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1.79. "Dollars" or "$" means United States Dollars. |
1.80. "DRC" means, with respect any Clinical Study conducted under the Initial Development Plan and Budget, the data review committee or data monitoring committee established in accordance with the Initial Development Plan and Budget and Applicable Law. |
1.81. "Drug Approval Application" means a Biologics License Application as defined in the FFDCA (a "BLA") or any corresponding foreign application in the Territory, including, with respect to the European Union, a marketing authorization application filed with the EMA pursuant to the centralized approval procedure or w... |
1.82. "Early Exercise Data Package" has the meaning set forth in Section 2.5.1. |
1.83. "Early Exercise Request" has the meaning set forth in Section 2.5.1. |
1.84. "EEA" means the European Economic Area. |
1.85. "Effective Date" has the meaning set forth in the preamble hereto. |
1.86. "EMA" means the European Medicines Agency and any successor agency(ies) or authority having substantially the same function. |
1.87. "European Union" means the economic, scientific, and political organization of member states known as the European Union, as its membership may be altered from time to time, and any successor thereto. |
1.88. "Excluded Compound" means any mutein, antibody, compound, molecule or other therapeutic that is or comprises an IL-2 Mutein for which an Fc-fusion protein that comprises such IL-2 Mutein has significantly less agonist activity to IL-2Rαβγ (expressed on CD4+Treg) compared with an Fc-fusion protein that comprises W... |
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 |
Low/High >200-fold reduction Greater than or comparable to WT IL2Fc and ranging to ≤10-fold reduction |
Low/Medium >200-fold reduction >10-fold to ≤100-fold reduction |
Medium/High >20-fold to ≤200-fold reduction Greater than or comparable to WT IL2Fc and ranging to ≤10-fold reduction |
Medium/Medium >20-fold to ≤200-fold reduction >10-fold to ≤100-fold reduction |
1.89. "Excluded Entity" has the meaning set forth in Section 10.2.1(u)(3). |
1.90. "Excluded Individual" has the meaning set forth in Section 10.2.1(u)(3). |
1.91. "Exercise Notice" has the meaning set forth in Section 3.2.1. |
1.92. "Existing Know-How" means, as of the Effective Date, or each Bring Down Date, as applicable, all Cugene Know-How existing as of such date. |
1.93. "Existing Patents" means, as of the Effective Date, or each Bring Down Date, as applicable, all Cugene Patents existing as of such date. |
1.94. "Existing Patents Schedule" means Schedule 1.94, as such schedule may be updated in connection with the delivery of any Updated Disclosure Schedules. |
1.95. "Existing Regulatory Documentation" means, as of the Effective Date or each Bring Down Date, as applicable, all Regulatory Documentation Controlled by Cugene or any of its Affiliates as of such date. |
1.96. "Exploit" means to make, have made, import, export, use, have used, sell, have sold, or offer for sale, including to Develop, Commercialize, register, modify, enhance, improve, Manufacture, have Manufactured, hold or keep (whether for disposal or otherwise), formulate, optimize, transport, distribute, promote, ma... |
1.97. "FDA" means the United States Food and Drug Administration and any successor agency(ies) or authority having substantially the same function. |
1.98. "FDA's Disqualified/Restricted List" has the meaning set forth in Section 10.2.1(u)(5). |
1.99. "FFDCA" means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations, and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto). |
1.100. "Field" means all human and non-human diagnostic, prophylactic and therapeutic uses. |
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... |
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