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(b) subject to the Parties' execution of a Transition Agreement in accordance with Section 12.5 and subject to Section 12.6, AbbVie shall, and hereby does, effective as of the effective date of termination, grant Cugene a royalty-bearing, sublicensable license under (i) the AbbVie Grantback Agreement Patents, the AbbVi... |
(c) AbbVie shall not, and shall not permit any of its Affiliates to, and shall use commercially reasonable efforts not to permit any of its and their Sublicensees or Distributors to, distribute, market, promote, offer for sale, or sell any Licensed Therapeutics or Licensed Products directly or indirectly (i) to any Per... |
(d) Cugene shall not, and shall not permit any of its Affiliates to, and shall use commercially reasonable efforts not to permit any of its and their (sub)licensees, or distributors to, distribute, market, promote, offer for sale, or sell any Reversion Product (or Licensed Therapeutic contained therein) directly or ind... |
(e) notwithstanding the amendment of AbbVie's licenses and other rights under this Agreement in the Terminated Territory, if, at the time of such termination, the First Commercial Sale of a Licensed Product has occurred in the Terminated Territory, then AbbVie shall have the right for 12 months after the effective date... |
12.5. Transition Agreement. |
12.5.1. In the event of any termination of this Agreement whether in its entirety or with respect to the Terminated Territory, except with respect to a termination by AbbVie pursuant to Section 12.2.1, Section 12.2.2(a) or Section 12.2.3, Cugene and AbbVie shall negotiate in good faith the terms and conditions of a wri... |
12.5.2. If this Agreement is terminated in its entirety, the Transition Agreement shall provide that AbbVie shall (and shall cause its Affiliates to): |
(a) where permitted by Applicable Law, transfer and assign, or cause to be transferred and assigned, to Cugene all of AbbVie's and its Affiliates' right, title, and interest in all Regulatory Documentation then Controlled by AbbVie or its Affiliates or Sublicensees applicable to the Reversion Products in the Territory ... |
(b) notify the applicable Regulatory Authorities and take any other action reasonably necessary to effect the transfer set forth in clause (a) above; |
(c) unless expressly prohibited by any Regulatory Authority, transfer control to Cugene of all Clinical Studies being conducted by AbbVie or its Affiliates as of the effective date of termination and continue to conduct such Clinical Studies, at Cugene's cost, for up to six months to enable such transfer to be complete... |
(d) if requested by Cugene, assign (or cause its Affiliates to assign) to Cugene all agreements between AbbVie or any of its Affiliates, on the one hand, and any Third Party, on the other hand, that solely relate to the conduct of pre-clinical Development activities or Clinical Studies for the Reversion Products, inclu... |
(e) if requested by Cugene, shall supply to Cugene any or all of the inventory of the Reversion Products held by AbbVie or its Affiliates or Sublicensees as of the date of termination at a price equal to the direct costs of manufacturing without markup, provided that AbbVie shall only be obligated to supply Cugene such... |
(f) assign to Cugene all right, title, and interest of AbbVie in each Product Trademark; provided that Cugene shall pay to AbbVie an amount equal to the fair market value of such Product Trademarks. |
12.5.3. If this Agreement is terminated with respect to a country or other jurisdiction but not in its entirety, the Transition Agreement shall: (x) include provisions regarding the maintenance of the global safety database for products that contain or comprise a Licensed Therapeutic and a process for the exchange of a... |
(a) where permitted by Applicable Law, transfer and assign, or cause to be transferred and assigned, to Cugene all of AbbVie's and its Affiliates' right, title, and interest in all Regulatory Approvals Controlled by AbbVie or its Affiliates or Sublicensees applicable to the Terminated Territory and to the Reversion Pro... |
(b) notify the applicable Regulatory Authorities and take any other action reasonably necessary to effect the transfer set forth in clause (a) above; |
(c) grant Cugene a right of reference to all Regulatory Documentation then owned by AbbVie or its Affiliates and in AbbVie's or its Affiliates' name that are not transferred to Cugene pursuant to clause (a) above that are necessary or reasonably useful for Cugene, any of its Affiliates or (sub)licensees to Develop or C... |
(d) if requested by Cugene, shall supply to Cugene any or all of the inventory of the Reversion Products intended for the Terminated Territory held by AbbVie or its Affiliates or Sublicensees as of the date of termination at a price equal to the direct costs of manufacturing without markup, provided that AbbVie shall o... |
(e) assign to Cugene all right, title, and interest of AbbVie or its Affiliates in each Product Trademark in such Terminated Territory; provided that Cugene shall pay to AbbVie an amount equal to the fair market value of such Product Trademarks. |
12.5.4. Except as expressly set forth above in this Section 12.5 or as otherwise agreed in the Transition Agreement, each Party shall be responsible for its own costs in connection with the Transition Agreement. |
12.6. Reverse Royalty. If this Agreement is terminated in its entirety or with respect to the Terminated Territory, and in connection therewith, AbbVie grants to Cugene a grantback royalty-bearing license pursuant to Section 12.4.2(d) or Section 12.4.3(b), then, on a Reversion Product-by-Reversion Product basis, Cugene... |
12.7. AbbVie Rights in Lieu of Termination. If it is determined pursuant to applicable dispute resolution procedure that AbbVie has the right to terminate this Agreement pursuant to Section 12.2.1, then in lieu of such termination, AbbVie may, by written notice to Cugene before the termination becomes effective, elect ... |
12.7.1. if Cugene's material breach of a material obligation by virtue of which AbbVie has the right to terminate this Agreement occurs on or prior to the License Option Effective Date, the amount of (a) the License Option Exercise Payment payable by AbbVie to Cugene pursuant to Section 7.2, (b) any Development Milesto... |
12.7.2. if Cugene's material breach of a material obligation by virtue of which AbbVie has the right to terminate this Agreement occurs after the License Option Effective Date, the amount of (a) any Development Milestone Payments payable by AbbVie to Cugene pursuant to Section 7.3 for any Development Milestone Event ac... |
12.7.3. AbbVie's diligence obligations under Section 5.2 shall terminate; |
12.7.4. the JGC shall disband and all activities of the Parties thereunder shall terminate; and |
12.7.5. all other provisions of this Agreement shall remain in full force and effect without change. |
12.8. Remedies. Except as otherwise expressly provided herein, termination of this Agreement (either in its entirety or with respect to one or more countries or other jurisdictions) in accordance with the provisions hereof shall not limit remedies that may otherwise be available in law or equity. |
12.9. Accrued Rights; Surviving Obligations. Termination or expiration of this Agreement (either in its entirety or with respect to one or more countries or other jurisdictions) for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expirat... |
ARTICLE 13 MISCELLANEOUS |
13.1. Force Majeure. Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from events beyond the reasonable contr... |
13.2. Export Control. This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States or other countries or jurisdictions that may be imposed on the Parties from time to time. Each Party shall not, and shall cause its Affiliates not to, export, direct... |
13.3. Assignment. |
13.3.1. Neither Party may assign its rights or, except as provided in Section 2.3.4, Section 4.3 or Section 5.4, delegate its obligations under this Agreement, whether by operation of law or otherwise, in whole or in part without the prior written consent of the other Party, which consent shall not be unreasonably cond... |
13.3.2. AbbVie and Cugene each agrees that, notwithstanding any provision of this Agreement to the contrary, if a Third Party becomes an Affiliate of a Party through merger, acquisition, consolidation or other similar transaction with such Party (such Party, the "Acquisition Party" and such Third Party and its Affiliat... |
13.4. Severability. If any provision of this Agreement is held to be illegal, invalid or unenforceable under any present or future law and if the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agreem... |
13.5. Dispute Resolution. Except for disputes resolved by the procedures set forth in Section 6.2.4, Section 7.12.2 or Section 13.10, if a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a "Dispute"), it shall be resolve... |
13.5.1. General. Any Dispute shall first be referred to the Senior Officers, who shall confer in good faith on the resolution of such Dispute. Any final decision mutually agreed to by the Senior Officers in writing shall be conclusive and binding on the Parties. If the Senior Officers are not able to agree on the resol... |
13.5.2. Intellectual Property Disputes. If a Dispute arises with respect the validity, scope, enforceability, inventorship or ownership of any Patent, Trademark or other intellectual property rights, and such Dispute cannot be resolved in accordance with Section 13.5.1, unless otherwise agreed by the Parties in writing... |
13.5.3. ADR. Any ADR proceeding under this Agreement shall take place pursuant to the procedures set forth in Schedule 13.5.3. |
13.5.4. Adverse Ruling. Any determination pursuant to this Section 13.5 that a Party is in material breach of its material obligations hereunder shall specify a (nonexclusive) set of actions to be taken to cure such material breach, if feasible. |
13.5.5. Interim Relief. Notwithstanding anything herein to the contrary, nothing in this Section 13.5 shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a Dispute, if necessary to protect th... |
13.6. Governing Law. |
13.6.1. Governing Law. This Agreement or the performance, enforcement, breach or termination hereof shall be interpreted, governed by and construed in accordance with the laws of the State of New York, United States excluding any conflicts or choice of law rule or principle that might otherwise refer construction or in... |
13.7. Notices. |
13.7.1. Notice Requirements. Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if delivered by hand or sent by facsimile transmission (with transmission c... |
13.7.2. Address for Notice. |
If to AbbVie, to: |
AbbVie Global Enterprises Ltd. Thistle House, 4 Burnaby Street Hamilton HM 11 Bermuda |
with a copy (which shall not constitute notice) to: |
AbbVie Inc. 1 North Waukegan Road North Chicago, Illinois 60064 United States Attention: Vice Chairman, External Affairs, Chief Legal Officer and Corporate Secretary |
If to Cugene, to: |
Cugene Inc. 411 Waverley Oaks Road Suite 142 Waltham, MA 02452 United States Attention: Luke Li |
with a copy (which shall not constitute notice) to: Goodwin Procter (Hong Kong) LLP 38th Floor, Edinburgh Tower, The Landmark 15 Queen's Road Central, Hong Kong Attention: Wenseng "Wendy" Pan Facsimile: +852 2801 5515 |
13.8. Entire Agreement; Amendments. This Agreement, together with the Schedules attached hereto, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understandings, promises and representations, whether written or oral... |
13.9. English Language. This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof and in the event of any conflict in interpretation between ... |
13.10. Equitable Relief. (a) Each Party acknowledges and agrees that the restrictions and obligations set forth in ARTICLE 8 and ARTICLE 9 and (b) Cugene acknowledges and agrees that the restrictions, rights, and obligations set forth in Section 4.6 and Section 5.3, in each case ((a) and (b)), are reasonable and necess... |
13.11. Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. T... |
13.12. No Benefit to Third Parties. Except as provided in ARTICLE 11, the covenants and agreements set forth in this Agreement are for the sole benefit of the Parties and their successors and permitted assigns and they shall not be construed as conferring any rights on any other Persons. |
13.13. Further Assurance. Each Party shall duly execute and deliver or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as the other Party ma... |
13.14. Relationship of the Parties. It is expressly agreed that Cugene, on the one hand, and AbbVie, on the other hand, shall be independent contractors and that the relationship between the Parties shall not constitute a partnership, joint venture or agency, including for all tax purposes. Neither Cugene, on the one h... |
13.15. References. Unless otherwise specified, (a) references in this Agreement to any Article, Section or Schedule shall mean references to such Article, Section or Schedule of this Agreement, (b) references in any Section to any clause are references to such clause of such Section and (c) references to any agreement,... |
13.16. Construction. Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word "or" is used in the inclusive sense (and/or). Whenever this Agreement refers to a number of days, unless ... |
13.17. Performance by Affiliates. AbbVie may use one or more of its Affiliates to perform its obligations and duties hereunder and AbbVie's Affiliates are expressly granted certain rights herein; provided that each such Affiliate will be bound by the corresponding obligations of AbbVie and, subject to an assignment to ... |
13.18. Change in Control of Cugene. |
13.18.1. Cugene (or its successor) shall provide AbbVie with written notice of any Change in Control of Cugene or Acquisition by Cugene within two Business Days following the closing date of such transaction (which closing date notice shall specify whether such Change in Control or Acquisition involved a Restricted Com... |
13.18.2. In the event of the Change in Control of Cugene or Acquisition by Cugene, AbbVie shall have the right, in its sole and absolute discretion, by written notice delivered to Cugene (or its successor) at any time during the 180 days following the written notice contemplated by Section 13.18.1, (a) if such Change i... |
13.18.3. Cugene covenants that, following a Change in Control of Cugene or Acquisition by Cugene, (a) there shall be no material change in the level or nature of efforts or resources expended by Cugene and its Affiliates with respect to, or the qualifications and experience of the personnel assigned to (including with ... |
13.19. Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Agreement may be executed by facsimile, .pdf format via email or other electronically transmitted signatures and such s... |
SCHEDULE 1.54 |
CORPORATE NAMES |
CUGENE INC. |
SCHEDULE 1.94 |
EXISTING PATENTS SCHEDULE |
Title Country Application No. Filed Priority Date Status |
Novel Interleukin-15 (IL-15) Fusion Proteins And Uses Thereof AUSTRALIA 2019288471 6/20/2019 12/16/2020 6/22/2018 Pending |
Novel Interleukin-15 (IL-15) Fusion Proteins And Uses Thereof CANADA 3,102,821 6/20/2019 12/04/2020 6/22/2018 Pending |
Novel Interleukin-15 (IL-15) Fusion Proteins And Uses Thereof CHINA 201980055119X 6/20/2019 6/22/2018 Pending |
Novel Interleukin-15 (IL-15) Fusion Proteins And Uses Thereof EPC 19822948.6 6/20/2019 1/12/2021 6/22/2018 Pending |
Novel Interleukin-15 (IL-15) Fusion Proteins And Uses Thereof JAPAN 2021-520275 6/20/2019 12/18/2020 6/22/2018 Pending |
Novel Interleukin-15 (IL-15) Fusion Proteins And Uses Thereof KOREA 10-2021-7002145 6/20/2019 01/21/2021 6/22/2018 Pending |
Novel Interleukin-15 (IL-15) Fusion Proteins And Uses Thereof UNITED STATES 17/254,004 6/20/2019 12/18/2020 6/22/2018 Pending |
Novel Interleukin-15 (IL-15) Fusion Proteins And Uses Thereof UNITED STATES 62/689,051 6/22/2018 N/A Closed |
Novel Interleukin-15 (IL-15) Fusion Proteins And Uses Thereof WIPO PCT/US2019/038210 6/20/2019 6/22/2018 Closed |
Novel Interleukin-15 (IL-15) Fusion Proteins And Uses Thereof UNITED STATES 62/947686 12/13/2019 N/A Closed |
Novel Interleukin-15 (IL-15) Fusion Proteins And Uses Thereof WIPO PCT/US2020/064515 12/11/2020 12/13/2019 National Entries 6-13-2022 |
Title Country Application No. Filed Priority Date Status |
Cytokine-Based Bioactivatable Drugs And Methods Of Uses Thereof AUSTRALIA 2019288484 6/20/2019 12/18/2020 6/22/2018 Pending |
Cytokine-Based Bioactivatable Drugs And Methods Of Uses Thereof CANADA 3,102,823 6/20/2019 12/4/2020 6/22/2018 Pending |
Cytokine-Based Bioactivatable Drugs And Methods Of Uses Thereof CHINA 2019800554357 6/20/2019 6/22/2018 Pending |
Cytokine-Based Bioactivatable Drugs And Methods Of Uses Thereof EPC 19821633.5 6/20/2019 1/12/2021 6/22/2018 Pending |
Cytokine-Based Bioactivatable Drugs And Methods Of Uses Thereof JAPAN 2021-520277 6/20/2019 12/18/2020 6/22/2018 Pending |
Cytokine-Based Bioactivatable Drugs And Methods Of Uses Thereof KOREA 10-2021-7002147 6/20/2019 01/21/2021 6/22/2018 Pending |
Cytokine-Based Bioactivatable Drugs And Methods Of Uses Thereof MEXICO MX/a/2020/014290 6/20/2019 12/18/2020 6/22/2018 Pending |
Cytokine-Based Bioactivatable Drugs And Methods Of Uses Thereof RUSSIA 2021100361 6/20/2019 1/12/2021 6/22/2018 Pending |
Cytokine-Based Bioactivatable Drugs And Methods Of Uses Thereof UNITED STATES 17/254,054 6/20/2019 12/18/2020 6/22/2018 Pending |
Cytokine-Based Bioactivatable Drugs And Methods Of Uses Thereof UNITED STATES 62/689,053 6/22/2018 N/A Closed |
Cytokine-Based Bioactivatable Drugs And Methods Of Uses Thereof WIPO PCT/US2019/038229 6/20/2019 6/22/2018 Closed |
Cytokine-Based Bioactivatable Drugs And Methods Of Uses Thereof UNITED STATES 62/947749 12/13/2019 N/A Closed |
Cytokine-Based Bioactivatable Drugs And Methods Of Uses Thereof WIPO PCT/US2020/064651 12/11/2020 12/13/2019 National Entries 6-13-2022 |
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