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1.228. "WuXi" means WuXi Biologics (Hong Kong) Limited, a company incorporated under the laws of Hong Kong. |
1.229. "WuXi Agreement" means the cell line license agreement entered into between WuXi and Cugene on April 2, 2019. |
ARTICLE 2 INITIAL DEVELOPMENT |
2.1. Initial Development Plan and Budget. |
2.1.1. Review of the Initial Development Plan and Budget. The JGC shall review the Initial Development Plan and Budget at least once each Calendar Quarter, or more frequently as determined by the JGC, for the purpose of considering appropriate amendments thereto, and either Party, through its representatives on the JGC... |
2.1.2. Principle Objective. The principle objective of the activities under Initial Development Plan and Budget is for Cugene to Develop and explore the potential for further Development of the Licensed Therapeutics and Licensed Products; it being understood that this Section 2.1.2 is not intended and shall not be cons... |
2.2. Diligence. Cugene shall perform the activities set forth in the Initial Development Plan and Budget and shall use Commercially Reasonable Efforts to achieve the objectives of the Initial Development Plan and Budget in accordance with the agreed timelines set forth therein; provided that, if a Safety Event occurs w... |
2.3. Performance of Initial Development and Regulatory Activities. |
2.3.1. Development. Subject to Section 2.2, Cugene shall and shall use Commercially Reasonable Efforts to cause applicable Third Party contractors to (a) perform all of the Development activities assigned to it under the Initial Development Plan and Budget (including all regulatory activities in support thereof) in goo... |
2.3.2. Regulatory. |
(a) Cugene shall have the sole right and responsibility to prepare, obtain and maintain all INDs and other submissions necessary to perform its obligations under the Initial Development Plan and Budget and to conduct communications with the Regulatory Authorities in the Territory with respect to the activities under th... |
(b) Cugene shall notify the JGC before initiating any communication or interaction with a Regulatory Authority, excluding any administrative or scheduling communications or interactions, with respect to the Licensed Products, and Cugene shall in good faith consider any reasonable advice or comments of AbbVie or its rep... |
(c) Prior to the License Option Effective Date, Cugene shall provide AbbVie with prior written notice of any scheduled meetings, conferences or discussions with a Regulatory Authority relating to a Licensed Product reasonably promptly after Cugene first receives notice of the scheduling of such meeting, conference or d... |
2.3.3. Manufacturing. Cugene shall be responsible for the Manufacture and supply of all pre-clinical and clinical requirements of Licensed Therapeutics and Licensed Products and all components of the foregoing necessary to perform its obligations under the Initial Development Plan and Budget in accordance with the term... |
2.3.4. Subcontracting. Cugene shall not subcontract any of its activities under the Initial Development Plan and Budget except to any Persons set forth on Schedule 2.3.4 ("Permitted Entities") without AbbVie's prior written consent (not to be unreasonably withheld, conditioned or delayed). |
2.3.5. Development Records. Prior to completion of the Development activities under the Initial Development Plan and Budget, Cugene shall, and shall cause its Affiliates to, maintain, in good scientific manner, complete and accurate books and records pertaining to its Development activities under the Initial Developmen... |
2.3.6. Material Transfer Agreement. Upon AbbVie's request, Cugene shall enter into a material transfer agreement, at no additional consideration to Cugene, promptly after the Effective Date, and in no event later than 90 days after the Effective Date, pertaining to certain non-clinical Development activities (a) with r... |
2.3.7. Samples. Cugene shall ensure that the informed consent used in connection with the Phase Ib Clinical Trial conducted under the Initial Development Plan and Budget for patients who consent to have blood samples collected in connection with such Phase Ib Clinical Trial permits Cugene to transfer (or have transferr... |
2.4. Information and Reports. |
2.4.1. Development Reports. Prior to Cugene's delivery of the Preliminary Final Data Package pursuant to Section 2.5.3, within 30 days following the end of each Calendar Quarter, Cugene shall provide to the JGC and AbbVie a detailed written report regarding Cugene's (and its Affiliates', if applicable) Development acti... |
2.4.2. Study Data. Cugene shall provide AbbVie with secure access to all data, and the results of analyses thereof, in each case, generated by Cugene, any of its Affiliates or contract research organizations, clinical sites and investigators on behalf of Cugene or any of its Affiliates under the Initial Development Pla... |
2.4.3. Material Events. In addition to the reports and information provided pursuant to Section 2.4.1 and Section 2.4.2, Cugene shall reasonably promptly notify AbbVie with any material events related to the Development of Licensed Therapeutics or Licensed Products (e.g., clinical hold, unexpected adverse safety events... |
2.4.4. Cugene Existing P19/126 Oncology Compounds. Cugene shall promptly inform AbbVie in writing of (a) any changes in the Cugene internal reference name (e.g., CUG123) of either of the Cugene Existing P19/126 Oncology Compounds and (b) the sequence of each Cugene Existing P19/126 Oncology Compound once that sequence ... |
2.5. Data Packages. |
2.5.1. Early Exercise Request. At any time before completion of the activities set forth in the Initial Development Plan and Budget, if AbbVie desires to consider exercising the License Option and provides written notice to Cugene of such desire (an "Early Exercise Request"), then, no later than 45 days after receipt o... |
2.5.2. Early Exercise Data Package. With respect to each Early Exercise Data Package, as applicable, for a period of 90 days after the date Cugene provides such Early Exercise Data Package, if AbbVie believes in good faith that any of the data or information required to be included in such Early Exercise Data Package i... |
2.5.3. Final Data Package. Within 60 days after completion of the activities in the Initial Development Plan and Budget that are necessary to generate the data, findings, results and information with respect to the Final Data Package, Cugene shall deliver to AbbVie the Final Data Package (such data package, the "Prelim... |
2.5.4. Additional Information. In addition to the Data Package(s), during the License Option Period, Cugene promptly shall provide to AbbVie, to the extent available or reasonably producible, any additional Information related to the Licensed Therapeutics and Licensed Products that Cugene or any of its Affiliates Contr... |
2.6. Expenses. Cugene shall be responsible for and shall bear all costs and expenses necessary to perform its obligations under the Initial Development Plan and Budget and this ARTICLE 2. |
ARTICLE 3 LICENSE OPTION |
3.1. License Option. Subject to the terms and conditions of this Agreement, Cugene hereby grants to AbbVie the exclusive option to obtain the licenses set forth in Section 4.1 (the "License Option"). |
3.2. License Option Exercise. |
3.2.1. Exercise Notice. AbbVie shall have the right to exercise the License Option at any time during the License Option Period by giving Cugene written notice of exercise (the "Exercise Notice"). |
3.2.2. HSR. |
(a) If AbbVie reasonably determines in good faith prior to the delivery of the Exercise Notice that the transactions to be consummated upon the exercise of the License Option require HSR Filings, AbbVie shall provide the Exercise Notice to Cugene prior to the end of the License Option Period, which notice shall include... |
(b) If AbbVie determines that HSR Filings are required, each Party shall use commercially reasonable efforts to prepare and file its respective HSR Filing as promptly as is practicable and advisable, with the goal of filing the HSR Filings within ten Business Days after Cugene receives the Exercise Notice. AbbVie shall... |
(c) In connection with obtaining HSR Clearance, each Party shall (i) cooperate with the other Party in connection with any investigation or other inquiry relating to an HSR Filing and the exercise of the License Option; (ii) keep the other Party or its counsel informed of any material communication received from or giv... |
(d) AbbVie and Cugene shall each use commercially reasonable efforts to resolve as promptly as practicable any objections that may be asserted by the FTC, the DOJ, or any other Governmental Authority with respect to the transactions notified in the HSR Filings. Nothing in this Section 3.2.2 or otherwise in this Agreeme... |
(e) If AbbVie determines that HSR Filings are necessary, then all rights and obligations related to the exercise of the License Option (including the payment under Section 7.2 and the granting of the licenses in Section 4.1 and ARTICLE 5 generally) shall be tolled until the HSR Clearance. |
3.3. Licensed Therapeutic and Licensed Product Responsibility. From and after the License Option Effective Date, AbbVie shall have the sole right to Exploit the Licensed Therapeutics and Licensed Products in the Field in the Territory in accordance with all Applicable Law and this Agreement and shall, subject to the te... |
3.4. Additional Cugene Obligations. After the License Option Effective Date, and without additional consideration to Cugene (other than as set forth in this Section 3.4 or mutually agreed by the Parties in writing and without limiting AbbVie's payment obligations under ARTICLE 7): |
3.4.1. Upon AbbVie's request, Cugene shall (and, in the case of agreements to which an Affiliate of Cugene is a party, shall cause such Affiliate to), assign to AbbVie, and AbbVie shall assume, any agreements, other than the In-License Agreements, to the extent relating to the Development or Manufacture of the Licensed... |
3.4.2. Upon AbbVie's request, Cugene shall transfer to AbbVie (a) copies of (i) all data, reports, records, materials and other information arising out of the activities under the Initial Development Plan and Budget or any Manufacturing activities thereunder, including all records maintained pursuant to Section 2.3.5 a... |
3.4.3. Cugene shall transfer to AbbVie all of its remaining GMP inventory of the Licensed Therapeutics and Licensed Products produced in accordance with the Initial Development Plan and Budget. Cugene shall deliver such inventory to AbbVie FCA (as defined in Incoterms 2010) at a location designated by AbbVie. Cugene sh... |
3.4.4. Upon the License Option Effective Date, to the extent permitted by Applicable Law, Cugene shall transfer and assign, or cause to be transferred and assigned, to AbbVie all of its right, title, and interest in and to all Regulatory Documentation then Controlled by Cugene or its Affiliates applicable to the Licens... |
3.4.5. Without limiting Section 3.4.2, Cugene shall assist and cooperate with AbbVie as AbbVie may reasonably request in the transition of prosecution, maintenance, enforcement and defense of the Product Patents from Cugene to AbbVie. |
3.4.6. Promptly after the License Option Effective Date, Cugene shall transfer to AbbVie in the manner and to the location specified by AbbVie (a) any blood samples of patients who consent after the Effective Date to have blood samples collected in connection with the Phase Ia Clinical Trial conducted under the Initial... |
3.4.7. Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary under or as the other Party may reasonably request i... |
3.5. Termination of License Option. Without limiting each Party's rights to terminate this Agreement in its entirety in accordance with Section 12.2, if (a) AbbVie has not delivered an Exercise Notice prior to the expiration of the License Option Period, or (b) prior to the expiration of the License Option Period AbbVi... |
ARTICLE 4 GRANT OF RIGHTS; EXCLUSIVITY |
4.1. Grants to AbbVie. Subject to Section 4.3 and Section 4.4, Cugene (on behalf of itself and its Affiliates) hereby grants to AbbVie and its Affiliates, effective upon the License Option Effective Date, (a) an exclusive (even as to Cugene and its Affiliates) license (or sublicense), with the right to grant sublicense... |
4.2. Grants to Cugene. AbbVie (on behalf of itself and its Affiliates) hereby grants to Cugene and its Affiliates, during the performance of Cugene's Development activities under the Initial Development Plan and Budget (including, for clarity, the Unfinished Initial Development Activities, if any, pursuant to Section 3... |
4.3. Sublicenses. Subject to the terms and conditions of this Agreement, including the rest of this Section 4.3, AbbVie shall have the right to grant sublicenses, through multiple tiers of sublicenses, under the licenses granted in Section 4.1, to its Affiliates and Third Parties; provided that any such sublicenses sha... |
4.4. No Implied Licenses. Except as expressly provided herein, Cugene grants no other right or license, including any rights or licenses to the Cugene IP, Cugene's interests in the Joint IP, if any, Cugene's Corporate Names or any other Patent or intellectual property rights not otherwise expressly granted herein. Cuge... |
4.5. Confirmatory Patent License. Cugene shall, and shall cause its Affiliates to, if requested to do so by AbbVie, immediately enter into confirmatory license agreements in such form as may be reasonably requested by AbbVie and reasonably acceptable to Cugene for purposes of recording the licenses granted under Sectio... |
4.6. Exclusivity. |
4.6.1. Cugene's Exclusivity Obligations. During the Term, Cugene shall not, and shall cause its Affiliates not to (a) Exploit or (b) license, authorize, appoint, or otherwise assist or enable any Third Party to, Exploit, in either case ((a) or (b)), any Competing Product in the Field in the Territory; provided that the... |
4.6.2. Exceptions. Subject to Section 4.1 and Section 4.2 and the remainder of this Section 4.6.2, if during the Term, Cugene or any of its Affiliates merges or consolidates with, or is acquired by, a Third Party through a Change in Control and such Third Party or any of its Affiliates prior to such transaction (collec... |
(a) no employees of the Pre-Existing Entity who work on or have worked on Exploiting any Competing Product shall have access to the Confidential Information of AbbVie, Product Information, Product Patents, Joint Patents or Joint Know-How; |
(b) no employees of Cugene who have or have had access to, the Confidential Information of AbbVie, Product Information, Product Patents, Joint Patents or Joint Know-How work for such Pre-Existing Entity in Exploiting such Competing Product(s); |
(c) all such Pre-Existing Entity's manufacturing, research, development, and commercialization activities (and the personnel conducting such activities) for such Competing Product(s) are kept separate from the Manufacturing, research, Development, and Commercialization activities for Licensed Products under this Agreem... |
(d) Cugene shall, and shall cause such Pre-Existing Entity to, establish, maintain and enforce internal safeguards reasonably designed to ensure that the foregoing requirements are satisfied. |
4.6.3. Acknowledgement. Cugene acknowledges and agrees that (a) this Section 4.6 has been negotiated by the Parties, (b) the geographical and time limitations on activities set forth in this Section 4.6 are reasonable, valid and necessary in light of the Parties' circumstances and necessary for the adequate protection ... |
ARTICLE 5 DEVELOPMENT AND COMMERCIALIZATION BY ABBVIE |
5.1. In General. After the License Option Effective Date, AbbVie (itself or through its Affiliates or its or their Sublicensees), at its sole cost and expense, shall, as between the Parties, have the sole right to further Develop, Manufacture, Commercialize and otherwise Exploit the Licensed Therapeutics and the Licens... |
5.2. Diligence. After the License Option Effective Date, AbbVie shall use Commercially Reasonable Efforts to Develop, seek Regulatory Approval and Commercialize one Licensed Product in the United States and three of the Major European Markets for one Indication in compliance with all Applicable Law. |
5.3. Manufacturing Technology Transfer. Upon AbbVie's request at any time after the License Option Effective Date and from time to time, Cugene shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Cugene Know-How and Joint Know-How relating to ... |
5.3.1. Cugene shall provide, and shall cause its Affiliates to provide, and shall use commercially reasonable efforts to cause Third Party manufacturers to provide (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entere... |
(a) Cugene shall make available, and shall cause its Affiliates to make available, and shall use commercially reasonable efforts to cause Third Party manufacturers to make available, to AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) from time to time as AbbVie may request, all Cugene Kn... |
(b) Cugene shall assign to AbbVie all of its right, title and interest in and to, and shall deliver to AbbVie, the cell banks and reference standards (and such other materials as the Parties may agree in writing) used by Cugene or any of its Affiliates or Third Party manufacturers in the Manufacturing Process; |
(c) Cugene shall cause all appropriate employees and representatives of Cugene and its Affiliates, and shall use commercially reasonable efforts to cause all appropriate employees and representatives of its Third Party manufacturers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Th... |
(d) Without limiting the generality of Section 5.3.1(c), Cugene shall cause all appropriate analytical and quality control laboratory employees and representatives of Cugene and its Affiliates, and shall use commercially reasonable efforts to cause all appropriate analytical and quality control laboratory employees and... |
(e) Cugene shall, and shall cause its Affiliates to, take such steps, and shall use commercially reasonable efforts to cause its Third Party manufacturers to take such steps, as are reasonably necessary or useful to assist AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) in obtaining any ... |
(f) Cugene shall provide, and shall cause its Affiliates and shall use commercially reasonable efforts to cause its Third Party manufacturers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) may reasonably request to enable AbbVie (or its Affiliate or ... |
5.3.2. Cugene shall reasonably promptly disclose to AbbVie (a) all modifications, enhancements and improvements, if any, to the Manufacturing Process transferred to AbbVie pursuant to this Section 5.3 and (b) any other Manufacturing process, in each case ((a) and (b)) conceived, discovered, developed or otherwise made ... |
5.4. Subcontracting; Distributors. AbbVie shall have the right to subcontract any of its Development, Manufacturing or Commercialization activities to a Third Party (including by appointing one or more contract sales forces, co-promotion partners or Distributors); provided that no such permitted subcontracting shall re... |
5.5. Records; Development and Commercialization Reports. |
5.5.1. AbbVie shall, and shall cause its Affiliates and Sublicensees to, maintain, in good scientific manner, complete and accurate books and records pertaining to its activities under this Agreement conducted after the License Option Effective Date, which books and records shall (a) be appropriate for Patent and regul... |
5.5.2. No later than 30 days after the License Option Effective Date, AbbVie will provide Cugene with a Development plan, including anticipated Development activities to be conducted during the next 24-month period. After the License Option Effective Date, no later than 30 days after the end of each Calendar Year, AbbV... |
5.6. Regulatory Activities. |
5.6.1. After the License Option Effective Date, AbbVie shall, as between the Parties, have the sole right to prepare, obtain and maintain Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals and other submissions and to conduct communications with th... |
5.6.2. After the License Option Effective Date, all Regulatory Documentation (including all Regulatory Approvals) in the Territory relating to the Licensed Products shall be owned by, and shall be the sole property and held in the name of, AbbVie or its designated Affiliate, Sublicensee or designee. |
5.7. Adverse Event and Safety Information Agreement. Within 90 days after the License Option Effective Date, the Parties shall enter into an agreement (the "Adverse Event and Safety Information Agreement") to initiate a process for the exchange of adverse event safety data in a mutually agreed format in order to monito... |
ARTICLE 6 COLLABORATION MANAGEMENT |
6.1. Joint Governance Committee. |
6.1.1. Formation. Within 15 days after the Effective Date, the Parties shall establish a joint governance committee (the "Joint Governance Committee" or "JGC") to serve as the oversight and decision-making body for the activities to be conducted by the Parties pursuant to this Agreement during the License Option Period... |
6.1.2. Responsibilities. During the License Option Period, the JGC shall perform the following functions, subject to the final decision-making authority of the respective Parties as set forth in Section 6.2.4: |
(a) oversee the Development of, and regulatory activities for, Licensed Therapeutics and Licensed Products in the Field in the Territory pursuant to the Initial Development Plan and Budget; |
(b) periodically (no less often than once per Calendar Quarter) review and serve as a forum for discussing the Initial Development Plan and Budget, and review and approve amendments thereto, including any Material Amendment; |
(c) serve as a forum for discussing, reviewing and approving any submissions to Governmental Authorities (or decisions to decline to do so) with respect to the preparation, filing, prosecution and maintenance by Cugene of Product Patents pursuant to Section 8.2.1(b); |
(d) coordinate the Parties' activities under this Agreement; |
(e) serve as a forum for providing advice and assistance on the conduct of the Phase Ib Clinical Trial for a Licensed Product in accordance with the Initial Development Plan and Budget, including advising Cugene on matters related to site selection, initiation and recruitment strategies; |
(f) review and discuss all real-time data and information received by either Party from activities conducted by contract research organizations, clinical sites and investigators under the Initial Development Plan and Budget; |
(g) review and discuss all material safety and efficacy data and information received by either Party under the Initial Development Plan and Budget, including any material toxicology or pharmacokinetics issue; |
(h) serve as a consultation forum for discussing any clinical hold placed on a Licensed Product and for discussing, reviewing and approving any Clinical Study that Cugene, after consultation with the DRC (if any), proposes to terminate due to a Safety Event; |
(i) serve as a forum for discussing and reviewing any amendment to IND, study protocol or other regulatory submission for a Licensed Product to be filed by Cugene, or any communication or interaction with a Regulatory Authority, excluding any administrative or scheduling communications or interactions, pursuant to Sect... |
(j) serve as a forum for discussing, reviewing and approving the study protocol for the GLP toxicology study (the "GLP Toxicology Protocol") to be performed under the Initial Development Plan and Budget; |
(k) serve as an initial forum for discussion of, and attempt to resolve, any issues or Disputes that may arise between the Parties or otherwise under this Agreement; and |
(l) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement. |
For clarity, the JGC shall not have any authority beyond the specific matters set forth in this Section 6.1.2, and in particular shall not have any power to amend or modify the terms of this Agreement or waive a Party's compliance with this Agreement or to decide or resolve any issues other than those specifically subj... |
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