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(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 the Selling Party, including bad debts, up to a limit of three percent (3%) of such total amount billed or invoiced; |
(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 such Licensed Product by the Selling Party in a manner consistent with the such party's accounting policies across its ot... |
(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 clauses (a) – (j) 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 the Selling Party in respect of the Licensed Product, whether such consideration... |
Net Sales shall be calculated in accordance with the standard internal policies and procedures of the Selling Party, 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 6.8 (Mode of Payment; Offsets). |
In the event that a Licensed Product is sold in any country or other jurisdiction in the form of a Combination Product, the Net Sales for such Combination Product shall be calculated as follows: |
(i) If a product containing as its sole active ingredient a Licensed Compound contained in such Combination Product (the "Mono Product") and products containing as their sole active ingredients Other Active Ingredients in such Combination Product are separately sold in such country or other jurisdiction, the Net Sales ... |
(ii) If the Mono Product is separately sold in such country or other jurisdiction, but products containing as their sole active ingredients Other Active Ingredients in such Combination Product are not separately sold in such country or other jurisdiction, the Net Sales attributable to such Combination Product shall be ... |
(iii) If the Mono Product is not separately sold in such country or other jurisdiction, but products containing as their sole active ingredients Other Active Ingredients contained in such Combination Product are separately sold in such country or other jurisdiction, the Net Sales attributable to such Combination Produc... |
(iv) If both the Mono Product and Other Active Ingredients or ingredients in such Combination Product are not separately sold in such country or other jurisdiction, the Parties shall negotiate in good faith to determine the Net Sales attributable to such Combination Product. If the Parties cannot agree on such Net Sale... |
1.116 "New License Agreement" has the meaning set forth in Section 4.7 (Sublicense Survival). |
1.117 "Non-Breaching Party" has the meaning set forth in Section 12.2.1 (Material Breach). |
1.118 "Option" has the meaning set forth in Section 4.1 (AbbVie Option). |
1.119 "Option Effective Date" means the date upon which AbbVie delivers to Licensor the Option Exercise Notice with respect to the Option in accordance with Section 13.8 (Notices); provided that, if AbbVie reasonably determines in good faith prior to the delivery of the Option Exercise Notice for the Option that the tr... |
1.120 "Option Exercise Data Package" means a data package containing the information set forth on Schedule 1.120 (Option Exercise Data Package). |
1.121 "Option Exercise Data Package Trigger Event" has the meaning set forth on Schedule 1.121 (Option Exercise Data Package Trigger Event). |
1.122 "Option Exercise Fee" has the meaning set forth in Section 6.4 (Option Exercise Fee). |
1.123 "Option Exercise Notice" has the meaning set forth in Section 4.2 (Option Exercise). |
1.124 "Option Exercise Period" means the period of time beginning on the Effective Date and, subject to Section 4.2 (Option Exercise) and Section 4.3 (HSR), ending ninety (90) days following the date that Licensor provides AbbVie with the Option Exercise Data Package; provided that, if Licensor has not provided AbbVie ... |
1.125 "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 is not Controlled by Licensor. |
1.126 "Other Licensed Molecules" has the meaning set forth in Section 1.97 (Licensed Compound). |
1.127 "Party" and "Parties" has the meaning set forth in the preamble hereto. |
1.128 "Patents" means (a) all national, regional and international patents and patent applications, including provisional patent applications and rights to claim priority from any of such patents or patent applications, (b) all patent applications filed either from such patents, patent applications or provisional appli... |
1.129 "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 polit... |
1.130 "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... |
1.131 "Phase 0" means an exploratory, first-in-human trial conducted in accordance with the FDA 2006 Guidance on Exploratory Investigational New Drug Studies (or the equivalent in any country or other jurisdiction outside of the United States) and designed to expedite the development of therapeutic or imaging agents by... |
1.132 "Phase I" means a human clinical trial of a Licensed Compound or Licensed 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 Regulatory Authoriti... |
1.133 "Phase II" means a human clinical trial of a Licensed Compound 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 s... |
1.134 "Phase II SLE Clinical Study" means a Phase II of a Licensed Compound or Licensed Product for the treatment of SLE that has the minimum characteristics set forth in the Development Plan. |
1.135 "Phase III" means a human clinical trial of a Licensed Compound or Licensed Product on a sufficient number of subjects in an indicated patient population that is designed to establish that a Licensed Compound or Licensed Product is safe and efficacious for its intended use and to determine the benefit/risk relati... |
1.136 "PHSA" means the United States Public Health Service Act, as amended from time to time. |
1.137 "Privacy and Security Obligations" has the meaning set forth in Section 10.2.22 (Additional Representations and Warranties of Licensor). |
1.138 "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... |
1.139 "Product Information" has the meaning set forth in Section 9.1 (Product Information). |
1.140 "Product Infringement" has the meaning set forth in Section 7.3.1 (Enforcement of Licensor Patents). |
1.141 "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 ... |
1.142 "Product Trademarks" means the Trademark(s) to be used by AbbVie or its Affiliates or its or their respective Sublicensees for the Development, Commercialization or Exploitation of Licensed Products in the Territory and any registrations thereof or any pending applications relating thereto in the Territory (exclu... |
1.143 "Proposed In-Licensed Rights" has the meaning set forth in Section 4.8.1 (In-License Agreements Prior to Option Exercise). |
1.144 "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 Product in such country or other jurisdiction, including,... |
1.145 "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 activitie... |
1.146 "Regulatory Data" has the meaning set forth in Section 5.3 (Regulatory Matters). |
1.147 "Regulatory Documentation" means all (a) applications (including all INDs and Drug 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 con... |
1.148 "Regulatory Exclusivity" means, with respect to any country or other jurisdiction in the Territory, an additional market protection, other than Patent protection or other patent-related exclusivity, granted by a Regulatory Authority in such country or other jurisdiction which confers an exclusive Commercializatio... |
1.149 "Royalty Term" means, with respect to each Licensed Product and each country or other jurisdiction in the Territory, the period beginning on the date of the First Commercial Sale of such Licensed Product in such country or other jurisdiction, and ending on the later to occur of (a) the expiration, invalidation, r... |
1.150 "Safety Data Exchange Agreement" has the meaning set forth in Section 5.4.1 (Safety Data Exchange Agreement). |
1.151 "Second Request" has the meaning set forth in Section 12.6 (Termination of Failure or Delay to Obtain HSR Clearance). |
1.152 "Selling Party" has the meaning set forth in the definition of "Net Sales." |
1.153 "Senior Officer" means, with respect to Licensor, its Chief Executive Officer, President, Chief Financial Officer or any of their designees, and with respect to AbbVie, its Chief Scientific Officer or his/her designee. |
1.154 "SLE" means systematic lupus erythematosus. |
1.155 "Sublicense Agreement" has the meaning set forth in Section 4.6 (Sublicenses). |
1.156 "Sublicensee" means a Person, other than an Affiliate, that is granted a sublicense by AbbVie under the grants in Section 4.4.1 (License Grants to AbbVie) as provided in Section 4.6 (Sublicenses), excluding any Third Party to which AbbVie or its Affiliate has granted such sublicense as a result of a settlement fo... |
1.157 "Successful Completion of the Bridging Study" means the achievement of the success criteria set forth on Schedule 1.157 (Bridging Study Success Completion Criteria). |
1.158 "Term" has the meaning set forth in Section 12.1 (Term). |
1.159 "Terminated Territory" means each (a) Major Market with respect to which this Agreement is terminated by Licensor pursuant to Section 12.2.2 (Material Breach Related to Diligence in a Major Market), (b) each country or other jurisdiction with respect to which this Agreement is terminated by AbbVie pursuant to Sec... |
1.160 "Territory" means the entire world. |
1.161 "Third Party" means any Person other than Licensor, AbbVie and their respective Affiliates. |
1.162 "Third Party Claims" has the meaning set forth in Section 11.1 (Indemnification of Licensor). |
1.163 "Third Party Payments" has the meaning set forth in Section 6.6.3(c) (Reductions). |
1.164 "Third Party Provider" has the meaning set forth in Section 13.1 (Subcontracting). |
1.165 "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, business symbol or domain names, whether or not registered, and any registrations t... |
1.166 "United States" or "U.S." means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico). |
1.167 "Valid Claim" means (a) a claim of any issued and unexpired Patent whose validity, enforceability or patentability has not been affected by any of the following: (i) irretrievable lapse, abandonment, revocation, cancellation, dedication to the public or disclaimer; or (ii) a holding, finding or decision of invali... |
1.168 "Voting Stock" has the meaning set forth in the definition of "Change in Control." |
1.169 "Withholding Amount" has the meaning set forth in Section 6.9.1 (Withholding Taxes). |
1.170 "Withholding Party" has the meaning set forth in Section 6.9.1 (Withholding Taxes). |
1.171 "Withholding Tax Action" has the meaning set forth in Section 6.9.2 (Withholding Taxes). |
1.172 "Working Group" has the meaning set forth in Section 3.1.9(a) (Working Groups). |
ARTICLE 2 LICENSOR ACTIVITIES |
2.1 Pre-Option Development. |
2.1.1 Development Plan and Activities. At all times during the Term prior to the Option Effective Date, Licensor shall conduct its Development efforts under a development plan (as may be amended pursuant to this Agreement from time to time, the "Development Plan"), which shall contain, at a minimum, all activities reas... |
2.1.2 Amendments to Development Plan. During the Term prior to the Option Effective Date, the Parties shall, through the JGC, and in accordance with Section 2.1.1 (Development Plan and Activities), review the then-current Development Plan, and as appropriate, propose any amendment, including a Material Amendment, to th... |
2.1.3 Expansion of the Phase II SLE Clinical Study. During the Term prior to the Option Effective Date, either Party may submit a request to the JGC that the Development Plan be amended to expand the Phase II SLE Clinical Study to a twenty-four (24) week in-life endpoint. For clarity, any such amendment shall be consid... |
2.1.4 Budget Increases. To the extent that (a) any Material Amendment initially proposed by AbbVie (other than a Material Amendment addressed in clause (b) below) is a Material Amendment as described in clause (b) of Section 1.113 ("Material Amendment") and is approved by the JGC, AbbVie shall pay Licensor quarterly, i... |
2.1.5 Compliance. Licensor shall perform all Development Activities in good scientific manner and in compliance with all Applicable Law. |
2.1.6 Reporting. During any period of time during the Term during which Licensor is performing Development Activities, on a Calendar Quarterly basis, Licensor shall provide to AbbVie a reasonably detailed written report reflecting the progress of the Development Activities and the aGVHD Clinical Study including, at a m... |
2.1.7 Records. Licensor shall, and shall ensure that its Affiliates and Third Party Providers, maintain records in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, and in compliance with Applicable Law, which shall be complete and accurate and shall properly reflect all wo... |
2.2 Regulatory Matters. During the Term prior to the Option Effective Date, Licensor or its designated Affiliates shall have the right and obligation to, at its sole cost and expense, (a) prepare, file and maintain Regulatory Documentation (including Regulatory Approvals) and (b) communicate with Regulatory Authorities... |
2.3 Manufacturing. Licensor shall have the obligation to, at its sole cost and expense, Manufacture and supply the Licensed Compound and Licensed Products necessary to complete the Development Activities in a manner consistent with the Development Plan, either itself or through one or more Affiliates or Third Parties s... |
2.4 Exclusivity. During the Term, Licensor shall not, and shall cause its Affiliates not to, (a) directly or indirectly, develop, commercialize, manufacture or otherwise exploit any Competing Product in any country in the Territory, or (b) license, authorize, appoint or otherwise enable any Third Party to, directly or ... |
2.5 Change in Control of Licensor. If Licensor undergoes a Change in Control during the Term, then: |
2.5.1 Licensor shall notify AbbVie thereof immediately upon the closing of the Change in Control; |
2.5.2 AbbVie shall have the right, in its sole and absolute discretion, by written notice delivered to Licensor (or its successor) at any time following the written notice contemplated by the foregoing Section 2.5.1 (Change in Control of Licensor), to continue this Agreement as modified by this Section 2.5.2 (Change in... |
2.5.3 In the event that AbbVie delivers notice to Licensor of its exercise of the right to conduct activities allocated to Licensor under the Development Plan prior to the Option Effective Date, Licensor hereby grants, and shall cause its Affiliates to grant, to AbbVie an exclusive license (including with regard to Lic... |
2.5.4 AbbVie shall have the right, at AbbVie's sole election, to disband the JGC and terminate the activities of the JGC and thereafter undertake all activities assigned by this Agreement to the JGC solely and exclusively by itself; |
2.5.5 AbbVie shall have the right, in its sole and absolute discretion, by written notice delivered to Licensor (or its successor) at any time within one hundred eighty (180) days following the written notice contemplated by the foregoing Section 2.5 (Change in Control of Licensor), to (a) terminate any or all provisio... |
2.5.6 Licensor covenants that, subject to the foregoing Section 2.5.2 (Change in Control of Licensor) and 2.5.3 (Change in Control of Licensor), there shall be no material change in the level or nature of efforts or resources expended by Licensor and its Affiliates or the qualifications and experience of Licensor's ass... |
ARTICLE 3 GOVERNANCE |
3.1 Joint Governance Committee. |
3.1.1 Formation. Within thirty (30) days after the Effective Date, the Parties shall establish a joint governance committee (the "Joint Governance Committee" or "JGC"). 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 ... |
3.1.2 Specific Responsibilities. The JGC shall: |
(a) oversee and monitor the performance of the Development Activities and the aGVHD Clinical Study and address any issues that arise in connection therewith, including the approval of Clinical Study protocols for the Phase II SLE Clinical Study; |
(b) review and discuss Information (including Clinical Data) arising from the performance of the Development activities set forth in the Development Plan and the aGVHD Clinical Study; |
(c) review and discuss any safety issues arising from the performance of the Development Activities or the aGVHD Clinical Study; |
(d) review, discuss and determine whether to approve any amendments (including Material Amendments) to the Development Plan, including whether to expand the Phase II SLE Clinical Study to twenty-four (24) weeks; |
(e) discuss communications and interactions with Regulatory Authorities with respect to the Licensed Compound or Licensed Products or any product with a common IND to a Licensed Product; |
(f) discuss the scope, logistics and details regarding any Manufacturing Technology Transfer; |
(g) establish, oversee, manage and resolve disputes within Working Groups; |
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