint Patents in the Licensee Territory.

(ii)In the event that Exelixis desires to abandon or cease prosecution

or maintenance of any Joint Patent in any country in the Licensee Territory, Exelixis shall

provide reasonable prior written notice to Licensee of such intention to abandon (which notice

shall, to the extent possible, be given no later than [ * ] prior to the next deadline for any action

that must be taken with respect to any such Joint Patent in the relevant patent office). In such

case, at Licensee’s sole discretion, upon written notice from Licensee to Exelixis, Licensee may

elect to continue prosecution or maintenance of any such Joint Patent at its own expense, and

Exelixis shall execute such documents and perform such acts, at Licensee’s expense, as may be

reasonably necessary to allow Licensee to continue the prosecution and maintenance of such

Joint Patent in such country in the Licensee Territory. Any such assignment shall be completed

in a timely manner to allow Licensee to continue prosecution and maintenance of any such Joint

Patent and any such Patent so assigned shall cease to be either a Joint Patent or a Licensee Patent

and shall no longer be subject to the licenses and other rights granted by Licensee to Exelixis

under this Agreement.

(d)Cooperation. Each Party agrees to cooperate fully in the preparation,

filing, prosecution, maintenance and defense, if any, of Patents under Section 11.2 and in the

obtaining and maintenance of any patent term extensions, supplementary protection certificates

and their equivalent with respect thereto respectively, at its own cost (except as expressly set

forth otherwise in this Article 11). Such cooperation includes: (i) executing all papers and

instruments, or requiring its employees or contractors, to execute such papers and instruments, so

as enable the other Party to apply for and to prosecute patent applications in any country as

permitted by Section 11.2; and (ii) promptly informing the other Party of any matters coming to

such Party’s attention that may affect the preparation, filing, prosecution or maintenance of any

such patent application and the obtaining of any patent term extensions, supplementary

protection certificates and their equivalent.

11.3Patent Enforcement.

(a)Notice. Each Party shall notify the other within [ * ] of becoming aware

of any alleged or threatened infringement by a Third Party of any of the Exelixis Patents

(including Joint Patents) in the Licensee Territory, which infringement adversely affects or is

expected to adversely affect any Product, including any declaratory judgment, opposition, or

similar action alleging the invalidity, unenforceability or non-infringement of any of the Exelixis

Patents (collectively “Product Infringement”).

(b)Enforcement Right. Exelixis shall have the first right to bring and

control any legal action in connection with such Product Infringement at its own expense as it

reasonably determines appropriate. If Exelixis (i) decides not to bring such legal action against a

Product Infringement (the decision of which Exelixis shall inform Licensee promptly) or (ii)

Exelixis otherwise fails to bring such legal action against a Product Infringement within [ * ] of

first becoming aware of such Product Infringement, Licensee shall have the right to bring and

54.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

control any legal action in connection with such Product Infringement at its own expense as it

reasonably determines appropriate after consultation with Exelixis.

(c)Collaboration. Each Party shall provide to the enforcing Party reasonable

assistance in such enforcement, at such enforcing Party’s request and expense, including to be

named in such action if required by Applicable Laws to pursue such action. The enforcing Party

shall keep the other Party regularly informed of the status and progress of such enforcement

efforts, shall reasonably consider the other Party’s comments on any such efforts, including,

without limitation, determination of litigation strategy, filing of material papers to the competent

court. The non-enforcing Party shall be entitled to separate representation in such matter by

counsel of its own choice and at its own expense, but such Party shall at all times cooperate fully

with the enforcing Party.

(d)Expense and Recovery.

(i)Except as set forth in clause (ii) below, the enforcing Party shall be

solely responsible for any cost and expenses incurred by such Party as a result of such

enforcement action. If such Party recovers monetary damages in such enforcement action, such

recovery shall be allocated first to the reimbursement of any expenses incurred by the enforcing

Party in such enforcement action, second to the reimbursement of any expenses incurred by the

other Party in such enforcement action, and any remaining amounts shall be retained by the

enforcing Party.

(ii)Notwithstanding the foregoing, if Exelixis is the enforcing Party

against a Product Infringement in the Licensee Territory, Licensee shall have the option to share

[ * ] percent ([ * ]%) of the cost and expense incurred by Exelixis in such enforcement action,

which option may be exercised by Licensee by providing written notice to Exelixis within [ * ]

after receiving a notice from Exelixis that Exelixis decides to bring such action. If Licensee

exercises such option, then (1) Licensee shall reimburse Exelixis for [ * ] percent ([ * ]%) of all

costs and expenses incurred by Exelixis in such enforcement action, within [ * ] from the date of

invoice for such costs and expenses provided by Exelixis; (2) If Exelixis recovers any monetary

damages in such enforcement action, such recovery shall be allocated [ * ] percent ([ * ]%) to

Exelixis and [ * ] percent ([ * ]%) to Licensee.

(e)Other Infringement. Except for Product Infringement as set forth above,

each Party shall have the exclusive right to enforce its own Patent against any infringement

anywhere in the world. For clarity, Exelixis shall have the exclusive right to enforce (i) the

Exelixis Patents against any infringement in the Licensee Territory that is not a Product

Infringement, and (ii) the Exelixis Patents and Joint Patents against any infringement in the

Exelixis Territory, in each case at its own expense as it reasonably determines appropriate. The

Parties shall discuss global enforcement strategy for the Exelixis Patents and Licensee Patents,

including the defense of validity and enforceability challenges arising from any enforcement

action.

11.4Infringement of Third Party Rights. If any Product used or sold by Licensee,

its Affiliates or Sublicensees becomes the subject of a Third Party’s claim or assertion of

infringement of any intellectual property rights in a jurisdiction within the Licensee Territory,

Licensee shall promptly notify Exelixis and the Parties shall promptly meet to consider the claim

or assertion and the appropriate course of action and may, if appropriate, agree on and enter into

a “common interest agreement” wherein the Parties agree to their shared, mutual interest in the

outcome of such potential dispute. Absent any agreement to the contrary, and subject to claims

55.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

for indemnification under Article 13, each Party defend itself from any such Third Party claim at

its own cost and expense, provided, however, that the provisions of Section 11.3 shall govern the

right of Licensee to assert a counterclaim of infringement of any Exelixis Patents.

11.5Patents Licensed From Third Parties. Each Party’s rights under this Article 11

with respect to the prosecution and enforcement of any Exelixis Patent and Licensee Patent shall

be subject to the rights: (a) retained by any upstream licensor to prosecute and enforce such

Patent Right, if such Patent Right is subject to an upstream license agreement; and (b) granted to

any Third Party prior to such Patent Right becoming subject to the license grant under this

Agreement.

11.6Trademarks.

(a)Product Trademarks. Exelixis shall develop and adopt trademarks,

including trade names, trade dresses, branding, and logos, to be used for the Products (the

“Product Marks”). Exelixis shall own the Product Marks throughout the world and all goodwill

in the Product Marks shall accrue to Exelixis. The Parties (including any Future Exelixis

Licensee to the extent feasible) shall collaborate to have a global, worldwide trademark to be

used on the Product. The Parties acknowledge that Exelixis has been using the trademark

Cometriq® for the Product in MTC, and unless otherwise mutually agreed, the Parties shall

continue to use Cometriq® in MTC. Exelixis shall select another Product Mark for the Product

to be used for all other indications. In the event Exelixis is unable to obtain or maintain the

Product Marks for the Product in the Licensee Territory or in some countries in the Licensee

Territory, the Parties shall collaborate to select such other Product Marks (i.e., back-up names) as

may be available for registration and marketing of the Product in those countries. Exelixis shall

be responsible for the registration, maintenance, defense and enforcement of the Product Marks

using counsel of its own choice in the Exelixis Territory and counsel mutually agreed to by the

Parties in the Licensee Territory. Licensee shall reimburse Exelixis for all costs and expenses

incurred with respect to the registration and maintenance of the Product Marks in the Licensee

Territory, within [ * ] from the date of invoice for such costs and expenses provided by Exelixis.

Exelixis shall keep Licensee informed of material progress with regard to the registration,

prosecution, maintenance and defense, if any, of Exelixis Trademarks in the Licensee Territory,

including content, timing and jurisdiction of the filing of such Exelixis Trademarks in the

Licensee Territory, sufficiently in advance for Licensee to be able to review any material

documents, and Exelixis shall consult with, and consider in good faith the requests and

suggestions of, Licensee with respect to strategies for filing, prosecuting and defending, if any,

Exelixis Trademarks in the Licensee Territory.

(i)Without limiting the generality of the foregoing Section 11.6(a),

the Parties shall use the trademark Cabometyx® for the Product in Canada to the extent that such

trademark is approved for use with the Product by Health Canada or other applicable Regulatory

Authority. If Exelixis is unable to obtain or register Cabometyx® for use with the Product in

Canada, the Parties shall collaborate to select another Product Mark to be used for the Product in

Canada. In accordance with Section 11.6(a), Exelixis shall own the Product Marks used for the

Product in Canada and all goodwill in such Products Marks shall accrue to Exelixis.

(b)Trademark License. Licensee shall use the Product Marks selected by

Exelixis to Commercialize the Product in the Licensee Territory. Where Licensee reasonably

believes the Product Mark is not appropriate for commercial use in a specific country, the Parties

shall agree on an alternative product trademark for such country and such alternative product

trademark shall be included in Product Mark. In addition, unless prohibited by Applicable Laws,

56.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Licensee shall use Commercially Reasonable Effort to include Exelixis’ corporate trademark on

the packaging and product information (i.e. SmPC) of the Products sold in the Licensee Territory

to indicate that the Product is licensed from Exelixis. Exelixis hereby grants to Licensee a

limited royalty-free license to use such Product Marks and Exelixis’ corporate trademark solely

in connection with the Commercialization of the Product in the Licensee Territory under this

Agreement. All use of the Product Marks and Exelixis’ corporate trademark shall comply with

Applicable Laws and regulations and shall be subject to Exelixis’ review and approval. For

clarity, Licensee shall also include its (or its Affiliate’s or Sublicensee’s) corporate logo in the

Product sold in the Licensee Territory.

12.Representations and Warranties

12.1Mutual Representations and Warranties. Each Party represents and warrants

to the other that, as of the Effective Date: (a) it is duly organized and validly existing under the

laws of its jurisdiction of incorporation or formation, and has full corporate or other power and

authority to enter into this Agreement and to carry out the provisions hereof, (b) it is duly

authorized to execute and deliver this Agreement and to perform its obligations hereunder, and

the person or persons executing this Agreement on its behalf has been duly authorized to do so

by all requisite corporate or partnership action, (c) this Agreement is legally binding upon it,

enforceable in accordance with its terms, and does not conflict with any agreement, instrument or

understanding, oral or written, to which it is a Party or by which it may be bound, nor violate any

material law or regulation of any court, governmental body or administrative or other agency

having jurisdiction over it, and (d) it has the right to grant the licenses granted by it under this

Agreement.

12.2Covenants.

(a)Employees, Consultants and Contractors. Each Party covenants that it

has obtained or will obtain written agreements from each of its employees, consultants and

contractors who perform Development activities pursuant to this Agreement, which agreements

will obligate such persons to obligations of confidentiality and non-use and to assign (or, in the

case of contractor, grant a license under) Inventions in a manner consistent with the provisions of

this Agreement.

(b)Debarment. Each Party represents, warrants and covenants to the other

Party that it is not debarred or disqualified under the U.S. Federal Food, Drug and Cosmetic Act,

as may be amended, or comparable laws in any country or jurisdiction other than the U.S., and it

does not, and will not during the Term, employ or use the services of any person who is debarred

or disqualified, in connection with activities relating to any Product. In the event that either

Party becomes aware of the debarment or disqualification or threatened debarment or

disqualification of any person providing services to such Party, including the Party itself or its

Affiliates or Sublicensees, that directly or indirectly relate to activities contemplated by this

Agreement, such Party shall immediately notify the other Party in writing and such Party shall

cease employing, contracting with, or retaining any such person to perform any such services.

(c)Compliance. Licensee covenants as follows:

(i)In the performance of its obligations under this Agreement,

Licensee shall comply and shall cause its and its Affiliates’ employees and contractors to comply

with all Applicable Laws.

57.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(ii)Licensee and its Affiliates’ employees and contractors shall not, in

connection with the performance of their respective obligations under this Agreement, directly or

indirectly through Third Parties, pay, promise or offer to pay, or authorize the payment of, any

money or give any promise or offer to give, or authorize the giving of anything of value to a

Public Official or Entity or other person for purpose of obtaining or retaining business for or

with, or directing business to, any person, including, Licensee (and Licensee represents and

warrants that as of the Effective Date, Licensee, and to its knowledge, its and its Affiliates’

employees and contractors, have not directly or indirectly promised, offered or provided any

corrupt payment, gratuity, emolument, bribe, kickback, illicit gift or hospitality or other illegal or

unethical benefit to a Public Official or Entity or any other person in connection with the

performance of Licensee’s obligations under this Agreement, and Licensee covenants that it and

its Affiliates’ employees and contractors shall not, directly or indirectly, engage in any of the

foregoing).

(iii)Licensee and its Affiliates, and their respective employees and

contractors, in connection with the performance of their respective obligations under this

Agreement, shall not cause its Indemnitees to be in violation of the FCPA, Export Control Laws,

or any other Applicable Laws, rules or regulations or otherwise cause any reputational harm to

Exelixis.

(iv)Licensee shall immediately notify Exelixis if Licensee has any

information or suspicion that there may be a violation of the FCPA, Export Control Laws, or any

other Applicable Laws, rules or regulations in connection with the performance of this

Agreement or the Development, manufacture or Commercialization of any Product.

(v)In connection with the performance of its obligations under this

Agreement, Licensee shall comply and shall cause its and its Affiliates’ employees and

contractors to comply with Licensee’s own anti-corruption and anti-bribery policy, a copy of

which has been provided to Exelixis prior to the Effective Date.

(vi)Exelixis will have the right, upon reasonable prior written notice

and during Licensee’s regular business hours, to conduct at its own cost and expenses inspections

of and to audit Licensee’s books and records in the event of a suspected violation or to ensure

compliance with the representations, warranties or covenants of this Section 12.2(c); provided,

however, that in the absence of good cause for such inspections and audits, Exelixis exercise this

right no more than annually.

(vii)In the event that Licensee has violated or been suspected of

violating any of the representations, warranties, or covenants in this Section 12.2(c), Licensee

will cause its or its Affiliates’ personnel or others working under its direction or control to

submit to periodic training that Licensee will provide on anti-corruption law compliance.

(viii)Licensee will, at Exelixis’ request, annually certify to Exelixis in

writing Licensee’s compliance, in connection with the performance of Licensee’s obligations

under this Agreement, with the representations, warranties, or covenants in Section 12.2(c),

which certification shall be issued by Licensee’s global commercial head for the Product.

(ix)Exelixis shall have the right to suspend or terminate this

Agreement in its entirety where there is a credible finding, after a reasonable investigation, that

Licensee, its Affiliates, or its Sublicensees, in connection with performance of Licensee’s

obligations under this Agreement, has engaged in chronic or material violations of the FCPA.

58.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

12.3Additional Exelixis Representations, Warranties and Covenants. Exelixis

represents, warrants and covenants, as applicable, to Licensee that, as of the Effective Date:

(a)Exhibit B-1 lists all Patents Controlled by Exelixis in the Licensee

Territory as of the Effective Date that claim the composition of matter or use of the Compound

and have been filed, prosecuted and maintained in a manner consistent with Exelixis’ standard

practice, in each applicable jurisdiction in which such Patent have been filed, that no official

final deadlines with respect to prosecution thereof have been missed and all applicable fees have

been paid on or before the due date for payment;

(b)All inventors of Inventions claimed in the Patent listed on Exhibit B-1

have assigned their entire right, title and interest in and to such inventions to Exelixis and the

inventors listed are correct and there are no claims or assertions in writing received by Exelixis

regarding the inventorship of such Patent alleging that additional or alternative Inventors ought

to be listed;

(c)Exelixis has the right to grant all rights and licenses it purports to grant to

Licensee with respect to the Exelixis Technology under this Agreement;

(d)Exelixis has not granted any liens or security interests on the Exelixis

Technology;

(e)Exelixis has not received any written notice from a Third Party that the

Development of any Product conducted by Exelixis prior to the Effective Date has infringed any

Patents of any Third Party;

(f)Exelixis has not as of the Effective Date, and will not during the Term,

grant any right to any Third Party under the Exelixis Technology that would conflict with the

rights granted to Licensee hereunder;

(g)no claim or action has been brought or, to Exelixis’ knowledge, threatened

in writing, by any Third Party alleging that the Exelixis Patents are invalid or unenforceable, and

no Exelixis Patent is the subject of any interference, opposition, cancellation or other protest

proceeding [ * ];

(h)to Exelixis’ knowledge, no Third Party is infringing or misappropriating

or has infringed or misappropriated the Exelixis Technology in the Licensee Territory;

(i)Exelixis has disclosed to Licensee all clinical and non-clinical data in the

Control of Exelixis that is material to the evaluation of the safety, efficacy and manufacturing

process of the Product; and

(j)to Exelixis’ knowledge, there are no issues or information, which to

Exelixis’ knowledge and reasonable opinion, are reasonably likely to have a material impact on

the Development of the Product that have not been fully disclosed to Licensee in the course of

Licensee’s due diligence.

12.4Additional Licensee Representations, Warranties and Covenants. Licensee

represents, warrants and covenants to Exelixis that, as of the Effective Date, Licensee has not

granted, and will not grant during the Term, any right to any Third Party under the Licensee

Technology that would conflict with the rights granted to Exelixis hereunder. Licensee further

59.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

represents, warrants and covenants to Exelixis that, as of the Effective Date, Licensee does not

own or control any Licensee Patents.

12.5Disclaimer. Except as expressly set forth in this Agreement, THE

TECHNOLOGY AND INTELLECTUAL PROPERTY RIGHTS PROVIDED BY EACH

PARTY HEREUNDER ARE PROVIDED “AS IS” AND EACH PARTY EXPRESSLY

DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED,

INCLUDING THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A

PARTICULAR PURPOSE, NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY

RIGHTS OF THIRD PARTIES, OR ARISING FROM A COURSE OF DEALING, USAGE OR

TRADE PRACTICES, IN ALL CASES WITH RESPECT THERETO. Without limiting the

foregoing, (a) neither Party represents or warrants that any data obtained from conducting

Clinical Trials in one country or jurisdiction will comply with the laws and regulations of any

other country or jurisdiction, and (b) neither Party represents or warrants the success of any study

or test conducted by pursuant to this Agreement or the safety or usefulness for any purpose of the

technology it provides hereunder.

13.Indemnification

13.1Indemnification by Exelixis. Exelixis hereby agrees to defend, indemnify and

hold harmless Licensee and its Affiliates and their respective directors, officers, employees and

agents (each, an “Licensee Indemnitee”) from and against any and all liabilities, expenses and

losses including any product liability, personal injury, property damage, including reasonable

legal expenses and attorneys’ fees (collectively, “Losses”), to which any Licensee Indemnitee

may become subject as a result of any claim, demand, action or other proceeding by any Third

Party to the extent such Losses arise out of: (a) the Development, use, handling, storage,

Commercialization or other disposition of any Compound or Product by Exelixis or its Affiliates

or licensees or the contractors of any of them (excluding any activities by or on behalf of

Licensee or its Affiliates or Sublicensees), (b) the gross negligence or willful misconduct of any

Exelixis Indemnitee, or (c) the breach by Exelixis of any warranty, representation, covenant or

agreement made by Exelixis in this Agreement; except, in each case (a)-(c), to the extent such

Losses arise out of any activities set forth in Section 13.2(a), (b) or (c) for which Licensee is

obligated to indemnify the Exelixis Indemnitee under Section 13.2.

13.2Indemnification by Licensee. Licensee hereby agrees to defend, indemnify and

hold harmless Exelixis, its Affiliates and licensees and their respective directors, officers,

employees and agents (each, a “Exelixis Indemnitee”) from and against any and all Losses to

which any Exelixis Indemnitee may become subject as a result of any claim, demand, action or

other proceeding by any Third Party to the extent such Losses arise out of: (a) the Development,

use, handling, storage, Commercialization or other disposition of any Compound or Product by

Licensee or its Affiliates or Sublicensees or the contractor of any of them, (b) the gross

negligence or willful misconduct of any Licensee Indemnitee, or (c) the breach by Licensee of

any warranty, representation, covenant or agreement made by Licensee in this Agreement;

except, in each case (a)-(c), to the extent such Losses arise out of any activities set forth in

Section 13.1(a), (b) or (c) for which Exelixis is obligated to indemnify the Licensee Indemnitee

under Section 13.1.

13.3Procedure. A party that intends to claim indemnification under this Article 13

(the “Indemnitee”) shall promptly notify the indemnifying Party (the “Indemnitor”) in writing

of any Third Party claim, demand, action or other proceeding (each, a “Claim”) in respect of

which the Indemnitee intends to claim such indemnification, and the Indemnitor shall have sole

60.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

control of the defense or settlement thereof. The Indemnitee may participate at its expense in the

Indemnitor’s defense of and settlement negotiations for any Claim with counsel of the

Indemnitee’s own selection. The indemnity arrangement in this Article 13 shall not apply to

amounts paid in settlement of any action with respect to a Claim, if such settlement is effected

without the consent of the Indemnitor, which consent shall not be withheld or delayed

unreasonably. The failure to deliver written notice to the Indemnitor within a reasonable time

after the commencement of any action with respect to a Third Party Claim shall only relieve the

Indemnitor of its indemnification obligations under this Article 13 if and to the extent the

Indemnitor is actually prejudiced thereby. The Indemnitee shall cooperate fully with the

Indemnitor and its legal representatives in the investigation of any action with respect to a Claim

covered by this indemnification.

13.4Insurance. Each Party, at its own expense, for a period until [ * ] after expiration

or termination of this Agreement, shall maintain commercial general liability insurance,

including public and product liability and other appropriate insurance (e.g., contractual liability,

bodily injury, property damage and personal injury coverage) (or self-insure) in an amount

consistent with sound business practice and reasonable in light of its obligations under this

Agreement during the Term, at a minimum equivalent to [ * ] dollars ($[ * ]) for any one claim or

in the aggregate. Each Party shall provide a certificate of insurance (or evidence of self-

insurance) evidencing such coverage to the other Party upon request. It is understood that such

insurance shall not be construed to create any limit of either Party’s obligations or liabilities with

respect to its indemnification obligations hereunder. In the event of use by either Party of

subcontractors, Sublicensees or any Third Party in the performance of such Party’s obligations

under the Agreement, such Party shall ensure that its subcontractor, Sublicensee or Third Party

shall have a proper and adequate general liability insurance to cover its risks with respect to the

other Party for damages mentioned above.

13.5Limitation of Liability. EXCEPT FOR LIABILITY FOR BREACH OF

ARTICLE 14, NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE

OTHER PARTY ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE

DAMAGES, INCLUDING LOST PROFITS IN CONNECTION WITH THIS AGREEMENT

OR ANY LICENSE GRANTED HEREUNDER; provided, however, that this Section 13.5 shall

not be construed to limit either Party’s indemnification obligations under this Article 13.

14.Confidentiality

14.1Confidential Information. Except to the extent expressly authorized by this

Agreement or otherwise agreed in writing by the Parties, the Parties agree that, during the Term

and for [ * ] thereafter, the receiving Party shall keep confidential and shall not publish or

otherwise disclose and shall not use for any purpose other than as expressly provided for in this

Agreement any Confidential Information of the other Party, and both Parties shall keep

confidential and, subject to Sections 14.2, 14.3 and 14.5, shall not publish or otherwise disclose

the terms of this Agreement. Each Party may use the other Party’s Confidential Information only

to the extent required to accomplish the purposes of this Agreement, including exercising its

rights or performing its obligations under this Agreement. Each Party will use at least the same

standard of care as it uses to protect proprietary or confidential information of its own (but no

less than reasonable care) to ensure that its employees, agents, consultants, contractors and other

representatives do not disclose or make any unauthorized use of the Confidential Information of

the other Party. Each Party will promptly notify the other upon discovery of any unauthorized

use or disclosure of the Confidential Information of the other Party.

61.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

14.2Exceptions. The obligations of confidentiality and restriction on use under

Section 14.1 will not apply to any information that the receiving Party can prove by competent

written evidence: (a) is now, or hereafter becomes, through no act or failure to act on the part of

the receiving Party, generally known or available to the public; (b) is known by the receiving

Party at the time of receiving such information, other than by previous disclosure of the

disclosing Party, or its Affiliates, employees, agents, consultants, or contractors; (c) is hereafter

furnished to the receiving Party without restriction by a Third Party who has no obligation of

confidentiality or limitations on use with respect thereto, as a matter of right; or (d) is

independently discovered or developed by the receiving Party without the use of Confidential

Information belonging to the disclosing Party.

14.3Authorized Disclosure. Each Party may disclose Confidential Information

belonging to the other Party as expressly permitted by this Agreement or if and to the extent such

disclosure is reasonably necessary in the following instances:

(a)filing, prosecuting, or maintaining Patents as permitted by this Agreement;

(b)regulatory filings for Products that such Party has a license or right to

Develop and Commercialize hereunder in a given country or jurisdiction;

(c)prosecuting or defending litigation as permitted by this Agreement;

(d)complying with applicable court orders or governmental regulations; and

(e)disclosure to its and its Affiliates’ employees, consultants, contractors and

agents, to its licensees and sublicensees, in each case on a need-to-know basis in connection with

the Development, manufacture and Commercialization of the Compound and Products in

accordance with the terms of this Agreement, in each case under written obligations of

confidentiality and non-use at least as stringent as those herein; and

(f)disclosure to potential and actual investors, acquirors, licensees and other

financial or commercial partners solely for the purpose of evaluating or carrying out an actual or

potential investment, acquisition or collaboration, in each case under written obligations of

confidentiality and non-use at least as stringent as those herein, provided that the disclosing Party

redacts the financial terms and other provisions of this Agreement that are not reasonably

required to be disclosed in connection with such potential investment, acquisition or

collaboration, which redaction shall be prepared in consultation with the other Party.

Notwithstanding the foregoing, in the event a Party is required to make a disclosure of the other

Party’s Confidential Information pursuant to Section 14.3(c) or 14.3(d), it will, except where

impracticable, give reasonable advance notice to the other Party of such disclosure and use

efforts to secure confidential treatment of such Confidential Information at least as diligent as

such Party would use to protect its own confidential information, but in no event less than

reasonable efforts. In any event, the Parties agree to take all reasonable action to avoid

disclosure of Confidential Information hereunder. Any information disclosed pursuant to

Section 14.3(c) or 14.3(d) shall remain Confidential Information and subject to the restrictions

set forth in this Agreement, including the foregoing provisions of this Article 14.

14.4Publications.

62.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(a)Each Party shall have the right to review and comment on any material

proposed for disclosure or publication by the other Party regarding results of and other

information regarding the other Party’s Development activities with respect to [ * ], whether by

oral presentation, manuscript or abstract. Before any such material is submitted for publication,

or presentation of any such material is made, each Party shall deliver a complete copy of the

material proposed for disclosure to the other Party at least three (3) weeks (for oral presentations

or abstracts) or five (5) weeks (for manuscripts) prior to submitting the material to a publisher or

initiating any other disclosure. Each Party shall review any such material and give its comments

to the other Party within two (2) weeks (for oral presentations or abstracts) or twenty (20) days

(for manuscripts) of the receipt of such material. With respect to oral presentation materials and

abstracts, each Party shall make reasonable efforts to expedite review of such materials and

abstracts, and shall return such items as soon as practicable to the other Party with appropriate

comments, if any. Each Party shall comply with the other Party’s request to delete references to

its Confidential Information in any such material and agrees to not make any submission for

publication or other public disclosure in order not to jeopardize the patentability of any results or

data for the purpose of preparing and filing appropriate patent applications as provided in Section

14.4(b).

(b)If the non-Publishing Party notifies the Publishing Party that such

publication or presentation, in the non-Publishing Party’s reasonable judgment, (i) contains an

invention for which such Party desires to obtain patent protection, (ii) contains any Confidential

Information of such Party, or (iii) could be expected to have an adverse effect on the commercial

value of any Confidential Information disclosed by such Party to the Publishing Party, the

Publishing Party shall delete such Confidential Information from the proposed publication or

presentation.

(c)For as long as the JDC or JCC remains in place, the JDC or JCC shall be

responsible for overseeing and facilitating the Parties’ communications and activities with

respect to publications and presentations under this Section, and for serving as the initial forum

for resolving any disputes between the Parties arising under this Section.

14.5Publicity; Public Disclosures. The Parties agree to issue a joint press release

substantially in a form agreed by the Parties and attached to this Agreement as Exhibit E

announcing the signature of this Agreement at or shortly after the Effective Date within the time-

period as required by relevant securities laws. It is understood that each Party may desire or be

required to issue subsequent press releases relating to this Agreement or activities hereunder.

The Parties agree to consult with each other reasonably and in good faith with respect to the text

and timing of such press releases prior to the issuance thereof, to the extent practicable, provided

that a Party may not unreasonably withhold, condition or delay consent to such releases by more

than [ * ], and that either Party may issue such press releases or make such disclosures to the

SEC or other applicable agency as it determines, based on advice of counsel, as reasonably

necessary to comply with laws or regulations or for appropriate market disclosure. Each Party

shall provide the other Party with advance notice of legally required disclosures to the extent

practicable. The Parties will consult with each other on the provisions of this Agreement to be

redacted in any filings made by a Party with the SEC or as otherwise required by Applicable

Laws; provided that each Party shall have the right to make any such filing as it reasonably

determines necessary under Applicable Laws. In addition, following the initial joint press

release announcing this Agreement, either Party shall be free to disclose, without the other

Party’s prior written consent, the existence of this Agreement, the identity of the other Party and

those terms of the Agreement which have already been publicly disclosed in accordance

herewith.

63.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

14.6Prior Confidentiality Agreement. As of the Effective Date, the terms of this

Article 14 shall supersede any prior non-disclosure, secrecy or confidentiality agreement

between the Parties (or their Affiliates) relating to the subject of this Agreement, including the

Confidentiality Agreement. Any information disclosed pursuant to any such prior agreement

shall be deemed Confidential Information for purposes of this Agreement.

14.7Equitable Relief. Given the nature of the Confidential Information and the

competitive damage that a Party would suffer upon unauthorized disclosure, use or transfer of its

Confidential Information to any Third Party, the Parties agree that monetary damages may not be

a sufficient remedy for any breach of this Article 14. In addition to all other remedies, a Party

shall be entitled to seek specific performance and injunctive and other equitable relief as a

remedy for any breach or threatened breach of this Article 14.

15.Term and Termination

15.1Term.

(a)This Agreement shall commence on the Restatement Date and, unless

terminated earlier as provided in this Article 15 or by mutual written agreement of the Parties,

shall continue until the expiration of the last Royalty Term in the Licensee Territory (the

“Term”).

(b)Notwithstanding anything herein, on a Product-by-Product and country-

by-country basis, upon the expiration of the Royalty Term (i.e., all royalty payment obligations

for a Product in a country), the licenses granted to Licensee in Section 2.1 shall be deemed to be

perpetual and fully paid-up with respect to such Product in such country, but thereafter shall be

on a non-exclusive basis.

15.2Termination for Cause.

(a)Material Breach. Each Party shall have the right to terminate this

Agreement immediately in its entirety upon written notice to the other Party if such other Party

materially breaches this Agreement and has not cured such breach to the reasonable satisfaction

of the other Party within [ * ] ([ * ] with respect to any payment breach) after notice of such

breach from the non-breaching Party. If the alleged breaching Party disputes in good faith the

existence or materiality of a breach specified in a notice provided by the other Party, and such

alleged breaching Party provides the other Party notice of such dispute within [ * ], then the other

Party shall not have the right to terminate this Agreement under this Section 15.2 unless and until

an arbitral panel, in accordance with Article 16, has determined that the alleged breaching Party

has materially breached the Agreement and that such Party fails to cure such breach within the

applicable cure period set forth above following such decision. In the event Exelixis commences

an arbitration alleging material breach by Licensee and Licensee later delivers notice of

voluntary termination under Section 15.3(b), then, at the election of Exelixis, the period of time

set forth in Section 15.3(b) shall be reduced by an amount of time equal to the duration of time

from the commencement of the arbitration to the delivery of such notice, [ * ].

(b)Bankruptcy. Each Party shall have the right to terminate this Agreement

immediately in its entirety upon written notice to the other Party if such other Party makes a

general assignment for the benefit of creditors, files an insolvency petition in bankruptcy,

petitions for or acquiesces in the appointment of any receiver, trustee or similar officer to

liquidate or conserve its business or any substantial part of its assets, commences under the laws

64.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

of any jurisdiction any proceeding involving its insolvency, bankruptcy, reorganization,

adjustment of debt, dissolution, liquidation or any other similar proceeding for the release of

financially distressed debtors or becomes a party to any proceeding or action of the type

described above and such proceeding is not dismissed within [ * ] after the commencement

thereof.

(c)Patent Challenge. Exelixis shall have the right to terminate this

Agreement immediately in its entirety upon written notice to Licensee if Licensee or any of its

Affiliates or Sublicensees directly, or indirectly through any Third Party, commences any

interference or opposition proceeding with respect to, challenges the validity or enforceability of,

or opposes any extension of or the grant of a supplementary protection certificate with respect to,

any Exelixis Patent.

(d)Safety Reasons. Either Party shall have the right to terminate this

Agreement upon written notice to the other Party if the terminating Party reasonably determines,

based upon additional information that becomes available or an analysis of the existing

information at any time, that the medical risk/benefit of such Product is so unfavorable that it

would be incompatible with the welfare of patients to Develop or Commercialize or to continue

to Develop or Commercialize such Product. Prior to any such termination, the terminating Party

shall comply with such internal review and management approval processes as it would normally

follow in connection with the termination of the development and commercialization of its own

products for safety reasons. The terminating Party shall document the decisions of such

committees or members of management and the basis therefor and shall make such minutes and

documentation available to the other Party promptly upon written request.

(e)Discontinuation of Clinical Trials. Licensee may terminate this

Agreement upon [ * ] advance written notice to Exelixis, if substantially all ongoing Clinical

Trials of the Product are ordered or required to be terminated by the FDA or the EMA.

15.3Termination without Cause.

(a)Termination in Its Entirety by Licensee. Licensee shall have the right

to terminate this Agreement in its entirety, or for only the countries that are under the EMA

jurisdiction, without cause upon [ * ] prior written notice to Exelixis if the EMA refuses to

approve the MAA for the Product in Renal Cell Carcinoma (2nd line therapy). For the purpose

of this Section 15.3(a), if EMA conditions such MAA Approval on the performance of additional

Phase 3b or other studies, then EMA shall not be deemed to have refused the approval of such

MAA.

(b)Termination by Region by Licensee. Licensee shall have the right to

terminate this Agreement on a Region-by-Region basis without cause upon [ * ] prior written

notice to Exelixis following the First Commercial RCC Sale of any Product in a given Region;

provided however that Licensee may not provide such notice of termination of this Agreement in

a Region prior to the [ * ] anniversary of the First Commercial RCC Sale of any Product (other

than Cometriq) in such Region. In the event that termination occurs for the EU, then termination

shall automatically be considered to have occurred for the entire Licensee Territory.

15.4Effects of Termination. Upon any termination of this Agreement by either

Party, the following will apply: If this Agreement is terminated only with respect to a particular

Region, then the following shall apply to the terminated Region and the terminated Region shall

be included in Exelixis Territory. For clarity, during the pendency of any dispute regarding

65.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

material breach and/or any termination notice period, all of the terms and conditions of this

Agreement shall remain in effect and the Parties shall continue to perform all of their respective

obligations hereunder.

(a)Licenses. All licenses granted by Exelixis to Licensee will automatically

terminate, including all sublicenses granted by Licensee to any Sublicensee. Except in the event

of termination by Licensee under Section 15.2(a) for material breach by Exelixis, the licenses

granted by Licensee to Exelixis shall survive such termination and shall automatically become

worldwide or for the terminated Region if the Agreement is terminated only for a particular

Region.

(b)Regulatory Materials; Data. Except in the event of termination by

Licensee under Section 15.2(a) for material breach by Exelixis, within [ * ] of the effective date

of such termination, Licensee shall transfer and assign to Exelixis, at no cost to Exelixis, all

Regulatory Filings and Regulatory Approvals for the Products, Data from all preclinical, non-

clinical and clinical studies conducted by or on behalf of Licensee, its Affiliates or Sublicensees

on the Product and all pharmacovigilance data (including all adverse event database) on the

Products. In addition, at Exelixis’ request, Licensee shall provide Exelixis with reasonable

assistance with any inquiries and correspondence with Regulatory Authorities regarding the

Product in the Licensee Territory, such assistance shall be limited to a period of [ * ] after such

termination and not to exceed a total of [ * ] of working time without charge (with any additional

time to be charged at the FTE Rate). The transfer and assignment under this Section 15.4(b)

shall apply with respect to the terminated Region if the Agreement is terminated only for a

particular Region.

(c)Development Wind-Down. Licensee shall either, as directed by Exelixis,

(i) wind-down any ongoing Development activities (including any Clinical Trials) of Licensee

and its Affiliates and Sublicensees with respect to any Product in the Licensee Territory in an

orderly fashion or (ii) promptly transfer such Development activities to Exelixis or its designee,

in compliance with all Applicable Laws.

(d)Cost of Ongoing Trials. If there is any ongoing Clinical Trial of the

Product under the GDP for which the Parties are sharing cost, then Licensee shall continue to

share the cost of such Clinical Trial until the effective date of termination. The remaining costs

from the effective date of termination until completion of such Clinical Trial (or early

termination of such Clinical Trial by Exelixis) shall be either (i) borne entirely by Exelixis

following the effective date of termination if termination occurs as a result of Exelixis’ breach, or

(ii) shared by Licensee for the duration of such Clinical Trial if termination occurs as a result of

Licensee’s breach, or pursuant to Section 15.3 or Section 2.8(c)(i).

(e)Commercial Wind-Down. Licensee shall, as directed by Exelixis, (i)

continue certain ongoing Commercial activities of Licensee and its Affiliates and Sublicensees

with respect to any Product in the Licensee Territory for a period of up to [ * ] as determined by

Exelixis, and (ii) handoff such Commercial activities to Exelixis or its designee, on a timetable to

be set by Exelixis, not to exceed [ * ], and in compliance with all Applicable Laws. During such

commercial wind-down period, the Licensee shall continue to book sales and pay royalties to

Exelixis. Except as necessary to conduct the foregoing activities as directed by Exelixis,

Licensee shall immediately discontinue its (and shall ensure that its Affiliates and Sublicensees

immediately discontinue their) promotion, marketing, offering for sale, and servicing of the

Product and its use of all Product Marks. In addition, Licensee shall immediately deliver to

66.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Exelixis (at Licensee’s expense) all samples, demonstration equipment, sales materials, catalogs,

and literature of Exelixis in Licensee’s possession or control.

(f)Transition Assistance. Licensee shall use Commercially Reasonable

Efforts to seek an orderly transition of the Development and Commercialization of the

Compound and Products to Exelixis or its designee. Except for termination by Licensee under

Section 15.2, Exelixis may, in its sole discretion, postpone the effective date of any termination

for a period of up to [ * ]. Except in the event of termination by Licensee under Section 15.2(a)

for material breach by Exelixis, Licensee shall, at no cost to Exelixis, provide reasonable

consultation and assistance for a period of no more than [ * ] after termination (and in any case

not to exceed a total of [ * ] of working time including the assistance provided under Section

15.4(b)) for the purpose of transferring or transitioning to Exelixis all Licensee Know-How not

already in Exelixis’ possession and, at Exelixis’ request, all then-existing commercial

arrangements relating to the Products that Licensee is able, using Commercially Reasonable

Efforts, to transfer or transition to Exelixis or its designee, in each case, to the extent reasonably

necessary or for Exelixis to continue the Development and/or Commercialization of the

Compound and Products in the Licensee Territory. If any such contract between Licensee and a

Third Party is not assignable to Exelixis or its designee (whether by such contract’s terms or

because such contract does not relate specifically to the Products) but is otherwise reasonably

necessary for Exelixis to continue the Development and/or Commercialization of the Compound

and Products in the Licensee Territory, or if Licensee is performing such work for the Compound

and Product itself (and thus there is no contract to assign), then Licensee shall reasonably

cooperate with Exelixis to negotiate for the continuation of such services for Exelixis from such

entity, or Licensee shall continue to perform such work for Exelixis, as applicable, for a

reasonable period (not to exceed [ * ]) after termination at Exelixis’ cost until Exelixis

establishes an alternate, validated source of such services.

(g)Remaining Inventories. Exelixis shall have the right, at its discretion, to

purchase from Licensee any or all of the inventory of the Products held by Licensee as of the

date of termination at a price equal to the transfer price paid by Licensee to acquire such

inventory from Exelixis. Exelixis shall notify Licensee within [ * ] after the date of termination

whether Exelixis elects to exercise such right.

(h)Non-Compete. Following any termination of this Agreement by Licensee

pursuant to Section 2.8(c)(i) or Section 15.3, or by Exelixis pursuant to Section 15.2, neither

Licensee nor any of its Affiliates shall (directly or indirectly, either with or without a bona fide

collaborator or any other Third Party) commercialize any Competing Product for either (i) a

period of [ * ] (in case of termination pursuant to Section 2.8(c)(i)) or [ * ] (in case of termination

by Licensee pursuant to Section 15.3 or Exelixis pursuant to Section 15.2) following the

effective date of such termination, or (ii) [ * ], whichever is shorter.

15.5Confidential Information. Upon expiration or termination of this Agreement in

its entirety, except to the extent that a Party obtains or retains the right to use the other Party’s

Confidential Information, each Party shall promptly return to the other Party, or delete or

destroy, all relevant records and materials in such Party’s possession or control containing

Confidential Information of the other Party; provided that such Party may keep one copy of such

materials for archival purposes only subject to continuing confidentiality obligations. All

Licensee Data and Regulatory Filings assigned to Exelixis upon termination of this Agreement

will be deemed Exelixis’ Confidential Information and no longer Licensee’s Confidential

Information.

67.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

15.6Survival. Expiration or termination of this Agreement shall not relieve the

Parties of any obligation or right accruing prior to such expiration or termination. Except as set

forth below or elsewhere in this Agreement, the obligations and rights of the Parties under the

following provisions of this Agreement shall survive expiration or termination of this

Agreement: Article 1 (Definitions); Article 10 (Payments, Records, Audits); Article 13

(Indemnification); Article 15 (Dispute Resolution); Article 17 (General Provisions); Section 5.10

(Sunshine Reporting Laws); Section 11.1 (IP Ownership); Sections 14.1, 14.2, 14.3, 14.6, 14.7

(Confidentiality); and Section 15.4 (Effects of Termination).

15.7Exercise of Right to Terminate. All rights and obligations of a Party accrued

prior to the effective date of a termination (including the rights to receive reimbursement for

costs incurred prior to the effective date of such termination and payments accrued or due prior

to the effective date of such termination) shall survive such termination.

15.8Rights in Bankruptcy. All rights and licenses granted under or pursuant to this

Agreement by one Party to the other Party are, and will otherwise be deemed to be, for purposes

of Section 365(n) of the U.S. Bankruptcy Code or comparable provision of applicable

bankruptcy or insolvency laws, licenses of right to “intellectual property” as defined under

Section 101 of the U.S. Bankruptcy Code or comparable provision of applicable bankruptcy or

insolvency laws. The Parties agree that a Party that is a licensee of such rights under this

Agreement will retain and may fully exercise all of its rights and elections under the U.S.

Bankruptcy Code or comparable provision of applicable bankruptcy or insolvency laws. The

Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or

against a Party to this Agreement under the U.S. Bankruptcy Code or comparable provision of

applicable bankruptcy or insolvency laws, the other Party will be entitled to a complete duplicate

of (or complete access to, as appropriate) any such intellectual property and all embodiments of

such intellectual property, and same, if not already in its possession, will be promptly delivered

to it (a) upon any such commencement of a bankruptcy or insolvency proceeding upon its written

request therefor, unless the bankrupt Party elects to continue to perform all of its obligations

under this Agreement, or (b) if not delivered under (a) above, following the rejection of this

Agreement by or on behalf of the bankrupt Party upon written request therefor by the other Party.

16.Dispute Resolution

16.1Objective. The Parties recognize that disputes as to matters arising under or

relating to this Agreement or either Party’s rights and obligations hereunder may arise from time

to time. It is the objective of the Parties to establish procedures to facilitate the resolution of

such disputes in an expedient manner by mutual cooperation and without resort to litigation. To

accomplish this objective, the Parties agree to follow the procedures set forth in this Article 16 to

resolve any such dispute if and when it arises.

16.2Executive Mediation. The Parties will try to settle any dispute, controversy or

claim that arises out of, or relates to, any provision of the Agreement (“Disputed Matter”) by

first referring the Disputed Matter to the CEO of Exelixis (or his designee) and the CEO of

Licensee (or his designee). Either Party may initiate such informal dispute resolution by sending

written notice of the Disputed Matter to the other Party, and, within [ * ] after such notice, such

CEOs (or their respective designees having the authority to settle such Disputed Matter) of the

Parties will meet for attempted resolution by good faith negotiations. If such CEOs (or their

respective designees) are unable to resolve such dispute within [ * ] of their first meeting for such

negotiations, either Party may seek to have such dispute resolved in accordance with Section

16.3 below.

68.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

16.3Dispute Resolution.

(a)If the Parties are unable to resolve a Disputed Matter using the process

described in Section 16.2, then a Party seeking further resolution of the Disputed Matter will

submit the Disputed Matter to resolution by final and binding arbitration. Whenever a Party will

decide to institute arbitration proceedings, it will give written notice to that effect to the other

Party. Arbitration will be held in London, the United Kingdom, and administered by the

International Chamber of Commerce pursuant to its ICC International Arbitration Rules then in

effect (the “Rules”), except as otherwise provided herein and applying the substantive law

specified in Section 16.1. The arbitration will be conducted by a panel of three (3) arbitrators

appointed in accordance with the Rules; provided that each Party will, within [ * ] after the

institution of the arbitration proceedings, appoint an arbitrator, and such arbitrators will together,

within [ * ], select a third (3rd) arbitrator as the chairman of the arbitration panel. Each arbitrator

must have significant business or legal experience in the pharmaceutical business. If the two (2)

initial arbitrators are unable to select a third (3rd) arbitrator within such [ * ] period, the third

(3rd) arbitrator will be appointed in accordance with Rules. The Parties hereby agree to engage

in discovery of information and evidence that is or might be relevant to the claims, defenses, and

issues in the dispute, including by means of [ * ]. The Parties further agree to the ability, right,

and power to subpoena Third Party witnesses for both discovery and hearing purposes. The

discovery provided for herein may commence once the Terms of Reference have been signed by

the Parties and the panel of arbitrators. The panel of arbitrators shall address the time required

for the completion of discovery at the initial case management conference and shall address any

discovery issues if any arise based on motion and arbitral order. After conducting any hearing

and taking any evidence deemed appropriate for consideration, the arbitrators will be requested

to render their opinion within [ * ] of the final arbitration hearing. No panel of arbitrators will

have the power to award damages excluded pursuant to Section 13.5 under this Agreement and

any arbitral award that purports to award such damages is expressly prohibited and void ab

initio. Decisions of the panel of arbitrators that conform to the terms of this Section 16.3 will be

final and binding on the Parties and judgment on the award so rendered may be entered in any

court of competent jurisdiction. The losing Party, as determined by the panel of arbitrators, will

pay all of the ICC administrative costs and fees of the arbitration and the fees and costs of the

arbitrators, and the arbitrators will be directed to provide for payment or reimbursement of such

fees and costs by the losing Party. If the panel of arbitrators determines that there is no losing

Party, the Parties will each bear or pay one-half of those costs and fees and the arbitrators’ award

will so provide. Notwithstanding the foregoing, each Party is to bear or pay its own attorneys’

fees, expert or witness fees, and any other fees and costs, and no such fees or costs will be shifted

to the other Party.

(b)Notwithstanding the terms of and procedures set forth in Section 16.2 or

16.3(a), any applications, motions or orders to show cause seeking temporary restraining orders,

preliminary injunctions or other similar preliminary or temporary legal or equitable relief

(“Injunctive Relief”) concerning a Disputed Matter (including, but not limited to, Disputed

Matters arising out of a potential or actual breach of the confidentiality and non-use provisions in

Article 14) may immediately be brought in the first instance and without invocation or

exhaustion of the procedures set forth in subsections 16.3(a) and 16.3(b) for hearing and

resolution in and by a court of competent jurisdiction. Alternatively, a party seeking Injunctive

Relief may immediately institute arbitral proceedings without invocation or exhaustion of the

procedures set forth in subsections 16.3(a) and 16.3(b), and any such Injunctive Relief

proceedings will be administered in accordance with by the ICC pursuant to its ICC emergency

arbitration procedures then in effect and applying the substantive law specified in Section 16.2.

In either event, once the Injunctive Relief proceedings have been conducted and a decision

69.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

rendered thereon by the court or arbitral forum, the Parties will, if the Disputed Matter is not

finally resolved by the Injunctive Relief, proceed to resolve the Disputed Matter in accordance

with the terms of Section 16.2 and 16.3(a).

(c)Notwithstanding the foregoing, this Section 16.3 shall not apply to any

dispute, controversy or claim that concerns (i) the validity, enforceability or infringement of a

patent, trademark or copyright; or (ii) any antitrust, anti-monopoly or competition law or

regulation, whether or not statutory.

17.General Provisions

17.1Governing Law. This Agreement, and all questions regarding the existence,

validity, interpretation, breach or performance of this Agreement, shall be governed by, and

construed and enforced in accordance with, the laws of the State of New York, United States,

without reference to its conflicts of law principles.

17.2Entire Agreement; Modification. This Agreement, including the exhibits, is

both a final expression of the Parties’ agreement and a complete and exclusive statement with

respect to all of its terms. This Agreement supersedes all prior and contemporaneous agreements

and communications, whether oral, written or otherwise, concerning any and all matters

contained herein, other than the Original Agreement, which governs the Parties’ rights and

obligations thereunder during the period from the Effective Date until the Restatement Date.

This Agreement may only be modified or supplemented in a writing expressly stated for such

purpose and signed by the Parties to this Agreement.

17.3Relationship Between the Parties. The Parties’ relationship, as established by

this Agreement, is solely that of independent contractors. This Agreement does not create any

partnership, joint venture or similar business relationship between the Parties. Neither Party is a

legal representative of the other Party, and neither Party can assume or create any obligation,

representation, warranty or guarantee, express or implied, on behalf of the other Party for any

purpose whatsoever.

17.4Non-Waiver. The failure of a Party to insist upon strict performance of any

provision of this Agreement or to exercise any right arising out of this Agreement shall neither

impair that provision or right nor constitute a waiver of that provision or right, in whole or in

part, in that instance or in any other instance. Any waiver by a Party of a particular provision or

right shall be in writing, shall be as to a particular matter and, if applicable, for a particular

period of time and shall be signed by such Party.

17.5Assignment. Except as expressly provided hereunder, neither this Agreement nor

any rights or obligations hereunder may be assigned or otherwise transferred by either Party

without the prior written consent of the other Party (which consent shall not be unreasonably

withheld); provided, however, that either Party may assign or otherwise transfer this Agreement

and its rights and obligations hereunder without the other Party’s consent:

(a)in connection with the transfer or sale of all or substantially all of the

business or assets of such Party relating to the Compound and Products to a Third Party, whether

by merger, consolidation, divesture, restructure, sale of stock, sale of assets or otherwise,

provided that in the event of any such transaction (whether this Agreement is actually assigned or

is assumed by the acquiring Party by operation of law (e.g., in the context of a reverse triangular

70.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

merger)), intellectual property rights of the acquiring Party to such transaction (if other than one

of the Parties to this Agreement) shall not be included in the technology licensed hereunder; or

(b)to an Affiliate, provided that the assigning Party shall remain liable and

responsible to the non-assigning Party hereto for the performance and observance of all such

duties and obligations by such Affiliate.

The rights and obligations of the Parties under this Agreement shall be binding upon and inure to

the benefit of the successors and permitted assigns of the Parties specified above, and the name

of a Party appearing herein will be deemed to include the name of such Party’s successors and

permitted assigns to the extent necessary to carry out the intent of this Section 17.5. Any

assignment not in accordance with this Section 17.5 shall be null and void.

17.6Severability. If, for any reason, any part of this Agreement is adjudicated invalid,

unenforceable or illegal by a court of competent jurisdiction, such adjudication shall not, to the

extent feasible, affect or impair, in whole or in part, the validity, enforceability, or legality of any

remaining portions of this Agreement. All remaining portions shall remain in full force and

effect as if the original Agreement had been executed without the invalidated, unenforceable or

illegal part.

17.7Notices. Any notice to be given under this Agreement must be in writing and

delivered either in person, by (a) air mail (postage prepaid) requiring return receipt, (b) overnight

courier, or (c) facsimile confirmed thereafter by any of the foregoing, to the Party to be notified

at its address(es) given below, or at any address such Party may designate by prior written notice

to the other in accordance with this Section 17.7. Notice shall be deemed sufficiently given for

all purposes upon the earliest of: (i) the date of actual receipt; (ii) if air mailed, five (5) days

after the date of postmark; (iii) if delivered by overnight courier, the next day the overnight

courier regularly makes deliveries or (iv) if sent by facsimile, the date of confirmation of receipt

if during the recipient’s normal business hours, otherwise the next business day.

If to Licensee, notices must be addressed to:

Ipsen Pharma SAS

70 rue Balard

75015 Paris

France

Attention: Executive VP, General Counsel

Facsimile: [ * ]

If to Exelixis, notices must be addressed to:

Exelixis, Inc.

1851 Harbor Bay

Parkway, Alameda, CA 94502

USA

Attention: General Counsel

Facsimile: [ * ]

71.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

17.8Standstill.

(a)Commencing the Effective Date and expiring on the fifth (5th) anniversary

date of the Effective Date, unless such provision is terminated earlier (the “Standstill Period”),

neither Licensee nor any of its Affiliates, without the prior consent of Exelixis or except as

provided for in this Agreement or in any agreement referred to herein, or in any agreement

executed after the Effective Date by Exelixis with Licensee or any of its Affiliates, will:

(i)make, effect, initiate, cause or participate in:

A.any acquisition of beneficial ownership of any securities of

Exelixis or any securities of any subsidiary or other Affiliate of Exelixis (each, a “Exelixis

Entity”) such that following any such acquisition, Licensee and its Affiliates then own more than

five percent (5%) of the securities of such Exelixis Entity;

B.any acquisition of any assets of any Exelixis Entity;

C.any tender offer, exchange offer, merger, business

combination, recapitalization, restructuring, liquidation, dissolution or extraordinary transaction

involving a Exelixis Entity, or involving any securities or assets of a Exelixis Entity; or

D.any “solicitation” of “proxies” (as those terms are used in

the proxy rules of the Securities and Exchange Commission) or consents with respect to any

securities of a Exelixis Entity;

(ii)form, join or participate in a “group” (as defined in the Securities

Exchange Act of 1934 and the rules promulgated thereunder) with respect to the beneficial

ownership of any securities of a Exelixis Entity;

(iii)act, alone or in concert with others, to seek to control or influence

the management, board of directors or policies of a Exelixis Entity;

(iv)take any action that might require a Exelixis Entity to make a

public announcement regarding any of the types of matters set forth in clause “(i)” of this Section

17.8(a);

(v)agree or offer to take, or encourage or propose (publicly or

otherwise) the taking of, any action referred to in clause “(i)”, “(ii)”, “(iii)” or “(iv)” of this

Section 17.8(a);

(vi)assist, induce or encourage any other person or entity to take any

action of the type referred to in clause “(i)”, “(ii)”, “(iii)”, “(iv)” or “(v)” of this Section 17.8(a);

(vii)enter into any discussions, negotiations, arrangement or agreement

with any other person or entity relating to any of the foregoing.

(viii)For clarity, the expiration of the Standstill Period will not terminate or otherwise affect

any of the other provisions of this Agreement.

72.

Exhibit 10.42

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

(b)Notwithstanding the foregoing provisions, Licensee or its Affiliates will

not be subject to any of the restrictions set forth in this Section 17.8 with respect to a Exelixis

Entity if either:

(i)such Exelixis Entity publicly announces its intention to pursue a

proposed Acquisition Transaction (as defined below);

(ii)such Exelixis Entity shall have entered into an agreement in

principle or definitive agreement providing for an Acquisition Transaction;

(iii)the board of directors of such Exelixis Entity shall have adopted a

formal plan of liquidation or dissolution;

(iv)if a Third Party commences a tender or exchange offer or bid

which, if successful, would result in such Third Party beneficially owning not less than thirty five

percent (35%) of the voting securities or equity interest in such Exelixis Entity; or

(v)if a Third Party makes a public announcement of a bone fide

takeover bid to acquire the outstanding voting securities or equity interest in such Exelixis Entity.

(vi)“Acquisition Transaction” means (A) any direct or indirect acquisition or purchase of

assets of the applicable Exelixis Entity at a purchase price representing [ * ] ([ * ]%) of the

voting securities of or equity interest in such Exelixis Entity by any person or “group”; (B) any

tender offer or exchange offer that if consummated would result in any person or “group”

beneficially owning [ * ] ([ * ]%) or more of any class of equity securities of such Exelixis

Entity; or (C) any merger, consolidation, business combination, sale of assets, recapitalization or

similar transaction involving such Exelixis Entity representing more than [ * ] ([ * ]%) of the

market capitalization of such Exelixis Entity.

(c)Notwithstanding the foregoing, the Parties agree that Licensee or its

Affiliates shall not be prohibited from (i) initiating private discussions with, and submitting

confidential private proposals to, the management or Chief Executive Officer of any acquisition

of beneficial ownership of any securities or any assets of any Exelixis Entity, including

discussing a right of first refusal before a Exelixis Entity intends to pursue any Acquisition

Transaction; or (ii) proposing other collaborative research agreements or other commercial

license agreements to Exelixis.

(d)the Parties agree to discuss whether to terminate the Standstill Period on a

biennial basis at the anniversary date of the Effective Date.

17.9Force Majeure. Each Party shall be excused from liability for the failure or

delay in performance of any obligation under this Agreement (other than failure to make

payment when due) by reason of any event beyond such Party’s reasonable control including

Acts of God, fire, flood, explosion, earthquake, pandemic flu, or other natural forces, war, civil

unrest, acts of terrorism, accident, destruction or other casualty, any lack or failure of

transportation facilities, any lack or failure of supply of raw materials, or any other event similar

to those enumerated above. Such excuse from liability shall be effective only to the extent and

duration of the event(s) causing the failure or delay in performance and provided that the Party

has not caused such event(s) to occur. Notice of a Party’s failure or delay in performance due to

force majeure must be given to the other Party within [ * ] after its occurrence. All delivery

73.

Exhibit 10.42

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BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

dates under this Agreement that have been affected by force majeure shall be tolled for the

duration of such force majeure. In no event shall any Party be required to prevent or settle any

labor disturbance or dispute.

17.10Interpretation. The headings of clauses contained in this Agreement preceding

the text of the sections, subsections and paragraphs hereof are inserted solely for convenience

and ease of reference only and shall not constitute any part of this Agreement, or have any effect

on its interpretation or construction. All references in this Agreement to the singular shall

include the plural where applicable. Unless otherwise specified, references in this Agreement to

any Article shall include all Sections, subsections and paragraphs in such Article, references to

any Section shall include all subsections and paragraphs in such Section, and references in this

Agreement to any subsection shall include all paragraphs in such subsection. The word

“including” and similar words means including without limitation. The word “or” means “and/

or” unless the context dictates otherwise because the subject of the conjunction are mutually

exclusive. The words “herein,” “hereof” and “hereunder” and other words of similar import

refer to this Agreement as a whole and not to any particular Section or other subdivision. All

references to days in this Agreement mean calendar days, unless otherwise specified.

Ambiguities and uncertainties in this Agreement, if any, shall not be interpreted against either

Party, irrespective of which Party may be deemed to have caused the ambiguity or uncertainty to

exist. This Agreement has been prepared in the English language and the English language shall

control its interpretation. In addition, all notices required or permitted to be given hereunder, and

all written, electronic, oral or other communications between the Parties regarding this

Agreement shall be in the English language.

17.11Counterparts; Electronic or Facsimile Signatures. This Agreement may be

executed in any number of counterparts, each of which shall be an original, but all of which

together shall constitute one instrument. This Agreement may be executed and delivered

electronically or by facsimile and upon such delivery such electronic or facsimile signature will

be deemed to have the same effect as if the original signature had been delivered to the other

Party.

{Signature Page Follows}

[Signature Page to A&R Collabaoration and License Agreement]

Ipsen

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In Witness Whereof, the Parties hereto have caused this Amended and Restated

Collaboration and License Agreement to be executed and entered into by their duly authorized

representatives as of the Restatement Date.


Exelixis, Inc. By: /s/ Christopher Senner Name: Christopher Senner Title: EVP and CFO	Ipsen Pharma S.A.S By: /s/ Aymeric Le Chatelier Name: Aymeric Le Chatelier Title: EVP CFO

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List of Exhibits:

Exhibit A:Chemical Structure of cabozantinib

Exhibit B-1:List of Exelixis Patents as of the Restatement Date

Exhibit B-2:List of Excluded Patents

Exhibit C:Approved Distributors

Exhibit D:Initial Global Development Plan and Budget

Exhibit E:Press Release

Exhibit F: Exelixis [ * ]

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Exhibit A

CHEMICAL STRUCTURE OF CABOZANTINIB

Cabozantinib (S)-malate salt

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Exhibit B-1

LIST OF EXELIXIS PATENTS AS OF THE RESTATEMENT DATE

{redacted Exhibit B-1 content comprises approximately 33 pages}

[ * ]

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Exhibit B-2

LIST OF EXCLUDED PATENTS

{redacted Exhibit B-2 content comprises approximately 15 pages}

[ * ]

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Exhibit C

APPROVED DISTRIBUTORS

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Exhibit D

GLOBAL DEVELOPMENT PLAN

{redacted Exhibit D content comprises 2 pages}

[ * ]

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Exhibit E

PRESS RELEASE



Exelixis Contacts Financial Community: Susan Hubbard Investor Relations and Corporate Communications (650) 837-8194 shubbard@exelixis.com Media: Hal Mackins For Exelixis, Inc. (415) 994-0040 hal@torchcomllc.com	Ipsen Contacts Media: Didier Véron Senior Vice-Président, Public Affairs and Communication Tel.: +33 (0)1 58 33 51 16 Fax: +33 (0)1 58 33 50 58 E-mail: didier.veron@ipsen.com Financial Community: Stéphane Durant des Aulnois Vice President, Investor Relations Tel.: +33 (0)1 58 33 60 09 Fax: +33 (0)1 58 33 50 63 E-mail: stephane.durant.des.aulnois@ipsen.com

EXELIXIS AND IPSEN ENTER INTO EXCLUSIVE LICENSING

AGREEMENT TO COMMERCIALIZE AND DEVELOP NOVEL CANCER THERAPY

CABOZANTINIB IN REGIONS OUTSIDE THE UNITED STATES, CANADA AND JAPAN

- Cabozantinib commercialized for medullary thyroid cancer (MTC)

and filed for advanced renal cell carcinoma (RCC) -

- $200 million upfront payment and subsequent regulatory and commercial milestones -

South San Francisco, Calif. and Paris, France – February 29, 2016 – Exelixis, Inc. (NASDAQ:EXEL)

and Ipsen (Euronext: IPN; ADR: IPSEY) today jointly announced an exclusive licensing agreement for the

commercialization and further development of cabozantinib, Exelixis’ lead oncology drug. Under the

agreement, Ipsen will have exclusive commercialization rights for current and potential future cabozantinib

indications outside of the United States, Canada and Japan. This agreement includes rights to

COMETRIQ®, which is currently approved in the European Union (EU) for the treatment of adult patients

with progressive, unresectable, locally advanced or metastatic medullary thyroid cancer (MTC). The

companies have agreed to collaborate on the development of cabozantinib for current and potential future

indications. Exelixis will maintain exclusive commercial rights for cabozantinib in the United States and

Canada, and continue its discussions to partner commercial rights in Japan.

Under the agreement, Exelixis will receive a $200 million upfront payment. Exelixis is eligible to receive

regulatory milestones, including $60 million upon the approval of cabozantinib in Europe for advanced

renal cell carcinoma (RCC) and $50 million upon the filing and approval of cabozantinib in Europe for

advanced hepatocellular carcinoma (HCC), as well as additional regulatory milestones for potential further

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indications. The agreement also includes up to $545 million of potential commercial milestones and

provides for Exelixis to receive tiered royalties up to 26% on Ipsen’s net sales of cabozantinib in its

territories.

Marc de Garidel, Chairman and Chief Executive Officer of Ipsen said: “The robust results from the

METEOR study in advanced renal cell carcinoma demonstrate that cabozantinib has the potential to become

a key oncology product in Europe. This transaction will help Ipsen accelerate the growth of the company

and strengthen its oncology footprint in Europe. We are excited to bring cabozantinib to patients and

clinicians around the world.”

Future commercial indications for cabozantinib could include advanced HCC, the subject of CELESTIAL,

an Exelixis-sponsored phase 3 pivotal trial for which top-line results are anticipated in 2017. Additional

earlier-stage studies are under way through Exelixis’ collaboration with the National Cancer Institute’s

Cancer Therapy Evaluation Program (NCI-CTEP), and its ongoing Investigator-Sponsored Trial (IST)

program. Through these two programs, there are more than 45 ongoing or planned studies including trials

in advanced RCC, bladder cancer, colorectal cancer, non-small cell lung cancer, and endometrial cancer.

“In Ipsen, Exelixis has an ideal partner to maximize the potential for cabozantinib to have a positive impact

on the treatment of cancer on a global basis,” said Michael M. Morrissey, Ph.D., President and Chief

Executive Officer of Exelixis. “Ipsen’s established international oncology marketing presence, late-stage

clinical development expertise and shared vision with Exelixis for the franchise potential of cabozantinib

will accelerate cabozantinib’s commercialization in its territories, while Exelixis remains focused on our

launch in the United States. While our immediate priority will be on advanced renal cell carcinoma,

Exelixis and Ipsen are committed to exploring and potentially developing cabozantinib in a variety of

cancer settings.”

Cabozantinib is a small molecule therapy that inhibits the activity of tyrosine kinases including VEGF

receptors, MET, AXL, and RET. Following positive results from the METEOR global phase 3 pivotal trial,

the tablet form of cabozantinib is the subject of pending U.S. and EU regulatory applications for use as a

treatment for advanced RCC in patients who have received one prior therapy. In the EU, the Marketing

Authorization Application (MAA) for cabozantinib in advanced RCC has been accepted and granted

accelerated assessment. With this designation, the MAA is eligible for a 150-day review, versus the

standard 210 days (excluding clock stops when information is requested by the EMA). Exelixis plans to

transfer sponsorship of this MAA to Ipsen. Exelixis also anticipates transitioning the commercialization

rights to COMETRIQ® outside the U.S. from Exelixis’ current international partner for COMETRIQ®,

Swedish Orphan Biovitrum AB (Sobi), to Ipsen, in accordance with the terms of its agreement with Sobi. In

March 2014, the capsule form of cabozantinib was approved by the European Commission under the trade

name COMETRIQ for the treatment of patients with progressive, unresectable, locally advanced or

metastatic MTC.

About the METEOR Phase 3 Clinical Trial

METEOR is a global, randomized open-label trial that compares cabozantinib to everolimus, a standard of

care therapy, in 658 patients with advanced RCC whose disease progressed following treatment with a

VEGF receptor (VEGFR) tyrosine kinase inhibitor (TKI). The trial’s primary endpoint is progression-free

survival (PFS), and secondary endpoints include overall survival (OS) and objective response rate (ORR).

Patients were randomized 1:1 to receive 60 mg of cabozantinib or 10 mg of everolimus daily, and were

1 Choueiri T.K. et al. N Engl J Med 2015;373:1814-23.

2 Cancer Facts & Figures 2015. American Cancer Society. Available at

http://www.cancer.org/acs/groups/content/@editorial/documents/document/acspc-044552.pdf

3 Jonasch et al., BMJ (2014) vol. 349, g4797.

4 http://www.cancer.org/cancer/kidneycancer/detailedguide/kidney-cancer-adult-survival-rates

5 ACS Cancer Facts and Figures 2015; Heng et al., Ann Oncol (2012) vol. 23 no. 6; internal data on file; Motzer et al., N Engl

J Med (2007) vol. 356 no. 2; NCIN (UK) report, April 2014, Available at http://www.ncin.org.uk/view?rid=2676.

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stratified based on number of prior VEGFR TKI therapies and on commonly applied RCC risk criteria. No

crossover was allowed.

As published in the New England Journal of Medicine, the trial met its primary PFS and secondary ORR

endpoints.1 Cabozantinib demonstrated a 42% reduction in the rate of disease progression or death as

compared with everolimus, with median PFS of 7.4 months versus 3.8 months for everolimus (Hazard Ratio

[HR]=0.58, 95% Confidence Interval [CI] 0.45-0.75, p<0.001).

Following a pre-planned interim analysis that showed a strong trend in OS favoring cabozantinib (HR=0.67,

95% CI 0.51-0.89, p=0.005) but did not reach statistical significance, Exelixis undertook a second interim

analysis after consulting with regulatory authorities. The results of this second interim analysis

demonstrated a highly statistically significant and clinically meaningful increase in OS for cabozantinib.

Exelixis has shared these data with regulators and intends to present them at a medical conference later this

year.

Cabozantinib’s safety profile was similar to that of other VEGFR TKIs in this patient population. The

incidence of adverse events (any grade), regardless of causality, was 100% with cabozantinib and more than

99% with everolimus. Serious adverse events occurred in 40% of cabozantinib patients and 43% of

everolimus patients. The rate of treatment discontinuation due to adverse events was low (~10%) in both

treatment arms.

About Advanced Renal Cell Carcinoma

The American Cancer Society’s 2015 statistics cite kidney cancer as among the top ten most commonly

diagnosed forms of cancer among both men and women in the U.S.2 Clear cell RCC is the most common

type of kidney cancer in adults.3 If detected in its early stages, the five-year survival rate for RCC is high;

however, the five-year survival rate for patients with advanced or late-stage metastatic RCC is under 10

percent, with no identified cure for the disease.4

Until the introduction of targeted therapies into the RCC setting a decade ago, treatments for metastatic

RCC had historically been limited to cytokine therapy (e.g., interleukin-2 and interferon). In the second-

and later-line settings, which encompass approximately 17,000 drug-eligible patients in the U.S. and 37,000

globally,5 two small-molecule therapies and an immune checkpoint inhibitor have been approved. The

currently approved small-molecule agents have shown little differentiation in terms of efficacy,

demonstrating only modest PFS benefit in patients refractory to sunitinib, a commonly-used first-line

therapy.

About Cabozantinib

Cabozantinib is currently marketed in capsule form under the brand name COMETRIQ® in the United

States for the treatment of progressive, metastatic MTC, and in the European Union for the treatment of

adult patients with progressive, unresectable locally advanced or metastatic MTC. COMETRIQ is not

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indicated for patients with RCC. In the METEOR trial, and all other cancer trials currently underway,

Exelixis is investigating a tablet formulation of cabozantinib distinct from the COMETRIQ capsule form.

The tablet formulation of cabozantinib is the subject of the NDA and MAA for advanced RCC.

Cabozantinib inhibits the activity of tyrosine kinases including VEGF receptors, MET, AXL and RET.

These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes

such as oncogenesis, metastasis, tumor angiogenesis and maintenance of the tumor microenvironment.

The European Commission granted COMETRIQ conditional approval for the treatment of adult patients

with progressive, unresectable locally advanced or metastatic MTC. Similar to another drug approved in

this setting, the approved indication states that for patients in whom Rearranged during Transfection (RET)

mutation status is not known or is negative, a possible lower benefit should be taken into account before

individual treatment decisions.

Important Safety Information, including Boxed WARNINGS

WARNING: PERFORATIONS AND FISTULAS, and HEMORRHAGE

•Serious and sometimes fatal gastrointestinal perforations and fistulas occur in COMETRIQ-treated

patients.

•Severe and sometimes fatal hemorrhage occurs in COMETRIQ-treated patients.

•COMETRIQ treatment results in an increase in thrombotic events, such as heart attacks.

•Wound complications have been reported with COMETRIQ.

•COMETRIQ treatment results in an increase in hypertension.

•Osteonecrosis of the jaw has been observed in COMETRIQ-treated patients.

•Palmar-Plantar Erythrodysesthesia Syndrome (PPES) occurs in patients treated with COMETRIQ.

•The kidneys can be adversely affected by COMETRIQ. Proteinuria and nephrotic syndrome have

been reported in patients receiving COMETRIQ.

•Reversible Posterior Leukoencephalopathy Syndrome has been observed with COMETRIQ.

•Avoid administration of COMETRIQ with agents that are strong CYP3A4 inducers or inhibitors.

•COMETRIQ is not recommended for use in patients with moderate or severe hepatic impairment.

•COMETRIQ can cause fetal harm when administered to a pregnant woman.

Adverse Reactions – The most commonly reported adverse drug reactions (≥25%) are diarrhea, stomatitis,

palmar-plantar erythrodysesthesia syndrome (PPES), decreased weight, decreased appetite, nausea, fatigue,

oral pain, hair color changes, dysgeusia, hypertension, abdominal pain, and constipation. The most

common laboratory abnormalities (≥25%) are increased AST, increased ALT, lymphopenia, increased

alkaline phosphatase, hypocalcemia, neutropenia, thrombocytopenia, hypophosphatemia, and

hyperbilirubinemia.

Please see full U.S. prescribing information, including Boxed WARNINGS, at www.COMETRIQ.com/

downloads/Cometriq_Full_Prescribing_Information.pdf

Please refer to the full European Summary of Product Characteristics for full European Union prescribing

information, including contraindication, special warnings and precautions for use at www.sobi.com once

posted.

About Ipsen

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Ipsen is a global specialty-driven biotechnological group with total sales exceeding €1.4 billion in 2015.

Ipsen sells more than 20 drugs in more than 115 countries, with a direct commercial presence in more than

30 countries. Ipsen’s ambition is to become a leader in specialty healthcare solutions for targeted

debilitating diseases. Its fields of expertise cover oncology, neurosciences and endocrinology (adult &

pediatric). Ipsen’s commitment to oncology is exemplified through its growing portfolio of key therapies

improving the care of patients suffering from prostate cancer, bladder cancer and neuro-endocrine tumors.

Ipsen also has a significant presence in primary care. Moreover, the Group has an active policy of

partnerships. Ipsen's R&D is focused on its innovative and differentiated technological platforms, peptides

and toxins, located in the heart of the leading biotechnological and life sciences hubs (Les Ulis/Paris-

Saclay, France; Slough/Oxford, UK; Cambridge, US). In 2015, R&D expenditure totaled close to €193

million, representing about 13% of Group sales. The Group has more than 4,600 employees worldwide.

Ipsen’s shares are traded on segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and

eligible to the “Service de Règlement Différé” (“SRD”). The Group is part of the SBF 120 index. Ipsen

has implemented a Sponsored Level I American Depositary Receipt (ADR) program, which trade on the

over-the-counter market in the United States under the symbol IPSEY. For more information on Ipsen, visit

www.ipsen.com.

About Exelixis

Exelixis, Inc. is a biopharmaceutical company committed to developing small molecule therapies for the

treatment of cancer. Exelixis is focusing its development and commercialization efforts primarily on

cabozantinib, an internally discovered inhibitor of multiple receptor tyrosine kinases. Another Exelixis-

discovered compound, COTELLIC™ (cobimetinib), a selective inhibitor of MEK, has been approved in

Switzerland, the United States, the European Union, and Canada, and is being evaluated by Roche and

Genentech (a member of the Roche Group) in a broad global development program under a collaboration

with Exelixis. For more information, please visit the company’s website at www.exelixis.com.

Exelixis Forward-Looking Statement Disclaimer

This press release contains forward-looking statements, including, without limitation, statements related to:

the business and financial terms of the collaboration agreement for cabozantinib with Ipsen, including, the

division of commercialization rights, development plans and Exelixis’ eligibility to receive regulatory and

commercial milestones and royalties; Exelixis’ plan to continue its discussions to partner commercial rights

for cabozantinib in Japan; the potential for cabozantinib to become a key oncology product in Europe and

the impact of the transaction on the growth of Ipsen; advanced HCC as a future potential commercial

indication for cabozantinib and the timing for anticipated top-line results from CELESTIAL; the impact of

the collaboration with Ipsen on Exelixis’ plan to maximize the potential for cabozantinib on a global basis;

Exelixis’ plan to stay focused on the potential launch of cabozantinib in advanced RCC in the United States;

advanced RCC as Exelixis’ immediate priority; Exelixis’ and Ipsen’s commitment to exploring and

potentially developing cabozantinib in a variety of cancers; the eligibility for an expedited review of

Exelixis’ MAA for cabozantinib in advanced RCC by the EMA and Exelixis’ plans to transfer sponsorship

of the MAA to Ipsen; Exelixis’ plans to transition the commercialization rights to COMETRIQ outside of

the U.S. from Sobi to Ipsen; and Exelixis’ intent to present data from the second interim analysis of OS for

METEOR at a medical conference later this year. Words such as “will,” “potential,” “future,” “continue,”

“eligible,” “priority,” “committed,” “plans,” “anticipates,” “intends,” or other similar expressions identify

forward-looking statements, but the absence of these words does not necessarily mean that a statement is

not forward-looking. In addition, any statements that refer to expectations, projections or other

characterizations of future events or circumstances are forward-looking statements. These forward-looking

statements are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and

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projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of

events could differ materially from those anticipated in the forward-looking statements as a result of these

risks and uncertainties, which include, without limitation: the clinical, therapeutic and commercial potential

of cabozantinib; Exelixis’ dependence on its relationship with Ipsen, including, the level of Ipsen’s

investment in the resources necessary to successfully commercialize cabozantinib in the territories where it

is approved; Exelixis’ ability to maintain its rights under the Ipsen collaboration; risks and uncertainties

related to regulatory review and approval processes and Exelixis' compliance with applicable legal and

regulatory requirements; the ability to conduct clinical trials of cabozantinib sufficient to achieve a positive

completion; Exelixis’ ability to judge the proper size and level of experience of the commercialization

teams required to support the launch of cabozantinib for advanced RCC; unanticipated complications

associated with the transition of the COMETRIQ commercialization rights from Sobi to Ipsen; the

availability of data at the referenced times; Exelixis’ ability to protect the company’s intellectual property

rights; market competition; changes in economic and business conditions, and other factors discussed under

the caption “Risk Factors” in Exelixis’ quarterly report on Form 10-Q filed with the Securities and

Exchange Commission (SEC) on November 10, 2015, and in Exelixis’ future filings with the SEC,

including, without limitation, Exelixis’ annual report on Form 10-K expected to be filed with the SEC on

February 29, 2016. The forward-looking statements made in this press release speak only as of the date of

this press release. Exelixis expressly disclaims any duty, obligation or undertaking to release publicly any

updates or revisions to any forward-looking statements contained herein to reflect any change in Exelixis’

expectations with regard thereto or any change in events, conditions or circumstances on which any such

statements are based.

Ipsen Forward-Looking Statement Disclaimer

The forward-looking statements, objectives and targets contained herein are based on the Group’s

management strategy, current views and assumptions. Such statements involve known and unknown risks

and uncertainties that may cause actual results, performance or events to differ materially from those

anticipated herein. All of the above risks could affect the Group’s future ability to achieve its financial

targets, which were set assuming reasonable macroeconomic conditions based on the information available

today. Use of the words "believes," "anticipates" and "expects" and similar expressions are intended to

identify forward-looking statements, including the Group’s expectations regarding future events, including

regulatory filings and determinations. Moreover, the targets described in this document were prepared

without taking into account external growth assumptions and potential future acquisitions, which may alter

these parameters. These objectives are based on data and assumptions regarded as reasonable by the

Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on

historical data. Actual results may depart significantly from these targets given the occurrence of certain

risks and uncertainties, notably the fact that a promising product in early development phase or clinical trial

may end up never being launched on the market or reaching its commercial targets, notably for regulatory

or competition reasons. The Group must face or might face competition from generic products that might

translate into a loss of market share. Furthermore, the Research and Development process involves several

stages each of which involves the substantial risk that the Group may fail to achieve its objectives and be

forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore,

the Group cannot be certain that favorable results obtained during pre-clinical trials will be confirmed

subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the

safe and effective nature of the product concerned. There can be no guarantees a product will receive the

necessary regulatory approvals or that the product will prove to be commercially successful. If underlying

assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from

those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited

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COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

to, general industry conditions and competition; general economic factors, including interest rate and

currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care

legislation; global trends toward health care cost containment; technological advances, new products and

patents attained by competitors; challenges inherent in new product development, including obtaining

regulatory approval; the Group's ability to accurately predict future market conditions; manufacturing

difficulties or delays; financial instability of international economies and sovereign risk; dependence on the

effectiveness of the Group’s patents and other protections for innovative products; and the exposure to

litigation, including patent litigation, and/or regulatory actions. The Group also depends on third parties to

develop and market some of its products which could potentially generate substantial royalties; these

partners could behave in such ways which could cause damage to the Group’s activities and financial

results. The Group cannot be certain that its partners will fulfill their obligations. It might be unable to

obtain any benefit from those agreements. A default by any of the Group’s partners could generate lower

revenues than expected. Such situations could have a negative impact on the Group’s business, financial

position or performance. The Group expressly disclaims any obligation or undertaking to update or revise

any forward looking statements, targets or estimates contained in this press release to reflect any change in

events, conditions, assumptions or circumstances on which any such statements are based, unless so

required by applicable law. The Group’s business is subject to the risk factors outlined in its registration

documents filed with the French Autorité des Marchés Financiers.

Exelixis, the Exelixis logo, and COMETRIQ are registered U.S. trademarks,

and COTELLIC is a U.S. trademark.

# # #

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE

COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Exhibit F

Exelixis [ * ]

[ * ]