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1.176. "Privacy and Security Obligations" has the meaning set forth in Section 10.2.1(i). |
1.177. "Processing" means any operation or set of operations that is performed upon Personal Data, whether or not by automatic means, such as collection, recording, organization, storage, adaptation or alternation, retrieval, consultation, use, disclosure by transmission, dissemination, or otherwise making available, a... |
1.178. "Product Information" has the meaning set forth in Section 9.1.1. |
1.179. "Product Infringement" has the meaning set forth in Section 8.3.1. |
1.180. "Product Labeling" means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) all labels and... |
1.181. "Product Patent" means any Cugene Patent that claims one or more Licensed Therapeutics or Licensed Products or the Exploitation thereof and does not claim one or more other therapeutics or products or the Exploitation thereof. For clarity, none of the following are Product Patents: (a) any Bispecific Patent, (b)... |
1.182. "Product Trademark" means the Trademark(s) to be used by AbbVie or its Affiliates or its or their respective Sublicensees for the Development or Commercialization of Licensed Products in the Territory and any registrations thereof or any pending applications relating thereto in the Territory (excluding, in any e... |
1.183. "Receiving Party" has the meaning set forth in Section 9.1.1. |
1.184. "Registrational Trial" means, with respect to a Licensed Product, a Clinical Study (regardless of whether such Clinical Study is referred to as a "phase 2/3 clinical trial", "phase 2b/3 clinical trial" or "phase 3 clinical trial") for such Licensed Product, the results of which, together with prior Information c... |
1.185. "Regulatory Approval" means, with respect to a country or other jurisdiction in the Territory, any and all approvals (including approvals of Drug Approval Applications), licenses, registrations or authorizations of any Regulatory Authority necessary to commercially distribute, sell and market a Licensed Product ... |
1.186. "Regulatory Authority" means any applicable supra-national, federal, national, regional, state, provincial, or local governmental or regulatory authority, agency, department, bureau, commission, council, or other entities (e.g., the FDA and EMA) regulating or otherwise exercising authority with respect to activi... |
1.187. "Regulatory Documentation" means all (a) applications (including all INDs and Drug Approval Applications), registrations, licenses, authorizations, and approvals (including Regulatory Approvals) and (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and officia... |
1.188. "Regulatory Exclusivity" means, with respect to a Licensed Product in any country or other jurisdiction in the Territory, any exclusive marketing rights and data exclusivity rights (other than Patent protection) conferred by any Regulatory Authority with respect to a pharmaceutical product, including new chemica... |
1.189. "Restricted Company" means, with respect to a Change in Control of Cugene or Acquisition by Cugene, any Person that is a party to such Change in Control or Acquisition that, as of the effective date of such Change in Control or Acquisition is a pharmaceutical, biotechnology, medical device or diagnostic company ... |
1.190. "Reversion Product" means: (a) if this Agreement is terminated with respect to a Terminated Territory, a Licensed Product that is being Developed, Commercialized or otherwise Exploited by or on behalf of AbbVie or its Affiliates or Sublicensees under this Agreement in the Terminated Territory as of the effective... |
1.191. "Review Period" has the meaning set forth in Section 2.5.3. |
1.192. "Royalty Claim" means, with respect to a Licensed Product in a country or other jurisdiction, a Valid Claim of a Cugene Patent in such country or other jurisdiction that claims a Licensed Therapeutic contained in such Licensed Product in such country or other jurisdiction. |
1.193. "Royalty Term" means, with respect to each Licensed Product and each country or other jurisdiction in the Territory, the period beginning on the date of the first Net Sale of such Licensed Product in such country or other jurisdiction and ending on the latest to occur of: (a) the expiration, invalidation, irretr... |
1.194. "Safety Event" means, with respect to a Clinical Study for a Licensed Product, the FDA or other Regulatory Authority placing a clinical hold or equivalent restriction on such Clinical Study as a result of a documented adverse event. |
1.195. "Sales Milestone Event" has the meaning set forth in Section 7.4. |
1.196. "Sales Milestone Payment" has the meaning set forth in Section 7.4. |
1.197. "Second Request" has the meaning set forth in Section 12.2.4. |
1.198. "Senior Officer" means, with respect to Cugene, its Chief Executive Officer and with respect to AbbVie, its Vice President of Immunology Therapeutic Area or any successor position with equivalent responsibilities. |
1.199. "Settlement Sublicensee" means any Third Party to which AbbVie grants a sublicense to settle or avoid litigation or any Patent dispute related to (a) the threatened (in writing) or alleged infringement by a Licensed Product or the Exploitation thereof of any Patents or other intellectual property of a Third Part... |
1.200. "Side Letter" means the side letter that Cugene delivered via email on May 4, 2022 (EDT) to the Director, Business Development & Acquisitions at AbbVie who was directly involved in the negotiation of this Agreement. |
1.201. "Skipped Milestone Payments" has the meaning set forth in Section 12.9. |
1.202. "Study Data" has the meaning set forth in Section 2.4.2. |
1.203. "Sublicensee" means a Person, other than an Affiliate or a Distributor, that is granted a sublicense (or further right of reference) by AbbVie or its Affiliate under the grants in Section 4.1, as provided in Section 4.3, except for a Settlement Sublicensee. |
1.204. "Successful Completion" means (a) the achievement of Treg cell counts of approximately 2-fold increase from the pre-treatment baseline and (b) the establishment of Phase Ib Clinical Trial (MAD) starting dose (Ph1bSD) with (i) no drug related serious adverse events, (ii) no clinically significant increased toxici... |
1.205. "Term" has the meaning set forth in Section 12.1. |
1.206. "Terminated Territory" means each country or other jurisdiction with respect to which this Agreement is terminated by Cugene pursuant to Section 12.2.1 or by AbbVie pursuant to Section 12.2.2(b), or, if this Agreement is terminated in its entirety, the entire Territory. |
1.207. "Termination Notice" has the meaning set forth in Section 12.2.1. |
1.208. "Territory" means the entire world other than the Terminated Territory. |
1.209. "Third Party" means any Person other than Cugene, AbbVie and their respective Affiliates. |
1.210. "Third Party Claims" has the meaning set forth in Section 11.1. |
1.211. "Third Party Infringement Claim" has the meaning set forth in Section 8.4.1. |
1.212. "Third Party Payments" has the meaning set forth in Section 7.5.4. |
1.213. "Trademark" means any word, name, symbol, color, shape, designation or any combination thereof, including any trademark, service mark, trade name, brand name, sub-brand name, trade dress, product configuration, program name, delivery form name, certification mark, collective mark, logo, tagline, slogan, design o... |
1.214. "Transition Agreement" has the meaning set forth in Section 12.5.1. |
1.215. "Triggering Event" has the meaning set forth in Section 12.9. |
1.216. "Unfinished Initial Development Activities" has the meaning set forth in Section 3.3. |
1.217. "United States" or "U.S." means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico). |
1.218. "Updated Disclosure Schedules" has the meaning set forth in Section 10.2.2(c). |
1.219. "Valid Claim" means, with respect to a claim of any issued and unexpired Patent, that the validity, enforceability or patentability of such claim has not been affected by (a) irretrievable lapse, abandonment, revocation, dedication to the public or disclaimer or (b) a holding, finding or decision of invalidity, ... |
1.220. "Vitokine Patent" means any Cugene Patent related to cytokine-based bioactivatable drugs, including WO/2019/246392 and WO/2021/119516. |
1.221. "Voting Stock" has the meaning set forth in the definition of "Change in Control". |
1.222. "Warranty" has the meaning set forth in Section 3.4.3. |
1.223. "Warranty Inventory" has the meaning set forth in Section 3.4.3. |
1.224. "Wild-Type IL-2" means the naturally occurring human IL-2 with C125S amino acid substitution. |
1.225. "Withholding Amount" has the meaning set forth in Section 7.9.2. |
1.226. "Withholding Party" has the meaning set forth in Section 7.9.2. |
1.227. "Working Group" has the meaning set forth in Section 6.3. |
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... |
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