Final Decision-Making. (i) On matters concerning COVID Products, other than the matters under (ii) and (iii) on which GSK has the deciding vote, if the JSC fails to reach unanimous agreement on a matter before it for decision for a period in excess of [*****] (which number shall be reduced to [*****] in case of a matter that is deemed urgent by either Party, acting reasonably), the matter may be referred by either Party to the Executive Officers, who shall meet in person or via teleconference within seven [*****] and attempt to resolve such matter in good faith. If the Executive Officers fail to reach agreement as to such matter for a period in excess of [*****] from their initial meeting (which number shall be reduced to five [*****] in case of a matter that is deemed urgent by either Party, acting reasonably), the final decision on such undecided matter may be brought for dispute resolution in accordance with Section 16.5 below. (ii) On matters concerning the Manufacturing of doses of the COVID Products for use in Clinical Studies, GSK shall have the right to make a final decision towards the Manufacturing by GSK of such doses for use in the Clinical Studies. (iii) Without limiting Section 7.4.2(iii), on matters concerning the Development, Manufacture and Commercialization of Pathogen Combination Products, GSK shall have the deciding vote, provided that GSK shall not unilaterally reduce its diligence obligations under this Agreement, make material amendments to the COVID R&D Plan(s) for such Pathogen Combination Products (including the budget and the number of FTEs agreed in the respective COVID R&D Plan) which have an adverse impact on CureVac or on the Development or Commercialization of other COVID Products, adopt a decision that would cause significant delay of the Development timelines as set forth in the respective COVID R&D Plan or would oblige CureVac to perform additional obligations under this Agreement or the COVID R&D Plan for the respective Pathogen Combination Product. (iv) GSK shall also have the deciding vote on any matter that jeopardizes GSK’s (or its Affiliates’) responsibilities as Regulatory Approval holder for a COVID Product in a given country (including those regarding certification of Manufactured batches by a qualified person and batch release in accordance with GMP).
Appears in 1 contract
Sources: Covid Cla Amendment and Restatement Agreement (CureVac N.V.)
Final Decision-Making.
(i) On matters concerning COVID Products, other than the matters under (ii) and (iii) on which GSK has the deciding vote, if a. If the JSC fails to reach unanimous agreement on a matter brought before it for decision for a period in excess of [*****] (which number shall be reduced to [*****] in case of a matter that is deemed urgent by either Party, acting reasonably), the matter may be referred by either Party to the Executive Officers, who shall meet in person or via teleconference within seven [*****] and attempt to resolve such matter in good faith. .
b. If the Executive Officers fail to reach agreement as to such matter for a period in excess of [*****] from their initial meeting (which number shall be reduced to five [*****] in case of a matter that is deemed urgent by either Party, acting reasonably), the final decision on such undecided matter may shall be brought for dispute resolution made by GSK in accordance good faith with Section 16.5 below. the following exceptions:
(iii) On matters concerning the Manufacturing of doses of the COVID Products for use in Clinical Studies, GSK shall have the right to make a final decision towards the Manufacturing by GSK of such doses for use in the Clinical Studies.
(iii) Without limiting Section 7.4.2(iii), on matters concerning the Development, Manufacture and Commercialization of Pathogen Combination Products, GSK shall have the deciding vote, provided that GSK shall not unilaterally reduce its diligence obligations under this Agreement, ;
(ii) GSK shall not unilaterally make material amendments to the COVID an R&D Plan(s) for such Pathogen Combination Products Plan (including the budget and the number of FTEs agreed in the respective COVID R&D Plan) which have an adverse impact on CureVac or on the Development or Commercialization of other COVID ProductsCureVac, adopt a decision that would cause significant delay of the Development timelines as set forth in the respective COVID an R&D Plan or would oblige CureVac to perform additional obligations under this Agreement or an R&D Plan, it being understood that if following an escalation to the COVID R&D Plan JSC and Executive Officers, the Parties are not aligned on the Manufacturing of doses of Product for use in Clinical Studies, the respective Pathogen Combination Product. decision by GSK to Manufacture such doses itself shall be deemed to comply with the aforementioned limitations as long as it does not cause a new delay to the Development timelines;
(iii) without limiting any right of GSK at law, GSK shall not unilaterally decide on any matter concerning Joint Patent Rights or any Inventions claimed therein, with the exception of decisions relating to (A) obtaining and maintaining supplementary protection certificates (B) enforcement against Third Parties in the Territory within the Field in accordance with Article 10;
(iv) subject to the Quality Agreements, GSK shall also have the deciding vote on not unilaterally decide any matter with respect to the CMC Development or the Manufacture of Products that jeopardizes GSK’s CureVac Manufactures for GSK (for either Development or its Affiliates’Commercial purposes); and
(v) responsibilities as Regulatory Approval holder for a COVID Product in a given country (including those regarding certification GSK shall not unilaterally alter or amend the terms and conditions of Manufactured batches by a qualified person this Agreement and batch release in accordance with GMP)shall have no jurisdiction over any dispute relating to the validity, performance, construction or interpretation of this Agreement.
Appears in 1 contract
Sources: Fourth Amendment and Restatement Agreement (CureVac N.V.)
Final Decision-Making.
(i) On matters concerning COVID Products, other than the matters under (ii) and (iii) on which GSK has the deciding vote, if If the JSC fails to reach unanimous agreement on a matter before it for decision for a period in excess of [*****] thirty (which number shall be reduced to [*****] in case of a matter that is deemed urgent by either Party, acting reasonably)30) days, the matter may be referred by either Party to the Executive Officers, who following provisions shall meet in person or via teleconference within seven [*****] and attempt to resolve such matter in good faith. If the Executive Officers fail to reach agreement as to such matter for a period in excess of [*****] from their initial meeting (which number shall be reduced to five [*****] in case of a matter that is deemed urgent by either Party, acting reasonably), the final decision on such undecided matter may be brought for dispute resolution in accordance with Section 16.5 below. apply:
(iii) On matters concerning the Manufacturing of doses of the COVID Products for use in Clinical Studies, GSK The JSC representatives appointed by Novartis shall have the right to make a final decision towards the Manufacturing by GSK of such doses for use in the Clinical Studies.
(iii) Without limiting Section 7.4.2(iii), on matters concerning the Development, Manufacture and Commercialization of Pathogen Combination Products, GSK shall have the deciding vote, provided that GSK shall not unilaterally reduce its diligence obligations under this Agreement, make material amendments to the COVID R&D Plan(s) for such Pathogen Combination Products (including the budget and the number of FTEs agreed in the respective COVID R&D Plan) which have an adverse impact on CureVac or on the Development or Commercialization of other COVID Products, adopt a decision that would cause significant delay of the Development timelines as set forth in the respective COVID R&D Plan or would oblige CureVac to perform additional obligations under this Agreement or the COVID R&D Plan for the respective Pathogen Combination Product.
(iv) GSK shall also have the deciding vote on any matter that jeopardizes GSK’s involving (A) the Development or its Affiliates’Commercialization of any c-MET Licensed Compound and c-MET Licensed Product (including selection of Indications); (B) responsibilities as Regulatory Approval holder for a COVID the Development or Commercialization of any JAK Licensed Compound or JAK Licensed Product in a given country the JAK Field (including those regarding certification selection of Manufactured batches by Indications) in the Novartis JAK Territory; (C) whether a qualified person Potential JAK Back-Up Compound is Developed in the JAK Field in the Novartis JAK Territory in a Randomized Clinical Trial and batch release beyond in accordance with GMP)Section 4.5 and (D) any matter within the scope of responsibility of the JIPC pertaining to the Secondary JAK Patent Rights in the Novartis JAK Territory. Incyte shall have the right to appeal any such decision of the JSC to the Novartis Executive Officer or a designee of the Novartis Executive Officer with decision-making authority for resolution. In such case, the Novartis Executive Officer or designee shall have the final decision-making authority on such issue.
(ii) The JSC representatives appointed by Incyte shall have the deciding vote on any matter involving (A) the Development or Commercialization of JAK Licensed Compound or JAK Licensed Product in the JAK Field (including selection of Indications) in the Incyte Territory; (B) the Development activities described in Section 4.2(b) until such time as Novartis assumes responsibility for such activities; (C) whether a Potential JAK Back-Up Compound is Developed in the JAK Field in the Incyte Territory in a Randomized Clinical Trial and beyond in accordance with Section 4.5; and (D) any matter within the scope of responsibility of the JIPC pertaining to (x) the INCY0039 Patent Rights worldwide and (y) Secondary JAK Patent Rights in the Incyte Territory. Novartis shall have the right to appeal any such decision of the JSC to the Incyte Executive Officer or a designee of the Incyte Executive Officer with decision-making authority for resolution. In such case, the Incyte Executive Officer or designee shall have the final decision-making authority on such issue.
Appears in 1 contract
Final Decision-Making. Should the Executive Officers not be able to reach agreement with respect to any matter referred to them by the JSC pursuant to Section 2.9.2, such matter shall be resolved pursuant to Sections 13.1-13.11, except as follows (the matters described in clauses (a) - (h) below, the “Excluded Matters”):
(a) Except where specifically allocated in clauses (b) through (h) of this Section 2.9.3, decisions regarding (i) On matters concerning COVID Development of Products specifically subject to approval by the JDC or JSC under this Agreement, including the global regulatory strategy and Development of Combination Products, other than the matters under (ii) and Commercialization of Products specifically subject to approval by the JCC or JSC under this Agreement, including Commercialization of Combination Products, subject to Section 4.1.6, (iii) on which GSK has Medical Affairs Activities regarding Products specifically subject to approval by the deciding voteJMAC or JSC under this Agreement, if the JSC fails to reach unanimous agreement on a matter before it for decision for a period in excess of [*****] (which number shall be reduced to [*****] in case of a matter that is deemed urgent by either Party, acting reasonably), the matter may be referred by either Party iv) Research activities with respect to the Executive OfficersLicensed Compound, who and (v) whether or not an AbbVie Withholding Tax Action represents the only commercially reasonable alternative to Commercialize a Product shall meet in person each case ((i) through (v)) require mutual agreement of the Parties (or via teleconference within seven [*****] and attempt to resolve such matter in good faiththe Parties’ respective representatives on the applicable Committee). If the Executive Officers fail Parties are unable to reach agreement as to mutually agree upon any such matter for a period in excess of [*****] from their initial meeting (which number shall be reduced to five [*****] in case of a matter that is deemed urgent by either Partymatter, acting reasonably), the final decision on such undecided matter may be brought for dispute resolution in accordance with Section 16.5 below.
(ii) On matters concerning the Manufacturing of doses of the COVID Products for use in Clinical Studies, GSK then neither Party shall have the right to make resolve the matter over the objection of the other Party, the matter shall remain unresolved unless and until agreed upon by the JSC, and shall not be subject to resolution pursuant to ARTICLE 13;
(b) Except where specifically allocated to a final decision towards Party in clauses (c) through (h) of this Section 2.9.3, decisions regarding (i) the Manufacturing by GSK of such doses for use in Global Branding Strategy, (ii) the Clinical Studies.
US Commercialization Plan, including the US Commercialization Budget (iii) Without limiting the Sales Force Deployment Plan, and (iv) the MSL Deployment Plan for the Territory shall be resolved pursuant to Section 7.4.2(iii), on matters concerning the Development, Manufacture and Commercialization of Pathogen Combination Products, GSK 13.13.
(c) AbbVie’s Executive Officer shall have the deciding vote, provided that GSK shall not unilaterally reduce its diligence obligations under this Agreement, make material amendments vote with respect to the COVID R&D Plan(sfollowing Commercialization matters to the extent related to the US Commercialization Plan in the US Territory, consistent with the Global Branding Strategy: (i) the promotional and educational materials for the Product; (ii) Sales Representative training materials related to the Product; (iii) managed care pricing activities and contracting, including final managed care pricing decisions consistent with each of the following: the established Product list price, targeted net pricing, sales-weighted average discounts and rebates, and pricing strategy (including, without limitation, the approach to pricing with different types of accounts and plans, including types of discounts and rebates) and (iv) HECOR;
(d) Infinity’s Executive Officer shall have the deciding vote with respect to the following Commercialization matters to the extent related to the US Commercialization Plan in the US Territory, consistent with the Global Branding Strategy: (i) distribution and patient services, (ii) contracting with advertising agencies and public relations firms, (iii) Product list price, targeted net pricing, sales-weighted average discounts and rebates, pricing strategy (including, without limitation, the approach to pricing with different types of accounts and plans, including types of discounts and rebates) and modifications to any of the foregoing, and (iv) commercial advisory boards;
(e) With respect to Medical Affairs Activities, (i) if such Pathogen Combination Products (activities relate to the support of a Clinical Study under the GDP, the Executive Officer of the Party conducting such study will have the deciding vote with respect to such support activities on a global basis, including the budget publication of data resulting from such Clinical Study consistent with the Global Publication Strategy, (ii) AbbVie’s Executive Officer will have the deciding vote with respect to (A) approval, funding and other support for Investigator Sponsored Clinical Studies which include AbbVie Combination Compound in the US Territory, including publication of the resulting data, (B) all Investigator Sponsored Clinical Studies in the Ex-US Territory, including publication of the resulting data, (C) physician education activities under the Medical Affairs Plan and (D) medical affairs support of managed care activities and (iii) Infinity’s Executive Officer will have the deciding vote with respect to (A) subject in all respects to Section 4.2.3, approval, funding and other support for all Investigator Sponsored Clinical Studies in the US Territory other than Investigator Sponsored Clinical Studies which include AbbVie Combination Compound, including publication of the resulting data and (B) development advisory boards (unless specific to a Clinical Study, in which case the Executive Officer of the Party conducting such study will have the deciding vote) and (C) Global Publication Strategy;
(f) AbbVie’s Executive Officer will have the deciding vote with respect to the Ex-US Commercialization Plan;
(g) AbbVie’s Executive Officer will have the deciding vote with respect to all matters relating to or involving the AbbVie Combination Compound (other than as to any Combination Product comprising the Abbvie Combination Compound and the number of FTEs agreed in the respective COVID R&D Plan) which have an adverse impact on CureVac or on the Development or Commercialization of other COVID Products, adopt a decision that would cause significant delay of the Development timelines Licensed Compound as set forth in Section 5.5.5) and, should Abbvie obtain the respective COVID R&D Plan or would oblige CureVac right to perform additional obligations under this Agreement or conduct such Clinical Studies pursuant to Section 4.1.6, the COVID R&D Plan Clinical Studies that include the AbbVie Combination Compound, including companion diagnostics for the respective Pathogen AbbVie Combination Product. Compound or a combination of the Licensed Compound and the AbbVie Combination Compound, all of which such Clinical Studies shall nonetheless be set forth in the GDP, subject to approval of the JDC, and governed by Section 2.9.3(a); and
(ivh) GSK Infinity’s Executive Officer shall also have the deciding vote on any matter that jeopardizes GSKall clinical and commercial Manufacturing-related matters until the Parties transition Manufacturing responsibility to AbbVie pursuant to Section 6.1.1, after which transition AbbVie’s (or its Affiliates’) responsibilities as Regulatory Approval holder for a COVID Product in a given country (including those regarding certification of Manufactured batches by a qualified person and batch release in accordance with GMP)Executive Officer shall have the deciding vote on all Manufacturing-related matters.
Appears in 1 contract
Sources: Collaboration and License Agreement (Infinity Pharmaceuticals, Inc.)