text stringlengths 1 5.46k |
|---|
ARTICLE 1 DEFINITIONS |
As used in this Agreement, the following terms will have the meanings set forth in this ARTICLE 1 (Definitions) unless context dictates otherwise: |
1.1 "AbbVie Collaboration Activities License" has the meaning set forth in Section 4.1.2 (Collaboration Activities License). |
1.2 "AbbVie License" has the meaning set forth in Section 4.1.1 (Commercial License). |
1.3 "Accounting Standards" means, with respect to a Party or its Affiliates or its or their (sub)licensees/Sublicensees, United States generally accepted accounting principles or International Financial Reporting Standards as issued by the International Accounting Standards Board, as applicable, in each case consistent... |
1.4 "ADC Inclusion Date" has the meaning set forth in Section 2.7.5 (Anima Discovered Compounds). |
1.5 "Additional Target Program Fee" has the meaning set forth in Section 7.2 (Additional Target Program Fee). |
1.6 "Additional Target Program Slot" has the meaning set forth in Section 2.2.2 (Additional Target Program Slots). |
1.7 "Additional Target Program Slot Designation Date" has the meaning set forth in Section 7.2 (Additional Target Program Fee). |
1.8 "ADR" has the meaning set forth in Section 14.2.1 (General). |
1.9 "Adverse Ruling" has the meaning set forth in Section 13.2.1(a) (Material Breach). |
1.10 "Affiliate" means, with respect to a Person, any Person that, directly or indirectly through one (1) or more intermediaries, controls, is controlled by, or is under common control with such first Person for so long as such Person controls, is controlled by, or is under common control with such first Person, regard... |
1.11 "Anima Acquirer" has the meaning set forth in Section 8.1.2 (Effect of Change of Control of Anima). |
1.12 "Anima Background Know-How" means (a) all Know-How that is Anima Platform Technology and (b) all other Know-How other than Collaboration Know-How that is Controlled by Anima or any of its Affiliates as of the Effective Date or at any time during the Term and that, in each case ((a) and (b)) is: (i) not generally k... |
1.13 "Anima Background Patents" means all Patent Rights, other than Collaboration Patents, that (a) are Controlled by Anima or any of its Affiliates as of the Effective Date or at any time during the Term and (b) (i) are necessary or reasonably useful for the conduct of activities allocated to either Party under any Co... |
1.14 "Anima Collaboration Patent" means any Collaboration Patent that claims Collaboration Know-How that is conceived, reduced to practice, generated, discovered, developed, or otherwise made solely by or on behalf of Anima or its Affiliates, except to the extent such Collaboration Patent claims any Anima Improvement. |
1.15 "Anima Compound Library" means the collection of compounds assembled by Anima or its Affiliates from commercially available sources to be used in the conduct of activities under a Collaboration Plan. |
1.16 "Anima Developed Compound" or "ADC" means, with respect to a Collaboration Target, any compound that (a) was discovered, developed, designed, or synthesized by or on behalf of Anima or its Affiliates during the conduct of activities under a Collaboration Plan, and (b) is Directed To the applicable Collaboration Ta... |
1.17 "Anima Improvement" means: (a) all Know-How that: (i) constitutes an improvement to the Anima Platform Technology, Anima Background Patents, or Anima Background Know-How; (ii) is conceived, reduced to practice, generated, discovered, developed, or otherwise made solely by or on behalf of Anima in the conduct of ac... |
1.18 "Anima Improvement Patents" has the meaning set forth in Section 1.17 ("Anima Improvement"). |
1.19 "Anima Platform Technology" means Anima's proprietary platform and related Know-How for discovery of small molecule compounds that control mRNA or protein biology (including bioinformatics, screening technologies and assays, image analysis, activity and selectivity analysis, mechanism of action and target ID eluci... |
1.20 "Anima Severe Material Breach" means, where AbbVie has the right to terminate this Agreement pursuant to Section 13.2.1 (Termination for Cause) for an uncured material breach by Anima of a material obligation, solely for the purpose of determining whether the modifications set forth in Sections 13.3.1 through 13.3... |
1.21 "Annual Net Sales" means, with respect to a Royalty-Bearing Product, the total Net Sales of such Royalty-Bearing Product in the Territory in a particular Calendar Year. |
1.22 "Annual Net Sales Milestone Threshold" has the meaning set forth in Section 7.7 (Sales-Based Milestone Payments). |
1.23 "Annual Net Sales-Based Milestone Payment" has the meaning set forth in Section 7.7 (Sales-Based Milestone Payments). |
1.24 "Annual Net Sales-Based Milestone Table" has the meaning set forth in Section 7.7 (Sales-Based Milestone Payments). |
1.25 "Audit Arbitrator" has the meaning set forth in Section 7.14.2 (Audit Dispute). |
1.26 "Available Target" means any target, other than a Collaboration Target, that is (a) a Reserved Target or (b) otherwise deemed to be an Available Target under Section 2.5 (Selection of Available Targets). |
1.27 "Bankruptcy Code Intellectual Property" has the meaning set forth in Section 4.7.1 (Section 365(n) of the Bankruptcy Code). |
1.28 "Board of Directors" has the meaning set forth in Section 1.34.1 ("Change of Control"). |
1.29 "Breaching Party" has the meaning set forth in Section 13.2.1(a) (Material Breach). |
1.30 "Business Day" means a day other than a Saturday or Sunday on which banking institutions in Chicago, Illinois are open for business. |
1.31 "Calendar Quarter" means a period of three (3) consecutive months ending on the last day of March, June, September, or December, respectively, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, Ju... |
1.32 "Calendar Year" means a period of twelve (12) consecutive months beginning on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall ... |
1.33 "CDA" has the meaning set forth in Section 14.11 (Entire Agreement; Amendments). |
1.34 "Change of Control" with respect to a Party, shall be deemed to have occurred if any of the following occurs after the Effective Date: |
1.34.1 any "person" or "group" (as such terms are defined below): (a) is or becomes the "beneficial owner" (as defined below), directly or indirectly, of shares of capital stock or other interests (including partnership interests) of such Party then outstanding and normally entitled (without regard to the occurrence of... |
1.34.2 such Party enters into a merger, consolidation, or similar transaction with another Person (whether or not such Party is the surviving entity) and as a result of such merger, consolidation, or similar transaction: (a) the members of the Board of Directors of such Party immediately prior to such transaction const... |
1.34.3 the holders of capital stock of such Party approve a plan or proposal for the liquidation or dissolution of such Party. |
For the purpose of this definition of Change of Control: (a) "person" and "group" have the meanings given such terms under Section 13(d) and 14(d) of the United States Securities Exchange Act of 1934 and the term "group" includes any group acting for the purpose of acquiring, holding, or disposing of securities within ... |
1.35 "Clinical Data" means all information with respect to any Royalty-Bearing Compound or Royalty-Bearing Product, which information is made, collected, or otherwise generated under or in connection with Clinical Trials (including Phase 4 Clinical Trials), including any data (including raw data), reports, and results ... |
1.36 "Clinical Trial" means a Phase 1 Clinical Trial, Phase 2 Clinical Trial, Phase 3 Clinical Trial, Phase 4 Clinical Trial, Registrational Clinical Trial, or any other study in which human subjects or patients are dosed with a drug, whether approved or investigational. |
1.37 "Collaboration Know-How" means all information (including regulatory data, files, approvals, and other documentation) and other Know-How that is not generally known and is conceived, reduced to practice, generated, discovered, developed, or otherwise made (a) solely or jointly by or on behalf of either Party or it... |
1.38 "Collaboration Patent" means any Patent Right that claims Collaboration Know-How. |
1.39 "Collaboration Plan" means, with respect to any Target Program Slot, a research and development plan for such Target Program Slot that (a) is approved by the JGC in accordance with the terms of this Agreement and (b) includes at least those elements set forth in Exhibit B-1, as may be amended from time to time in ... |
1.40 "Collaboration Target" means: (a) those "Initial Collaboration Targets" identified in Exhibit A-1 attached hereto; and (b) any other target that is designated a Collaboration Target in accordance with the terms of this Agreement. |
1.41 "Collaboration Target Substitution Fee" has the meaning set forth in Section 7.3 (Collaboration Target Substitution Fee). |
1.42 "Collaboration Target Substitution Notice" has the meaning set forth in Section 2.3 (Collaboration Target Substitution). |
1.43 "Collaboration Term" means, with respect to each Target Program Slot, the period commencing on the Effective Date and ending upon: (a) if AbbVie does not exercise the License Option with respect to such Target Program Slot during the applicable License Option Period, the end date of such License Option Period; or ... |
1.44 "Combination Product" means a Royalty-Bearing Product that contains a Royalty-Bearing Compound as an active ingredient, together with one (1) or more other active ingredients that are not Royalty-Bearing Compounds, and is sold either as a fixed dose/unit or as separate doses/units in a single package or for a sing... |
1.45 "Commercialization" and "Commercialize" means any and all activities related to the preparation for sale of, offering for sale of, or sale of a Royalty-Bearing Compound or Royalty-Bearing Product, including activities related to marketing, promoting, distributing, importing, and exporting such Royalty-Bearing Comp... |
1.46 "Commercially Reasonable Efforts" means, (a) with respect to the efforts and resources to be expended by AbbVie with respect to any objective, activity, or decision to be undertaken, such reasonable efforts and resources to accomplish such objective, activity, or decision that would be comparable with the efforts ... |
1.47 "Committee" has the meaning set forth in Section 3.2(f) (Responsibilities). |
1.48 "Confidential Information" means any information or data provided orally, visually, in writing, or in any other form by or on behalf of one (1) Party (or an Affiliate or representative of such Party) to the other Party (or to an Affiliate or representative of such Party) in connection with this Agreement, whether ... |
1.49 "Control" means, subject to Section 14.3.2 (Assignment), with respect to a Person and any Regulatory Filings, material, Know-How, Patent Right, or other intellectual property right, the possession by such Person or any of its Affiliates of the right, whether through ownership or license (other than by a license un... |
1.50 "Convicted Individual" or "Convicted Entity" means an individual or entity, as applicable, who has been convicted of a criminal offense that falls within the ambit of 21 U.S.C. §335a (a) or 42 U.S.C. §1320a - 7(a), but has not yet been excluded, debarred, suspended, or otherwise declared ineligible. |
1.51 "Credentialed MoA Target" means a mechanism of action target identified in the License Option Exercise Data Package that satisfies the success criteria set forth in the "Lead Generation – Mode of action and target ID" section of Exhibit C-2. |
1.52 "Data Security and Privacy Laws" means all applicable Laws relating to the privacy, Processing, or security of Personal Data. |
1.53 "Debarred Entity" means a corporation, partnership, or association that has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from submitting or assisting in the submission of any abbreviated drug application, or a subsidiary or Affiliate of a Debarred Entity. |
1.54 "Debarred Individual" means an individual who has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from providing services in any capacity to a Person that has an approved or pending drug or biological product application. |
1.55 "Default Notice" has the meaning set forth in Section 13.2.1(a) (Material Breach). |
1.56 "Development" means all activities related to research, pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, Clinical Trials (other than Phas... |
1.57 "Development Milestone Event" has the meaning set forth in Section 7.6 (Development and Regulatory Milestone Payments). |
1.58 "Development Milestone Payment" has the meaning set forth in Section 7.6 (Development and Regulatory Milestone Payments). |
1.59 "Directed To" means, (a) with respect to a Collaboration Target and a compound, that such compound binds to, inhibits, activates, or modulates the activity, translation, expression, or mRNA of such Collaboration Target to a level that meets the Hit Confirmation criteria of Exhibit C-1, and (b) with respect to a Re... |
1.60 "Dispute" has the meaning set forth in Section 14.2 (Dispute Resolution). |
1.61 "Dispute Settlement Sublicensee" means any Sublicensee that is granted a sublicense under the rights granted to AbbVie under Section 4.1 (Licenses to AbbVie) (a) in order to settle a litigation or dispute related to any Patent Rights in connection with a Royalty-Bearing Product or a Generic Product thereof, includ... |
1.62 "Distracting Product" has the meaning set forth in Section 8.1.2 (Effect of Change of Control of Anima). |
1.63 "Distributor" means any Person appointed by AbbVie or any of its Affiliates or its or their Sublicensees (other than Dispute Settlement Sublicensees) to distribute, market, and sell a Royalty-Bearing Product with or without packaging rights, in one (1) or more countries in the Territory, in circumstances where suc... |
1.64 "DOJ" means the Antitrust Division of the United States Department of Justice, and any successor entity thereto. |
1.65 "Dollars" or "$" means the legal tender of the U.S. |
1.66 "EMA" means the European Medicines Agency, and any successor entity thereto. |
1.67 "EU" means the European Union as constituted as of the Effective Date and any other country or countries admitted to the European Union from time to time. |
1.68 "Excluded ADC" means any compound for which the applicable ADC Inclusion Date occurs prior to the initiation of hit validation activities under the applicable Collaboration Plan and that is (a) independently developed by Anima prior to the applicable ADC Inclusion Date pursuant to a definitive agreement between An... |
1.69 "Excluded Individual" or "Excluded Entity" means: (a) an individual or entity, as applicable, who has been excluded, debarred, suspended, or is otherwise ineligible to participate in federal health care programs such as Medicare or Medicaid by the Office of the Inspector General (OIG/HHS) of the U.S. Department of... |
1.70 "Excluded Target" has the meaning set forth in Section 2.5.1 (Available Targets and Excluded Targets). |
1.71 "Executive Officers" means the Chief Executive Officer, or his or her designee, in the case of Anima, and the Vice President and Global Head Discovery Research, or his or her designee, in the case of AbbVie. |
1.72 "Existing In-License Agreements" means the licenses and other agreements between Anima or any of its Affiliates and a Third Party existing as of the Effective Date under which Anima or its Affiliates is granted a (sub)license or other right to be used or practiced in the conduct of activities allocated to Anima un... |
1.73 "Existing Patent Rights" has the meaning set forth in Section 11.2 (Representations, Warranties, and Covenants, as applicable, of Anima). |
1.74 "Exploit," "Exploiting," or "Exploitation" means to make, have made, import, export, use, have used, sell, have sold, or offer for sale, including to research, Develop, Commercialize, register, modify, enhance, improve, Manufacture, have Manufactured, hold, or keep (whether for disposal or otherwise), formulate, o... |
1.75 "FDA" means the United States Food and Drug Administration, and any successor entity thereto. |
1.76 "FDA's Disqualified/Restricted List" means the list of clinical investigators restricted from receiving investigational drugs, biologics, or devices if the FDA has determined that the investigators have repeatedly or deliberately failed to comply with regulatory requirements for studies or have submitted false inf... |
1.77 "FFDCA" means the 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). |
1.78 "Field" means all human and non-human diagnostic, prophylactic, and therapeutic uses. |
1.79 "First Commercial Sale" means, with respect to a Royalty-Bearing Product and a country in the Territory, the first sale for monetary value and for end use or consumption of such Royalty-Bearing Product in such country after all Regulatory Approvals for the sale of such Royalty-Bearing Product in such country have ... |
1.80 "FTC" means the United States Federal Trade Commission, and any successor entity thereto. |
1.81 "Gatekeeper" has the meaning set forth in Section 2.4 (Gatekeeper). |
1.82 "Gatekeeping Term" has the meaning set forth in Section 2.5.1 (Available Target Selection). |
1.83 "Generic Product" means, with respect to a Royalty-Bearing Product, any product sold by a Third Party that is approved, or sought to be approved, by a Regulatory Authority in reliance, in whole or in part, on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such Roya... |
1.84 "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... |
1.85 "Hit Validation Data Package" has the meaning set forth in Section 1.105 ("License Option Exercise Data Package"). |
1.86 "HSR Act" means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. |
1.87 "HSR Clearance" means the earlier of (a) notification to the Parties from the FTC or DOJ of early termination of the applicable waiting period under the HSR Act with respect to the HSR Filings, or (b) expiration of the applicable waiting period under the HSR Act with respect to the HSR Filings; provided, however, ... |
1.88 "HSR Extension Period" has the meaning set forth in Section 2.11.1 (HSR). |
1.89 "HSR Filings" means the filings by Anima and AbbVie with the FTC and 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 the matters set forth in this Agreement, together with all required documentary attachments thereto. |
1.90 "In-License Agreement" means (a) any Existing In-License Agreement, and (b) any other agreement between Anima or its Affiliate, on one hand, and a Third Party, on the other hand, under which (i) AbbVie is granted a sublicense or other right under this Agreement as provided in Section 4.6 (In-License Agreements), o... |
1.91 "In-License Agreement Notification Period" has the meaning set forth in Section 4.6 (In-License Agreements). |
1.92 "IND" means an application filed with a Regulatory Authority for authorization to commence Clinical Trials, 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 IND in other countries or reg... |
1.93 "IND-Enabling Studies" means, with respect to a Royalty-Bearing Product that has achieved candidate selection in accordance with AbbVie's internal policies and procedures, those studies contemplated to be conducted by AbbVie in Section 8 of Exhibit B-1. |
1.94 "Independent Affiliate" has the meaning set forth in Section 14.3.2 (Assignment). |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.