Joint Executive Committee. As of the Effective Date, the Parties have established a joint executive committee (the “Joint Executive Committee” or the “JEC”), composed of an equal number of up to [ * ] senior officers/representatives of each Party, to oversee and guide the strategic direction of the collaboration of the Parties under this Agreement. The JEC shall act as a joint consultative body and to the extent expressly provided herein, a joint decision-making body. The JEC in particular shall: (a) review the overall status of the Development and Commercialization of the Compound and Products in the Exelixis Territory and the Collaborator Territory, as presented by the JDC and JCC; (b) review and approve any proposed amendments to the GDP, including corresponding budgets, following recommendation by the JDC; (c) review and approve the Commercialization Plans for the Collaborator Territory, including proposed amendments, following recommendation by the JCC; (d) review and approve Minimum Commercial Performance thresholds pursuant to Section 6.3(b), following recommendation by the JCC; (e) review the status and strategy of manufacturing and supply, following recommendation by the JDC or JCC; (f) resolve any disputed matter submitted to it by the JDC or JCC; (g) establish additional Committees as it deems necessary or advisable to further the purpose of this Agreement; and (h) perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or allocated to it by the Parties’ written agreement, including providing financial oversight of the activities conducted pursuant to this Agreement. For clarity, any information sharing of Commercialization matters regarding the Exelixis Territory shall be solely for purposes of the coordination of the Parties’ activities, and Exelixis shall retain all decision making authority with respect to such matters without requiring any approvals except as expressly provided in Sections 13.4 and 13.5.
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Samples: Collaboration and License Agreement (Exelixis, Inc.)
Joint Executive Committee. As of the Effective Date, the Parties have established a joint executive committee (the “Joint Executive Committee” or the “JEC”), composed of an equal number of up to [ * ] senior officers/representatives of each Party, to oversee and guide the strategic direction of the collaboration of the Parties under this Agreement. The JEC shall act as a joint consultative body and to the extent expressly provided herein, a joint decision-making body. The JEC in particular shall:
(a) review the overall status of the Development and Commercialization of the Compound and Products in the Exelixis Territory and the Collaborator Territory, as presented by the JDC and JCC;
(b) review and approve any proposed amendments to the GDP, including corresponding budgets, following recommendation by the JDC;
(c) review and approve the Commercialization Plans for the Collaborator Territory, including proposed amendments, following recommendation by the JCC;; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(d) review and approve Minimum Commercial Performance thresholds pursuant to Section 6.3(b), following recommendation by the JCC;
(e) review the status and strategy of manufacturing and supply, following recommendation by the JDC or JCC;
(f) resolve any disputed matter submitted to it by the JDC or JCC;
(g) establish additional Committees as it deems necessary or advisable to further the purpose of this Agreement; and
(h) perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or allocated to it by the Parties’ written agreement, including providing financial oversight of the activities conducted pursuant to this Agreement. For clarity, any information sharing of Commercialization matters regarding the Exelixis Territory shall be solely for purposes of the coordination of the Parties’ activities, and Exelixis shall retain all decision making authority with respect to such matters without requiring any approvals except as expressly provided in Sections 13.4 and 13.5.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Joint Executive Committee. As of the Effective Date, the Parties have established a joint executive committee (the “Joint Executive Committee” or the “JEC”), composed of an equal number of up to [ * ] senior officers/representatives of each Party, to oversee and guide the strategic direction of the collaboration of the Parties under this Agreement. The JEC shall act as a joint consultative body and to the extent expressly provided herein, a joint decision-making body. The JEC in particular shall:
(a) review the overall status of the Development and Commercialization of the Compound and Products in the Exelixis Territory and the Collaborator Territory, as presented by the JDC and JCC;
(b) review and approve any proposed amendments to the GDP, including corresponding budgets, following recommendation by the JDC;
(c) review and approve the Commercialization Plans for the Collaborator Territory, including proposed amendments, following recommendation by the JCC;
(d) review and approve Minimum Commercial Performance thresholds pursuant to Section 6.3(b), following recommendation by the JCC;
(e) review the status and strategy of manufacturing and supply, following recommendation by the JDC or JCC;
(f) resolve any disputed matter submitted to it by the JDC or JCC;
(g) establish additional Committees as it deems necessary or advisable to further the purpose of this Agreement; andand [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(h) perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or allocated to it by the Parties’ written agreement, including providing financial oversight of the activities conducted pursuant to this Agreement. For clarity, any information sharing of Commercialization matters regarding the Exelixis Territory shall be solely for purposes of the coordination of the Parties’ activities, and Exelixis shall retain all decision making authority with respect to such matters without requiring any approvals except as expressly provided in Sections 13.4 and 13.5.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Joint Executive Committee. As Except as otherwise provided herein, the JEC shall be governed by, and shall act in accordance with, Section 6 of the US JV Operating Agreement (without regard to Section 6.2 of such agreement). The JEC shall have overall authority and responsibility with respect to the Commercialization Activities and any other activities conducted pursuant to the Agreement or any Co-Promotion Agreement (except for those matters reserved to the Parties or their respective Affiliates pursuant to this Agreement or any Co-Promotion Agreement). Without limitation of the foregoing, the JEC shall have the following powers and duties with respect to the activities conducted pursuant to this Agreement or any Co-Promotion Agreement:
(a) to oversee the work of the Operating Committees;
(b) if possible, resolve disputes referred to the JEC by the Alliance Managers pursuant to Section 2.5;
(c) to approve each annual update and Significant Interim Update of the Commercialization Plan or the Commercialization Budget, as the case may be;
(d) to approve Cost Allocation Proposals;
(e) to approve the JFC’s reports submitted hereunder on financial matters that the JEC designates for the implementation of the financial aspects of the arrangements between the Parties and their Affiliates set forth herein with respect to the Exploitation of Territory Combination Product;
(f) to review recommendations of the JFC with respect to, and approve, one or more means of reconciling, one to the other, the internal reporting and accounting standards of each of the Parties or its applicable Affiliates where reasonably necessary, and methods of charging costs and expenses of each of the Parties and its applicable Affiliates pursuant to this Agreement and the Co-Promotion Agreements;
(g) to review and, if applicable, recommend to the Parties changes to the Pricing Rules and Discount Rules pursuant to Section 4.1(g);
(h) to resolve disputes within the EUOC with respect to (i) the initially proposed marketing materials for the Combination Product for each country in the Territory, and thereafter, updates of any Approved Marketing Materials, and (ii) a Party’s obligation, if any, pursuant to Section 5.11 to provide the other Party with access to certain of such Party’s records, documentation and data; [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT REQUESTED UNDER 17 C.F.R. §§ 200.80 (b)(4) AND 230.406
(i) to decide major strategic issues and any other matters relating to the collaboration between the Parties with respect to the Exploitation of Territory Combination Product that are not (i) within the purview of the EUOC, the JFC or the JLOCs or (ii) reserved to the Parties pursuant to this Agreement;
(j) to consider any dispute referred to the JEC by a Party pursuant to Section 2.6;
(k) to determine, with respect to each country in the Territory (other than with respect to a Designated Territory A Country or a Third Party Distributor Country, which, in each case, shall require mutual written agreement of the Parties to Launch the Combination Product in such country), whether Launch of the Combination Product in such country should occur and, if so, the timing thereof (where the Parties acknowledge that as of the Effective Date, the Parties Launch of the Combination Product in the United Kingdom and Germany has been approved); provided, however, that, at any time on or after the date on which all of the Anticipated Agreements have established a joint executive committee been executed, in the case of any Price Approval Country or Reference Price Country (the “Joint Executive Committee” or the “JEC”in each case, other than any Designated Territory A Country), composed of an equal number of up subject to [ * ] senior officers/representatives of each PartySection 5.1, the Selling Party shall have the right to oversee and guide Launch the strategic direction of Combination Product at any time after the collaboration of the Parties under this Agreement. The JEC shall act as a joint consultative body and Approved Price that corresponds to the extent expressly price at which the Combination Product is to be sold to wholesalers or others purchasing directly from the Selling Party in such country has been established, provided hereinthat, a joint decision-making body. The JEC in particular shall:
(a) review the overall status of the Development and Commercialization of the Compound and Products in the Exelixis Territory and case of a Price Approval Country, such Approved Price is at or above the Collaborator Territory, as presented by the JDC and JCC;
(b) review and approve any proposed amendments to the GDP, including corresponding budgets, following recommendation by the JDC;
(c) review and approve the Commercialization Plans Minimum Approved Price for the Collaborator Territory, including proposed amendments, following recommendation by the JCC;
(d) review and approve Minimum Commercial Performance thresholds pursuant to Section 6.3(b), following recommendation by the JCC;
(e) review the status and strategy of manufacturing and supply, following recommendation by the JDC or JCC;
(f) resolve any disputed matter submitted to it by the JDC or JCC;
(g) establish additional Committees as it deems necessary or advisable to further the purpose of this Agreementsuch country; and
(hl) perform to take such other functions actions as appropriate are reserved to further the purposes of this Agreement, as expressly set forth JEC in this Agreement or allocated any Covered Agreement to it by which the Parties’ written agreementParties (or their respective Affiliates) are parties or as the Parties may mutually agree in writing, including providing financial oversight except that the JEC may not amend or take any action that would conflict with any provision of this Agreement (or such Covered Agreement if applicable). Notwithstanding the enumerated authority of the activities conducted JEC in this Agreement and the express reservation to the decision-making authority of the Parties with respect to certain matters herein, in the event that the JEC, acting (i) by unanimous affirmative Member Votes (as defined in the US JV Operating Agreement) pursuant to this Section 6.5(d) of the US JV Operating Agreement. For clarity, any information sharing or (ii) by unanimous written consent pursuant to Section 6.5(c) of Commercialization matters regarding the Exelixis US JV Operating Agreement, takes action on a matter relating to the Exploitation of Territory Combination Product, but with respect to which matter authority and responsibility have not been delegated to or vested in the JEC hereunder, the Parties shall be solely deemed to waive (and each Party shall cause its Affiliates to waive) any objection to the effect that the JEC acted beyond the scope of its authority or responsibility, and the resolution of such matter shall be binding on the Parties (and each Party shall cause its Affiliates to be bound) for purposes of the coordination of the Parties’ activities, this Agreement and Exelixis shall retain all decision making authority with respect to such matters without requiring any approvals except as expressly provided in Sections 13.4 and 13.5Co-Promotion Agreement.
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