text stringlengths 1 5.46k |
|---|
1.131.4 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; |
1.131.5 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 Earn-Out Product; |
1.131.6 any invoiced amounts from a prior period which are not collected and are written off by AbbVie or its Affiliates, including bad debts; |
1.131.7 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 Earn-Out Products; |
1.131.8 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 Earn-Out Product; and |
1.131.9 any other similar and customary deductions that are consistent with Accounting Standards, but which may not be duplicative of the deductions specified in Sections 1.131.1-1.131.8 above. |
Net Sales shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical, regulatory, or governmental purposes. Net Sales shall not include sales between or among AbbVie, its Affiliates, Licensees and/or Sublicensees; provided that such transfer is intended for further sale, transfer, l... |
Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of AbbVie, its Affiliates, or applicable Licensees and/or 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 7.16 (Methods of Payments; Offsets). |
In the event an Earn-Out 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 the Earn-Out Antibody contained in such Combination Product (the "Mono Product") and (ii) products containing as their sole active ingredients the other active ingredients in such Combin... |
(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 active ingredients in such Combination Product, the Net Sales attributable to such Combination ... |
(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 active ingredients contained in such Combination Product, the Net Sales attributable to such Combination Product shall be calcula... |
(d) If a Selling Party does not separately sell in such country or other jurisdiction both the Mono Product and the other active ingredient or ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be determined by the Parties in good faith based on the relative fair marke... |
1.132 "Nominated Target" means a target nominated by AbbVie (a) in accordance with Section 2.2.3 (Additional Option Programs) with respect to an Additional Option Program, or (b) Section 2.3 (Research Target Substitution) with respect to an existing Target Program. |
1.133 "Nomination Date" means the date on which AbbVie delivers an Additional Option Program Notice or Research Target Substitution Notice, as applicable. |
1.134 "Non-Breaching Party" has the meaning set forth in Section 13.2.1(a) (Material Breach). |
1.135 "Option Program" means any Initial Option Program and any Additional Option Program. |
1.136 "Option Program Assets" means, with respect to an applicable Option Program, (a) any inventions conceived, reduced to practice, generated, discovered, Developed or otherwise made by or on behalf of AbCellera, including without limitation any Project Antibodies, (b) all Research Know-How and Research Patents, (c) ... |
1.137 "OrthoMab Earn-Out Antibody" has the meaning set forth in Section 4.1.4 (OrthoMab License). |
1.138 "OrthoMab Earn-Out Product" means any pharmaceutical preparation in final form that contains an OrthoMab Earn-Out Antibody, alone or in combination with one (1) or more other active ingredients, together with all forms, presentations, strengths, doses and formulations. |
1.139 "OrthoMab License" has the meaning set forth in Section 4.1.4 (OrthoMab License). |
1.140 "OrthoMab Platform Technology" means the Patent Rights and/or Know-How under the license agreement between AbCellera and The University of North Carolina at Chapel Hill, effective February 22, 2019, as amended, that are necessary or useful for generating bispecific Antibody(ies). |
1.141 "Party" and "Parties" has the meaning set forth in the introductory paragraph. |
1.142 "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 applic... |
1.143 "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 1.143 (Person). |
1.144 "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 Pri... |
1.145 "Phase 1 Clinical Trial" means a human clinical trial of an Earn-Out Antibody or Earn-Out Product, the principal purpose of which is a preliminary determination of safety, tolerability, pharmacological activity or pharmacokinetics in healthy individuals or patients or similar clinical study prescribed by the appl... |
1.146 "Phase 2 Clinical Trial" means a human clinical trial of an Earn-Out Antibody or Earn-Out 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 Phase 3 Clinic... |
1.147 "Phase 3 Clinical Trial" means a human clinical trial of an Earn-Out Antibody or Earn-Out Product on a sufficient number of subjects in an indicated patient population that is designed to establish that an Earn-Out Antibody or Earn-Out Product is safe and efficacious for its intended use and to determine the bene... |
1.148 "Phase 4 Clinical Trial" means a post-marketing human clinical study for an Earn-Out 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. |
1.149 "Preliminary Data Package" means the Data Package without inclusion of the Functional Characterization Data. |
1.150 "Pricing Approval" means such approval, agreement, determination or decision establishing prices for an Earn-Out Product that can be charged to consumers or will be reimbursed by Governmental Authorities in a country or other jurisdiction in the Territory where Governmental Authorities of such country or other ju... |
1.151 "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... |
1.152 "Product Information" has the meaning set forth in Section 10.1 (Product Information). |
1.153 "Program Leader" has the meaning set forth in Section 3.1 (Program Leader). |
1.154 "Prohibited Activities" has the meaning set forth in Section 2.7.1(b) (Grant of Acquisition Option). |
1.155 "Project Antibody" means any of the Antibodies which (a) sequences are set forth in the applicable Data Package and (b) is discovered, generated, characterized and optimized by AbCellera in the course, and as a result, of performance of the Research Plan. |
1.156 "Registrational Clinical Trial" means a human clinical trial of an Earn-Out Product for which the applicable Regulatory Authority has provided guidance that the design of such clinical trial and results of such clinical trial, together with prior data and information concerning such Earn-Out Product, (a) are suff... |
1.157 "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... |
1.158 "Regulatory Approval Application" means (a) a BLA, 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 jurisdic... |
1.159 "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 and EMA) regulating or otherwise exercising authority with respect to activit... |
1.160 "Research Know-How" means all Know-How that is conceived, reduced to practice, generated, discovered, developed or otherwise made solely or jointly by or on behalf of either Party or its Affiliates in the conduct of activities under a Research Plan, including the contents of each Data Package, but excluding any p... |
1.161 "Research License" has the meaning set forth in Section 4.1.3 (Research License). |
1.162 "Research Patent" means any Patent Right that claims Research Know-How. |
1.163 "Research Plan" means, with respect to any Target Program, a research and development plan for such Target Program that (a) is mutually agreed by the Parties in accordance with the terms of this Agreement and (b) initially includes at least those elements not expressly marked as optional set forth in Exhibit A (R... |
1.164 "Research Target" means (a) each of the following targets, in each case until such target is substituted by another target in accordance with the terms of this Agreement: (i) Pathological Alpha-synuclein and (ii) CD200R1, and (b) any other mono or bispecific target that is, or targets that are, nominated by AbbVi... |
1.165 "Research Target Substitution Notice" has the meaning set forth in Section 2.3 (Research Target Substitution). |
1.166 "Research Term" means, with respect to each Target Program, (a) with respect to the Collaboration Program, the period commencing on the Effective Date and ending on the date on which AbCellera delivers and AbbVie accepts the Collaboration Program Assets, and (b) with respect to the Option Programs, the period com... |
1.167 "Reverse Royalty Term" means, with respect to each Terminated Antibody that is the subject of a license pursuant to Section 13.4.6 (Grantback IP), the period beginning on the date of the first sale of such Terminated Antibody in such country or other jurisdiction after termination of this Agreement with respect t... |
1.168 "Second Request" means a request for additional information or documentary material, as described in 16 C.F.R. § 803.20. |
1.169 "Skipped Milestone Event" has the meaning set forth in Section 7.5 (Development and Regulatory Milestone Payments). |
1.170 "Sublicensee" has the meaning set forth in Section 4.3 (Sublicensing Rights). |
1.171 "Substitute Target" has the meaning set forth in Section 2.3 (Research Target Substitution). |
1.172 "Substitution Confirmation Date" has the meaning set forth in Section 2.3 (Research Target Substitution). |
1.173 "Substitution Fee" has the meaning set forth in Section 7.3 (Substitution Fee). |
1.174 "Target Program" means a research program for the conduct of discovery, research and development activities pursuant to a Research Plan. Each Target Program will correspond to a single Research Plan and, at any given time, a Research Target. Target Program includes the Collaboration Program, the Initial Option Pr... |
1.175 "Target Program Assets" means, collectively, (a) the Collaboration Program Assets, and (b) the Option Program Assets for which AbbVie has not exercised its Acquisition Option. |
1.176 "Term" has the meaning set forth in Section 13.1 (Term). |
1.177 "Terminated Antibody" means each Earn-Out Antibody that is the subject of termination under this Agreement. For clarity, if the Agreement is terminated in its entirety, all Earn-Out Antibodies shall be Terminated Antibodies. |
1.178 "Terminated Product" means any pharmaceutical preparation in final form containing a Terminated Antibody, alone or in combination with one (1) or more other active ingredients, together with all forms, presentations, strengths, doses and formulations. |
1.179 "Terminated Target" means each Research Target that is the subject of termination under this Agreement. For clarity, if the Agreement is terminated in its entirety, all Research Targets shall be Terminated Targets. |
1.180 "Territory" means worldwide. |
1.181 "Third Party" means any Person that is neither a Party nor an Affiliate of a Party. |
1.182 "Third Party Infringement Claim" has the meaning set forth in Section 9.4 (Infringement Claims by Third Parties). |
1.183 "Third Party Payments" has the meaning set forth in Section 7.10 (Third-Party Licenses). |
1.184 "Third Party Right" means any Patent Right, trade secret or other Intellectual Property Right of a Third Party in any country or other jurisdiction in the Territory. |
1.185 "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 or... |
1.186 "Trianni Flagship Mouse" means Trianni, Inc.'s (an Affiliate of AbCellera) proprietary transgenic mouse research and development platform for the generation of human monoclonal antibodies. |
1.187 "Unblocking License" has the meaning set forth in Section 4.1.5 (Unblocking License). |
1.188 "United States" or "U.S." means the United States of America and all of its territories and possessions. |
1.189 "Updated Alloy Selection Notice" has the meaning set forth in Section 5.3 (Alloy Selection Notice; Updated Alloy Selection Notice). |
1.190 "Updated Disclosure Schedule" has the meaning set forth in Section 11.7 (Bring Down Limitations). |
1.191 "Voting Stock" has the meaning set forth in Section 1.54 (Change of Control). |
1.192 "Withholding Party" has the meaning set forth in Section 7.17.2 (Withholding Taxes). |
1.193 "Working Group" has the meaning set forth in Section 3.10 (Working Groups). |
ARTICLE 2 DEVELOPMENT; ACQUISITION OPTION |
2.1 Overview. During the applicable Research Term, AbCellera, and AbbVie if applicable, will perform and complete certain discovery, research and development activities in accordance with the terms of this Agreement and the applicable Research Plan with respect to each individual Target Program to generate, identify, D... |
2.2 Target Programs. |
2.2.1 Collaboration Program. The Research Target for the collaboration program (the "Collaboration Program") is Pathological Alpha-synuclein. |
2.2.2 Initial Option Program. The Research Target for the first Target Program for which AbbVie has an option as of the Effective Date (an "Initial Option Program") is CD200R1. |
2.2.3 Additional Option Programs. At any time following the Effective Date, and in no event later than the second anniversary of the Effective Date, AbbVie will have the right to nominate up to three (3) additional targets for Target Programs for which AbbVie shall have an option as of the date of such nomination (each... |
2.3 Research Target Substitution. On a Target Program-by-Target Program basis, if the JGC determines that a Research Target in a given Target Program (relative to other target opportunities) no longer warrants further research, AbbVie will have the right to substitute the Research Target with respect to each Target Pro... |
2.4 Research Plans. |
2.4.1 Research Plans. The initial Research Plans for the Collaboration Program and the Initial Option Program are attached as Exhibit A-1 and Exhibit A-2 hereto. For each Additional Option Program, the Parties will, within sixty (60) days after the Addition Confirmation Date, acting through a Working Group if existing ... |
2.4.2 Amendments to Research Plans. Either Party may propose an amendment to a Research Plan by submitting (through a Working Group if existing at the time) such proposed amendment in writing to the JGC for review and approval. Funding for amendments that increase the activities conducted by AbCellera by more than five... |
2.5 Conduct of Research Activities. |
2.5.1 Responsibility. |
(a) AbCellera will have sole responsibility for the conduct of all activities under each Research Plan, except for activities to conduct certain functional and biophysical characterization activities of the Project Antibody ("Functional Characterization Activities") which are specifically allocated to AbbVie under the ... |
(b) AbbVie will have sole responsibility under each Research Plan for the Functional Characterization Activities. AbbVie will bear all costs and expenses incurred by or on behalf of it in the performance of Functional Characterization Activities (the necessary data, results, and information generated from the Functiona... |
2.5.2 Diligence; Data Package Submission; Information Requests. |
(a) AbCellera will (i) perform and complete all activities under each Research Plan in accordance with the timelines set forth therein and (ii) use Commercially Reasonable Efforts to achieve the objectives set forth in each Research Plan. |
(b) AbbVie will perform and complete mid-scale Functional Characterization Activities as set forth under each Research Plan in accordance with the timelines set forth therein, subject to AbCellera's performance and completion of its designated activities pursuant to each Research Plan and delivery of the Preliminary Da... |
(c) Without limiting the foregoing, for each Target Program, AbCellera will submit to AbbVie a Data Package within sixty (60) days following (i) with respect to the Collaboration Program, completion of the Collaboration Program, and (ii) with respect to an Option Program, receipt of the Functional Characterization Data... |
(d) AbbVie shall have ninety (90) days after the date AbCellera provides a Data Package in which to review such Data Package, and, if AbbVie believes in good faith that any of the information required to be included in such Data Package that was to be generated from the activities allocated to AbCellera is missing, the... |
2.5.3 Information and Reports. On a Target Program-by-Target Program basis, after the Effective Date and prior to delivery of a Data Package with respect to such Target Program pursuant to Section 2.5.2(a) (Diligence; Data Package Submission; Information Requests), AbCellera will provide to a Working Group (if existing... |
2.5.4 Alloy Mouse. AbCellera has entered a license agreement with Alloy Therapeutics, LLC ("Alloy") providing for the use of Alloy's proprietary transgenic mouse platform (the "Alloy Mouse") in the derivation of human monoclonal Antibodies from the Alloy Mouse for use in the Field. Under the terms of this Agreement, th... |
2.5.5 AbbVie Materials. To the extent that AbbVie provides any supplies, reagents, equipment or other tangible asset (the "AbbVie Supplies") to AbCellera in connection with a Research Plan, (a) title to the AbbVie Materials shall remain with AbbVie at all times, (b) risk of loss shall pass to AbCellera while such AbbVi... |
2.6 IP Assignment Obligation. Except where applicable Law requires otherwise: (a) AbCellera shall cause all Persons who perform activities on behalf of AbCellera or its Affiliates under this Agreement or who conceive, reduce to practice, generate, discover, Develop or otherwise make any inventions on behalf of AbCeller... |
2.7 Acquisition Option. |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.