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1.101. "Final Data Package" means the research and development report containing all data, findings, results and information described in the Initial Development Plan and Budget as being part of the Final Data Package. |
1.102. "First Commercial Sale" means, with respect to a Licensed Product and a country or other jurisdiction, the first sale for monetary value for use or consumption by the end user of such Licensed Product in such country or other jurisdiction by AbbVie, its Affiliates or its or their Sublicensees to a Third Party af... |
1.103. "FTC" means the United States Federal Trade Commission. |
1.104. "FTE" means the equivalent of the work of one employee full time for one Calendar Year of work performing applicable activities with respect to the Manufacturing Technology Transfer. |
1.105. "GLP Toxicology Protocol" has the meaning set forth in Section 6.1.2(j). |
1.106. "GMP" means the current good manufacturing practices applicable from time to time to the Manufacturing of a Licensed Therapeutic or Licensed Product or any intermediate thereof pursuant to Applicable Law. |
1.107. "Governmental Authority" means any multinational, federal, national, state, provincial, local or other entity, office, commission, bureau, agency, political subdivision, instrumentality, branch, department, authority, board, court, arbitral or other tribunal exercising executive, judicial, legislative, police, r... |
1.108. "HSR Act" means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as codified at 15 U.S.C. § 18a, as may be amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions and modifications thereto). |
1.109. "HSR Clearance" means the expiration or termination of all applicable waiting periods and requests for information (and any extensions thereof) under the HSR Act or the antitrust laws in all jurisdictions in which HSR Filings are required with respect to AbbVie's exercise of the License Option. |
1.110. "HSR Filing" means (a) filings by Cugene and AbbVie with the United States Federal Trade Commission and the Antitrust Division of the DOJ of a Notification and Report Form for Certain Mergers and Acquisitions (as that term is defined in the HSR Act) with respect to AbbVie's exercise of the License Option, togeth... |
1.111. "HSR Proceeding" has the meaning set forth in Section 3.2.2(d). |
1.112. "IL-2" means the mature form of the interleukin 2 with UniProt: P60568, encoded by the gene with NCBI gene ID: 3558. For clarity, when referring to an amino acid position of an IL-2 for purposes of this Agreement, the first amino acid immediately after the signal peptide of the interleukin 2 with UniProt: P60568... |
1.113. "IL-2 Mutein" means a mutated form of IL-2 with at least one change in the amino acid sequence (i.e., UniProt: P60586) (other than the Wild-Type IL-2). For clarity, "IL-2 Mutein" means mutated form of IL-2 standing-alone, i.e., not linked, conjugated or fused to another antibody, compound, molecule or other ther... |
1.114. "Immunology Test" means, with respect to a mutein, antibody, compound, molecule or other therapeutic, that such mutein, antibody, compound, molecule or other therapeutic is or comprises an IL-2 Mutein for which an Fc-fusion protein that comprises such IL-2 Mutein demonstrates enhanced regulatory T cell biased ag... |
Bioassay Criteria EC50 fold change for pSTAT5 comparing with Fc-fusion protein comprising Wild-Type IL-2 in the Assay |
CD4+Treg/CD8+T CD4+Treg CD8+T |
High/Low Greater than or comparable to WT IL2Fc and range to ≤20-fold reduction >100-fold reduction ranging to flat line* |
High/Medium Greater than or comparable to WT IL2Fc and range to ≤20-fold reduction >10-fold to ≤100-fold reduction |
Medium/Low >20-fold to ≤200-fold reduction >100-fold reduction ranging to flat line* |
Low/Low >200-fold reduction >100-fold reduction ranging to flat line* |
*Flat line refers to close to background signal due to extremely low potency |
1.115. "In-License Agreements" means all license and other agreements between Cugene or any of its Affiliates, on the one hand, and any Third Party, on the other hand, pursuant to which Cugene or its Affiliate in-licenses any Patents or Information that are Cugene Patents or Cugene Know-How, as applicable. |
1.116. "In-License Schedule" means Schedule 1.116, as such schedule may be updated in connection with the delivery of any Updated Disclosure Schedules. |
1.117. "In-Licensed Patents" has the meaning set forth in Section 10.2.1(c). |
1.118. "Included In-License Agreement" means an In-License Agreement entered into between Cugene or any of its Affiliates, on the one hand, and any Third Party, on the other hand, prior to the License Option Effective Date. |
1.119. "IND" means an application filed with a Regulatory Authority for authorization to commence Clinical Studies, including (a) an Investigational New Drug Application as defined in the FFDCA or any successor application or procedure filed with the FDA, (b) any equivalent of a United States Investigational New Drug A... |
1.120. "Indemnification Claim Notice" has the meaning set forth in Section 11.3.1. |
1.121. "Indemnified Party" has the meaning set forth in Section 11.3.1. |
1.122. "Indemnifying Party" has the meaning set forth in Section 11.3.1. |
1.123. "Indication" means, with respect to a Licensed Product, a diagnostic, prophylactic or therapeutic use for a disease or condition, with respect to which use at least one adequate and well-controlled Clinical Study is required to support the addition of such disease or condition to the indication statement of a pa... |
1.124. "Indirect Taxes" has the meaning set forth in Section 7.9.3. |
1.125. "Information" means all information and data of a technical, scientific, business or other nature, including know-how, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, comput... |
1.126. "Initial Development Plan and Budget" means the mutually agreed research and development plan and budget, attached hereto as Schedule 1.126, as the same may be amended from time to time in accordance with the terms hereof, for the Licensed Therapeutics and Licensed Products. |
1.127. "Initial Disclosure Schedules" has the meaning set forth in Section 10.2.1. |
1.128. "Initiation" or "Initiate" means, with respect to a Clinical Study, the first dosing of the first human subject with the applicable Licensed Product in such Clinical Study in accordance with the applicable protocol and Applicable Law. |
1.129. "Joint Governance Committee" or "JGC" has the meaning set forth in Section 6.1.1. |
1.130. "Joint IP" has the meaning set forth in Section 8.1.2. |
1.131. "Joint Know-How" has the meaning set forth in Section 8.1.2. |
1.132. "Joint Patents" has the meaning set forth in Section 8.1.2. |
1.133. "Knowledge" means: (a) with respect to Cugene, the actual knowledge after performing a diligent investigation with respect to the applicable facts and information of the Chief Executive Officer, VP/head of research, director of business, director of business development, internal patent prosecution counsel, inte... |
1.134. "License Option" has the meaning set forth in Section 3.1. |
1.135. "License Option Effective Date" means the date AbbVie delivers Cugene the Exercise Notice in accordance with Section 3.2.1; provided that, 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 req... |
1.136. "License Option Exercise Payment" has the meaning set forth in Section 7.2. |
1.137. "License Option Period" means the time period commencing upon the Effective Date and terminating 90 days after AbbVie receives, or is deemed to have received, the complete Final Data Package from Cugene pursuant to Section 2.5.3. |
1.138. "Licensed IL-2 Mutein" means an IL-2 Mutein, the amino acid sequence of which IL-2 Mutein is set forth in the Side Letter. |
1.139. "Licensed IP" means the Cugene IP and Cugene's interest in the Joint IP, if any. |
1.140. "Licensed Product" means any product containing a Licensed Therapeutic, alone or in combination with one or more other active ingredients in any and all forms, in current and future formulations, dosage forms and strengths, and delivery modes including any improvements thereto; provided that the licenses granted... |
1.141. "Licensed Therapeutic" means (a) (i) CUG252, (ii) any mutein, antibody, compound, molecule or other therapeutic that is or comprises the Licensed IL-2 Mutein, (iii) any mutein, antibody, compound, molecule or other therapeutic that is or comprises any IL-2 Mutein contained in the Fc-fusion protein with any of th... |
1.142. "Losses" has the meaning set forth in Section 11.1. |
1.143. "Major European Market" means any of the United Kingdom, Germany, France, Italy and Spain. |
1.144. "Manufacture" and "Manufacturing" means all activities related to the synthesis, making, production, manufacture, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping and holding of any Licensed Therapeutic, any Licensed Product or any intermediate thereof, including process deve... |
1.145. "Manufacturing Process" has the meaning set forth in Section 5.3. |
1.146. "Manufacturing Technology Transfer" has the meaning set forth in Section 5.3. |
1.147. "Marketing Authorization Application" has the meaning set forth in the definition of "Drug Approval Application". |
1.148. "Material Amendment" means any material amendment to the Initial Development Plan and Budget, including (a) a change to the scope, timing or resource allocation of any Development activities that would reasonably be expected to result in an delay in the timing to complete the activities set forth in the then-cur... |
1.149. "Missing Information" has the meaning set forth in Section 2.5.3. |
1.150. "Missing Information Notice" has the meaning set forth in Section 2.5.3. |
1.151. "Mixed Cugene Patent" means any Other Cugene Patent that claims one or more Licensed Therapeutics or Licensed Products or the Exploitation thereof and also claims one or more other therapeutics or products or the Exploitation thereof. For clarity, any Bispecific Patent, Vitokine Patent and 418 Patent are each Mi... |
1.152. "MTA" has the meaning set forth in Section 2.3.6. |
1.153. "Net Sale Anniversary" has the meaning set forth in the definition of "Royalty Term". |
1.154. "Net Sales" means, with respect to a Licensed Product for any period, the total amount billed or invoiced on sales of such Licensed Product during such period by AbbVie, its Affiliates, or Sublicensees in the Territory to Third Parties (including Distributors), in bona fide arm's length transactions, less the fo... |
(a) normal trade, cash and quantity discounts actually given in the ordinary course of business; |
(b) price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to Governmental Authorities or other payees; |
(c) taxes on sales (such as sales, value added, or use taxes) to the extent added to the sale price and set forth separately as such in the total amount invoiced which, for clarity, exclude income taxes; |
(d) amounts repaid or credited by reason of rejections, defects, return goods allowance, recalls or returns, or because of retroactive price reductions, including rebates or wholesaler charge backs; |
(e) the portion of administrative fees paid during the relevant time period to group purchasing organizations, pharmaceutical benefit managers or Medicare Prescription Drug Plans to the extent allocated to such Licensed Product; |
(f) if a Delivery System is bundled together with such Licensed Product and the total amount billed or invoiced includes both the Delivery System and such Licensed Product, any consideration actually paid or payable for any Delivery System related to a billed or invoiced sale of such Licensed Product, where for purpose... |
(g) any invoiced amounts from a prior period that are not collected and are written off by AbbVie, its Affiliates or Sublicensees, including bad debts; provided that the amount of any uncollected amounts or bad debt deducted pursuant to this exception and actually collected in a subsequent Calendar Quarter shall be inc... |
(h) that portion of the annual fee on prescription drug manufacturers imposed by the Patient Protection and Affordable Care Act, Pub. L. No. 111-148 (as amended) and reasonably allocable to sales of such Licensed Product; |
(i) customary freight, insurance, import/export, and other transportation charges to the extent added to the sale price and set forth separately as such in the total amount invoiced, as well as any fees for services provided by wholesalers and warehousing chains related to the distribution of such Licensed Product; and |
(j) any other similar and customary deductions that are consistent with the Accounting Standards, but which may not be duplicative of the deductions specified in Section 1.154(a) through Section 1.154(i). |
In no event shall any particular amount, identified above, be deducted more than once in calculating Net Sales (i.e., no "double counting" of any deductions). Notwithstanding anything to the contrary in this Section 1.154, to the extent any amounts deducted pursuant to this Section 1.154 are subsequently recovered by o... |
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. |
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