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 [*****], the matter may be referred by either Party to the Executive Officers, who shall meet in person or via teleconference within [*****] 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, the final decision on such undecided matter may be brought for dispute resolution in accordance with Section 16.5 below. (ii) 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. (iii) 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 2 contracts
Sources: Covid Collaboration and License Agreement, Covid Collaboration and License 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 before it for decision for a period in excess of [*****], ] the matter may be referred by either Party to the Executive Officers, who shall meet in person or via teleconference within [*****] 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, 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) 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 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;
(ii) without limiting any right of GSK at law, GSK shall not unilaterally decide on any matter concerning Joint Patent Rights, Joint Product Inventions or Joint Other Inventions, with the COVID R&D Plan for exception of decisions relating to (i) obtaining and maintaining supplementary protection certificates (ii) enforcement against Third Parties in the respective Pathogen Combination Product.Territory within the Field in accordance with Section 10;
(iii) GSK shall also have the deciding vote on not unilaterally decide any matter with respect to the CMC Development and, for so long as CureVac Manufactures a Product under this Agreement, Manufacture of that jeopardizes GSK’s Product; and
(iv) GSK shall not unilaterally alter or its Affiliates’) responsibilities as Regulatory Approval holder for a COVID Product in a given country (including those regarding certification 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: 2020 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 [*****] 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 meetingmeeting (which number shall be reduced to [*****] 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) 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 also have the deciding vote not unilaterally decide on any matter that jeopardizes GSK’s concerning Joint Patent Rights or any Inventions claimed therein, with the exception of decisions relating to (or its Affiliates’A) responsibilities as Regulatory Approval holder for a COVID Product obtaining and maintaining supplementary protection certificates (B) enforcement against Third Parties in a given country (including those regarding certification of Manufactured batches by a qualified person and batch release the Territory within the Field in accordance with GMPArticle 10;
(iv) subject to the Quality Agreements, GSK shall not unilaterally decide any matter with respect to the CMC Development or the Manufacture of Products that CureVac Manufactures for GSK (for either Development or Commercial purposes); and
(v) GSK shall not unilaterally alter or amend the terms and conditions of this Agreement and 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 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 meetingmeeting (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..
(iiiiv) 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 before it for decision for a period in excess of [*****], the matter may be referred by either Party to the Executive Officers, who shall meet in person or via teleconference within [*****] 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, 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) 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 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;
(ii) without limiting any right of GSK at law, GSK shall not unilaterally decide on any matter concerning Joint Patent Rights, Joint Product Inventions or Joint Other Inventions, with the COVID R&D Plan for exception of decisions relating to (i) obtaining and maintaining supplementary protection certificates (ii) enforcement against Third Parties in the respective Pathogen Combination Product.Territory within the Field in accordance with Section 10;
(iii) GSK shall also have the deciding vote on not unilaterally decide any matter with respect to the CMC Development and, for so long as CureVac Manufactures a Product under this Agreement, Manufacture of that jeopardizes GSK’s Product; and
(iv) GSK shall not unilaterally alter or its Affiliates’) responsibilities as Regulatory Approval holder for a COVID Product in a given country (including those regarding certification 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