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1.39 "Annual Net Sales-Based Milestone Payment" has the meaning set forth in Section 7.7 (Sales-Based Milestone Payments). |
1.40 "Annual Net Sales-Based Milestone Table" has the meaning set forth in Section 7.7 (Sales-Based Milestone Payments). |
1.41 "Antibody" means any polypeptide, including full immunoglobulin molecules (such as IgG, IgM, IgE, IgA, and IgD molecules), single chain immunoglobulin molecules (such as VHH, VHH-Fc, or engineered single cell IgG molecules), and immunoglobulin fragments (such as ScFv, Fv, and Fab molecules), that has a paratope by... |
1.42 "Antibody Discovery" means the antibody discovery stage as set forth in the Research Plan. |
1.43 "Antibody Validation and Characterization" means the antibody validation and characterization stage as set forth in the Research Plan. |
1.44 "Audit Arbitrator" has the meaning set forth in Section 7.15.2 (Audit Dispute). |
1.45 "Available Target" means any target that is not, as of the date nominated by AbbVie, the subject of the conditions under the Exposure Analysis. |
1.46 "Biosimilar Product" means, with respect to an Earn-Out Product in a country or other jurisdiction, any biological product sold by a Third Party (other than a Licensee, Sublicensee or a Person authorized by a Party or its Affiliate Licensee, or Sublicensee) that (a) has been granted a Regulatory Approval as a bios... |
1.47 "BLA" means a Biologics License Application (as more fully defined in 42 U.S.C. § 262, 21 C.F.R. § 601.2(a), as amended from time to time) submitted to the FDA, or any foreign counterpart to the foregoing filed with any Regulatory Authority outside of the United States, in each case, including all amendments and s... |
1.48 "Board of Directors" has the meaning set forth in Section 1.54.1 (Change of Control). |
1.49 "Breaching Party" has the meaning set forth in Section 13.2.1(a) (Material Breach). |
1.50 "Business Day" means a day other than a Saturday or Sunday on which banking institutions in Vancouver, British Columbia, Canada and Chicago, Illinois, United States are open for business. |
1.51 "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... |
1.52 "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 ... |
1.53 "CDA" has the meaning set forth in Section 14.12 (Entire Agreement; Amendments). |
1.54 "Change of Control" with respect to a Party, shall be deemed to have occurred if any of the following occurs after the Effective Date: |
1.54.1 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 ... |
1.54.2 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 constitu... |
1.54.3 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 t... |
1.55 "Clinical Data" means all information with respect to any Earn-Out Antibody or Earn-Out 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 with respect t... |
1.56 "Clinical Trial" means any study in which human subjects or patients are dosed with an Earn-Out Antibody or Earn-Out Product, whether approved or investigational. |
1.57 "Collaboration Program" has the meaning set forth in Section 2.2.1 (Collaboration Program). |
1.58 "Collaboration Program Assets" means, with respect to the Collaboration Program, (a) any inventions conceived, reduced to practice, generated, discovered, Developed or otherwise made by or on behalf of AbCellera, including without limitation all Project Antibodies, (b) all Research Know-How and Research Patents, (... |
1.59 "Combination Product" means an Earn-Out Product that contains an Earn-Out Antibody as an active ingredient, together with one (1) or more other active ingredients that are not Earn-Out Antibodies, and is sold either as a fixed dose/unit or as separate doses/units in a single package. |
1.60 "Commercial Milestone Event" has the meaning set forth in Section 7.6 (Commercial Milestone Payments). |
1.61 "Commercial Milestone Payment" has the meaning set forth in Section 7.6 (Commercial Milestone Payments). |
1.62 "Commercialization" and "Commercialize" means any and all activities related to the preparation for sale of, offering for sale of, or sale of an Earn-Out Antibody or Earn-Out Product, including activities related to marketing, promoting, distributing, importing and exporting such Earn-Out Antibody or Earn-Out Prod... |
1.63 "Commercially Reasonable Efforts" means, with respect to the efforts and resources to be expended by AbCellera with respect to any objective, activity or decision to be undertaken, such reasonable, diligent, and good faith efforts that would be comparable with the efforts and resources normally used in the biotech... |
1.64 "Competing Program" has the meaning set forth in Section 14.3.2 (Assignment). |
1.65 "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 ... |
1.66 "Contract" means any written legally binding contract, agreement, instrument, commitment or undertaking (including leases, licenses, mortgages, notes, guarantees, sublicenses, subcontracts and purchase orders). |
1.67 "Control" means, subject to Section 14.3.2 (Assignment), with respect to a Person and any 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 under this Agreement), ... |
1.68 "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. |
1.69 "Data Package" means, with respect to each Target Program, (a) a data package containing all necessary or useful data (including intermediate data as set forth in the Research Plan or as reasonably requested by AbbVie), findings, results and information required to be delivered to AbbVie by AbCellera as set forth ... |
1.70 "Data Security and Privacy Laws" means all applicable Laws relating to the privacy, Processing and security of Personal Data. |
1.71 "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 an Affiliate of a Debarred Entity. |
1.72 "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. |
1.73 "Default Notice" has the meaning set forth in Section 13.2.1(a) (Material Breach). |
1.74 "Derived Antibody" means any Antibody (including, without limitation, any chimeric, humanized, human, non-human, single chain, monovalent, divalent, polyvalent, monospecific, bispecific, or other Antibody, fragment thereof, or polynucleotide encoding any of the foregoing) generated by or on behalf of AbbVie or any... |
1.75 "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, including Manuf... |
1.76 "Development Milestone Event" has the meaning set forth in Section 7.5 (Development and Regulatory Milestone Payments). |
1.77 "Development Milestone Payment" has the meaning set forth in Section 7.5 (Development and Regulatory Milestone Payments). |
1.78 "Development Report" has the meaning set forth in Section 5.3.2 (Development Report). |
1.79 "Dispute" has the meaning set forth in Section 14.2 (Dispute Resolution). |
1.80 "Dispute Settlement Licensee" means any Licensee or Sublicensee that is granted a sublicense under the rights granted to AbbVie under Section 4.1 (Assignment and License Grants to AbbVie) (a) in order to settle a litigation or dispute related to any Patent Rights in connection with an Earn-Out Product or a Biosimi... |
1.81 "Distributor" means any Person appointed by AbbVie or any of its Affiliates or its or their Licensees and/or Sublicensees (other than Dispute Settlement Licensees) to distribute, market and sell an Earn-Out Product with or without packaging rights, in one or more countries in the Territory, in circumstances where ... |
1.82 "DOJ" means the Antitrust Division of the United States Department of Justice, and any successor entity thereto. |
1.83 "Dollars" or "$" means the legal tender of the U.S. |
1.84 "Earn-Out Antibody" means, with respect to (a) the Research Target for the Collaboration Program, and/or (b) an applicable Research Target for an Option Program for which AbbVie has exercised the Acquisition Option, any Project Antibody or Derived Antibody. |
1.85 "Earn-Out Product" means any pharmaceutical preparation in final form that contains an Earn-Out Antibody, alone or in combination with one (1) or more other active ingredients, together with all forms, presentations, strengths, doses and formulations. |
1.86 "Earn-Out Term" has the meaning set forth in Section 7.9 (Earn-Out Term). |
1.87 "Effective Date" has the meaning set forth in the introductory paragraph. |
1.88 "EMA" means the European Medicines Agency, and any successor entity thereto. |
1.89 "Encumbrance" means any lien, pledge, charge, mortgage, owner's mortgage, easement, encroachment, imperfection of title, title exception, title defect, right of possession, right of negotiation or refusal, leasehold interest, security interest, encumbrance, adverse claim, interference, or other restriction on tran... |
1.90 "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 H... |
1.91 "Excluded Liabilities" has the meaning set forth in Section 4.1.2 (Excluded Liabilities). |
1.92 "Executive Officers" means the Chief Executive Officer, or his or her designee, in the case of AbCellera, and the Vice President, Head of Discovery Research, or his or her designee, in the case of AbbVie. |
1.93 "Exercise Notice" has the meaning set forth in Section 2.7.2(a) (Exercise of Acquisition Option). |
1.94 "Existing In-License Agreements" means the license and other agreements between AbCellera or any of its Affiliates and a Third Party existing as of the Effective Date under which: (a) AbbVie is granted a sublicense or other right under this Agreement as provided in Section 4.1.5 (Unblocking License), including und... |
1.95 "Existing Patent Rights" has the meaning set forth in Section 11.2.6 (Representations, Warranties, and Covenants, as applicable, of AbCellera). |
1.96 "Exploit" 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, optimize, have u... |
1.97 "Exposure Analysis" means an analysis conducted by AbCellera with respect to a Nominated Target to determine whether (a) any agreement by and between AbCellera and a Third Party contains an existing exclusivity obligation with respect to such Nominated Target, (b) AbCellera is engaged in bona fide and active negot... |
1.98 "FDA" means the United States Food and Drug Administration, and any successor entity thereto. |
1.99 "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... |
1.100 "Feasibility Assessment" has the meaning set forth in Section 2.2.3 (Additional Option Programs). |
1.101 "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). |
1.102 "Field" means all human and non-human diagnostic, prophylactic, and therapeutic uses, including Animal Health uses. |
1.103 "First Commercial Sale" means, with respect to an Earn-Out Product and a country or other jurisdiction in the Territory, the first sale for monetary value and for end use or consumption of such Earn-Out Product in such country or jurisdiction after all Regulatory Approvals and Pricing Approvals for the sale of su... |
1.104 "FTC" means the United States Federal Trade Commission, and any successor entity thereto. |
1.105 "Functional Characterization Activities" has the meaning set forth in Section 2.5.1(a) (Responsibility). |
1.106 "Functional Characterization Data" has the meaning set forth in Section 2.5.1(b) (Responsibility). |
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, re... |
1.108 "Grantback IP" has the meaning set forth in Section 13.4.6 (Effects of Termination of Agreement). |
1.109 "HSR Act" means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. |
1.110 "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, or any voluntary agreement not to consummate the t... |
1.111 "HSR Extension Period" has the meaning set forth in Section 2.9.1 (HSR). |
1.112 "HSR Filings" means the filings by AbCellera 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. |
1.113 "In-License Agreement" means (a) any Existing In-License Agreement, and (b) any other agreement between AbCellera 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 4.1.5 (Unblocking License),... |
1.114 "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, 21 C.F.R. Part 312, or any successor application or procedure filed with the FDA, (b) any equivalent of a United States IND in ... |
1.115 "Independent Affiliate" has the meaning set forth in Section 14.3.2 (Assignment). |
1.116 "Indirect Taxes" has the meaning set forth in Section 7.17.3 (Indirect Taxes). |
1.117 "Initial Disclosure Schedule" has the meaning set forth in Section 11.7 (Bring Down Limitations). |
1.118 "Initial Option Program" has the meaning set forth in Section 2.2.2 (Initial Option Program). |
1.119 "Intellectual Property Rights" shall mean any and all proprietary rights provided under (a) patent law, including any Patent Rights; (b) trademark law; (c) copyright law; (d) design patent or industrial design law; (e) semi-conductor chip or mask work law; or (f) any other applicable statutory provision or common... |
1.120 "JGC" has the meaning set forth in Section 3.2 (Joint Governance Committee). |
1.121 "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, ... |
1.122 "Knowledge" means the knowledge of a Party or any of its Affiliates, or any its employees or consultants, after performing a diligent investigation (including consulting any direct reports and consulting the Party's external legal counsel, including the Party's external intellectual property counsel) with respect... |
1.123 "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 effect ... |
1.124 "Liabilities" means all debts, damages, losses, costs, expenses, liabilities and obligations, whether presently in existence or arising hereafter, accrued or fixed, absolute or contingent, matured or unmatured, determined or determinable, asserted or unasserted, known or unknown, including those arising under any... |
1.125 "Licensee" means any Third Party to which AbbVie has granted a license to Develop, Manufacture, and/or Commercialize in any manner in the Field any Earn-Out Antibody or Earn-Out Product. |
1.126 "Machine Learning" has the meaning set forth in Section 9.1.4 (Limited Right to Use Research Know-How). |
1.127 "Major European Markets" means the United Kingdom, France, Germany, Italy and Spain. |
1.128 "Manufacture" and "Manufacturing" means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping, and holding of the Earn-Out Antibody, any Earn-Out Product, or any intermediate thereof, including process development, proces... |
1.129 "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 Earn-Out Antibodies or Earn-Out Products, including activities of medical scientific liaisons and the... |
1.130 "Mono Product" has the meaning set forth in Section 1.131.9(a) (Net Sales). |
1.131 "Net Sales" means with respect to any Earn-Out Product, the total amount invoiced by AbbVie, any of its Affiliates, Licensees, and/or Sublicensees (other than a Dispute Settlement Licensee) (each, a "Selling Party") to a Third Party (including wholesalers or Distributors) in bona fide arm's length transactions, l... |
1.131.1 trade, cash and quantity discounts; |
1.131.2 price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to Governmental Authorities or other payees; |
1.131.3 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; |
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