Dated March 11, 2024
ELOXX PHARMACEUTICALS, INC. (1)
AND
ALMIRALL, S.A. (2)
LICENSE AGREEMENT

Tel +44 (0)370 903 1000 Fax +44 (0)370 904 1099 mail@gowling.com gowlingwlg.com
Exhibit 10.41
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
Dated March 11, 2024
ELOXX PHARMACEUTICALS, INC. (1)
AND
ALMIRALL, S.A. (2)
LICENSE AGREEMENT

Tel +44 (0)370 903 1000 Fax +44 (0)370 904 1099 mail@gowling.com gowlingwlg.com
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CONTENTS |
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Clause |
Heading |
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Page |
1 |
DEFINITIONS |
3 |
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2 |
LICENSE |
29 |
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3 |
GOVERNANCE |
33 |
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4 |
DEVELOPMENT AND DILIGENCE |
36 |
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5 |
FINANCIAL PROVISIONS |
47 |
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6 |
CONFIDENTIALITY |
63 |
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7 |
PATENT MAINTENANCE AND DEFENCE [PENDING IP DEPT.] |
67 |
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8 |
TERM AND TERMINATION |
73 |
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9 |
REPRESENTATIONS, WARRANTIES AND COVENANTS |
84 |
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10 |
ANTI-BRIBERY AND ANTI-CORRUPTION |
87 |
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11 |
INDEMNIFICATION |
89 |
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12 |
MISCELLANEOUS |
95 |
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SCHEDULE 1 |
LICENSED INTELLECTUAL PROPERTY BOOKMARK NOT DEFINED. |
104 |
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SCHEDULE 2 |
ELOXX TRANSITIONAL PLAN BOOKMARK NOT DEFINED. |
106 |
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SCHEDULE 3 |
EXISTING SUBCONTRACT AGREEMENTS BOOKMARK NOT DEFINED. |
122 |
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SCHEDULE 4 |
[DEVELOPMENT PLAN] |
123
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SCHEDULE 5 |
Licensed Compound |
125 |
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SCHEDULE 6 |
PRESS RELEASE
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126 |
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SCHEDULE 7 |
Eloxx’s Information and Documents being part of the Licensed Know How
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127 |
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THIS LICENSE AGREEMENT (the "Agreement") is entered into as of March 11th, 2024 (the "Effective Date").
In this Agreement, Eloxx and Licensee are collectively referred to as the "Parties" and each individually a "Party".
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NOW, THEREFORE, in consideration of the respective covenants set forth herein, the Parties agree as follows:
Affiliate |
any person which directly or indirectly controls, is controlled by or is under common control with the Party in question at the relevant time. As used in this definition of Affiliate the term "control" shall mean, as to any person:
(a) direct or indirect ownership of 50% or more (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) of the voting interests or other ownership interests in the person in question; or
(b) possession, directly or indirectly, of the power to direct or cause the direction of management or policies of the person in question (whether through ownership of securities or other ownership interests, by contract or otherwise); |
Agreement |
the meaning set forth in the Preamble; |
Alliance Manager |
the meaning set forth in clause 3.8; |
Anti-Corruption Laws |
the U.S. Foreign Corrupt Practices Act, as amended, the UK Bribery Act 2010, as amended, and any other applicable anti- corruption laws and laws for the prevention of fraud, racketeering, money laundering or terrorism in any country in the Territory; |
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API |
active pharmaceutical ingredient; |
Auditor |
the meaning set forth in clause 5.12(b); |
Bankruptcy Code |
the meaning set forth in clause 8.6(b); |
Blocking Third Party Patent Right |
with respect to any country, a Patent in such country controlled by a Third Party that would be necessary or reasonably useful for the Exploitation of the Licensed Compound or Licensed Products; |
Business Day |
any Monday, Tuesday, Wednesday, Thursday or Friday that is not a public holiday in Barcelona or New York; |
Calendar Quarter |
a period of three consecutive months corresponding to the calendar quarters commencing on the first day of January, April, July or October; |
Calendar Year |
a period of 12 consecutive months corresponding to the calendar year commencing on the first day of January; |
cGCP |
current Good Clinical Practices as specified in the United States Code of Federal Regulations, ICH Guideline E6, or equivalent Laws of an applicable Governmental Authority of any other relevant country where a clinical trial is being conducted; |
Change of Control |
with respect to either Party:
(a) the sale of all or substantially all of such Party’s assets or business relating to this Agreement (other than to an Affiliate of such Party); |
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(b) 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 50% of the combined voting power of the surviving entity immediately after such merger, reorganization, or consolidation; or
(c) an entity, or group of entities that acquire more than 50% of the voting equity securities or management control of such Party provided, that this clause I shall not include a bona fide equity financing of such Party in which investors acquire newly issued shares of capital stock of such Party and which does not involve the purchase and/or redemption of more than 50% of the voting equity securities of such Party that were outstanding immediately prior to such financing; |
Clinical Trial |
any of a Phase I Clinical Trial, Phase II Clinical Trial, Phase III Clinical Trial or a clinical trial conducted after the obtaining of Regulatory Approval; |
CMC Data |
the chemistry, manufacturing and controls data required by applicable laws to be included in an IND or an NDA for a Licensed Product or any other Regulatory Approval outside the Unites States and any other technical information necessary for the development or the manufacturing of the Licensed Compound or the Licensed Product; |
Combination Products |
products in forms suitable for human applications that contain a Licensed Compound or Licensed Product together with one or more other active ingredients that are sold either as a fixed dose/unit or as separate doses/units in a single package; |
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Commercialize |
any and all activities (whether before or after Regulatory Approval for a product) directed to commercially manufacturing, obtaining pricing and reimbursement approvals and regulatory activities pertaining to the same, promotion, marketing, importing, distribution or sale (and offer for sale or import or export for sale) for a product "Commercializing" and "Commercialization" shall have corresponding meanings; |
Commercially Reasonable Efforts |
efforts that are not less than those efforts a Third Party with similar resources to Licensee would make with respect to products, other than those licensed hereunder, in its portfolio at a similar stage of research, development or commercialization, as applicable, or in a similar stage of product life, in a similar area with similar developmental risk profiles and of similar market and commercial potential, and taking into account all other relevant factors including the patent and other proprietary position of the product, other competitive products in the market place or under development, product labelling or anticipated labelling, performance of other products that are of similar market potential, financial return, medical and clinical considerations, anticipated or actual entry of a Generic Product, regulatory environment, the regulatory structure involved, and other relevant factors. |
Committee Deadlock |
has the meaning set forth in clause 3.6; |
Competitive Product |
any products inducing read-through of premature termination codons to treat dermatological genetic diseases or familial adenomatous polyposis (“FAP”), provided that products having an indication for treatment of FAP with nonsense mutations shall not be considered a Competitive Product after Licensee having notified to Eloxx its decision not to Exploit the Licensed Product in FAP with nonsense mutations (provided that such |
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product is not indicated or used for the treatment of other dermatological genetic diseases); |
Competitive Transaction |
has the meaning set forth in clause 2.6; |
Confidential Information |
all information or Know-How, whether provided in written, oral, graphic, video, computer or other form, provided by one Party (the "Disclosing Party") to the other Party (the "Receiving Party") pursuant to this Agreement, in each case that is marked "confidential", or "proprietary", or which by the nature of the information or the circumstances of its disclosure, should reasonably be expected to be confidential, including information relating to the Disclosing Party's existing or proposed research, development efforts or Patent applications, business or Exploitation of any Licensed Compound or Licensed Product and any other materials that have not been made available by the Disclosing Party to the general public (including but not limited to all information disclosed pursuant to the Confidential Disclosure Agreement between the Parties dated 2 January 2023). Notwithstanding the foregoing sentences, the Receiving Party's obligations with respect to Confidential Information shall not apply to any information or materials that:
(a) were already known to the Receiving Party (other than under an obligation of confidentiality) at the time of disclosure by the Disclosing Party to the extent such Receiving Party has documentary evidence to that effect; (b) were generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party through no breach of the Agreement by the Receiving Party; |
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for purposes hereof, Confidential Information constituting:
specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the Receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the Receiving Party.
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Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the Receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the Receiving Party unless the combination and its principles are in the public domain or in the possession of the Receiving Party. This definition and references to Confidential Information in this Agreement replaces the Confidential Disclosure Agreement entered into by the Parties on 2 January 2023; |
Consumer Price Index |
means the United States Department of Labor, Bureau of Labor Statistics, All Cities Average Consumer Price Index, or such other index as may be published in substitution; |
Control |
and its correlative terms, "Controlled" or "Controls" shall mean, with respect to any Intellectual Property right or other intangible property, that a Party owns or has a license or sublicense to such item or right (other than by operation of the licenses in clause 2.1), and has the ability to grant access, license or sublicense in or to such right without violating the terms of any agreement or other arrangement with any Third Party. For the avoidance of doubt, Third Party Intellectual Property shall only be considered "Controlled" by a Party, if the Party has the right to disclose, assign, or grant a license, sublicense or other right to the other Party as provided for in this Agreement, at no additional cost (unless the other Party agrees to assume such cost) and without prior Third Party approval; |
Data Package |
means the full data package to be compiled upon completion of the SAD Activity Plan, in the format and with the contents set forth in Part B of Schedule 2 bis; |
10
Development |
discovery and research activities and any and all activities, including non-clinical, pre-clinical and clinical trials, post approval studies, supporting manufacturing, production process development and formulation and related regulatory activities, directed to obtaining and maintaining Regulatory Approval for a product. "Develop" and "Developing" shall have corresponding meanings; |
Development and Launch Milestone Event |
the meaning set forth in clause 5.2(a); |
Development and Launch Milestone Payment |
the meaning set forth in clause 5.2(a); |
Development Plan |
the meaning set forth in clause 4.8(a)(i); |
Discontinued Patent |
the meaning set forth in clause 7.1; |
Dispute Auditor |
the meaning set forth in clause 5.12(d); |
Distributor |
any Third Party appointed by Licensee or any of its Affiliates or its or their Sublicensees to distribute, market and sell Licensed Product(s), with or without packaging rights, in one or more countries in the Territory, in circumstances where the person purchases its requirements of Licensed Product(s) from Licensee or its Affiliates or its or their Sublicensees without any Intellectual Property right or license grant from Licensee or its Sublicensees under the Licensed IP; |
Divestment |
has the meaning set forth in clause 2.7; |
Effective Date |
has the meaning given at the start of this Agreement; |
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Eloxx Manufacturing Activities |
the meaning set forth in clause 4.9; |
Eloxx Platform |
Eloxx's proprietary TURBO-ZM chemistry technology platform to develop novel ribosome modulating agents and related processes; |
Eloxx Platform Improvements |
the meaning set forth in clause 2.3(b); |
Eloxx Platform IP |
all Patents and Know-How Controlled by Eloxx that relates to the Eloxx Platform; |
Eloxx Transitional Plan |
the plan with research and development activities attached at Schedule 2; |
EMA |
the European Medicines Agency and any successor or replacement agency; |
EU |
the European Union as at the Effective Date; |
Existing Patents |
the Patents listed in Schedule 1 as at the Effective Date; |
Exploit |
to make, have made, import, use, sell or offer for sale, including to Develop, Commercialize, register, hold or keep (whether for disposal or otherwise), have used, export, transport, distribute, promote, market or have sold or otherwise dispose of. "Exploitation" means the act of Exploiting a compound, product or process; |
Fast Track |
is a process designed by the FDA to facilitate the development and expedite the review of investigational drugs to treat an unmet medical need; |
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FDA |
the US Food and Drug Administration, and any successor or replacement agency; |
Field |
the treatment and/or prevention of all human diseases and conditions; |
Force Majeure Event |
the meaning set forth in clause 12.4; |
FTE |
a full-time equivalent person year consisting of a total of 1800 hours of work per Calendar Year directed to scientific, medical, technical, research, clinical, regulatory and managerial activities under Eloxx Transitional Plan; |
FTE Rate |
the quantity per annum per FTE specified in the Research Budget in reference to each relevant group of employees and increasing, on each anniversary of the Effective Date during the Research Term at the rate of the Consumer Price Index; |
Generic Product |
with respect to a Licensed Product, any pharmaceutical or biological product that is distributed or sold by a Third Party under a Regulatory Approval approved by a Regulatory Authority in reliance, in whole or in part, on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such Licensed Product, including any product authorized for sale:
(a) in the U.S. pursuant to Section 505(b)(2) or Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(2) and 21 U.S.C. 355(j), respectively); (b) in the EU pursuant to a provision of Articles 10, 10a or 10b of Parliament and Council Directive 2001/83/EC as amended (including an application under Article 6.1 of |
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Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision); or
(c) in any other country or jurisdiction pursuant to all equivalents of such provisions. A Licensed Product distributed under an NDA or foreign equivalent Drug Approval Application held by Licensee (i.e., an authorized generic product) will not constitute a Generic Product with respect to such Licensed Product; |
Governmental Authority |
any court, tribunal, arbitrator, agency, legislative body, commission, official or other instrumentality of:
(a) any government of any country;
(b) a federal, state, province, county, city or other political subdivision thereof; or
(c) any supranational body; |
Government Official |
(a) any person employed by or acting on behalf of a government, government-controlled agency or entity or public international organization;
(b) any political party, party official or candidate;
(c) any person who holds or performs the duties of an appointment, office or position created by custom or convention; or (d) any person who holds himself out to be the authorized intermediary of any of the foregoing; |
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GxP |
collectively, all relevant good practice quality guidelines and regulations, encompassing such internationally recognized standards as Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Distribution Practice (GDP), and Good Review Practice (GRP); |
Harvard License Agreement |
the Amended and Restated License Agreement dated 31 March 2020 and made between Zikani Therapeutics, Inc. (now, Eloxx) and President and Fellows of Harvard College, as amended by Amendment No.1 dated 17 July 2023, copies of which were provided to Licensee prior to the execution of this Agreement; |
Harvard Licensed Patents |
Patents owned by Harvard University and exclusively licensed to Zikani Therapeutics Inc. under the Harvard License Agreement. Such Patents shall form part of the Licensed Patents as more particularly identified in Schedule 1; |
Harvard University |
President and Fellows of Harvard College, an educational and charitable corporation existing under the laws and the constitution of the Commonwealth of Massachusetts, having a place of business at Richard A. and Susan F. Smith Campus Center, Suite 727E, 1350 Massachusetts Avenue, Cambridge, Massachusetts 02138 |
IFRS |
with respect to a Party or its Affiliates or its or their Sublicensees, International Financial Reporting Standards or such other similar national standards as such Party, Affiliate or Sublicensee adopts, in each case, consistently applied; |
IND |
any Investigational New Drug application, as defined in Title 21 of the Code of Federal Regulations, on file with the FDA before commencement of Clinical Trials, or any comparable filing with |
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any relevant Regulatory Authority in any country or jurisdiction in the Territory; |
Indemnification Claim Notice |
the meaning set forth in clause 11.3; |
Indemnified Party |
the meaning set forth in clause 11.3; |
Indemnifying Party |
the meaning set forth in clause 11.3; |
Indemnitee |
the meaning set forth in clause 11.3; |
Indication |
means each separate and distinct disease, disorder, illness, health condition, or interruption, cessation or disruption of a bodily function, system, tissue type or organ, for which Regulatory Approval by the submission of a new or supplemental NDA is required. |
Infringement |
the meaning set forth in clause 7.6(a); |
Intellectual Property |
Patents, utility models, rights to inventions, copyright and related rights, moral rights, trademarks and service marks, business names and domain names, rights in get-up, goodwill and the right to sue for passing off or unfair competition, rights in designs, database rights, rights to use, and protect the confidentiality of, confidential information (including Know-How and trade secrets), and all other intellectual property rights, in each case whether registered or unregistered and including all applications and rights to apply for and be granted, renewals or extensions of, and rights to claim priority from, such rights and all similar or equivalent rights or forms of protection which subsist or will subsist now or in the future in any part of the world; |
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IRB |
the meaning set forth in clause 4.2(b); |
Joint Steering Committee or JSC |
the meaning set forth in clause 3.1; |
Know-How |
technical and other information which is not in the public domain including, ideas, concepts, inventions, discoveries, data, formulae, algorithms, specifications, clinical data, information (including biological and chemical structures and functions as well as methods for synthesising chemical compounds), procedures for experiments and tests, results of experimentation and testing, results of research and development including laboratory records and data analyses. Information in a compilation or a compilation of information may be Know-How notwithstanding that some or all of its individual elements are in the public domain; |
Launch |
on a Licensed Product-by-Licensed Product and country-by- country basis, the first invoiced commercial sale which is a Net Sale by Licensee, its Affiliates or their respective Sublicensees of such Licensed Products for a particular Indication after grant of Regulatory Approval in such country for such Indication for such Licensed Product, but excluding in each case any sale, transfer, or other disposition of Licensed Product:
(a) in connection with the research, development or testing of a Licensed Product (including, without limitation, the conduct of Clinical Trials or named patient trials);
(b) for purposes of distribution as promotional samples; or
(c) for named patient, indigent or similar public support or compassionate use programs; |
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Law |
all laws, statutes, ordinances, rules, regulations, writs, judgments, decrees, injunctions (whether preliminary or final), orders and other pronouncements having the effect of law of any Governmental Authority; |
Licensee Background IP |
all Patents or Know-How that are Controlled by Licensee or its Affiliates as at the Effective Date or during the Research Term, as are necessary or useful for Eloxx to perform activities under the Eloxx Transitional Plan; |
Licensed Compound |
the compound coded ZKN-013 and further detailed in Schedule 5, as claimed in the [***] and any modification, improvement, analogue or derivative thereof and any salts, esters, hydrates, solvates, enantiomers, regioisomers, isomers, stereoisomers, free acid form, free base form, crystalline form, co-crystalline form, amorphous form, polymorphs, metabolites and pro-drugs (including ester pro- drugs), racemate, chelate, tautomer or optically active form thereof; |
Licensed IP |
the Licensed Know-How, and Licensed Patents and Eloxx's interest in the Research Program IP; |
Licensed Know-How |
means all Know-How Controlled by Eloxx as of the Effective Date or during the Term that is necessary or reasonably useful for the Development, manufacture or Commercialization of the Licensed Compound or Licensed Products, including without limitation all Know How and data contained in the information listed in Schedule 7; |
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Licensed Patents |
means: |
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(a) any Patents Controlled by Eloxx filed prior to, on or after the Effective Date claiming any Licensed Compounds or Licensed Products, or that are necessary or reasonably useful for the Development or Commercialization of the Licensed Compounds or Licensed Products; and
(b) any Patents claiming priority from the Patents described in (a); in each case (a) and (b) as set out in Part 1 of Schedule 1, which Schedule 1 may be updated by written agreement of the Parties from time |
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to time during the Term of this Agreement
(c) excluding in each case the Patents listed in part 3 of Schedule 1; |
Licensed Products |
any and all pharmaceutical products containing a Licensed Compound as an active ingredient, including Combination Products, in any and all formulations, forms of administration, presentations, and dosages to be developed and exploited in the Field; |
Licensee Improvements |
any improvements, enhancements or modification to the Licensed IP that is developed, made, conceived, reduced to practice or generated |
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by or on behalf of Licensee; |
Losses |
the meaning set forth in clause 11.1; |
MAD Trial |
the meaning set forth in Schedule 2; |
Materials |
any tangible chemical or biological material, including any small molecules, DNA, RNA, clones, cells, and any expression product, progeny, derivative or other improvement thereto, along with any tangible chemical or biological material; |
Manufacturing Technology Transfer |
the meaning set forth in clause 4.10; |
Milestone Events |
the meaning set forth in clause 5.2(a); |
Milestone Payments |
the meaning set forth in clause 5.2(a); |
NDA |
a New Drug Application filed with the FDA in conformance with applicable laws and regulations, or the foreign equivalent of any such application in any other country filed with a Regulatory Authority to |
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obtain marketing approval for a pharmaceutical product; |
Net Sales |
with respect to a Licensed Product for any period, the gross amount billed or invoiced by Licensee, its Affiliates or its or their Sublicensees for the sale of a Licensed Product to Third Parties (including Distributors), less the following deductions (as determined in accordance with IFRS ):
:
(a) normal and customary trade, quantity and prompt settlement discounts including adjustments and allowances to Third Parties, including without limitation for price and floor stock adjustments, shortages, promotional payments, billing |
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errors, rejections, returns, damaged or destroyed Licensed Product, recall and bad debts;
(b) credits, refunds, rebates, chargebacks (allowed, given or accrued, including but not limited to cash, governmental and managed care rebates, hospital or other buying group chargebacks, and governmental taxes in the nature of a rebate based on usage levels or sales of the Product, or the like), administrative fee arrangements, |
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reimbursements, fees or similar payments to wholesalers, buying groups, pharmacy benefits management companies, health maintenance organizations or other institutions or health care organizations or other customers;
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Any of the deductions listed above that involves a payment by Licensee, its Affiliates or its or their Sublicensees shall be taken as a deduction in the Calendar Quarter in which the payment is accrued by such entity. For the purposes of determining Net Sales, a Licensed Product shall be deemed to be sold when invoiced and a "sale" shall not include transfers or dispositions of such Licensed Product for pre-clinical or clinical purposes, as samples, or for charitable, regulatory or government purposes, in each case, without charge or to the extent sold for no more than the manufacturing costs thereof, but shall include commercial sales to government purchasers. Licensee's, its Affiliates' or its or their Sublicensees' transfer of any Licensed Product to an Affiliate or Sublicensee shall not result in any Net Sales, unless such Licensed Product is consumed by such Affiliate or Sublicensee in the course of its commercial activities.
In the event that a Licensed Product is sold in any country in the form of a Combination Product, Net Sales of such Combination Product shall be adjusted by multiplying actual Net Sales of such Combination Product in such country calculated pursuant to the foregoing definition of Net Sales by the fraction A/(A+B), where A is the average invoice price in such country of any Licensed Product that contains the same Licensed Compound(s) as such Combination Product as its sole active ingredient(s), if sold separately in such country and B is the average invoice price in such country of each product that contains active ingredient(s) other than the Licensed Compound(s) contained in such Combination Product as its sole active ingredient(s), if sold separately in such country;
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provided that the invoice price in a country for each Licensed Product that contains only the Licensed Compound(s) and each product that contains solely active ingredient(s) other than the Licensed Compound(s), included in the Combination Product shall be for a quantity comparable to that used in such Combination Product and of substantially the same class, purity and potency or functionality, as applicable. If either such Licensed Product that contains the Licensed Compound(s) as its sole active ingredient or a product that contains the active ingredient(s) (other than the Licensed Product), in the Combination Product as its sole active ingredient(s) is not sold separately in a particular country, the Parties shall negotiate in good faith a reasonable adjustment to Net Sales in such country that takes into account the medical contribution to the Combination Product of and all other factors reasonably relevant to the relative value of, the Licensed Compound(s), on the one hand and all of the other active ingredient(s), as applicable, collectively, on the other hand.
Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of Licensee, its Affiliates or its or their Sublicensees, which must be in accordance with IFRS; |
Orphan Drug Designation |
is a designation by the FDA (and other Regulatory Authorities outside the US) to drugs that have the potential to treat patients with rare diseases; |
Party Representatives |
the meaning set forth in clause 10.1; |
Patent Challenge |
the meaning set forth in clause 8.7; |
Patents |
all patents or patent applications, including any continuations, continuations-in-part (to the extent relating to existing patents |
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or patent applications and not to any new subject matter), divisions, provisional or any substitute applications, any patent issued with respect to any such patent applications, any reissue, re-examination, renewal or extension (including any supplementary protection certificate) of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent, and all foreign counterparts of any of the foregoing, or as applicable portions thereof or individual claims therein; |
Phase I Clinical Trial |
as to a specific Licensed Product, a first clinical study conducted in humans. For the avoidance of doubt, the dose escalation and dose expansion parts of a Phase Ia/Ib clinical trial shall be considered part of the same Phase I Clinical Trial; |
Phase II or Proof Of Concept (POC) Clinical Trial |
as to a specific Licensed Product for a specific Indication, a clinical study in patients conducted in accordance with cGCP which may use a variety of study designs and is intended to confirm pharmacokinetics and pharmacodynamics, efficacy, evaluate safety and efficacy in target populations, and/or inform the design or endpoints for a subsequent trial, as described in ICH Guideline E8, General Considerations for Clinical Trials; |
Phase III or Pivotal Clinical Trial |
as to a specific Licensed Product for a specific Indication, a clinical study conducted in humans in accordance with cGCP to demonstrate or confirm the therapeutic benefit of the Licensed Product in such Indication and to provide an adequate basis for obtaining Regulatory Approval, as described in ICH Guideline E8, General Considerations for Clinical Trials; |
Plan |
has the meaning set forth in clause 4.8(c)(i); |
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Priority Review Voucher |
means a priority review voucher awarded by the FDA under Section 524 or Section 529 of the Federal Food, Drug and Cosmetic Act or awarded under any successor or comparable government program in the United States or another country; |
Priority Review Voucher Income |
all consideration, in any form, received by Licensee (or Eloxx if applicable), a Sublicensee, or any of their Affiliates, as the case may be, in connection with the sale or transfer to an unrelated Third Party in a bona fide arm’s-length transaction of a Priority Review Voucher awarded in connection with the Licensed Compound or a Licensed Product; |
Product Trademark |
has the meaning set forth in clause 8.8(b)(x); |
PRV Fair Market Value |
with respect to each Priority Review Voucher, the average of the sale price of the most recent three (3) Priority Review Vouchers sold in the U.S. in publicly announced, bona fide arm’s-length transactions prior to the issuance of such Priority Review Voucher; |
Regulatory Approval |
any and all approvals (excluding pricing and reimbursement approvals), licenses, registrations or authorizations of any Regulatory Authority, necessary to commercially distribute, sell or market a product in a country, including any:
(a) conditional or accelerated approval;
(b) approval for a product (including any supplements and amendments thereto); (c) pre- and post-approval marketing approvals or authorizations (including any manufacturing approval or authorization related thereto); |
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(d) labelling approval; and
(e) technical, medical and scientific licenses; |
Regulatory Authority |
any national, supranational, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity (including the FDA and the EMA and any other agencies in any country) regulating or otherwise exercising authority with respect to the research, development, manufacture, distribution, marketing, storage, transportation, use or sale of pharmaceutical products; |
Regulatory Exclusivity |
with respect to a Licensed Product in a country, any exclusive marketing right, data exclusivity right, orphan drug designation, or another exclusive right which would prevent a Generic Product or competing product from obtaining a Regulatory Approval or being marketed or sold in such country, conferred by any Governmental Authority with respect to such Licensed Product in such country, other than a Patent right; |
Research Budget |
has the meaning set forth in clause 4.2(a); |
Research Program IP |
has the meaning set forth in clause 7.9; |
Research Term |
the period from the Effective Date until completion of the work specified in the Eloxx Transitional Plan or such later date as may be agreed by the Parties through the JSC; |
Reversion Product |
any Licensed Product; |
Reversion IP |
on a Reversion Product-by-Reversion Product basis, all Patents and Know-How that at the Termination Date are Controlled by Licensee or its Affiliates and are incorporated |
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into or necessary or used by Licensee for the Exploitation of, such Reversion Product; |
Royalty Payment |
the meaning set forth in clause 5.3; |
Royalty Term |
the meaning set forth in clause 5.3; |
SAD Activity Plan |
the plan with research and development activities attached set forth in Part A of Schedule 2 bis; |
SAD Trial |
the meaning set forth in Schedule 2; |
Sales Milestone Event |
the meaning set forth in clause 5.2(b); |
Sales Milestone Payment |
the meaning set forth in clause 5.2(b); |
Second Indication |
means the Indication of familial adenomatous polyposis with nonsense mutations; |
Senior Officer |
the Chief Executive Officer of Eloxx and the Chief Executive Officer of Licensee, or the functional successor in their respective organizations; |
Sublicensee |
a Third Party to whom Licensee or its Affiliate has granted a sublicense under clause 2.1 to make, have made, use, sell offer for sale, import or commercialize a Licensed Product, but excluding Distributors and wholesalers and resellers who do not have a sublicense from Licensee of Licensed IP under clause 2.1; |
Term |
the meaning set forth in clause 8.1; |
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Termination Date |
the date on which any termination of this Agreement becomes effective; |
Territory |
worldwide; |
Third Party |
any person who is not a Party or an Affiliate of a Party; |
Third Party Claim |
the meaning set forth in clause 11.1; |
Third Party Payments |
the meaning set forth in clause 5.4(a); |
US |
the United States of America, including all of its territories and possessions; |
USD or $ |
United States Dollars; |
Valid Claim |
(a) a claim of an issued and unexpired Patent included within the Licensed Patents or Patent forming part of the Research Program IP or which has not been abandoned, cancelled or held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction unappealed within the time allowed for appeal, or which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise; or
(b) a claim of a pending Patent application included within the Licensed Patents or Patent forming part of the Research Program IP which claim was filed and is being prosecuted in good faith and has not been cancelled, withdrawn from consideration, abandoned or finally disallowed without the possibility of appeal or refiling of the application; |
33
|
provided that such prosecution has not been on-going for more than seven years; |
Value Added Tax |
(a) in relation to any jurisdiction within the EU, the tax imposed by the Council Directive on the common system of value added tax (2006/112) and any national legislation implementing that directive together with legislation supplemental thereto and the equivalent tax (if any) in that jurisdiction; and (b) in any other country, any other value added, goods and services or similar tax chargeable on the supply or deemed supply of goods or services under applicable legislation; but, in each event, excluding any US sales tax. |
34
35
development and approval process terms contained herein shall be defined by the FDA, Center for Drug Evaluation & Research and the equivalent terms used by the EMA.
Eloxx grants to Licensee, and Licensee hereby accepts:
36
which case all Royalty Payments otherwise payable hereunder shall be subject to reduction in accordance with clause 5.5(b) of this Agreement.
37
Subject to the terms and conditions of this Agreement, Licensee grants to Eloxx, and Eloxx hereby accepts, a non-exclusive, royalty-free, license to and under Licensee Background IP for the sole purpose of carrying out the Eloxx Transitional Plan in accordance with this Agreement. Eloxx may grant sublicenses under this license through a single tier solely to subcontractors appointed in accordance with clause 4.5.
Subject to clause 2.7, Eloxx shall not, and shall procure that its Affiliates shall not, during the Term of this Agreement, (directly itself or indirectly by granting any rights or assisting any Third Party) Develop or Commercialise any Competitive Product.
38
decision-making activities in connection with such Competitive Product in the Territory or (ii) in the case of a Competitive Transaction falling within subclause (a) above, commence or continue the Development, manufacture and Commercialization of such Competitive Product, provided that Eloxx may not make available, use or practice, or permit the Third Party acquirer to use or practice under any of the Eloxx Platform, Licensed IP including Eloxx Platform IP, Eloxx Platform Improvements, or Licensee Background IP in connection with such Competitive Product.
Licensee shall be entitled to grant to its Affiliates or a Third Party a sublicense of the rights granted to Licensee under clause 2.1 without the prior written consent of Eloxx. Any such sublicense shall be granted on terms that are consistent with the terms of this Agreement. Licensee shall notify Eloxx in writing of the identity of each such Sublicensee and shall provide a copy of each such sublicense agreement (which may have redacted specific provisions, such as financials) to Eloxx promptly following the execution of such sublicense agreement. Licensee shall be responsible for ensuring that each such Sublicensee complies with the terms of this Agreement.
Eloxx shall, if requested to do so by Licensee, immediately enter into confirmatory license agreements substantially in the form reasonably requested by Licensee for purposes of recording the licenses granted under this Agreement with such patent offices in the Territory as Licensee considers appropriate.
Eloxx shall not, and if any Licensed IP or the Eloxx Platform IP is transferred to an Affiliate in accordance with this Agreement, shall procure that its Affiliates shall not:
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Within 30 days of the Effective Date, the Parties shall establish a Joint Steering Committee (te "Joint Steering Committee" or "JSC") consisting of two (2) representatives, designated by each Party. The initial members of the JSC will be nominated by the Parties promptly following the Effective Date. Such representatives shall be individuals suitable in seniority and experience and having delegated authority to carry out the activities of the JSC with respect to matters within the scope of the JSC's responsibilities. The JSC shall operate in accordance with the provisions of clauses 3.2 to 3.8, and shall have no authority to alter or amend the terms and conditions of this Agreement, including any payment conditions or terms, periods for performance, or obligations of the Parties. A Party may change one or more of its representatives serving on the JSC at any time upon written notice to the other Party. At its meetings, the JSC shall discuss the matters described below and such other matters as are reasonably requested by either Party's Alliance Manager.
The JSC shall, during the term of this Agreement perform the following functions:
40
The JSC shall meet at least twice per Calendar Year, or at a frequency determined by the JSC, and JSC meetings can be called at other times by agreement between the Parties for any reason including if it is necessary to resolve Committee Deadlocks in accordance with clause
3.6. JSC meetings may be conducted by telephone, video-conference or in person. Any in- person JSC meetings shall be held on an alternating basis between Eloxx's and Licensee's facilities, unless otherwise agreed by the Parties. Each Party shall be responsible for its own expenses in attending such meetings. As appropriate, the JSC may invite a reasonable number of non-voting employees, consultants and scientific advisors to attend its meetings as non- voting observers; provided that such invitees are bound by appropriate written confidentiality obligations no less restrictive than those set forth herein. Each Party may also call for special meetings of a JSC to discuss particular matters requested by such Party. The Alliance Managers shall provide the members of the JSC with no less than ten Business Days' notice of each regularly scheduled meeting and, to the extent reasonably practicable under the circumstances, no less than five Business Days' notice of any special meetings called by either Party.
Minutes will be kept of all JSC meetings by the chair of the JSC (or their designees) (which shall be a representative of Licensee) and sent to all members of the JSC by facsimile or e-mail for review and approval within 30 days after each such meeting. The JSC shall formally accept the minutes of the previous meeting at or before the next meeting of the JSC. Minutes will be deemed approved unless any member of the JSC objects to the accuracy of such minutes by providing written notice to the other members of the JSC within 30 days following circulation of the minutes. Minutes shall list action items and shall designate any issues that need to be resolved by the JSC or applicable resolution process. In the event of any objection to the minutes that is not resolved by mutual agreement of the Parties, such minutes will be amended to reflect such unresolved dispute.
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Decisions of the JSC shall be made by unanimous vote, with each Party having one (1) vote; in order to make any decision, the JSC must have present (in person or via telephone or videoconference) and voting at least one representative of each Party, unless the meeting has been reconvened on not less than five days' notice because the prior meeting was not quorate.
If the JSC cannot resolve a material matter within its responsibilities by consensus (a "Committee Deadlock"), then such Committee Deadlock shall be escalated to the Senior Officers for further consideration; provided that such escalation and further consideration shall not prevent a Party from exercising its casting vote on the JSC or implementing any decision of the JSC following such escalation. Either Party shall have the right to select a Third Party who has experience of issues that are relevant to the disputed issue to present their views to the JSC which shall in good faith listen and consider such views. For the purpose of this clause 3.6, a matter shall be considered material if it might reasonably be expected to have a material adverse effect on the achievement of the milestones listed in clause 5.2(a). If the JSC is unable to resolve such dispute following such Third Party consultation, either Party may refer such dispute to the Senior Officers for resolution. If the Senior Officers are unable to resolve a Committee Deadlock within fifteen (15) Business Days after such matter is referred to them, Licensee shall have final decision-making authority with regard to such matter provided that in connection with such exercise of final decision-making authority: (i) Eloxx shall not be under an obligation to carry out activities under the Eloxx Transitional Plan if the costs of those activities are not to be reimbursed by Licensee pursuant to an approved budget, and (ii) Eloxx shall not be required to increase the number of FTEs allocated to the Eloxx Transitional Plan unless it so agrees in writing, and (iii) Licensee shall not have the final decision making authority with regard to any proposed amendment to the budget for Eloxx's activities under the Eloxx Transitional Plan.
The JSC is not a substitute for the rights of the Parties under this Agreement and is intended to coordinate and facilitate the activities of the Parties during the Research Term. The JSC will
42
not be involved with the day-to-day management of activities to be performed by a Party under this Agreement. The JSC will have no power to amend this Agreement.
Each Party shall designate an individual to serve as the main point of contact for such Party to exchange information, facilitate communication and coordinate the Parties' activities under this Agreement (each, an "Alliance Manager"). The Alliance Managers shall on no less frequently than once every six months provide oral reports to the JSC (or designate an appropriate representative to attend meetings and provide such reports on the Alliance Manager's behalf) unless more frequent updates are requested by the JSC; provided, however, that the Alliance Managers shall not be counted as members of the JSC (and shall not vote on matters discussed at any JSC meeting). Each Party may change its designated Alliance Manager from time to time upon written notice to the other Party.
(i) SAD Activity Plan and (ii) the Eloxx Transitional Plan, to Develop the Licensed Compound.
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44
45
Within the Research Term, Eloxx shall carry out the activities allocated to it under the SAD Activity Plan and the Eloxx Transitional Plan in accordance with good scientific standards and practices and in compliance in all material respects with the requirements of applicable Laws and regulations, including, as applicable, ICH and GxP guidelines and regulations, informed consent and IRB/Ethics Committee regulations. Eloxx will allocate to the Eloxx Transitional Plan the number of FTEs set out in the Eloxx Transitional Plan. Eloxx will carry out the SAD Activity Plan and the Eloxx Transitional Plan in conformity with standard pharmaceutical and biotechnology industry practices and the terms and conditions of this Agreement and will prepare and maintain, or will cause to be prepared and maintained, complete and accurate laboratory notebooks and other written records, accounts, notes, reports and data with respect to such activities that properly reflect all work done and results achieved in the performance of the SAD Activity Pland and the Eloxx Transitional Plan in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, and in compliance with applicable Laws. Upon Licensee's written request and at its expense, Eloxx will send legible copies of the aforesaid to Licensee. Such records shall be retained by Eloxx for at least five years after the expiration or termination of the Eloxx Transitional Plan and Eloxx shall transfer these records to Licensee after the end of such 5-year period.
Either Party may perform its Development activities pursuant to this Agreement through one or more Third Party subcontractors, provided that:
46
Eloxx shall keep Licensee reasonably informed as to the progress achieved and results, discoveries and technical developments made in the course of performing activities under the Eloxx Transitional Plan, including by providing a complete final report of the Clinical Trials carried out as part of the Eloxx Transitional Plan.
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48
49
Each report must contain a sufficient level of detail for Eloxx and Harvard University to assess whether Licensee is in compliance with its obligations under clause 4.8(a) and a discussion of intended efforts for the then current Calendar Year. Together with each report, Licensee shall provide Eloxx with a copy of the then current Development Plan. All reports delivered pursuant to this clause 4.8(b)(i) shall be deemed Confidential Information of Licensee pursuant to this Agreement.
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Approvals for Licensed Products, including preparing all reports necessary as part of a regulatory filing or Regulatory Approval. Eloxx shall provide all documentation and reasonable assistance of up to one hundred (100) hours for all such regulatory filings. Any additional support shall be charged at a rate of [***] per hour to Licensee.
(i) result in Eloxx not being in compliance with applicable Laws or conflict with Eloxx’s regulatory obligations as sponsor, or (ii) could result in safety or efficacy issues with regard to a Licensed Product.
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Transitional Planduring the Research Term to observe and participate in any such meeting or conference call. Eloxx shall promptly furnish Licensee with copies of all substantive contact reports concerning substantive, non-administrative conversations or minutes from any substantive meetings with a Regulatory Authority with respect to any IND or CTA related to the Development of the Licensed Product.
Eloxx shall be responsible for the manufacture, control, release and supply of the Licensed Product and the API required to carry out the SAD Trial, the MAD Trial and for the non-clinical toxicology studies. Eloxx shall, if requested by Licensee, be responsible for the manufacture, control, release and supply of the Licensed Product and the API required to carry out the Phase
II Clinical Trial. Eloxx will perform such manufacturing obligations (collectively the “Eloxx Manufacturing Activities”) itself or through a Third Party clinical manufacturing organisation
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approved in writing by Licensee. Where Eloxx uses or, has prior to the Effective Date, used a Third Party clinical manufacturing organisation, Eloxx shall not be liable to Licensee for any failure by such Third Party with respect to the supply of the Licensed Product but shall use its reasonable endeavours to enforce its rights under the terms of any contract with such Third Party. The actual costs related to carrying out the Eloxx Manufacturing Activities shall be paid by Licensee in accordance with clause 4.7. Licensee shall be responsible for the manufacture and supply of the Licensed Product and the API to carry out Phase II Clinical Trials onwards unless otherwise agreed by the Parties.
Licensee shall determine the appropriate time to transfer to Licensee (or Licensee’s Third Party designee) all information in the possession of Eloxx that is necessary or reasonably useful for Licensee to manufacture or have manufactured the Licensed Compound and Licensed Products for Development and Commercialization in the Territory (the “Manufacturing Technology Transfer”). Commencing from the Effective Date, Licensee shall have the right to initiate or conduct the Manufacturing Technology Transfer and Eloxx shall provide all documentation and reasonable assistance for such transfer free of charge. Upon completion of a satisfactory Manufacturing Technology Transfer, Licensee shall pay to Eloxx an additional amount of [***].
Each Party shall perform its responsibilities under this Agreement, including the manufacture of the Licensed Compound and Licensed Products, in accordance with all applicable Laws.
As part consideration for the grant of rights under this Agreement, and on the terms and subject to the conditions set forth herein Licensee shall pay to Eloxx the non-refundable, non-creditable, one-time, sum of [***] as partial consideration for the grant of the license in clause 2.1. Payment shall be made to Eloxx by Licensee as follows: (i) with
54
respect to the amount of [***], within ten (10) days after receiving the corresponding invoice from Eloxx after signature of this Agreement and (ii) the remaining amount of [***], within ten (10) days after receiving the corresponding invoice from Eloxx after receipt by Licensee of complete copies of the contracts to be entered into by Eloxx with all four subcontractors identified in Schedule 3 for Clinical Activities ([***]) together with a evidence of payment of the initial fees agreed with each of them. Except for an agreed amount of [***] or as otherwise agreed to by the Parties, Eloxx shall be prohibited from using any part of this Upfront Payment to prepay or repay any of its debt obligations to any Third Party (including Hercules Capital).
Milestone Number |
Milestone Event |
Milestone Payment for the first Licensed Product in the first Indication (USD) |
Milestone Payment for the first Licensed Product in the Second Indication (USD) |
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|
Clinical Milestone |
|
|
1 |
Receipt by Licensee of Data Package delivered by Eloxx after completion of the SAD Activity Plan |
[***] |
[***] |
2 |
Acceptance of IND in the US |
[***] |
[***] |
3 |
First patient dosed in the first Proof of Concept Clinical Trial |
***] |
[***] |
4 |
First patient dosed in the first Pivotal Clinical Trial |
[***] |
[***] |
5 |
Upon NDA filing in the US |
[***] |
[***] |
6 |
Upon MAA filing in the EU |
[***] |
[***] |
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|
Launch Milestone |
|
|
7 |
First Launch in the US |
[***] |
[***] |
8 |
First Launch in the UK or any country in the EU |
[***] |
[***] |
9 |
First Launch in Japan |
[***] |
[***] |
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Eloxx in writing of the achievement of any such Sales Milestone Event in a given Calendar Quarter with its royalty report for such Calendar Quarter under clause 5.6.
Milestone number |
Milestone Event (figures in USD) |
Milestone Payment USD |
Sales Milestones |
||
1 |
First Calendar Year in which aggregate global Net Sales of Licensed Product for that Calendar Year surpass $100,000,000 |
[***] |
2 |
First Calendar Year in which aggregate global Net Sales of Licensed Product for that Calendar Year surpass $250,000,000 |
[***] |
3 |
First Calendar Year in which aggregate global Net Sales of Licensed Product for that Calendar Year surpass $500,000,000 |
[***] |
4 |
First Calendar Year in which aggregate global Net Sales of Licensed Product for that Calendar Year surpass $750,000,000 |
[***] |
5 |
First Calendar Year in which aggregate global Net Sales of the Licensed Product for that Calendar Year surpass $1,000,000,000 |
[***] |
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On a Licensed Product-by-Licensed Product and country-by-country basis, Licensee shall pay Eloxx a royalty on aggregate worldwide annual Net Sales of Licensed Products in the Territory as set forth below ("Royalty Payment"). The Royalty Payment shall be payable on a country- by-country and Licensed Product-by-Licensed Product basis from the date of Launch of a Licensed Product by Licensee of such Licensed Product in such country until the later of:
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(collectively the "Royalty Term").
Licensee shall have no obligation to pay any Royalty Payment with respect to Net Sales of any Licensed Product in any country after the Royalty Term for such Licensed Product in such country has expired.
The Royalty Payments for Licensed Products shall be as follows;
Trigger (figures in USD) for Royalties (on a Licensed Product-by- Licensed Product basis): |
Royalty Rate |
For that portion of aggregate annual worldwide Net Sales of all Licensed Products in any given Calendar Year of less than or equal to $250,000,000 |
[***] |
For that portion of aggregate annual worldwide Net Sales of all Licensed Products in any given Calendar Year of greater than $250,000,000 but less than or equal to $500,000,000 |
[***] |
For that portion of aggregate annual worldwide Net Sales of all Licensed Products in any given Calendar Year of greater than $500,000,000 but less than or equal to $1,000,000,000 |
[***] |
For that portion of aggregate annual worldwide Net Sales of all Licensed Products in any given Calendar Year of greater than $1,000,000,000 |
[***] |
For clarity, these royalty rates are tiered and are based on the aggregate of Net Sales in the Territory in a given Calendar Year, such that, for example, if Net Sales in the Territory are
$1,000,000,000 in a given Calendar Year, the royalty payable for such Calendar Year is [***]
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on the first $250 million, [***] on the second $250 million and then [***] on the next $500 million.
It is expressly agreed by the Parties that the foregoing Royalty Rates on Net Sales shall be reduced to a fixed Royalty Rate of [***] upon and from the moment when Eloxx becomes subject to any of the insolvency situations set forth in Clause 8.6(a) in this Agreement (and the limitations of clause 5.4(d) below shall not apply in this case).
If, during the Term, Licensee determines, in its reasonable judgment, that it is necessary or desirable to obtain rights under any Blocking Third Party Patent Rights in order to Exploit a Licensed Product in accordance with this Agreement, then Licensee shall promptly notify Eloxx. In the event that Licensee obtains a license or similar right under a Blocking Third Party Patent Right and any royalties or other payments are paid by Licensee to the Third Party to license or acquire such Blocking Third Party Patent Rights ("Third Party Payments"), Licensee shall have the right to reduce up to [***] of any Royalty Payments otherwise payable to Eloxx under clause 5.3 in a given period to offset [***] of the Third Party Payments made in such period, subject to the Maximum Royalty Adjustment and the possible carry over of any excess, as set forth in clause 5.4(d) below.
On a Licensed Product-by-Licensed Product basis, if a Generic Product obtains Regulatory Approval in any country in the Territory during the Royalty Term for a Licensed Product, then the royalty rates in clause 5.3 shall be reduced by [***] (but not below a minimum of [***]) until the end of the Royalty Term for such Licensed Product in such country, subject to clause 5.4(d) below.
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On a country-by-country and Licensed Product-by-Licensed Product basis, if, during the Royalty Term, there are no Valid Claims of a Licensed Patent covering the composition of matter, method of use, formulation or method of manufacture of such Licensed Product in such country then Licensee shall have the right to reduce the Royalty Payments otherwise payable to Eloxx for such Licensed Product under clause
5.3 in a given period in the relevant country by [***], subject to clause 5.4(d) below.
Licensee shall pay to Eloxx the Royalty Payment quarterly in accordance with this clause 5.6 by means of wire transfer of immediately available funds to an account designated in advance
63
in writing by Eloxx to Licensee. Licensee shall calculate all amounts payable to Eloxx pursuant to clause 5.3 as adjusted pursuant to clause 5.4 at the end of each Calendar Quarter, which amounts shall be converted to USD, in accordance with clause 5.11. Licensee shall pay to Eloxx the royalty amounts due with respect to a given Calendar Quarter within forty-five (45) days after the end of such Calendar Quarter, subject to receiving the corresponding invoice issued by Eloxx, based on the report sent by Licensee to Eloxx within thirty-five (35) days after the end of such Calendar Quarter, setting forth for such Calendar Quarter the following information for Licensed Product:
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Licensed Product, and (ii) redemption of such Priority Review Voucher for any product other than in connection with the Licensed Compound or a Licensed Product (a “Non- Royalty-Bearing Product”) with the goal of obtaining Regulatory Approval to market and sell such Non-Royalty-Bearing Product, Licensee (or the applicable Sublicensee) shall pay Eloxx [***] of the Net Sales (such defined term applied mutatis mutandis to such Non-Royalty-Bearing Product) of such Non-Royalty Bearing Product (“PRV Product Revenue Share Payments”) until the cumulative amount of all such PRV Product Revenue Share Payments equals [***] ([***]) of the PRV Fair Market Value of such Priority Review Voucher.
If following the Effective Date Eloxx or Affiliate receives a Priority Review Voucher in connection with the Development of the Licensed Product in the Second Indication Eloxx shall promptly notify Licensee.
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(iii) send evidence of the obligation together with proof of payment to the other Party within sixty (60) calendar days following that payment if required. Each Party shall provide such cooperation as the other Party may reasonably request to obtain refunds of any amounts withheld in accordance with applicable Laws, including applicable tax treaties and/or European Union Directives. Each Party shall furnish the other Party with appropriate documents to secure application of the most favorable rate of withholding tax under applicable Laws.
Notwithstanding anything contained in clause 5.8 and 5.9, this clause 5.10 shall apply with respect to value added tax ("VAT"). All Payments are exclusive of VAT. If any VAT is chargeable in respect of any Payments, Licensee shall pay VAT at the applicable rate in respect of any such Payments following the receipt of a VAT invoice in the appropriate form in compliance with applicable Law issued by Eloxx in respect of those Payments.
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All Milestone Payments to Eloxx under this Agreement shall be made by Licensee within thirty
(30) days (or such other period specifically set forth in this Agreement) after receiving the corresponding invoice by deposit of USD in the requisite amount to such bank account specified in Clause 5.13 below. All expenses or costs incurred or to be incurred by Eloxx in relation to the Eloxx Transitional Plan as indicated in the Research Budget in Schedule 2 shall be paid within fifteen (15) days after receiving the corresponding invoice as shall be notified to the Licensee by Eloxx in writing. For the purpose of calculating any sums due under, or otherwise reimbursable pursuant to, this Agreement (including the calculation of Net Sales expressed in currencies other than USD), Licensee shall convert any amount expressed in a foreign currency into USD equivalents using its, its Affiliate's or Sublicensee's standard conversion methodology consistent with IFRS.
Each Party shall and shall cause its Affiliates and its and their Sublicensees to, keep complete and accurate financial books and records pertaining to the Development and Commercialization of Licensed Products hereunder (including with respect to Licensee, Net Sales of Licensed Products) to the extent required to calculate and verify all amounts payable hereunder. Licensee shall, and shall cause its Affiliates and its and their Sublicensees to, retain such books and records until the later of:
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Eloxx shall have the right to have an independent certified public accounting firm of internationally recognized standing reasonably acceptable to Licensee ("Auditor") to have access during normal business hours, upon reasonable prior written notice, to such of the records of Licensee and its Affiliates as may be required to verify the accuracy of the calculation of Milestone Payments, Net Sales, Royalty Payments, Priority Review Voucher Income or PRV Product Revenue Share Payments due for any year. All information subject to review under this clause 5.12(b) is subject to the confidentiality provisions of clause 6 and Eloxx shall cause the Auditor to enter into a reasonably acceptable confidentiality agreement with Licensee obligating such firm to retain all such financial information in confidence pursuant to such confidentiality agreement. Any and all records of Licensee and its Affiliates and Sublicensees examined by such Auditor shall be deemed Licensee's Confidential Information, which may not be disclosed by said Auditor to any Third Party or (except for the information expressly sought to be confirmed by Eloxx as set forth in this clause 5.12(b)) to Eloxx. Eloxx shall bear all costs of such audit, unless the audit reveals a discrepancy in its favour of more than ten percent (10%), in which case Licensee shall bear the cost of the audit. Licensee shall use Commercially Reasonable Efforts to cause its Sublicensees to grant Eloxx a right to audit each such Sublicensee's financial records pursuant to this clause 5.12(b), and, in any event, upon Eloxx's written request, Licensee shall exercise its financial audit rights under any applicable agreements with respect to the financial records of any Sublicensee.
Payment of Additional Amounts. If, based on the results of any audit conducted under clause 5.12(b), additional payments are owed to Eloxx under this Agreement or a refund is owed to Licensee, then Licensee or Eloxx, as applicable, shall make such additional payments within forty-five (45) days of receiving the corresponding invoice issued after the Auditor’s written report is delivered to the Parties. If the report is contested by either Party, the Parties shall follow the dispute resolution procedures described in clause 5.12(d).
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In the event of a dispute with respect to any audit under clause 5.12(b), Eloxx and Licensee shall work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within thirty (30) days, the dispute shall be submitted for resolution to a certified public accounting firm jointly selected by each Party’s certified public accountants or to such other person as the Parties shall mutually agree (the “Dispute Auditor”). The decision of the Dispute Auditor shall be final and the costs of such arbitration as well as the initial audit shall be borne between the Parties in such manner as the Auditor shall determine. Not later than thirty (30) days after such decision and in accordance with such decision, any Party owing a reconciliatory sum to the other Party shall pay the additional amounts, with interest from the date originally due as provided in clause 5.14.
Any payments due to be paid by Licensee to Eloxx shall be made to the account details set out below:
Bank Routing Number: [***]
SWIFT Code: [***]
General Bank Reference: [***]
Account Number: [***]
Account Name: Eloxx Pharmaceuticals, Inc.
Or such other account in the US as Eloxx shall designate before any such payment is due.
If any payment due to either Party under this Agreement is not paid when due, then such paying Party shall pay interest thereon (before and after any judgment) at an annual rate (but with interest accruing on a daily basis) of four (4) percentage points above the then-current prime rate reported in The Wall Street Journal or the highest rate allowed by applicable Laws, whichever is lower.
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The Receiving Party shall not disclose or disseminate Confidential Information of the Disclosing Party to any Third Party, unless expressly permitted hereunder, and shall not use such Confidential Information for any purpose other than in performing the Receiving Party's obligations or exercising the Receiving Party's rights hereunder. In addition, the Receiving Party shall take reasonable steps to protect the Confidential Information of the Disclosing Party from unauthorized use or disclosure, which steps shall be no less than those the Receiving Party takes to protect its own confidential and/or proprietary material of a similar nature but in any even no less than a reasonable degree of care. The foregoing obligations shall apply equally to all copies, extracts and summaries of the Disclosing Party's Confidential Information.
Notwithstanding the foregoing, each of Eloxx and Licensee may disclose Confidential Information of the other Party to a Third Party to the extent such disclosure is made in response to a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial and local governmental or regulatory body of competent jurisdiction or, if in the reasonable opinion of the Receiving Party's legal counsel, such disclosure is otherwise required by Law, including by reason of filing with securities regulators; provided, however, that if a Party is required by Law to make any such disclosure of the Disclosing Party's Confidential Information, to the extent it may legally do so it shall give reasonable advance notice to the Disclosing Party of such disclosure to permit the Disclosing Party to use its reasonable efforts to secure confidential treatment of such Confidential Information prior to disclosure (whether through protective orders or otherwise) and shall cooperate with Disclosing Party in connection therewith; and provided, further, that the Confidential Information disclosed in response to such court or governmental order shall be limited to that information which is legally required to be disclosed in response to such court or governmental order.
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The Receiving Party may disclose such of the Disclosing Party's Confidential Information to its Affiliates, and their respective employees, consultants, and permitted subcontractors who each have a need to know such Confidential Information and who are bound by written obligations of confidentiality and non-use at least as stringent as those by which the Receiving Party is bound hereunder.
Licensee and its Affiliates and its and their Sublicensees may disclose the Licensed Know-How to the extent that such disclosure is made to its or their attorneys, auditors, advisors, consultants, contractors, existing or prospective collaboration partners, investors, acquirers, licensees, Sublicensees, any Regulatory Authorities or other Third Parties for use by such persons as may be reasonably necessary or useful in connection with the Exploitation of Licensed Compound or Licensed Products (including in connection with any filing, application or request for Regulatory Approval by or on behalf of Licensee or any of its Affiliates or its or their Sublicensees) or otherwise in connection with the performance of its obligations or exercise of Licensee's rights as contemplated by this Agreement.
Licensee may disclose Licensed Know-How that is Confidential Information of Eloxx to a Third Party to the extent such disclosure is made by or on behalf of Licensee to a patent authority as may be reasonably necessary or useful for purposes of obtaining or enforcing a Patent covering a Licensed Compound or a Licensed Product; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information, to the extent such protection is available.
The Receiving Party may disclose such of the Disclosing Party's Confidential Information to potential or actual attorneys, auditors, advisors, consultants, contractors,
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investors, collaboration partners, licensees, Sublicensees, or acquirers as may be necessary in connection with their evaluation of such potential or actual partnership, investment or acquisition; provided, however, that each such person shall be bound by written obligations of confidentiality and non-use at least as stringent as those by which the Receiving Party is bound under clause 6.
Upon expiration or termination of this Agreement, the Receiving Party shall promptly return, or at the Disclosing Party's request, destroy or delete (and certify such deletion in writing), all of the Disclosing Party's Confidential Information except to the extent that the Receiving Party has a continuing license to use such Confidential Information, provided that the Receiving Party may retain one copy for its legal files subject to ongoing confidentiality and non-use obligations.
If either Party becomes aware or has knowledge of any unauthorized use or disclosure of the Disclosing Party's Confidential Information, it shall promptly notify the Disclosing Party of such unauthorized use or disclosure.
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the Licensed IP to Licensee, its Affiliates and Sublicensees. For this purpose, each Party may name and use the logo (whether or not such name or logo is registered as a trademark) of the other Party in a form agreed by the other Party, and may make a high level non-confidential statement about the existence and nature of this contractual relationship, provided that any such statement is limited to statements previously included in a press release or other mutually agreed communication agreed by the other Party or otherwise agreed by that Party.
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applicable Law and industry practices (which approval shall not be unreasonably withheld or delayed by Eloxx).
Licensee shall through the use of outside counsel as it may reasonably determine, prepare, file, prosecute and maintain the Licensed Patents as indicated in Part 1 of Schedule 1 on a worldwide basis and to be responsible for any related interference, re-issuance, re-examination and opposition proceedings and Licensee shall assume all internal patent portfolio management costs and external patent counsel fees and expense. Where Licensee wishes to file any new Patents based on the Licensed Know-How it shall notify Eloxx and provide Eloxx with the relevant information and support in advance and reimburse Eloxx's internal and external costs and expense associated with such filing. Licensee shall prosecute and maintain such Licensed Patents at least in the US, EU, China, Australia and Japan, in each case consistent with Licensee's patent strategy for Patents as notified in advance to Eloxx by Licensee, provided that for clarity, Licensee may also file in additional countries upon Licensee's request and expense. In the event Licensee decides that it is no longer interested in paying for the prosecution or maintenance of any particular Patent(s) included in Part 1 of Schedule 1 of the Licensed Patents in a particular country (each a "Discontinued Patent"), Licensee shall notify Eloxx and Eloxx may, at Eloxx's expense, assume and continue to control the prosecution and/or maintenance of such Licensed Patents. In such circumstances, the rights and licenses granted to Licensee under clause 2.1 shall not include rights under any Discontinued Patents. Eloxx shall sign and provide all forms and documents as may be reasonably requested by Licensee in order to carry out the filing, maintenance and prosecution activities set forth in this clause.
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As between the Parties, Licensee shall have the sole right to make decisions regarding and to apply for (in each case in consultation with Eloxx and subject to Licensee paying Eloxx's external costs and expense), patent term extensions, including supplementary protection certificates and any other extensions that are now or become available in the future, wherever applicable, for the Licensed Patents as set out in Part 1 of Schedule 1. Eloxx shall provide prompt and reasonable assistance, as requested by Licensee at Licensee's cost and expense, including by taking such action as patent holder as is required under any applicable Law to obtain such extension or supplementary protection certificate.
As between the Parties, Licensee shall have the sole right to make all filings with Regulatory Authorities in the Territory with respect to the Licensed Patents as set out in Part 1 of Schedule 1, including as required or allowed in the US, in the FDA's Orange Book or other international equivalents.
Licensee shall keep Eloxx reasonably apprised of material developments regarding the preparation, filing, maintenance and prosecution of the Licensed Patents, and shall provide Eloxx with a reasonable opportunity to comment and make requests regarding the same. Licensee shall, or shall instruct its patent counsel to, furnish Eloxx with copies of all correspondence relating to the Licensed Patents from the patent offices, as well as copies of all proposed responses to such correspondence in time for Eloxx to review and comment on such response. Upon Eloxx's request, Licensee shall also provide to Eloxx an updated list of the relevant Licensed Patents no more frequently than every six (6) months from the Effective Date, which list shall detail the current status of each applicable Licensed Patent. Eloxx shall cooperate with Licensee to the extent reasonably necessary for Licensee to prosecute the
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applicable Licensed Patents in the Territory, including the execution and delivery of documents at Licensee’s cost.
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that, if Licensee has notified Eloxx that it had elected not to initiate such proceedings because it reasonably believed that such proceedings would be detrimental or prejudicial to Licensee, Eloxx shall not have the right to initiate or litigate any proceedings with respect to such Infringement. In any event, the Party not directing such proceeding shall reasonably assist the Party directing such proceeding and cooperate in any such litigation at the request and expense of the Party directing the proceeding. Each Party may at its own expense and with its own counsel join any proceeding initiated and directed by the other Party under this clause 7.6.
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defence of such proceeding and cooperate in any such litigation at the request and expense of Licensee, including, if requested by Licensee, joining such action, and executing all papers and performing such acts as Licensee may reasonably require. Eloxx may at its own expense and with its own counsel join any defence initiated and directed by Licensee under this clause 7.7.
Eloxx shall own the Eloxx Platform and the Eloxx Platform IP. Eloxx shall also own all Eloxx Platform Improvements, whether or not created, invented, identified or synthesised by Eloxx, Licensee or jointly by Eloxx and Licensee during the Term. At the request of Eloxx and at Eloxx’s expense, Licensee shall, and shall procure that any of its employees, agents and subcontractors shall, do all acts and things (including making declarations, oaths and providing assistance in relation to the supply of information for any patent applications) and execute all documents that may be reasonably necessary under the laws of any country for ensuring that all rights in any Eloxx Platform Improvements are assigned to Eloxx together with the right to sue for past infringement and recover damages, provided that for clarity, all Eloxx Platform Improvements will be included within the Eloxx Platform IP regardless of inventorship. Eloxx will be solely responsible, at its expense, for the preparation, filing, prosecution, maintenance and enforcement of all Patents within the Eloxx Platform IP including, without limitation, any related interference, re-issuance, re-examination and opposition proceedings. Eloxx will be solely responsible for defending any proceedings initiated
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by a Third Party claiming that the Eloxx Platform IP are invalid or any patent owned by or licensed to such Third Party is infringed by use of the Eloxx Platform or any Eloxx Platform Improvement to identify, generate or optimise compounds.
At the request of Licensee or Eloxx (as the case may be), the other Party shall, and shall procure that any of its or its Affiliates’ employees, agents and subcontractors shall, do all acts and things (including making declarations, oaths and providing assistance in relation to the supply of information for any patent applications) and execute all documents that may be reasonably necessary under the laws of any country for giving effect to the ownership provisions of clauses
2.4II and 7.8.
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Each Party shall ensure that all persons that provide any Development activities under this Agreement on behalf of such Party are under a written or other legally enforceable obligation to assign all right, title and interest in any Intellectual Property rights created pursuant to such Development activities directly to such Party or such Party's nominee for the purpose of giving effect to the ownership provisions of clauses 2.4(c) and 7.8.
Licensee shall be solely responsible for developing, selecting, searching, registering and maintaining, and shall be the exclusive owner of, all trademarks, trade dress, logos, slogans, designs, copyrights and domain names used on and/or in connection with Licensed Products.
Each Party shall be solely responsible for any remuneration that may be due to such Party's inventors under any applicable inventor remuneration Laws.
Unless terminated earlier pursuant to this clause 8 the term of this Agreement shall commence on the Effective Date and shall continue in full force and effect on a Licensed Product-by- Licensed Product and country-by-country basis until the expiration of the Royalty Term for all Licensed Products (the "Term"). Upon expiration of the Royalty Term, on a Licensed Product- by-Licensed Product and country-by-country basis the license granted to Licensee pursuant to clause 2.1 shall be a fully paid, irrevocable, perpetual license.
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on 90 days' prior written notice to Eloxx. Licensee shall remain liable to pay (i) any Milestone Payments that have become due for payment and/or (ii) Royalty Payments on Net Sales accrued by Licensee (in accordance with IFRS), in each case (i) and (ii) on or before the Termination Date.
Eloxx shall have the right to terminate this Agreement on thirty (30) days' written notice to Licensee if after the end of the Research Term, for a continuous period of eighteen (18) months, no material Development activities have been undertaken by or on behalf of Licensee on any Licensed Compound or Licensed Product; provided that, at least six (6) months prior to exercising such termination right Eloxx shall notify Licensee of its concerns and the Parties shall discuss in good faith the reasons why Licensee is not undertaking such material Development activities and its plans for recommencing such activities and if there is a dispute regarding Eloxx's right to terminate under this clause the Parties shall refer the matter to the dispute resolution provisions of clause 8.5. For the avoidance of doubt, this right of termination by Eloxx shall not apply in the event that Licensee is negotiating the performance of the Development activities with an actual or potential Sublicensee during the aforementioned six month period and Licensee executes within such period a sublicense agreement with such Sublicensee that is consistent with the terms of this Agreement.
In the event of a material breach of this Agreement, the non-breaching Party shall have the right to terminate this Agreement in its entirety (if the breach is material to the Agreement as a whole)
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by written notice to the breaching Party specifying the nature of such breach in reasonable detail. Such termination shall become effective 90 days from receipt of such notice by the breaching Party, except that such period shall be 30 days in the event the basis of the alleged material breach is a failure to make payment(s) under this Agreement, unless in each case the breaching Party has cured such breach within such ninety (90) or 30 day period (as applicable). Notwithstanding the foregoing:
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material breach, the applicable cure period shall commence upon such final resolution.
Any dispute arising out of an allegation of material breach of this Agreement or any other dispute, controversy or claim that may arise relating to this Agreement (each a "Dispute"), will be resolved as follows the Senior Officers will meet to attempt to resolve the Dispute by good faith negotiations. If the Senior Officers cannot resolve the Dispute within 30 days after a Party requests such a meeting, then either Party may, by written notice to the other Party, elect to initiate an arbitration proceeding pursuant to the procedures set forth in clause 12.3, which shall fully and finally settle the Dispute, and any Dispute concerning the propriety of the commencement of the arbitration or the applicability of the Agreement to arbitrate shall be finally settled by the arbitral tribunal.
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If Licensee or its Affiliates directly commence, or knowingly assist a Third Party (save where such assistance is ordered by a court, patent office or other tribunal) to commence any interference or opposition proceeding, challenge the validity or enforceability in any patent office or court proceedings of, or oppose any extension of or the grant of a supplementary protection certificate with respect to a Licensed Patent ("Patent Challenge"), Eloxx may terminate this Agreement on 60 days' prior written notice stating Eloxx's intention to terminate this Agreement
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if the Patent Challenge has not been stopped within such period, provided that Eloxx may not terminate this Agreement pursuant to this clause 8.7 if:
Expiration or termination of this Agreement for any reason shall not release either Party from any obligation or liability which, at the time of such expiration or the Termination Date, has already accrued to the other Party or which is attributable to a period prior to such expiration or the Termination Date.
If this Agreement is terminated by Licensee pursuant to clause 8.2, or Eloxx for Material Breach (including under Section 4.8(c)) or Insolvency or Patent Challenge pursuant to clauses 8.3, 8.4, 8.6 or 8.7 (it being understood and agreed that rejection pursuant to Bankruptcy Code section 365(b) or similar insolvency law shall not constitute termination), then:
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manufacture and Commercialization of any Reversion Products to Eloxx, to the extent contemplated by this clause 8.8(b) and
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Upon the expiration or termination of this Agreement for any reason, all rights and obligations of the Parties under this Agreement shall terminate. Notwithstanding any provision herein to the contrary, the rights and obligations of the Parties set forth in the Preamble, clause 11 (Definitions) (to the extent applicable to other surviving provisions), clause 2.7 (Retention of Rights), clause 5 (Financial Provisions) (solely with respect to payment obligations that have accrued prior to the effective date of such expiration or termination), clause 5.12 (Record Retention), clause 6 (Confidentiality), clause 7.8 (Eloxx Platform IP), clause 7.10 (Co- operation), clause 8.8 (Effect of Expiration or Termination of this Agreement), this clause 8.9 (Survival), clause 8.10 (Effect of Termination on Sublicenses), clause 8.11 (Termination Not Sole Remedy), clause 11 (Indemnification), clause 12.1 (Assignment) (solely with respect to assignment of surviving rights), clause 12.2 (Governing Law), clause 12.3 (Arbitration), clause
12.6 (No Agency), clause 12.7 (No Third Party Beneficiaries), clause 12.8 (Entire Agreement; Amendment), clause 12.9 (Illegality, Non-Enforceability), clause 12.10 (Extension, Waiver), clause 12.11 (Notices), clause 12.12 (Further Assurances), clause 12.13 (No Strict Construction), clause 12.14 (Headings; Interpretation) and clause 12.16 (Non-Exclusive Remedies) and shall survive the expiration or termination of this Agreement for any reason.
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If this Agreement terminates for any reason or is rejected by either Party pursuant to Bankruptcy Code section 365(a) or similar insolvency law, any Sublicensee that is not an Affiliate of Licensee will, from the Termination Date and if requested in writing by such Sublicensee within
30 days of the Termination Date, automatically and without any additional consideration become a direct licensee of Eloxx with respect to the rights sublicensed to the Sublicensee by Licensee under this Agreement; so long as:
Termination is not the sole remedy under this Agreement and, whether or not termination is effected, all other remedies at equity or law shall remain available to the Parties.
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As of the Effective Date, each of Eloxx and Licensee warrants and covenants to the other Party that:
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an FDA debarment investigation or proceeding (or similar proceeding of EMA or foreign equivalent), for the conduct of its activities under this Agreement;
this Agreement is a legal and valid obligation binding upon such Party and enforceable in accordance with its terms.
Eloxx represents and warrants to Licensee that as at the Effective Date:
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Except as expressly set forth in this agreement, neither Party makes any warranties or conditions, express, implied, statutory or otherwise, with respect to the subject matter of this Agreement.
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subject matter of this Agreement (together with the Party, the "Party Representatives") that for the performance of its obligations under this Agreement:
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In each case except to the extent that such Losses are subject to indemnification by Licensee pursuant to clause 11.2 below (or would be subject to indemnification if the claim were made against Eloxx).
Licensee shall defend, indemnify and hold Eloxx, its Affiliates and its and their respective directors, officers, employees and agents, at Licensee’s cost and expense, harmless from and against any and all Losses incurred in connection with or arising out of any Third Party Claims resulting from or arising out of or in connection with:
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in each case except to the extent that such Losses are subject to indemnification by Eloxx pursuant to clause 11.1 above (or would be subject to indemnification if the claim were made against Licensee).
All indemnification claims in respect of any person seeking indemnification under clause 11.1 or 11.2 (collectively, the "Indemnitees" and each an "Indemnitee") shall be made by the corresponding Party (the "Indemnified Party"). The Indemnified Party shall give the indemnifying Party (the "Indemnifying Party") prompt written notice (an "Indemnification Claim Notice") of any Losses or the discovery of any fact upon which such Indemnified Party intends to base a request for indemnification under clause 11.1 or 11.2, but in no event shall the Indemnifying Party be liable for any Losses that result from any delay by the Indemnified Party in providing such notice. Each Indemnification Claim Notice must contain a description of the claim and the nature and amount of such Loss (to the extent that the nature and amount of such Loss are known at such time). Together with the Indemnification Claim Notice, the Indemnified Party shall furnish promptly to the Indemnifying Party copies of all notices and documents (including court papers) received by any Indemnitee in connection with the Third Party Claim. The Indemnifying Party shall not be obligated to indemnify the Indemnified Party to the extent any admission or statement made by the Indemnified Party materially prejudices the defence of such Third Party Claim. Where required the Indemnifying Party shall promptly
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send a copy of the Indemnification Claim Notice to its relevant insurers and shall permit them to exercise their rights of subrogation and hereafter in this clause 11 "Indemnifying Party" shall be deemed to include any such insurers.
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Each Party shall have and maintain, at its sole cost and expense, an adequate liability
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insurance or self-insurance program (including product liability insurance) to protect against potential
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liabilities and risk arising out of activities to be performed under this Agreement and any agreement related hereto and upon such terms (including coverages, deductible limits and self- insured retentions) as are customary in the pharmaceutical industry generally for the activities to be conducted by such Party under this Agreement. Such liability insurance or self-insurance program shall insure against all types of liability, including personal injury, physical injury or property damage arising out of such Party's activities hereunder. This clause 11.6 shall not create any limitation on the Parties' liability under this Agreement. Such insurance information shall be kept in confidence in the same manner as any other Confidential Information disclosed by the Parties hereunder.
In no event shall either Party or any of its Affiliates or Sublicensees be liable for special, indirect, incidental, punitive, treble or consequential damages or indirect lost profits, whether based on contract, tort or any other legal theory; provided, however, that this limitation shall not limit:
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This Agreement, or any of the rights and obligations under this Agreement, may not be assigned or otherwise transferred by either Party without the prior written consent of the other Party; provided, however, that either Party may assign this Agreement, or any of the rights and obligations under this Agreement, without the consent of the other Party:
provided that, in each case (a) and (b), the proposed assignee is not a resident or is not located in a country being regarded as a tax haven in accordance with any Law applicable to the non assigning Party.
In all cases, the assigning Party shall provide the other Party with prompt written notice of any such assignment and the permitted assignee shall assume the obligations of the assigning Party hereunder in writing. No assignment of this Agreement shall act as a novation or release of either Party from responsibility for the performance of any accrued obligations. Any assignment not in accordance with this clause 12.1 shall be null and void.
This Agreement and any dispute or claim arising out of or in connection with it (whether contractual or non-contractual in nature such as claims in tort, from breach of statute or regulation or otherwise) shall be governed by and construed in accordance with the laws of Delaware; provided that any dispute with respect to infringement, validity, or enforceability of any Patent, shall be governed by and construed and enforced in accordance with the laws of the jurisdiction in which such Patent is issued or published.
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any rulings or awards shall be kept confidential by the Parties and the arbitral tribunal except:
to the extent disclosure may be necessary to conduct the arbitration, or in connection with a court application for a preliminary remedy, a judicial challenge to an award or its enforcement, or unless otherwise required by law or judicial decision; or where such information is already in the public domain other than as a result of a breach of this Agreement.
Neither Party shall be liable to the other for any failure or delay in the fulfilment of its obligations under this Agreement (other than the payment of monies due and owing to a Party under this Agreement), when any such failure or delay is caused by any event that is beyond the reasonable control of the affected Party (each, a "Force Majeure Event"), including without limitation, fire, flood, earthquakes, explosions, sabotage, terrorism, civil commotions, riots, invasions, wars, peril of the sea, Acts of God, or requirements of Governmental Authorities. In the event that either Party is prevented from discharging its obligations under this Agreement on account of a Force Majeure Event, the performing Party shall notify the other Party in writing forthwith, and shall nevertheless use Commercially Reasonable Efforts to discharge its obligations, even if in a partial or compromised manner. In the event that the Force Majeure Event is a recognized widespread epidemic or pandemic that delays or renders impracticable or unsafe the performance by either or both of the Parties under this Agreement, the Parties will negotiate in good faith appropriate modifications to this Agreement to allow performance hereunder that is consistent with the health and safety of the Parties, their representatives, and the general public including appropriate delays to the timetable for carrying out activities under Eloxx Transitional Plan.
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Except as otherwise expressly provided herein or mutually agreed, all costs and expenses incurred in connection with this Agreement and the transactions contemplated hereby shall be borne by the Party incurring such costs and expenses.
Nothing herein contained shall be deemed to create an agency, joint venture, amalgamation, partnership or similar relationship between Eloxx and Licensee. Notwithstanding any of the provisions of this Agreement, neither Party shall at any time enter into, incur, or hold itself out to Third Parties as having authority to enter into or incur, on behalf of the other Party, any commitment, expense, or liability whatsoever, and all contracts, expenses and liabilities undertaken or incurred by one Party in connection with or relating to the Exploitation of Licensed Compound or the Exploitation of Licensed Products shall be undertaken, incurred or paid exclusively by that Party, and not as an agent or representative of the other Party. All persons employed by a Party will be the employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such first Party.
Except for any rights and immunities granted in this Agreement to any Affiliates, the Contracts (Rights of Third Parties) Act 1999 shall not apply to this Agreement. No person who is not a party to this Agreement (including any employee, officer, agent, representative or subcontractor of either Party) shall have the right (whether under the Contracts (Rights of Third Parties) Act 1999 or otherwise) to enforce any provision of this Agreement which expressly or by implication confers a benefit on that person without the express prior agreement in writing of the Parties, which agreement must refer to this clause 12.7.
This Agreement (including all schedules and exhibits hereto) sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter
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hereof and supersedes all prior agreements or understandings, promises, misrepresentations and representations, whether oral or written, with respect to such matters. Each Party confirms that it is not relying on any representations, misrepresentations or warranties of the other Party except as specifically set forth in this Agreement. This Agreement may be amended or modified only by a writing signed by both Parties. No release or discharge shall be binding upon the Parties unless in a writing signed by both Parties.
If the whole or any part of this Agreement is or becomes or is declared illegal, invalid or unenforceable in any jurisdiction for any reason (including both by reason of the provisions of any legislation and also by reason of any decision of any court or Governmental Authority which either has jurisdiction over this Agreement or has jurisdiction over any of the Parties):
At any time, either Eloxx or Licensee may:
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Any agreement on the part of either Party to any such extension or waiver shall be valid only if set forth in an instrument executed by such Party.
No such waiver shall be operative as a waiver of any other right hereunder or of any breach or failure by the other Party whether of a similar nature or otherwise. The failure or delay of any Party to assert any of its rights under this Agreement or otherwise shall not constitute a waiver of such rights or of any other rights hereunder.
All communications, including notices, requests, demands, waivers, consents or approvals, required to be made under this Agreement shall be in writing in the English language and effective upon receipt, and shall be sent to the addresses set out below, or to such other addresses as may be designated by one Party to the other by notice pursuant hereto, by:
If to Eloxx, as follows: Eloxx Pharmaceuticals Inc.
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26 Upton Street, Apt 1
Boston MA 02118 USA
Attn: Sumit Aggarwal saggarwal@eloxxpharma.com
With a copy (which will not constitute notice) to: Latham & Watkins
100 Clarendon Street
Boston MA 02116 Attn: Peter Handrinos
peter.handrinos@lw.com
If to Licensee, as follows: Almirall, S.A
Ronda General Mitre 151 08022 Barcelona, Spain
Attn: Karl Ziegelbauer, Executive VP R&D, CSO,
With a copy (which will not constitute notice) to: Almirall, S.A
Ronda General Mitre 151 08022 Barcelona, Spain
Attn: Corporate Legal Director
This clause 12.11 is not intended to govern the day-to-day business communications necessary between the Parties in performing their obligations under the terms of this Agreement, which may be made by any means mutually agreeable to the Parties.
Each Party shall perform, or caused to be performed, all further acts and things and execute and deliver such further documents as may be necessary or as the other Party may reasonably require to implement or give effect to this Agreement.
This Agreement shall be construed as if it were drafted jointly by the Parties.
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The headings herein are for convenience purposes only and shall not be used to interpret any of the provisions hereof. Unless otherwise expressly provided herein or the context of this Agreement otherwise requires:
This Agreement may be executed in any number of counterparts, each of which shall be deemed an original and all of which taken together shall be deemed to constitute one and the same instrument. Signatures to this Agreement or its amendments, transmitted by email in “portable document format” (“.pdf”), via DocuSign, or by any other electronic means intended to preserve the original graphic and pictorial appearance of this Agreement, or its amendment, shall have the same effect as physical delivery of the paper document bearing original signature.
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The remedies set forth in this Agreement shall be in addition to, and shall not be to the exclusion of, any other remedies available to the Parties at Law, in equity or under this Agreement.
IN WITNESS WHEREOF this Agreement has been signed by the duly authorized representatives of the Parties on the day and year first before written.
/s/ Sumit Aggarwal
SIGNED by SUMIT AGGARWAL
Chief Executive Officer
/s/ Carlos Gallardo
SIGNED by Carlos Gallardo President & CEO
ZIKANI THERAPEUTICS, INC.
/s/ Sumit Aggarwal
SIGNED by SUMIT AGGARWAL
Chief Executive Officer
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