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1.68 "Injectable Breast Implant Product Milestone Event" has the meaning set forth in Section 6.4.2 (Injectable Breast Implant Product Milestones). |
1.69 "Injectable Breast Implant Product Milestone Payment" has the meaning set forth in Section 6.4.2 (Injectable Breast Implant Product Milestones). |
1.70 "Injectable Breast Implant Product Negotiation Period" has the meaning set forth in Section 2.3.1 (Injectable Breast Implant Product Option). |
1.71 "Injectable Breast Implant Product Option" means AbbVie's right to first negotiate a definitive license agreement with CollPlant with respect to Injectable Breast Implant Products pursuant to Section 2.3.1 (Injectable Breast Implant Product Option). |
1.72 "Injectable Breast Implant Product Option Data Package" means a data package that includes the following, in each case as applicable to Injectable Breast Implant Products: physical and mechanical characterization and properties (e.g. extrusion force, rheology, etc.), biocompatibility package, large animal implanta... |
1.73 "In-License Agreement" means any agreement between CollPlant or its Affiliate and a Third Party under which CollPlant or its Affiliate is granted a license or other right to any intellectual property within the CollPlant Technology or that otherwise relates to the CollPlant Collagen. |
1.74 "Israel Innovation Authority" means the Israel Innovation Authority, formerly known as the Office of the Chief Scientist of the Ministry of Economy and Industry of the State of Israel, and any successor agency or authority having substantially the same function. |
1.75 "Japan PMDA" means Japan's Pharmaceuticals and Medical Devices Agency and any successor agency or authority having substantially the same function. |
1.76 "JGC" has the meaning set forth in Section 3.1 (Joint Governance Committee). |
1.77 "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, ass... |
1.78 "Knowledge" means, with respect to CollPlant, the actual knowledge of the chief executive officer, chief financial officer, deputy chief executive officer, chief operations officer, chief scientist, president, any executive vice-president, any vice president (including the vice president of R&D), the head of regul... |
1.79 "Law" means (a) any federal, state, local, national and supra-national laws, statutes, standards, ordinances, codes, rules, regulations, regulatory guidelines, resolutions or promulgations (including written governmental interpretations thereof, the guidance related thereto), (b) any judicial, governmental or admi... |
1.80 "LLB Work Plan" has the meaning set forth in Section 2.2.4 (Next Generation CollPlant Collagen Feasibility Studies). |
1.81 "Lyophilized Low Bioburden Project" means the Development Program conducted pursuant to the Lyophilized Low Bioburden Project Development Plan. |
1.82 "Lyophilized Low Bioburden Project Development Plan" means the Development Plan attached as Exhibit D (Lyophilized Low Bioburden Project Development Plan) hereto, as may be amended in accordance with the terms of this Agreement. |
1.83 "Major Market Country" means each of the United States, the United Kingdom, Germany, France, Italy and Spain. |
1.84 "Manufacture" and "Manufacturing" means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labeling, transporting, shipping, storing and holding of any product, or any intermediate thereof, including process development, process qualifica... |
1.85 "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 Exclusive Products, including activities of medical scientific liaisons and the provision of medical i... |
1.86 "Mono Product" has the meaning set forth in Section 1.87(a) (Net Sales). |
1.87 "Net Sales" means with respect to an Exclusive Product, the gross amount invoiced by AbbVie, any of its Affiliates or any Third Party Transferee (each, a "Selling Party") to a Third Party (including a customer, Distributor, wholesaler or end user) that is not a Third Party Transferee in bona fide arm's length tran... |
1.87.1 trade, cash and quantity discounts; |
1.87.2 price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to Governmental Authorities or other payees; |
1.87.3 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; |
1.87.4 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; |
1.87.5 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 Exclusive Product; |
1.87.6 any consideration actually paid or payable for any Delivery System related to a billed or invoiced sale of such Exclusive Product, and separately itemized on such invoice, where for purposes of this Net Sales definition, a "Delivery System" means any delivery system designed to assist in the administration of su... |
1.87.7 any invoiced amounts from a prior period which are not collected and are written off by AbbVie or its Affiliates, including bad debts, provided that such amounts shall be included in Net Sales if and when actually received; |
1.87.8 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 Exclusive Products; |
1.87.9 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 Exclusive Product; and |
1.87.10 any other similar and customary deductions that are consistent with Accounting Standards, but which may not be duplicative of the deductions specified in Sections 1.87.1-1.87.9 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 Third Party Transferees in respect of the Exclusive Pr... |
Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of AbbVie, its Affiliates, or Third Party Transferees, consistently applied, 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 6.11 (Methods of Payments; Offsets). |
In the event an Exclusive 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 ingredients the Primary Components contained in such Combination Product and containing no Other Components contained in the Combination Product (the "Mono Product") and (ii) products containing as... |
(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 ingredients the Other Components in such Combination Product and not containing any Primary Components contained in s... |
(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 ingredients the Other Components in such Combination Product and not containing any Primary Components contained in such Combination Product, then the ... |
(d) If a Selling Party does not separately sell in such country or other jurisdiction both the Mono Product and the Other Components in such Combination Product, the Net Sales attributable to such Combination Product shall be reasonably determined by the Parties based on the relative fair market value of such Mono Prod... |
If CollPlant and APIL enter into a definitive license agreement pursuant to Section 2.3.1 (Injectable Breast Implant Product Option), such definitive license agreement will provide, unless otherwise agreed upon by the Parties in writing, that the Combination Product terms set forth in this Agreement will apply to the a... |
1.88 "Next Generation Studies Option Period" means the period commencing on the date of the later of (a) the completion of the activities under the Sterile 50 Project Development Plan and CollPlant's delivery to AbbVie of the successful outcomes specified in Work Plan II under the Sterile 50 Project Development Plan an... |
1.89 "Non-Breaching Party" has the meaning set forth in Section 11.2.1(a) (Material Breach). |
1.90 "OP Trigger Product" means, with respect to an Option Product and a country, a generic version of such Option Product in such country. |
1.91 "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 Right. |
1.92 "Opt-Out" means opting out of the jurisdiction of Unified Patent Court, such as the opt-out of a Patent Right 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). |
1.93 "Option Product" means either of (a) an Injectable Breast Implant Product and (b) a Photocurable Dermal Filler Product. |
1.94 "Other Component" has the meaning set forth in Section 1.29 (Combination Product). |
1.95 "Party" and "Parties" have the meanings set forth in the Preamble. |
1.96 "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 applica... |
1.97 "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 1.97 (Person). |
1.98 "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 or more Data Security and Priv... |
1.99 "Phase 1 Clinical Trial" means a human clinical trial of a product that provides for the first introduction into humans of a pharmaceutical or biological product with the principal purpose of a preliminary determination of safety, tolerability, pharmacological activity or pharmacokinetics in healthy individuals or... |
1.100 "Phase 2 Clinical Trial" means a human clinical trial of a 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 Pivotal Clinical Trial, or a similar clinical... |
1.101 "Phase 3 Clinical Trial" means a human clinical trial of a product on a sufficient number of subjects in an indicated patient population that is designed to establish that a product is safe and efficacious for its intended use and to determine the benefit/risk relationship, warnings, precautions, and adverse reac... |
1.102 "Phase 4 Clinical Trial" means a post-marketing human clinical study for a 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. |
1.103 "Photocurable Dermal Filler Favorable Terms Offer Notice" has the meaning set forth in Section 2.3.2 (Photocurable Dermal Filler Product Option). |
1.104 "Photocurable Dermal Filler Product" means any photocurable dermal or soft tissue filler product Developed or Manufactured by or on behalf of CollPlant or its Affiliates that is injected into the head (including face or lips), neck or décolletage and that contains CollPlant Collagen, alone or in combination with ... |
1.105 "Photocurable Dermal Filler Product Milestone Event" has the meaning set forth in Section 6.4.3 (Photocurable Dermal Filler Product Milestones). |
1.106 "Photocurable Dermal Filler Product Milestone Payment" has the meaning set forth in Section 6.4.3 (Photocurable Dermal Filler Product Milestones). |
1.107 "Photocurable Dermal Filler Product Negotiation Period" has the meaning set forth in Section 2.3.2 (Photocurable Dermal Filler Product Option). |
1.108 "Photocurable Dermal Filler Product Option" means AbbVie's right of first negotiation of a definitive license agreement with CollPlant with respect to Photocurable Dermal Filler Products pursuant to Section 2.3.2 (Photocurable Dermal Filler Product Option). |
1.109 "Photocurable Dermal Filler Product Option Data Package" means a data package that includes the following, in each case as applicable to Photocurable Dermal Filler Products: physical characterization and properties (e.g. extrusion force, rheology, etc.), biocompatibility package, implantation studies with histolo... |
1.110 "Pivotal Clinical Trial" means any (a) Phase 3 Clinical Trial or (b) other Clinical Trial (or any arm thereof) of a product on a sufficient number of patients, the results of which, together with prior data and information concerning such product, are intended to be or otherwise are sufficient, without any additi... |
1.111 "Pricing Approval" means such approval, agreement, determination or decision establishing prices for a 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 pricing for pharmaceut... |
1.112 "Primary Component" means, with respect to an Exclusive Product, each of (a) the CollPlant Collagen and (b) (i) the filler product described in Section 1.50.1 or 1.50.2 or (ii) the topical product described in Section 1.50.3 that, in each case ((a) and (b)), is included in such Exclusive Product. |
1.113 "Privacy and Security Obligations" has the meaning set forth in Section 9.2.21 (Representations, Warranties and Covenants, as applicable, of CollPlant). |
1.114 "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, discrimination or otherwise ... |
1.115 "Product Information" has the meaning set forth in Section 8.1 (Product Information). |
1.116 "Product Trademarks" has the meaning set forth in Section 7.6.1 (Ownership of Product Trademarks). |
1.117 "Regulatory Approval" means, with respect to a country or other jurisdiction in the Territory, all approvals of the applicable Regulatory Authority necessary for the commercial marketing and sale of a product in such country or jurisdiction, including, where applicable, (a) pre- and post-approval marketing author... |
1.118 "Regulatory Approval Application" means any 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 jurisdiction. |
1.119 "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, Notified Body and Japan PMDA) regulating or otherwise exercising author... |
1.120 "Regulatory Filing" means all (a) applications (including all 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 contact repo... |
1.121 "rhCollagen" has the meaning set forth in Section 1.21 (CollPlant Collagen). |
1.122 "Royalty Term" has the meaning set forth in Section 6.6 (Royalty Term). |
1.123 "Sterile 20 Project" means the Development Program conducted pursuant to the Sterile 20 Project Development Plan. |
1.124 "Sterile 20 Project Development Plan" means the Development plan attached as Exhibit B (Sterile 20 Project Development Plan) hereto, as may be amended in accordance with the terms of this Agreement. |
1.125 "Sterile 20 Specifications Collagen" has the meaning set forth in Section 2.2.1 (Sterile 20 Project). |
1.126 "Sterile 50 Project" means the Development Program conducted pursuant to the Sterile 50 Project Development Plan. |
1.127 "Sterile 50 Project Development Plan" means the Development plan attached as Exhibit C (Sterile 50 Project Development Plan) hereto, as may be amended in accordance with the terms of this Agreement. |
1.128 "Sterile 50 Work Plan" has the meaning set forth in Section 2.2.4 (Next Generation CollPlant Collagen Feasibility Studies). |
1.129 "Subcommittee" has the meaning set forth in Section 3.2(d) (Responsibilities). |
1.130 "Successful Conclusion of the First Stability Study" means AbbVie's receipt of (a) written notice from CollPlant that the First Stability Study has ended and that the CollPlant Collagen subject to such First Stability Study has met or exceeded the stability parameters set forth in the applicable Development Plan ... |
1.131 "Successful Conclusion of the Stability Study Work Plan" means AbbVie's receipt of (a) written notice from CollPlant that the stability study under a Work Plan has ended and that the CollPlant Collagen subject to such stability study has met or exceeded the stability parameters set forth in the applicable Work Pl... |
1.132 "Supply Agreement" has the meaning set forth in Section 2.5 (Supply Agreement). |
1.133 "Tax Treatment" has the meaning set forth in Section 6.12.3 (Allocation of Payment). |
1.134 "Term" has the meaning set forth in Section 11.1 (Term). |
1.135 "Terminated Product" means each Exclusive Product that is terminated pursuant to Section 11.2 (Termination). If the Agreement is terminated in its entirety, all Exclusive Products shall be Terminated Products. |
1.136 "Terminated Territory" has the meaning set forth in Section 11.5 (Effects of Termination in Terminated Territory). |
1.137 "Territory" means worldwide. |
1.138 "Third Party" means any Person that is neither a Party nor an Affiliate of a Party. For clarity, APIL and its Affiliates are not Third Parties. |
1.139 "Third Party Infringement Claim" has the meaning set forth in Section 7.4 (Infringement Claims by Third Parties). |
1.140 "Third Party Transferee" means any Third Party to whom AbbVie or its Affiliates has granted (a) a license under intellectual property rights owned or otherwise Controlled by AbbVie or its Affiliates or (b) any Exclusivity Rights, in whole or in part, in each case with respect to an Exclusive Product. |
1.141 "Trademark" means any word, name, mark, 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, des... |
1.142 "United States" or "U.S." means the United States of America and all of its territories and possessions. |
1.143 "Valid Claim" means (a) with respect to a claim of any issued and unexpired patent within the Patent Rights, that the validity, enforceability or patentability of such claim has not been affected by (i) irretrievable lapse, abandonment, revocation, cancellation, dedication to the public or disclaimer or (ii) a ho... |
1.144 "VAT" has the meaning set forth in Section 6.12.2 (Indirect Taxes). |
1.145 "Voting Stock" has the meaning set forth in Section 1.16.1 (Change of Control). |
1.146 "Withholding Taxes" has the meaning set forth in Section 6.12.1 (Withholding Taxes). |
1.147 "Work Plan" has the meaning set forth in Section 2.2.4 (Next Generation CollPlant Collagen Feasibility Studies). |
ARTICLE 2 - DEVELOPMENT; RIGHT OF FIRST NEGOTIATION |
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