Dispute Resolution by Executive Officers. If the JSC is unable to resolve any dispute within the responsibilities of the JSC specified in Section 2.1(b), or to unanimously agree on any matter set forth in subsection (iii) below, within [**] days, or the JSC no longer remains in place at the time of a dispute within the responsibilities of the JSC specified in Section 2.1(b) and the Parties are unable to resolve such dispute within [**] days, such dispute or other matter shall be referred to the Executive Officers for resolution pursuant to Section 13.1. If the Executive Officers are unable to resolve any such matter that is within the responsibilities of the JSC pursuant to Section 13.1, then SANOFI-AVENTIS shall have final decision-making authority with respect to the development and commercialization of Collaboration Compounds and Licensed Products (including, in the case where MERRIMACK has not opted out of or terminated Co-Promotion of Co-Promoted Product(s), matters concerning Co-Promotion of Co-Promoted Product(s)), provided that: (i) SANOFI-AVENTIS may not make a decision that is not consistent with the terms and conditions of this Agreement and with the Global Development Plan or Commercialization Plan, as the case may be; (ii) MERRIMACK shall have final decision-making authority with respect to operational decisions related to any human clinical trial conducted by MERRIMACK, provided, that such clinical trial is conducted in compliance with the terms and conditions of this Agreement and with the Global Development Plan; and (iii) the following decisions must be decided [**] (or, if not able to be decided [**], pursuant to Article XIII), in that [**]: (A) increase [**]’s obligations or reduce [**]’s rights under this Agreement in connection with Collaboration Compounds or Licensed Products, including any obligation to devote additional personnel or financial resources to a specific activity or project to be conducted by [**] under the Global Development Plan; (B) amend any of the Co-Promotion Guidelines or the allocation of Sales Force Costs or Marketing Costs between the Parties in connection with any Co-Promoted Product hereunder; (C) if [**] has agreed to perform any human clinical trial(s) under the Global Development Plan, amend the scope, protocols, criteria or endpoints of such human clinical trial(s); (D) determine that the events required for the payment of development, regulatory or sales milestone payments have not occurred; (E) resolve disputes regarding the Parties’ rights and obligations under this Agreement; (F) unilaterally make a decision that is expressly stated in this Agreement to require [**]’s prior approval or consent, or the mutual agreement of the Parties; or (G) otherwise expand [**]’s rights or reduce [**]’s obligations under this Agreement in connection with Collaboration Compounds or Licensed Products.
Appears in 2 contracts
Samples: License and Collaboration Agreement (Merrimack Pharmaceuticals Inc), License and Collaboration Agreement (Merrimack Pharmaceuticals Inc)
Dispute Resolution by Executive Officers. If the JSC is unable to resolve any dispute within the responsibilities of the JSC specified in Section 2.1(b3.1(b), or to unanimously agree on any matter set forth in subsection clause (iii) below, within [**] days, or days after one Party notifies the JSC no longer remains other Party in place at the time writing of a dispute within the responsibilities of the JSC specified in Section 2.1(b) and the Parties are unable to resolve such dispute within [**] daysdispute, such dispute or other matter shall be referred to the Executive Officers for resolution pursuant to Section 13.114.1. If the Executive Officers are unable to resolve any such matter that is within the responsibilities of the JSC pursuant to Section 13.1, 14.1 then SANOFI-AVENTIS shall have final decision-making authority with respect to the development and commercialization of Collaboration Compounds and Licensed Products (including, in the case where MERRIMACK has not opted out of or terminated Co-Promotion of Co-Promoted Product(s), matters concerning Co-Promotion of Co-Promoted Product(s)), provided that:
(i) SANOFI-AVENTIS may not make a decision that is not consistent with the terms and conditions of this Agreement and with the Global Development Plan or Commercialization Plan, as the case may be;
(ii) MERRIMACK shall have final decision-making authority with respect to operational decisions all matters related to any human clinical trial conducted by MERRIMACKthe (x) Development of the Licensed Compound or the Licensed Product and (y) Commercialization of the Licensed Compound or the Licensed Product outside the PEI Territory, provided, provided that:
(i) MERRIMACK may not exercise its final decision-making authority to make a decision that such clinical trial is conducted in compliance [**] with the terms and conditions of this Agreement and with the Global Development Plan; andAgreement;
(ii) MERRIMACK may not exercise its final decision-making authority to make any decision regarding [**].
(iii) the following decisions must be decided [**] (or, if not able to be decided [**], pursuant to Article XIII), in that and MERRIMACK shall [**]:
(A) increase [**]’s obligations or reduce [**]’s rights under this Agreement in connection with Collaboration Compounds or Licensed Products, including any obligation to devote additional personnel or financial resources to a specific activity or project to be conducted by [**] under the Global Development Plan;
(B) amend any of the Co-Promotion Guidelines or the allocation of Sales Force Costs or Marketing Costs between the Parties in connection with any Co-Promoted Product hereunder;
(C) if [**] has agreed to perform any human clinical trial(s) under the Global Development Plan, amend the scope, protocols, criteria or endpoints of such human clinical trial(s);
(D) determine that the events required for the payment of development, regulatory or sales milestone payments have not occurred;
(E) resolve disputes regarding the Parties’ rights and obligations under this Agreement;
(FC) unilaterally [**] make a decision that is expressly stated in this Agreement to require [**]’s ] prior approval or consent, or the mutual agreement of the Parties; or
(GD) otherwise expand [**]’s ] rights or reduce [**]’s ] obligations under this Agreement in connection with Collaboration Compounds the Licensed Compound or the Licensed ProductsProduct. For clarity, if any of the matters in the foregoing clauses (A)-(D) are not decided [**], they shall be resolved as provided in Article XIV.
Appears in 2 contracts
Samples: Assignment, Sublicense and Collaboration Agreement (Merrimack Pharmaceuticals Inc), Assignment, Sublicense and Collaboration Agreement (Merrimack Pharmaceuticals Inc)