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1.95 "Inflation Reduction Act" means P.L. 117-169 (Aug. 16, 2022), as codified at 42 U.S.C. § 1320f, 42 U.S.C. § 1395w-3a and 42 U.S.C. § 1395w-114a (inter alia), and as it may be amended from time to time, together with any rules, regulations, and requirements promulgated thereunder (including all additions, supplemen... |
1.96 "Initial Target Program Slot" has the meaning set forth in Section 2.2.1 (Initial Target Program Slots). |
1.97 "Intellectual Property" means all copyrights, Patents Rights, Trademarks, service marks, goodwill, moral rights, Know-How, and any and all other intellectual property or proprietary rights (including applications relating thereto), whether or not now known or hereafter recognized in any jurisdiction. |
1.98 "Japan PMDA" means Japan's Pharmaceuticals and Medical Devices Agency and any successor agency or authority having substantially the same function. |
1.99 "Know-How" means all knowledge, materials, and information of a technical, scientific, business, and other nature, including: inventions, know-how, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, ... |
1.100 "Knowledge" means, with respect to Anima, the knowledge of the chief executive officer, chief business officer, chief scientific officer, chief operating officer, and each vice president of Anima or any of its Affiliates or any personnel holding positions equivalent to such job titles (but only to the extent such... |
1.101 "Law" means federal, state, local, national, and supra-national laws, statutes, rules, and regulations, including any rules, regulations, regulatory guidelines, or other requirements of the Regulatory Authorities, major national securities exchanges, or major securities listing organizations, that may be in effec... |
1.102 "Lead Optimization Data Package" has the meaning set forth in Section 1.105 ("License Option Exercise Data Package"). |
1.103 "License Option" has the meaning set forth in Section 2.9.1 (Grant of License Option). |
1.104 "License Option Effective Date" means, with respect to each Target Program Slot, the date upon which AbbVie delivers to Anima the License Option Exercise Notice with respect to such Target Program Slot in accordance with Section 14.5 (Notices); provided that, if AbbVie determines in its sole discretion prior to t... |
1.105 "License Option Exercise Data Package" means, with respect to each Target Program Slot: |
1.105.1 prior to AbbVie's payment of the License Option Period Extension Fee for the then-current Collaboration Target for such Target Program Slot, a data package containing all data (including raw data), findings, results, and information demonstrating the achievement of the success criteria set forth in Exhibit C-1 ... |
1.105.2 following AbbVie's payment of the License Option Period Extension Fee for the then-current Collaboration Target for such Target Program Slot, a data package containing all data (including raw data), findings, results, and information demonstrating the achievement of the success criteria set forth in Exhibit C-2... |
1.106 "License Option Exercise Fee" has the meaning set forth in Section 7.5 (License Option Exercise Fee). |
1.107 "License Option Exercise Notice" has the meaning set forth in Section 2.9.3(a) (Exercise of License Option). |
1.108 "License Option Period" means, with respect to each Target Program Slot, the time period commencing on the Effective Date (or, with respect to any Additional Target Program Slot, the date on which such Additional Target Program Slot is selected) and terminating as follows: |
1.108.1 prior to AbbVie's payment of the License Option Period Extension Fee for the then-current Collaboration Target for such Target Program Slot, and subject to extension pursuant to Section 2.11 (HSR), sixty (60) days after AbbVie's acceptance of a Hit Validation Data Package provided by Anima for the then-current ... |
1.108.2 following AbbVie's payment of the License Option Period Extension Fee for the then-current Collaboration Target for such Target Program Slot, and subject to extension pursuant to Section 2.11 (HSR), one hundred and eighty (180) days after AbbVie's acceptance of a Lead Optimization Data Package provided by Anima... |
1.109 "License Option Period Extension Fee" has the meaning set forth in Section 7.4 (License Option Period Extension Fee). |
1.110 "Licensed IP" means Anima's and its Affiliates' rights, title, and interests in and to the Collaboration Patents and the Collaboration Know-How (including, for clarity, the ADC Royalty-Bearing Compounds). For clarity, Licensed IP excludes Anima Platform Technology, Anima Background Patents, Anima Background Know-... |
1.111 "Major European Market" means each of France, Germany, Italy, Spain, or the UK. |
1.112 "Manufacture" and "Manufacturing" means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping, and holding of Royalty-Bearing Compounds, any Royalty-Bearing Products, or any intermediates thereof, including process develo... |
1.113 "Medical Affairs Activities" means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Royalty-Bearing Compounds or Royalty-Bearing Products, including activities of medical scientific lia... |
1.114 "Mono Product" has the meaning set forth in Section 1.116(a) ("Net Sales"). |
1.115 "NDA" means a New Drug Application, as defined in the FFDCA, or any corresponding foreign application in the Territory, including, with respect to the EU, a Regulatory Approval Application filed with the EMA pursuant to the Centralized Approval Procedure or with the applicable Regulatory Authority of a country in... |
1.116 "Net Sales" means with respect to any Royalty-Bearing Product, the gross amount invoiced by AbbVie, any of its Affiliates, or any Sublicensee (other than a Dispute Settlement Sublicensee) (each, a "Selling Party") to a Third Party (including a customer, Distributor, wholesaler, or end user) in bona fide arm's len... |
1.116.1 trade, cash, and quantity discounts; |
1.116.2 price reductions or rebates, retroactive or otherwise, imposed by, negotiated with, or otherwise paid to Governmental Authorities or other payees; |
1.116.3 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; |
1.116.4 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; |
1.116.5 the portion of administrative fees paid during the relevant time period to group purchasing organizations, pharmaceutical benefit managers, or Medicare Prescription Drug Plans relating to such Royalty-Bearing Product; |
1.116.6 any invoiced amounts from a prior period which are not collected and are written off by AbbVie or its Affiliates, including bad debts; |
1.116.7 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 the Royalty-Bearing Products; |
1.116.8 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 Royalty-Bearing Product; an... |
1.116.9 any other similar and customary deductions that are consistent with the Accounting Standards, but which may not be duplicative of the deductions specified in Sections 1.116.1-1.116.8 above. |
Net Sales shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical, regulatory, or governmental purposes. Net Sales shall include the amount or fair market value of all other consideration received by AbbVie, its Affiliates, or applicable Sublicensees (other than Dispute Settlemen... |
Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of AbbVie, its Affiliates, or applicable Sublicensees (other than Dispute Settlement Sublicensees), which must be in accordance with Accounting Standards. |
For purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 7.15 (Methods of Payments; Offsets). |
In the event a Royalty-Bearing Product is a Combination Product, the Net Sales for such Combination Product shall be calculated as follows: |
(a) If a Selling Party separately sells in such country or other jurisdiction, (i) a product containing as its sole active ingredient(s) the Royalty-Bearing Compound(s) contained in such Combination Product (the "Mono Product") and (ii) products containing as their sole active ingredient(s) the other active ingredient(... |
(b) If a Selling Party 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 ingredient(s) the other active ingredients in such Combination Product, then the Net Sales attributable to such Combi... |
(c) If a Selling Party does not separately sell in such country or other jurisdiction the Mono Product but does separately sell products containing as their sole active ingredient(s) the other active ingredients contained in such Combination Product, then the Net Sales attributable to such Combination Product shall be ... |
(d) If a Selling Party does not separately sell in such country or other jurisdiction both the Mono Product and the other active ingredient(s) in such Combination Product, then the Net Sales attributable to such Combination Product shall be determined by the Parties in good faith based on the relative fair market value... |
1.117 "Non-Breaching Party" has the meaning set forth in Section 13.2.1(a) (Material Breach). |
1.118 "Patent Right" means: (a) all national, regional, and international patents and patent applications, including provisional patent applications and rights to claim priority from any of these patents or applications; (b) all patent applications filed either from such patents, patent applications, or provisional app... |
1.119 "Person" means any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization, Governmental Authority, or any other entity not specifically listed in this Section 1.119 ("Person"). |
1.120 "Personal Data" means: (a) all information identifying, or in combination with other information, identifiable to an individual, including pseudonymized (key-coded) Clinical Data containing such information; and (b) any other information that is governed, regulated, or protected by one (1) or more Data Security a... |
1.121 "Phase 1 Clinical Trial" means a human clinical trial of a Royalty-Bearing Compound or Royalty-Bearing Product, the principal purpose of which is a preliminary determination of safety, tolerability, pharmacological activity, or pharmacokinetics in healthy individuals or patients, or a similar clinical study presc... |
1.122 "Phase 2 Clinical Trial" means a human clinical trial of a Royalty-Bearing Compound or Royalty-Bearing 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 a P... |
1.123 "Phase 3 Clinical Trial" means a human clinical trial of a Royalty-Bearing Compound or Royalty-Bearing Product on a sufficient number of subjects in an indicated patient population that is designed to establish that a Royalty-Bearing Compound or Royalty-Bearing Product is safe and efficacious for its intended use... |
1.124 "Phase 4 Clinical Trial" means a post-marketing human clinical study for a Royalty-Bearing Product with respect to any indication as to which Regulatory Approval has been received or for a use that is the subject of an investigator-initiated study program. |
1.125 "Post-License Option Exercise Activities" has the meaning set forth in Section 2.10.2 (Post-License Option Exercise Activities). |
1.126 "Pricing Approval" means such approval, agreement, determination, or decision establishing prices for a Royalty-Bearing Product that can be charged to consumers or will be reimbursed by Governmental Authorities in a country in the Territory where Governmental Authorities of such country approve or determine prici... |
1.127 "Processing" (or its conjugates) 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 m... |
1.128 "Product Information" has the meaning set forth in Section 10.1 (Product Information). |
1.129 "Product Infringement" has the meaning set forth in Section 9.4.1 (Enforcement). |
1.130 "Product Labeling" means, with respect to a Royalty-Bearing Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority approved full prescribing information for such Royalty-Bearing Product for such country or other jurisdiction, including any required patient information, and (b) a... |
1.131 "Proposed In-License Agreement" has the meaning set forth in Section 4.6 (In-License Agreements). |
1.132 "Proposed In-Licensed Rights" has the meaning set forth in Section 4.6 (In-License Agreements). |
1.133 "Proposed Target" has the meaning set forth in Section 2.5.1 (Available Target Selection). |
1.134 "Ramot Agreement" means the Settlement Agreement between Anima Biotech Inc. and Ramot at Tel Aviv University Ltd., dated February 27, 2019. |
1.135 "Registrational Clinical Trial" means a human clinical trial of a Royalty-Bearing Product for which the applicable Regulatory Authorities have provided guidance that the design of such clinical trial and results of such clinical trial, together with prior data and information concerning such Royalty-Bearing Produ... |
1.136 "Regulatory Approval" means, with respect to a country or other jurisdiction in the Territory, the approvals (including Regulatory Approval Applications), licenses, registrations, or authorizations of any Regulatory Authority necessary to Commercialize a Royalty-Bearing Compound or Royalty-Bearing Product in such... |
1.137 "Regulatory Approval Application" means (a) an NDA, or (b) any other corresponding foreign application in the Territory to seek Regulatory Approval of a product in any country or multinational jurisdiction, as defined in applicable Laws and filed with the relevant Regulatory Authorities of such country or jurisdi... |
1.138 "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, EMA, and Japan PMDA) regulating or otherwise exercising authority with respe... |
1.139 "Regulatory Filing" means all: (a) applications (including all INDs and Regulatory Approval Applications), registrations, licenses, authorizations, and approvals (including Regulatory Approvals); (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official co... |
1.140 "Reserved Target" means each target identified as a "Reserved Target" on Exhibit A-2. |
1.141 "Royalty-Bearing Compound" means, with respect to a Collaboration Target for which AbbVie has exercised the License Option, any compound that is: (a) an ADC that is (i) included in the applicable License Option Exercise Data Package and (ii) not generally known to bind to, inhibit, activate, or modulate the activ... |
1.142 "Royalty-Bearing Product" means any product for use in the Field comprising or containing a Royalty-Bearing Compound, alone or in combination with one (1) or more other active ingredient(s) that may or may not be Royalty-Bearing Compounds, in any form, in current and future formulations, dosage forms and strength... |
1.143 "Royalty Term" has the meaning set forth in Section 7.9 (Royalty Term). |
1.144 "Second Request" means a request for additional information or documentary material, as described in 16 C.F.R. 803.20. |
1.145 "Subcommittee" has the meaning set forth in Section 3.2(f) (Responsibilities). |
1.146 "Sublicensee" has the meaning set forth in Section 4.2 (Sublicensing Rights). |
1.147 "Target Program Slot" means a collaboration program for the conduct of discovery, research, and development activities pursuant to a Collaboration Plan. Each Target Program Slot will correspond to a single Collaboration Plan and, at any given time, a single Collaboration Target. Target Program Slot includes the I... |
1.148 "Term" has the meaning set forth in Section 13.1 (Term). |
1.149 "Terminated Product" means each Royalty-Bearing Product that is the subject of termination under this Agreement. If the Agreement is terminated in its entirety, then all Royalty-Bearing Products shall be Terminated Products. |
1.150 "Terminated Target" means each Collaboration Target that is the subject of termination under this Agreement. If the Agreement is terminated in its entirety, then all Collaboration Targets shall be Terminated Targets. |
1.151 "Terminated Territory" has the meaning set forth in Section 13.5 (Effects of Termination in Terminated Territory). |
1.152 "Territory" means worldwide. |
1.153 "Third Party" means any Person that is neither a Party nor an Affiliate of a Party. |
1.154 "Third Party Infringement Claim" has the meaning set forth in Section 9.5 (Infringement Claims by Third Parties). |
1.155 "Third Party Right" means any Patent Right, Know-How, or other intellectual property right of a Third Party in any country in the Territory. |
1.156 "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, ... |
1.157 "UK" means the United Kingdom of Great Britain and Northern Ireland. |
1.158 "United States" or "U.S." means the United States of America and all of its territories and possessions. |
1.159 "UPenn" has the meaning set forth in Section 1.161 ("UPenn Technology"). |
1.160 "UPenn Agreement" has the meaning set forth in Section 1.161 ("UPenn Technology"). |
1.161 "UPenn Technology" means "Penn Patent Rights," "Technical Information," and "Know-How," in each case as defined in the Patent License Agreement between Anima Biotech Inc. and The Trustees of the University of Pennsylvania ("UPenn"), dated June 25, 2010, as amended by that certain First Amendment to Patent License... |
1.162 "Voting Stock" has the meaning set forth in Section 1.34.1 ("Change of Control"). |
1.163 "Withholding Amount" has the meaning set forth in Section 7.16.2 (Withholding Taxes). |
ARTICLE 2 DEVELOPMENT; LICENSE OPTION |
2.1 Overview. On a Target Program Slot-by-Target Program Slot basis, during the applicable Collaboration Term for such Target Program Slot, Anima will perform and complete certain discovery, research, and development activities in accordance with the terms of this Agreement and the applicable Collaboration Plan to gene... |
2.2 Target Program Slots. |
2.2.1 Initial Target Program Slots. The initial Collaboration Targets for the first three (3) Target Program Slots as of the Effective Date (each, an "Initial Target Program Slot") are identified as "Initial Collaboration Targets" in Exhibit A-1 attached hereto. |
2.2.2 Additional Target Program Slots. At any time following the Effective Date and until the five- (5-) year anniversary thereof, AbbVie will have the right to select up to three (3) additional Target Program Slots (each, an "Additional Target Program Slot") in accordance with the terms of this Section 2.2.2 (Addition... |
2.3 Collaboration Target Substitution. On a Target Program Slot-by-Target Program Slot basis, AbbVie will have the right to substitute the Collaboration Target with respect to each Target Program Slot with an Available Target up to a total of two (2) times per Target Program Slot (i.e., replace the original Collaborati... |
2.4 Gatekeeper. Within thirty (30) days after the Effective Date, the Parties will appoint an independent Third Party legal counsel reasonably acceptable to both Parties (the "Gatekeeper") to carry out the functions of the Gatekeeper as set out in this Agreement, provided that Anima will not unreasonably withhold, dela... |
2.5 Selection of Available Targets. All Reserved Targets shall be deemed to be Available Targets. A target that is not a Reserved Target may only be deemed to be an Available Target in accordance with the terms of this Section 2.5 (Selection of Available Targets), unless the Parties otherwise mutually agree that such t... |
2.5.1 Available Targets and Excluded Targets. If, during the period when AbbVie has the right to select an Additional Target Program Slot pursuant to Section 2.2.2 (Additional Target Program Slots) or substitute a Collaboration Target pursuant to Section 2.3 (Collaboration Target Substitution) (the "Gatekeeping Term"),... |
2.5.2 Available Target Selection. After the Gatekeeper has determined that a Proposed Target is an Available Target, upon AbbVie's request, Anima will perform in silico target feasibility analysis with respect to such Proposed Target (to the extent not already performed by Anima), at Anima's expense, and provide AbbVie... |
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