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1.98 "Mono Product" has the meaning set forth in the definition of "Net Sales." |
1.99 "Net Sales" means, with respect to a Licensed Product for any period, the total amount billed or invoiced on sales of such Licensed Product during such period by AbbVie, its Affiliates, or Sublicensees in the Territory to Third Parties (including wholesalers or Distributors), in bona fide arm's length transactions... |
(a) trade, cash and quantity discounts; |
(b) price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to governmental authorities or other payees; |
(c) 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; |
(d) 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; |
(e) 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 Licensed Product; |
(f) any consideration actually paid or payable for any Delivery System related to a billed or invoiced sale of such Licensed Product, where for purposes of this Net Sales definition, a "Delivery System" means any delivery system designed to assist in the administration of such Licensed Product; |
(g) any invoiced amounts from a prior period which are not collected and are written off by AbbVie or its Affiliates, including bad debts; |
(h) 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 Licensed Products; |
(i) 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 Licensed Product; and |
(j) any other similar and customary deductions that are consistent with Accounting Standards, but which may not be duplicative of the deductions specified in (a) – (i) above. |
(k) 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, or Sublicensees. |
Subject to the above, each of the components of Net Sales shall be calculated in accordance with the standard internal policies and procedures of AbbVie, its Affiliates, or Sublicensees, and where all applicable Accounting Standards. For purposes of calculating Net Sales, all Net Sales shall be converted into Dollars i... |
In the event a Licensed Product is a Combination Product, the Net Sales for such Combination Product shall be calculated as follows: |
(i) If AbbVie, its Affiliate, or Sublicensee separately sells in such country or other jurisdiction, (A) a product containing as its sole active ingredient a Licensed Antibody in the same strength and using the same route of administration as in such Combination Product (the "Mono Product") and (B) products containing ... |
(ii) If AbbVie, its Affiliate, or Sublicensee 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 the same strength and using the same route of admi... |
(iii) If AbbVie, its Affiliates, and Sublicensees do not separately sell in such country or other jurisdiction the Mono Product but do separately sell products containing as their sole active ingredients the Other Active Ingredients in the same strength and using the same route of administration as in such Combination ... |
If AbbVie, its Affiliates, and Sublicensees do not separately sell in such country or other jurisdiction either the Mono Product or the Other Active Ingredient in the same strength and using the same route of administration as in such Combination Product, the Net Sales attributable to such Combination Product shall be ... |
1.100 "Neutral" has the meaning set forth in Schedule 13.8.3. |
1.101 "Non-Breaching Party" has the meaning set forth in Section 12.3.1. |
1.102 "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. |
1.103 "Opt-Out" means opting out of the jurisdiction of Unified Patent Court, such as the opt-out of a Patent 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). |
1.104 "OSE" has the meaning set forth in the preamble hereto. |
1.105 "OSE Indemnitees" has the meaning set forth in Section 11.1. |
1.106 "OSE Know-How" would mean all Know How that is Controlled by OSE before or on the Effective Date or at any time during the Term that is not generally known and is necessary or useful to Exploit a Licensed Antibody or Licensed Product in the Field in the Territory, but excluding any information to the extent publi... |
1.107 "OSE Patents" would mean all Patents Controlled by OSE before or on the Effective Date or at any time during the Term that are necessary or useful (or, with respect to patent applications, would be necessary or useful if such patent applications were to issue as patents) to Exploit a Licensed Antibody or Licensed... |
1.108 "Other Active Ingredient" means any component that provides pharmacological activity or other direct therapeutic effect in the Field or that therapeutically affects the structure or any function of the body whereby such component: (a) is not covered by a Valid Claim of the OSE Patents or the Joint Patents and (b)... |
1.109 "Out-of-Pocket Costs" means costs and expenses paid to Third Parties (or payable to Third Parties and accrued in accordance with the Accounting Standards consistently applied) by a Party (or its Affiliate) directly incurred in the conduct of any applicable activities under this Agreement, including costs for inde... |
1.110 "Party" and "Parties" has the meaning set forth in the preamble hereto. |
1.111 "Patents" means (a) all national, regional, and international patents and patent applications, including provisional patent applications, (b) all patent applications filed either from such patents, patent applications, or provisional applications or from an application claiming priority from either of these, incl... |
1.112 "Person" means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture, or other similar entity or organization, including a government or poli... |
1.113 "Personal Data" means (a) all information identifying, or in combination with other information, identifiable to an individual, including pseudonymized (key-coded) Data containing such information; and (b) any other information that is governed, regulated, or protected by one or more Data Security and Privacy Law... |
1.114 "Phase 1 Study" means a Clinical Study of a Licensed Antibody or Licensed Product, the principal purpose of which is a preliminary determination of safety, tolerability, pharmacological activity, pharmacodynamics or pharmacokinetics in healthy individuals or patients or similar clinical study prescribed by the Re... |
1.115 "Phase 2 Study" means a Clinical Study of a Licensed Antibody or Licensed 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 pivotal clinical trials, or a si... |
1.116 "Phase 3 Study" means a Clinical Study of a Licensed Antibody or Licensed Product on a sufficient number of subjects in an indicated patient population that is designed to establish that a Licensed Antibody or Licensed Product is safe and efficacious for its intended use and to determine the benefit/risk relation... |
1.117 "Phase 4 Study" means a post-marketing Clinical Study for a Licensed Product for a country or jurisdiction in the Territory with respect to any indication as to which all Regulatory Approvals have been received in such country or jurisdiction or for a use that is the subject of an investigator-initiated study pro... |
1.118 "PHSA" means the United States Public Health Service Act, as amended from time to time. |
1.119 "Price Applicability Period" has the meaning set forth in Section 1191(b)(2) of the Social Security Act. |
1.120 "Privacy and Security Obligations" has the meaning set forth in Section 10.2.26. |
1.121 "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 ... |
1.122 "Product Information" has the meaning set forth in Section 9.1. |
1.123 "Product Infringement" has the meaning set forth in Section 7.3.1. |
1.124 "Product Labeling" means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority-approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) all labels and ... |
1.125 "Product Trademarks" means the Trademark(s) to be used by AbbVie or its Affiliates or its or their respective Sublicensees for the Development or Commercialization of Licensed Products in the Territory and any registrations thereof or any pending applications relating thereto in the Territory (excluding, in any e... |
1.126 "Proposed Future In-Licensed Rights" has the meaning set forth in Section 5.4. |
1.127 "Regulatory Approval" means, with respect to a country or other jurisdiction in the Territory, the approvals (including Drug Approval Applications), licenses, registrations, or authorizations of any Regulatory Authority necessary to Commercialize a Licensed Antibody or Licensed Product in such country or other ju... |
1.128 "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 PMDA) regulating or otherwise exercising authority with respect to ... |
1.129 "Regulatory Documentation" means all (a) applications (including all INDs and Drug Approval Applications and other major regulatory filings), registrations, licenses, authorizations, and approvals (including Regulatory Approvals), (b) correspondence and reports submitted to or received from Regulatory Authorities... |
1.130 "Regulatory Exclusivity" means, with respect to a Licensed Product in any country or other jurisdiction in the Territory, an additional market protection, other than Patent protection, granted by a Regulatory Authority in such country or other jurisdiction that confers an exclusive Commercialization period during... |
1.131 "Reversion Product" has the meaning set forth in Section 12.8.1. |
1.132 "Royalty Term" means, with respect to each Licensed Product and each country in the Territory, the period beginning on the date of the First Commercial Sale of such Licensed Product in such country, and ending on the later to occur of (a) the expiration, invalidation, cancellation or abandonment date of the last ... |
1.133 "Selected Drug" means a drug selected under the Drug Price Negotiation Program, as described in Section 1192 of the Social Security Act. |
1.134 "Senior Officer" means, with respect to OSE, its Chief Executive Officer or Chief Operating Officer or his/her designee, and with respect to AbbVie, its Chief Scientific Officer or his/her designee. |
1.135 "Separation Conditions" has the meaning set forth in Section 13.4.1. |
1.136 "Settlement Sublicensee" means any Third Party to which AbbVie grants a sublicense to settle or avoid litigation or any Patent dispute related to (a) the alleged infringement by a Licensed Product or the Exploitation thereof of any Patents or other intellectual property of a Third Party or (b) the alleged non-inf... |
1.137 "Sublicensee" means a Person, other than an Affiliate or a Distributor, which is granted a sublicense by AbbVie under the grants in Section 5.1. |
1.138 "Sublicensee Income" means consideration in any form received by AbbVie or its Affiliate in connection with a grant to any Third Party of a sublicense to use the OSE Know-How or OSE Patents to Exploit the Licensed Products, but excluding consideration for (a) any upfront license fees or milestone payments made by... |
1.139 "Term" has the meaning set forth in Section 12.2.1. |
1.140 "Terminated Territory" means each country with respect to which this Agreement is terminated by AbbVie pursuant to Section 12.3.3, or, if this Agreement is terminated in its entirety, the entire Territory. |
1.141 "Terminated Territory Grantback Option" has the meaning set forth in Section 12.7.2. |
1.142 "Territory" means the entire world. |
1.143 "Third Country" or "Third Countries" means a country outside the EEA or a country not deemed to provide an adequate level of protection for Personal Data by the European Commission. |
1.144 "Third Party" means any Person other than OSE, AbbVie, and their respective Affiliates. |
1.145 "Third Party Claims" has the meaning set forth in Section 11.1. |
1.146 "Third Party Infringement Claim" has the meaning set forth in Section 7.4.1. |
1.147 "Third Party Payments" has the meaning set forth in Section 6.7. |
1.148 "Third Party Provider" has the meaning set forth in Section 3.3. |
1.149 "Trademark" means any word, name, symbol, color, designation, or device or any combination thereof that functions as a source identifier, including any trademark, trade dress, brand mark, service mark, trade name, brand name, logo, tagline, slogan, business symbol, or domain name, whether or not registered, and a... |
1.150 "Transition Activities" means the activities outlined and described in the Transition Development Plan. |
1.151 "Transition Development Plan" means the plan setting forth the Development activities to be undertaken by OSE and the data packages and reports to be delivered by OSE (to the extent, in each case, not already completed and provided by OSE prior to the Effective Date). The Transition Development Plan is attached h... |
1.152 "Transition Term" means the period commencing on the Effective Date and ending on the earlier of the date that (i) the Transition Activities have been completed by OSE in accordance with the Transition Development Plan or (ii) AbbVie agrees to assume or waive the Transition Activities that have not been completed... |
1.153 "United States" or "U.S." means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico). |
1.154 "Updated Disclosure Schedule" has the meaning set forth in Section 10.2.30. |
1.155 "Valid Claim" means a claim of any issued and unexpired Patent whose validity, enforceability, or patentability has not been affected by any of the following: (a) irretrievable lapse, abandonment, revocation, dedication to the public, or disclaimer; or (b) a holding, finding, or decision of invalidity, unenforcea... |
1.156 "Voting Stock" has the meaning set forth in the definition of "Change in Control." |
1.157 "Withholding Amount" has the meaning set forth in Section 6.11. |
1.158 "Withholding Party" has the meaning set forth in Section 6.11. |
1.159 "Working Group" has the meaning set forth in Section 2.2.6. |
ARTICLE 2 TRANSITION GOVERNANCE |
2.1 Transition Governance Committee. |
2.1.1 Formation. As soon as practical after the Effective Date, no later than thirty (30) days after the Effective Date, the Parties shall establish a joint governance committee for the Transition Term (the "JGC") to serve as the oversight and decision-making body for the Transition Activities to be conducted by OSE pu... |
2.1.2 Responsibilities. The JGC shall perform the following functions, subject to the final decision-making authority of the respective Parties as set forth in Section 2.2.4: |
(a) monitor the transfer of Development responsibility from OSE to AbbVie and any other Transition Activities; |
(b) oversee and discuss the performance of OSE in completing the Transition Activities; |
(c) review, discuss and approve any material updates or amendments to the Transition Development Plan proposed by AbbVie, including in the event that OSE or its subcontractors experience technical difficulties, provided that no such update or amendment would result in (i) materially amending its objectives, including t... |
(d) serve as an initial forum for discussion of, and attempt to resolve, any issues or Disputes that may arise during the Transition Term; |
(e) coordinate the Parties' activities under the Transition Development Plan; and |
(f) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement. |
For clarity, the JGC shall not have any authority beyond the specific matters set forth in this Section 2.1.2, and in particular shall not have any power to amend or modify the terms of this Agreement or waive a Party's compliance with this Agreement or to decide or resolve any issues other than those specifically subj... |
2.2 General Provisions Applicable to the JGC. |
2.2.1 Composition. The JGC shall consist of three (3) representatives from each of the Parties, each with the requisite experience and seniority to enable such person to make decisions on behalf of the Parties with respect to the issues falling within the jurisdiction of the JGC. From time to time, each Party may subst... |
2.2.2 Meetings and Minutes. The JGC shall meet quarterly or as otherwise agreed to by the Parties, with the location of any in-person meetings alternating between locations designated by OSE and locations designated by AbbVie. Alternatively, the JGC may meet by means of teleconference, videoconference or other similar ... |
2.2.3 Procedural Rules. The JGC shall have the right to adopt such standing rules as shall be necessary for its work, to the extent that such rules are not inconsistent with this Agreement. A quorum of the JGC shall exist whenever there is present at a meeting at least one (1) representative appointed by each Party. Re... |
2.2.4 Dispute Resolution. If the JGC cannot, or does not, reach consensus on an issue, including any dispute, then the dispute shall be finally and definitively resolved by the Senior Officer of AbbVie. Disputes arising between the Parties in connection with or relating to this Agreement or any document or instrument d... |
2.2.5 Limitations on Authority. Each Party shall retain the rights, powers, and discretion granted to it under this Agreement and no such rights, powers, or discretion shall be delegated to or vested in the JGC unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expres... |
2.2.6 Working Groups. From time to time, the JGC may establish and delegate duties to other committees or directed teams (each, a "Working Group") on a monthly or an "as-needed" basis to oversee particular projects or activities. Each such Working Group shall be constituted and shall meet on a monthly basis and operate... |
2.2.7 JGC Discontinuation; Disbandment. The JGC shall be terminated and shall have no further rights or obligations under this Agreement upon completion of the Transition Term. |
2.2.8 Alliance Manager. Promptly following the Effective Date, each Party shall appoint an employee(s) who shall oversee contact for all matters and communication between the Parties in respect of the collaboration, including facilitating review of press releases and the provision by AbbVie of annual reports concerning... |
2.3 Expenses. Each Party shall be responsible for all travel and related costs and expenses for its members and other representatives to attend meetings of, and otherwise participate on the JGC. |
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