This Amendment is entered into as of November 20, 2024 (the “Amendment Effective Date”) by and between Aegis Therapeutics, LLC, having a principal place of business at 3430 Carmel Mount Road, Suite 300, San Diego, CA 92121 (“Aegis”), Indivior Inc., having a principal place of business at 10710 Midlothian Turnpike, Suite 125, Midlothian, Virginia 23235 (“Indivior”), and Indivior UK Limited, having a principal place of business at The Chapleo Building, Henry Boot Way, Priority Park, Hull HU4 7DY, United Kingdom (“Indivior UK”) (individually each a “Party” and collectively the “Parties”).
WHEREAS, on January 1, 2017, Aegis entered into a License Agreement with Opiant Pharmaceuticals, Inc. (“Licensee”) whereby Aegis granted to Licensee a license to certain Aegis Technology in combination with certain Compounds as set forth therein (“License Agreement”);
WHEREAS, on March 2, 2023, Indivior acquired Licensee, and subsequently Licensee was merged with and into Indivior and as a result (i) succeeded Licensee with respect to Licensee’s rights and obligations under the License Agreement, and (ii) acquired Licensee’s rights in Opiant’s Patents;
WHEREAS, the Parties have been in discussion concerning the Party best suited to handle the prosecution and enforcement of certain Aegis Patent Rights that are exclusively licensed from Aegis to Indivior pursuant to the License Agreement that pertain to the Product and the Parties have agreed that such Patent Rights identified herein should be assigned to Indivior;
NOW THEREFORE, in consideration of the foregoing and for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree to amend and hereby do amend the License Agreement as follows:
1.All capitalized terms in this Amendment that are not specifically defined herein shall have the meaning set forth in the License Agreement.
2.Section 6.2 is amended and restated in its entirety as follows:
6.2 Prosecution and Maintenance of Opiant Patent Rights. Opiant shall have the sole right (but not the obligation), at its expense, to prepare, file, prosecute and maintain the OPIANT Patent Rights.
6.2.1 Assignment of Certain AEGIS Patent Rights. Aegis hereby assigns all right, title and interest in and to (a) the Patents and Patent Applications set forth in Exhibit 1, (b) all patents that in the future may issue from any of the Patent Applications in Exhibit 1, and (c) all divisionals, continuations, continuations-in-part, reissues, renewals, extensions or additions to any Patents and Patent Applications in Exhibit 1 (collectively, the “Assigned Patents”). As of the Amendment Effective Date, such Assigned Patents
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shall be deemed Opiant Patent Rights and Opiant shall have all right, title and interest to prosecute, maintain and enforce such Patent Rights. Aegis shall execute the assignments set forth in Exhibits 2A and 2B, and any other lawful paper or instrument as may be necessary to effectuate such assignment. SUCH PATENT ASSIGNMENTS ARE “AS IS” AND AEGIS MAKES NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY, OR INVENTORSHIP REGARDING THE PATENTS AND PATENT APPLICATIONS IN EXHIBIT 1. AEGIS HEREBY REPRESENTS THAT, TO AEGIS’ KNOWLEDGE: EACH OWNER AND INVENTOR OF EACH OF THE PATENTS AND APPLICATIONS IN EXHIBIT 1 HAS COMPLIED WITH ALL APPLICABLE DUTIES OF CANDOR AND GOOD FAITH IN DEALING WITH ANY PATENT OFFICE, INCLUDING THE DUTY TO DISCLOSE TO ANY APPLICABLE PATENT OFFICE ALL INFORMATION KNOWN TO BE MATERIAL TO PATENTABILITY OF ANY CLAIM IN ANY PATENT OR APPLICATION IN EXHIBIT 1; AND NEITHER AEGIS NOR ANY THIRD PARTY HAS UNDERTAKEN OR OMITTED TO UNDERTAKE ANY ACTS, AND TO ITS KNOWLEDGE, NO CIRCUMSTANCES OR GROUNDS EXIST, THAT WOULD INVALIDATE, REDUCE OR ELIMINATE, IN WHOLE OR IN PART, THE ENFORCEABILITY, VALIDITY, OR SCOPE OF ANY CLAIM IN ANY PATENT OR APPLICATION IN EXHIBIT 1.
3.Section 6.5.2 is amended and restated in its entirety as follows:
6.5.2 Paragraph IV Claims. Notwithstanding Section 6.5.6, Opiant shall have the right, at its sole discretion and expense, to institute, prosecute, defend, and control any patent infringement litigation suit based on a Paragraph IV certification (i.e., an ANDA patent infringement litigation involving a patent listed pursuant to 21 U.S.C. Section 355(a)(2)(A)(iv)) or any equivalent action outside the United States involving any Assigned Patent. If required or requested by Opiant, Aegis shall cooperate fully in such litigation as a third-party at its own expense. In the event that AEGIS is named in or becomes a party to such litigation, OPIANT shall pay for all expenses, including attorneys’ fees, incurred by AEGIS. Any recovery realized as a result of such litigation shall be first applied to litigation expenses incurred by OPIANT under this Section 6.5.2. Any remaining recovery realized from litigation brought pursuant to this Section 6.5.2 shall be treated as profits on sales of Products for purposes of determining Net Sales under this License Agreement, with AEGIS receiving the applicable royalty for purposes of Section 4.4 on such deemed Net Sales, and OPIANT receiving the remainder. For purposes of illustration, if the recovery under this Section 6.5.2 is $100 Million (U.S. $100,000,000), after reimbursement of any reasonable litigation expenses, and OPIANT’s gross margin for the Product as determined for the most-recent Calendar Quarter completed prior to the initial certification or infringing action was eighty percent
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(80%), then the Net Sales would be deemed to be One Hundred Twenty-Five Million U.S. dollars ($125,000,000) and such amount would be included in the next royalty report pursuant to Section 4.5.
4.Section 10.8 is amended and restated in its entirety as follows:
10.8 Notices. Any notice, report, communication, or consent required or permitted by this License Agreement shall be in writing and shall be sent by a Party (a) by prepaid registered or certified mail, return receipt requested, or (b) by overnight express delivery service by a nationally recognized courier, addressed to the other Party at the address shown below or at such other address as such Party gives notice hereunder. Such notice will be deemed to have been given when delivered or, if delivery is not accomplished by some fault of the addressee, when tendered.
If to Aegis:
Aegis Therapeutics, LLC
3430 Carmel Mount Road
Suite 300
San Diego, CA 92121
Attn: Jenny Alonso
with a copy to (which alone shall not constitute notice):
DLA Piper US LLP
One Liberty Place
1650 Market Street, Suite 5000
Philadelphia, PA 19103
Attn: Raymond A. Miller
If to Indivior or Indivior UK:
Indivior, Inc.
10710 Midlothian Turnpike
Suite 125
North Chesterfield, Virginia, 23235
Attn: Chief Legal Officer
5.The definition of “Valid Claim” as set forth in Exhibit A (Definitions) is amended and restated in its entirety as follows:
“Valid Claim” shall mean, on a country-by-country basis, either (a) a claim of an issued and unexpired patent in any of the Assigned Patents, which has not been held permanently revoked, unenforceable, or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable, or unappealed within the time allowed for appeal, or
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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 in any of the Assigned Patents, which claim was filed in good faith and has not been abandoned or finally disallowed without the possibility of appeal or refiling of such application.
6.Except as set forth in this Amendment, the Agreement is unaffected and shall continue in full force and effect in accordance with its terms. If there is a conflict between this Amendment and the Agreement, the terms of this Amendment shall prevail and control.
7.This Amendment and each Party’s obligations shall be binding on the respective party and its representatives, assigns and successors. Each Party has signed this Amendment through its authorized representatives.
The Parties hereby agree to the above terms of the Amendment to the License Agreement, and acknowledge the same by the following signatures.
COMPOSITIONS AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
62/354,465
6/24/2016
EXPIRED
148570-002801
UNITED STATES
COMPOSITIONS, DEVICES AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
16/311,944
12/20/2018
ABANDONED
148570-002802
WIPO
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
PCT/US2017/039300
6/26/2017
NAT PHASE
148570-002803
EUROPE
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
17816377.0
6/26/2017
PUBLISHED
148570-002804
JAPAN
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
2018-567665
6/26/2017
ABANDONED
148570-002805
CANADA
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
3028731
6/26/2017
PUBLISHED
148570-002806
MEXICO
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
MX/a/2018/015985
6/26/2017
396982
ISSUED
148570-002807
AUSTRALIA
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
2017281941
6/26/2017
ABANDONED
148570-002808
CHINA
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
201780044057.3
6/26/2017
ABANDONED
148570-002809
SOUTH KOREA
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
10-2019-7001264
6/26/2017
10-2453781
ISSUED
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148570-002810
UNITED STATES
COMPOSITIONS AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
62/419,736
11/9/2016
EXPIRED
148570-002811
UNITED STATES
COMPOSITIONS, DEVICES AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
18/392,008
12/21/2023
PENDING
148570-002813
HONG KONG
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
19128321.7
6/26/2017
PUBLISHED
148570-002814
JAPAN
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
2022-058125
6/26/2017
7492548
ISSUED
148570-002816
NEW ZEALAND
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
750067
6/26/2017
PUBLISHED
148570-002817
AUSTRALIA
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
2023202420
6/26/2017
PUBLISHED
148570-002819
SOUTH KOREA
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
10-2022-7034876
6/26/2017
10-2634829
ISSUED
148570-002826
PHILIPPINES
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
1-2018-502738
6/26/2017
PUBLISHED
148570-002827
SINGAPORE
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
11201811580S
6/26/2017
ABANDONED
148570-002828
RUSSIA
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
2019101810
6/26/2017
2767062
ISSUED
148570-002836
MEXICO
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
MX/a/2022/013671
6/26/2017
PUBLISHED
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Execution Version
148570-002837
SINGAPORE
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
10202013034Q
6/26/2017
PUBLISHED
148570-002838
RUSSIA
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
2022103366
6/26/2017
PUBLISHED
148570-002846
PHILIPPINES
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF ALCOHOL USE DISORDER
MAILED
148570-002900
UNITED STATES
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE AND OPIOID RECEPTOR MEDIATED CONDITIONS
62/419,743
11/9/2016
EXPIRED
148570-002901
UNITED STATES
COMPOSITIONS, DEVICES AND METHODS FOR THE TREATMENT OF OPIOID-RECEPTOR-MEDIATED CONDITIONS
16/348,031
5/7/2019
ABANDONED
148570-002902
WIPO
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OPIOID-RECEPTOR-MEDIATED CONDITIONS
PCT/US2017/060963
11/9/2017
NAT PHASE
148570-002903
EUROPE
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OPIOID-RECEPTOR-MEDIATED CONDITIONS
17868907.1
11/9/2017
PUBLISHED
148570-002905
CANADA
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OPIOID-RECEPTOR-MEDIATED CONDITIONS
3043028
11/9/2017
PUBLISHED
148570-002910
UNITED STATES
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OPIOID-OVERDOSE AND OPIOID-RECEPTOR-MEDIATED CONDITIONS
62/525,057
6/26/2017
EXPIRED
148570-002911
UNITED STATES
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OPIOID-RECEPTOR-MEDIATED CONDITIONS
17/024,149
9/17/2020
TO ABAND
Page 7 of 29
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148570-002913
HONG KONG
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OPIOID-RECEPTOR-MEDIATED CONDITIONS
62020003373.1
11/9/2017
PUBLISHED
148570-002921
UNITED STATES
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OPIOID-RECEPTOR-MEDIATED CONDITIONS
18/758,640
6/28/2024
PENDING
148570-003000
UNITED STATES
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
62/424,378
11/18/2016
EXPIRED
148570-003001
UNITED STATES
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
16/461,354
5/15/2019
11,458,091
ISSUED
148570-003002
WIPO
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
PCT/US2017/060964
11/9/2017
NAT PHASE
148570-003003
EUROPE
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
17871739.3
11/9/2017
PUBLISHED
148570-003004
JAPAN
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
2019-526565
11/9/2017
7312698
ISSUED
148570-003005
CANADA
INTRANASAL NALMEFENE COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
3044221
11/9/2017
PUBLISHED
148570-003006
ISRAEL
COMPOSITIONS, DEVICES AND METHODS OF USING INTRANASAL NALMEFENE AND DODECYL MALTOSIDE FOR TREATMENT OF OPIOID OVERDOSE
266674
11/9/2017
266674
ISSUED
148570-003007
AUSTRALIA
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
2017360910
11/9/2017
2017360910
ISSUED
148570-003008
CHINA
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
201780081719.4
11/9/2017
PUBLISHED
Page 8 of 29
Execution Version
148570-003009
RUSSIA
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
2019118465
11/9/2017
2769397
ISSUED
148570-003011
UNITED STATES
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
17/881,191
8/4/2022
ABANDONED
148570-003013
HONG KONG
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
62020001439.2
11/9/2017
PUBLISHED
148570-003014
JAPAN
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
2023-112864
11/9/2017
PUBLISHED
148570-003016
ISRAEL
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
312012
11/9/2017
PUBLISHED
148570-003017
AUSTRALIA
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
2024201047
11/9/2017
PUBLISHED
148570-003021
UNITED STATES
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
18/753,188
6/25/2024
PENDING
148570-003100
UNITED STATES
FORMULATIONS AND METHODS FOR THE PREVENTION OF OPIOID OVERDOSE
62/672,950
5/17/2018
EXPIRED
148570-003101
UNITED STATES
FORMULATIONS AND METHODS FOR THE PREVENTION OF OPIOID OVERDOSE
17/055,647
11/16/2020
ABANDONED
148570-003102
WIPO
FORMULATIONS AND METHODS FOR THE PREVENTION OF OPIOID OVERDOSE
PCT/US2019/032498
5/15/2019
NAT PHASE
148570-003103
EUROPE
FORMULATIONS AND METHODS FOR THE PREVENTION OF OPIOID OVERDOSE
19804071.9
5/15/2019
PUBLISHED
148570-003105
CANADA
FORMULATIONS AND METHODS FOR THE PREVENTION OF OPIOID OVERDOSE
3100834
5/15/2019
PUBLISHED
148570-003111
UNITED STATES
FORMULATIONS AND METHODS FOR THE PREVENTION OF OPIOID OVERDOSE
18/436,976
2/8/2024
PUBLISHED
Page 9 of 29
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148570-003133
HONG KONG
FORMULATIONS AND METHODS FOR THE PREVENTION OF OPIOID OVERDOSE
62021039241.6
5/15/2019
PUBLISHED
148570-003200
UNITED STATES
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS
62/782,943
12/20/2018
EXPIRED
148570-003201
UNITED STATES
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS
16/721,872
12/19/2019
ABANDONED
148570-003202
WIPO
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS
PCT/US2019/067513
12/19/2019
NAT PHASE
148570-003203
EUROPE
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS
19898164.9
12/19/2019
PUBLISHED
148570-003204
JAPAN
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS
2021-535535
12/19/2019
ABANDONED
148570-003205
CANADA
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS
3124202
12/19/2019
PUBLISHED
148570-003206
MEXICO
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS
MX/a/2021/007522
12/19/2019
PUBLISHED
148570-003207
AUSTRALIA
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS
2019403368
12/19/2019
PUBLISHED
148570-003208
CHINA
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS
201980092189.2
12/19/2019
PUBLISHED
Page 10 of 29
Execution Version
148570-003209
SOUTH KOREA
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS
10-2021-7022386
12/19/2019
PUBLISHED
148570-003211
UNITED STATES
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS
18/392,013
12/21/2023
PENDING
148570-003214
JAPAN
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS
2024-141729
12/19/2019
PENDING
148570-003237
NEW ZEALAND
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS
777994
12/19/2019
PUBLISHED
148570-003238
ISRAEL
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS
284117
12/19/2019
PUBLISHED
148570-003239
PHILIPPINES
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS
1-2021-551465
12/19/2019
PUBLISHED
148570-003243
HONG KONG
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS
62021043484.6
12/19/2019
PUBLISHED
148570-003246
RUSSIA
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS
2021121189
12/19/2019
PUBLISHED
148570-003248
SINGAPORE
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS
11202106531V
12/19/2019
ABANDONED
148570-003258
SINGAPORE
COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OVERDOSE AND REWARD-BASED DISORDERS
10202301750Q
12/19/2019
PUBLISHED
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UNITED STATES
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
17/881,306
08/04/2022
PUBLISHED
UNITED STATES
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
63/229,300
8/4/2021
AUSTRALIA
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
2022323269
2/2/2024
CANADA
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
3227828
2/1/2024
EUROPE
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
22853922.7
3/4/2024
ISRAEL
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
310566
1/31/2024
MEXICO
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
MX/a/2024/001659
2/2/2024
NEW ZEALAND
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
807981
2/5/2024
WIPO
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
PCT/US/2022/039463
08/04/2022
EUROPE
METHODS, PARENTERAL PHARMACEUTICAL FORMULATIONS, AND DEVICES FOR THE PREVENTION OF OPIOID OVERDOSE
19881497.2
6/7/2021
HONG KONG
METHODS, PARENTERAL PHARMACEUTICAL FORMULATIONS, AND DEVICES FOR THE PREVENTION OF OPIOID OVERDOSE
62022049987
3/15/2022
UNITED STATES
METHODS, PARENTERAL PHARMACEUTICAL FORMULATIONS, AND DEVICES FOR THE PREVENTION OF OPIOID OVERDOSE
62/756,903
11/7/2018
Page 12 of 29
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UNITED STATES
METHODS, PARENTERAL PHARMACEUTICAL FORMULATIONS, AND DEVICES FOR THE PREVENTION OF OPIOID OVERDOSE
17/291,979
5/6/2021
UNITED STATES
METHODS, PARENTERAL PHARMACEUTICAL FORMULATIONS, AND DEVICES FOR THE PREVENTION OF OPIOID OVERDOSE
17/319,221
5/13/2021
UNITED STATES
METHODS, PARENTERAL PHARMACEUTICAL FORMULATIONS, AND DEVICES FOR THE PREVENTION OF OPIOID OVERDOSE
18/174,858
2/27/2023
WIPO
METHODS, PARENTERAL PHARMACEUTICAL FORMULATIONS, AND DEVICES FOR THE PREVENTION OF OPIOID OVERDOSE
PCT/US2019/060185
11/7/2019
Page 13 of 29
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Exhibit 2A
PATENT ASSIGNMENT AGREEMENT
This Patent Assignment Agreement (this “Patent Assignment”) is entered this the 20th day of November 2024, by and among Aegis Therapeutics, LLC, having a principal place of business at 3430 Carmel Mount Road, Suite 300, San Diego, CA 92121 (“Aegis”), and Indivior Inc., having a principal place of business at 10710 Midlothian Turnpike, Suite 125, Midlothian, Virginia 23235 (“Indivior”), individually (each a “Party”) and collectively (the “Parties).
WHEREAS, on January 1, 2017, Aegis entered into a License Agreement with Opiant Pharmaceuticals, Inc. (“Licensee”) whereby Aegis granted to Licensee a license to certain Aegis Technology in combination with certain Compounds as set forth therein (“License Agreement”);
WHEREAS, on March 2, 2023, Indivior acquired Licensee, and subsequently Licensee was merged with and into Indivior and as a result (i) succeeded Licensee with respect to Licensee’s rights and obligations under the License Agreement, and (ii) acquired Licensee’s rights in Opiant’s Patents;
WHEREAS, simultaneously herewith, the Parties entered into an Amendment to the License Agreement;
NOW, THEREFORE, in consideration of the Amendment to the License Agreement and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties, intending to be legally bound, agree as follows:
1.Conveyance and Acceptance of the Patents. (a) Aegis does hereby sell, convey, deliver, set over, transfer and assign to Indivior or its heirs, successors, assigns, or other legal representatives to all of their rights, title and interest in and to (i) all patents and patent applications listed on Schedule A attached hereto, (ii) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, substitutions, provisionals, converted provisionals, and continued prosecution applications, renewals, supplementary protection certificates, registrations, extensions, reissues, or reexaminations, (iii) any and all patents that have issued or in the future issue from the foregoing patents and patent applications described in clause (i), including utility models, petty patents and design patents and certificates of invention, (iv) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations, supplemental examinations, inter partes reviews, post- grant reviews, oppositions and other existing or future post-issuance proceedings, and extensions (including future pending or issued unexpired patent term extension or supplemental protection certificate or equivalent extension right) of the foregoing patents or patent
Page 14 of 29
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applications described in clauses (i)–(iii), (v) any and all letters patent in the United States and all foreign countries which may be granted therefore and thereon, (vi) all rights under the International Convention for the Protection of Industrial Property, and (vii) file any and all divisional, continuation, and continuation-in-part applications claiming priority to the patents or patent applications described in clauses (i)–(iii) and seek reissues, reexaminations, adjustments, or extensions of any patent claiming priority to the patents or patent applications described in clauses (i)–(iii) (collectively, the “Patents”), in each case (i)-(vii), the same to be held and enjoyed by Indivior for its own use and benefit to the full end of the term for the Patents that may be granted or extended, as fully and entirely as the same would have been held and enjoyed by Aegis had this assignment not been made, including all benefits, privileges, causes of action and remedies relating to, or otherwise derived from, such Patents, including the right to any damages accrued for infringement of the Patents prior to the date of this Assignment of Patents and the right to any extension, supplemental protection certificate or equivalent extension right; and (b) Indivior accepts such assignment.
2.Recordation. Aegis does hereby consent to and authorize the United States Patent and Trademark Office or any other governmental office or agency in each jurisdiction outside of the United States to record this Patent Assignment and to issue any and all patents or certificates of invention which may be granted upon any of the Patents in the name of Indivior, as the assignee to the entire interest therein. Indivior shall have the right to file patent applications related to the Patents in any country.
3.Further Acts. Aegis will assist Indivior (at Indivior’s sole cost and expense) in connection with any such recording, and shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as Indivior may reasonably request in order to fulfill the purposes and intent of this Patent Assignment. Aegis hereby authorizes and requests the Director of the United States Patent and Trademark Office and any foreign patent office to issue such letters patent as shall be granted upon said application, or applications based on the Patents, to Indivior, its successors, assigns, or legal representatives.
[Signature page follows]
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IN WITNESS WHEREOF, Aegis and Indivior have executed this Patent Assignment as of the date first written above.
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
62/424,378
11/18/2016
EXPIRED
148570-003001
UNITED STATES
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
16/461,354
5/15/2019
11,458,091
ISSUED
148570-003002
WIPO
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
PCT/US2017/060964
11/9/2017
NAT PHASE
148570-003003
EUROPE
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
17871739.3
11/9/2017
PUBLISHED
148570-003004
JAPAN
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
2019-526565
11/9/2017
7312698
ISSUED
148570-003005
CANADA
INTRANASAL NALMEFENE COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
3044221
11/9/2017
PUBLISHED
148570-003006
ISRAEL
COMPOSITIONS, DEVICES AND METHODS OF USING INTRANASAL NALMEFENE AND DODECYL MALTOSIDE FOR TREATMENT OF OPIOID OVERDOSE
266674
11/9/2017
266674
ISSUED
148570-003007
AUSTRALIA
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
2017360910
11/9/2017
2017360910
ISSUED
148570-003008
CHINA
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
201780081719.4
11/9/2017
PUBLISHED
148570-003009
RUSSIA
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
2019118465
11/9/2017
2769397
ISSUED
148570-003011
UNITED STATES
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
17/881,191
8/4/2022
ABANDONED
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148570-003013
HONG KONG
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
62020001439.2
11/9/2017
PUBLISHED
148570-003014
JAPAN
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
2023-112864
11/9/2017
PUBLISHED
148570-003016
ISRAEL
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
312012
11/9/2017
PUBLISHED
148570-003017
AUSTRALIA
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
2024201047
11/9/2017
PUBLISHED
148570-003021
UNITED STATES
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
18/753,188
6/25/2024
PENDING
148570-003100
UNITED STATES
FORMULATIONS AND METHODS FOR THE PREVENTION OF OPIOID OVERDOSE
62/672,950
5/17/2018
EXPIRED
148570-003101
UNITED STATES
FORMULATIONS AND METHODS FOR THE PREVENTION OF OPIOID OVERDOSE
17/055,647
11/16/2020
ABANDONED
148570-003102
WIPO
FORMULATIONS AND METHODS FOR THE PREVENTION OF OPIOID OVERDOSE
PCT/US2019/032498
5/15/2019
NAT PHASE
148570-003103
EUROPE
FORMULATIONS AND METHODS FOR THE PREVENTION OF OPIOID OVERDOSE
19804071.9
5/15/2019
PUBLISHED
148570-003105
CANADA
FORMULATIONS AND METHODS FOR THE PREVENTION OF OPIOID OVERDOSE
3100834
5/15/2019
PUBLISHED
148570-003111
UNITED STATES
FORMULATIONS AND METHODS FOR THE PREVENTION OF OPIOID OVERDOSE
18/436,976
2/8/2024
PUBLISHED
UNITED STATES
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
17/881,306
08/04/2022
PUBLISHED
UNITED STATES
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
63/229,300
8/4/2021
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AUSTRALIA
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
2022323269
2/2/2024
CANADA
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
3227828
2/1/2024
EUROPE
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
22853922.7
3/4/2024
ISRAEL
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
310566
1/31/2024
MEXICO
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
MX/a/2024/001659
2/2/2024
NEW ZEALAND
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
807981
2/5/2024
WIPO
COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE
PCT/US/2022/039463
08/04/2022
EUROPE
METHODS, PARENTERAL PHARMACEUTICAL FORMULATIONS, AND DEVICES FOR THE PREVENTION OF OPIOID OVERDOSE
19881497.2
6/7/2021
HONG KONG
METHODS, PARENTERAL PHARMACEUTICAL FORMULATIONS, AND DEVICES FOR THE PREVENTION OF OPIOID OVERDOSE
62022049987
3/15/2022
UNITED STATES
METHODS, PARENTERAL PHARMACEUTICAL FORMULATIONS, AND DEVICES FOR THE PREVENTION OF OPIOID OVERDOSE
62/756,903
11/7/2018
UNITED STATES
METHODS, PARENTERAL PHARMACEUTICAL FORMULATIONS, AND DEVICES FOR THE PREVENTION OF OPIOID OVERDOSE
17/291,979
5/6/2021
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UNITED STATES
METHODS, PARENTERAL PHARMACEUTICAL FORMULATIONS, AND DEVICES FOR THE PREVENTION OF OPIOID OVERDOSE
17/319,221
5/13/2021
UNITED STATES
METHODS, PARENTERAL PHARMACEUTICAL FORMULATIONS, AND DEVICES FOR THE PREVENTION OF OPIOID OVERDOSE
18/174,858
2/27/2023
WIPO
METHODS, PARENTERAL PHARMACEUTICAL FORMULATIONS, AND DEVICES FOR THE PREVENTION OF OPIOID OVERDOSE
PCT/US2019/060185
11/7/2019
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Exhibit 2B
PATENT ASSIGNMENT AGREEMENT
This Patent Assignment Agreement (this “Patent Assignment”) is entered this the 20th day of November 2024, by and among Aegis Therapeutics, LLC, having a principal place of business at 3430 Carmel Mount Road, Suite 300, San Diego, CA 92121 (“Aegis”), Indivior Inc., having a principal place of business at 10710 Midlothian Turnpike, Suite 125, Midlothian, Virginia 23235 (“Indivior”), and Indivior UK Limited, having a principal place of business at The Chapleo Building, Henry Boot Way, Priority Park, Hull HU4 7DY, United Kingdom (“Indivior UK”), individually (each a “Party”) and collectively (the “Parties).
WHEREAS, on January 1, 2017, Aegis entered into a License Agreement with Opiant Pharmaceuticals, Inc. (“Licensee”) whereby Aegis granted to Licensee a license to certain Aegis Technology in combination with certain Compounds as set forth therein (“License Agreement”);
WHEREAS, on March 2, 2023, Indivior acquired Licensee, and subsequently Licensee was merged with and into Indivior and as a result (i) succeeded Licensee with respect to Licensee’s rights and obligations under the License Agreement, and (ii) acquired Licensee’s rights in Opiant’s Patents;
WHEREAS, simultaneously herewith, the Parties entered into an Amendment to the License Agreement;
NOW, THEREFORE, in consideration of the Amendment to the License Agreement and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties, intending to be legally bound, agree as follows:
1.Conveyance and Acceptance of the Patents. (a) Aegis does hereby sell, convey, deliver, set over, transfer and assign to Indivior UK or its heirs, successors, assigns, or other legal representatives to all of their rights, title and interest in and to (i) all patents and patent applications listed on Schedule B attached hereto, (ii) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, substitutions, provisionals, converted provisionals, and continued prosecution applications, renewals, supplementary protection certificates, registrations, extensions, reissues, or reexaminations, (iii) any and all patents that have issued or in the future issue from the foregoing patents and patent applications described in clause (i), including utility models, petty patents and design patents and certificates of invention, (iv) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations, supplemental examinations, inter partes reviews, post- grant reviews, oppositions and other existing or future post-issuance proceedings, and extensions (including future pending or issued unexpired patent term extension or supplemental
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protection certificate or equivalent extension right) of the foregoing patents or patent applications described in clauses (i)–(iii), (v) any and all letters patent in the United States and all foreign countries which may be granted therefore and thereon, (vi) all rights under the International Convention for the Protection of Industrial Property, and (vii) file any and all divisional, continuation, and continuation-in-part applications claiming priority to the patents or patent applications described in clauses (i)–(iii) and seek reissues, reexaminations, adjustments, or extensions of any patent claiming priority to the patents or patent applications described in clauses (i)–(iii) (collectively, the “Patents”), in each case (i)-(vii), the same to be held and enjoyed by Indivior UK for its own use and benefit to the full end of the term for the Patents that may be granted or extended, as fully and entirely as the same would have been held and enjoyed by Aegis had this assignment not been made, including all benefits, privileges, causes of action and remedies relating to, or otherwise derived from, such Patents, including the right to any damages accrued for infringement of the Patents prior to the date of this Assignment of Patents and the right to any extension, supplemental protection certificate or equivalent extension right; and (b) Indivior UK accepts such assignment.
2.Recordation. Aegis does hereby consent to and authorize the United States Patent and Trademark Office or any other governmental office or agency in each jurisdiction outside of the United States to record this Patent Assignment and to issue any and all patents or certificates of invention which may be granted upon any of the Patents in the name of Indivior UK, as the assignee to the entire interest therein. Indivior UK shall have the right to file patent applications related to the Patents in any country.
3.Further Acts. Aegis will assist Indivior UK (at Indivior UK’s sole cost and expense) in connection with any such recording, and shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as Indivior UK may reasonably request in order to fulfill the purposes and intent of this Patent Assignment. Aegis hereby authorizes and requests the Director of the United States Patent and Trademark Office and any foreign patent office to issue such letters patent as shall be granted upon said application, or applications based on the Patents, to Indivior UK, its successors, assigns, or legal representatives.
[Signature page follows]
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IN WITNESS WHEREOF, Aegis and Indivior have executed this Patent Assignment as of the date first written above.