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Subject to the above, each of the components of Net Sales shall be calculated in accordance with the standard internal policies and procedures of AbbVie, its Affiliates, or Sublicensees, and, where applicable, Accounting Standards. |
For purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 7.8. |
If a Licensed Product is a Combination Product, the Net Sales for such Combination Product in each country or other jurisdiction shall be calculated as follows: |
(i) If AbbVie or any of its Affiliates or Sublicensees separately sells in such country or other jurisdiction, (A) a product containing as its sole active ingredient the Licensed Therapeutic in the same strength and using the same route of administration as in such Combination Product (the "Mono Product") and (B) produ... |
(ii) If AbbVie or any of its Affiliates or Sublicensees separately sells in such country or other jurisdiction the Mono Product but does not separately sell in such country or other jurisdiction products containing as their sole active ingredients the Other Actives in the same strength and using the same route of admin... |
(iii) If AbbVie and its Affiliates and Sublicensees do not separately sell in such country or other jurisdiction the Mono Product but do separately sell products containing as their sole active ingredients the Other Actives in the same strength and using the same route of administration as contained in such Combination... |
(iv) If AbbVie, its Affiliates and Sublicensees do not separately sell in such country or other jurisdiction either the Mono Product or the Other Active(s) in the same strength and using the same route of administration as in such Combination Product, the Net Sales attributable to such Combination Product shall be dete... |
1.155. "Non-Breaching Party" has the meaning set forth in Section 12.2.1. |
1.156. "Notice Period" has the meaning set forth in Section 12.2.1. |
1.157. "Opt-In" means opting into the jurisdiction of Unified Patent Court, such as through withdrawal under Article 83(4) of the Agreement on a Unified Patent Court between the participating member states of the European Union (2013/C 175/01) of the Opt-Out of a Patent. |
1.158. "Opt-Out" means opting out of the jurisdiction of Unified Patent Court, such as the opt-out of a Patent from the exclusive competence of the Unified Patent Court under Article 83(3) of the Agreement on a Unified Patent Court between the participating member states of the European Union (2013/C 175/01). |
1.159. "Other Active" has the meaning set forth in the definition of "Net Sales". |
1.160. "Other Cugene Patents" means the Cugene Patents other than the Product Patents. |
1.161. "Owned Patents" has the meaning set forth in Section 10.2.1(c). |
1.162. "P19/126 Mutation Compound" means an IL-2 Mutein with any amino acid substitutions at both position L19 and position Q126, excluding Cugene Existing P19/126 Oncology Compounds. |
1.163. "P65 Mutation Compound" means an IL-2 Mutein with any amino acid substitution at position P65. |
1.164. "Party" and "Parties" have the meaning set forth in the preamble hereto. |
1.165. "Patents" means: (a) all national, regional and international patents and patent applications, including provisional patent applications; (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, incl... |
1.166. "Permitted Entities" has the meaning set forth in Section 2.3.4. |
1.167. "Person" means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or poli... |
1.168. "Personal Data" means (a) all information identifying, or in combination with other information, identifiable to an individual, including pseudonymized (key-coded) data from Clinical Studies containing such information; and (b) any other information that is governed, regulated, or protected by one or more Data P... |
1.169. "Phase Ia Clinical Trial" means a human Clinical Study of a Licensed Product, the principal purpose of which is a preliminary determination of safety, pharmacokinetics, and pharmacodynamic parameters in healthy individuals, including the applicable trials referred to in 21 C.F.R. § 312.21(a), as amended from tim... |
1.170. "Phase Ib Clinical Trial" means a human Clinical Study that provides for the first introduction of a Licensed Product into patients having the disease of interest with the primary purpose of determining safety and pharmacokinetic properties and clinical pharmacology of such Licensed Product, including the applic... |
1.171. "Phase II Clinical Trial" means a Clinical Study of a Licensed Therapeutic or Licensed Product, the principal purpose of which is a determination of safety and efficacy in the target patient population, which is prospectively designed to generate sufficient data that may permit commencement of pivotal clinical t... |
1.172. "PHSA" means the United States Public Health Service Act, as amended from time to time. |
1.173. "Pre-Existing Entities" has the meaning set forth in Section 4.6.2. |
1.174. "Pre-Transaction Entities" has the meaning set forth in Section 13.3.2. |
1.175. "Preliminary Final Data Package" has the meaning set forth in Section 2.5.3. |
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... |
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