Development Plan Dispute. If, with respect to a matter that is within the JDC’s duties and involves (i) approval of an initial Development Plan or any material change to any Development Plan, (ii) any other strategic issues regarding development or Regulatory Approval of a Product for the Territory, (iii) approval of any steps to address a Cost Overrun or (iv) a dispute as to whether any Cost Overrun (x) is attributable to a Party or (y) represents a Permissible Cost Overrun, the JDC cannot reach consensus within 15 days after it has met and attempted to reach such consensus, then either Party may, by written notice to the other Party (an “Escalation Notice”), have such matter referred for resolution to, on behalf of Arena, the Chairman of the Managing Directors of Arena and to, on behalf of Eisai, the President of Eisai (collectively, the “Senior Executives”). The Senior Executives shall use good faith efforts to resolve any matter referred to them as soon as practicable. If the Senior Executives are unable to resolve any matter set forth in an Escalation Notice within 30 days after the applicable Party receives such Escalation Notice, then no action will be taken with respect to such matter; provided that: (A) subject to clause (C), Arena shall have final decision-making authority with respect to any Development Plan for any Pre-Approval Required U.S. Development or any Post-Approval Required U.S. Development (subject to Section 3.2(a) and the cost allocation parameters set forth in Section 3.2(a)(Y) or (Z)), except that if Eisai does not approve the use of Arena FTEs with respect to such Pre-Approval Required U.S. Development or Post-Approval Required U.S. Development, as applicable, (such approval not to be unreasonably conditioned, withheld or delayed) Arena shall have the right to use such FTEs at its own expense in conducting such development work, with the costs of such FTEs not included in Development Expenses for such Pre-Approval Required U.S. Development or Post-Approval Required U.S. Development, as applicable; (B) subject to clause (C) below, Arena shall have final decision-making authority with respect to any Development Plan for any Pre-Approval Required Additional Territory Development or any Post-Approval Required Additional Territory Development (subject to Sections 3.2(c) and 3.2(f) and the cost allocation parameters set forth in Section 3.2(c)); (C) notwithstanding clauses (A) and (B) above, in the event of any Change of Control of Arena during the Non-Compete Period that results in Arena or any of its Affiliates filing an NDA, a BLA or any equivalent thereof for, marketing, promoting, detailing, offering for sale, selling or distributing, or conducting other similar activities related to the commercial sale of, any Competing Product in the Territory, then Eisai shall have final decision-making authority with respect to all decisions regarding each Development Plan, including whether or not to enter into such Development Plan, if Arena and its Affiliates have not divested such Competing Program within six months after such Change of Control, except that Eisai may not (X) obligate Arena to (1) perform any clinical trials or development work other than the Pre-Approval Required U.S. Development and the Post-Approval Required U.S. Development or (2) perform or fund any clinical trials or other development work for which a Development Plan does not exist as of the date of such Change of Control or (Y) amend any existing Development Plan in a manner that imposes additional economic obligations on Arena; and (D) with respect to any dispute as to whether any Cost Overrun (1) is attributable to a Party or (2) represents a Permissible Cost Overrun, either Party may submit such dispute to arbitration pursuant to the procedures set forth in Section 12.7.
Appears in 1 contract
Sources: Marketing and Supply Agreement (Arena Pharmaceuticals Inc)
Development Plan Dispute. If, with respect to a matter that is within the JDC’s duties and involves (i) approval of an initial Development Plan or any material change to any Development Plan, (ii) any other strategic issues regarding development or Regulatory Approval of a Product for in the Territory, (iii) approval of any steps to address a Cost Overrun or (iv) a dispute as to whether any Cost Overrun (x) is attributable to a Party or (y) represents a Permissible Cost Overrun, the JDC cannot reach consensus within 15 days after it has met and attempted to reach such consensus, then either Party may, by written notice to the other Party (an “Escalation Notice”), have such matter referred for resolution to, on behalf of Arena, the Chairman of the Managing Directors of Arena and to, on behalf of Eisai, the President of Eisai (collectively, the “Senior Executives”). The Senior Executives shall use good faith efforts to resolve any matter referred to them as soon as practicable. If the Senior Executives are unable to resolve any matter set forth in an Escalation Notice within 30 days after the applicable Party receives such Escalation Notice, then no action will be taken with respect to such matter; provided that: that (A) subject to clause (CB), Arena shall have final decision-making authority with respect to any Development Plan for any Pre-Approval Required U.S. Development or any Post-Approval Required U.S. Development (subject to Section 3.2(a) and the cost allocation parameters set forth in Section 3.2(a)(Y) or (Z)), except that if Eisai does not approve the use of Arena FTEs with respect to such Pre-Approval Required U.S. Development or Post-Approval Required U.S. Development, as applicable, (such approval not to be unreasonably conditioned, withheld or delayed) Arena shall have the right to use such FTEs at its own expense in conducting such development work, with the costs of such FTEs not included in Development Expenses for such Pre-Approval Required U.S. Development or Post-Approval Required U.S. Development, as applicable; (B) subject to clause (C) below, Arena shall have final decision-making authority with respect to any Development Plan for any Pre-Approval Required Additional Territory Development or any Post-Approval Required Additional Territory Development (subject to Sections 3.2(c) and 3.2(f) and the cost allocation parameters set forth in Section 3.2(c)); (C) notwithstanding clauses (A) and (B) above, in the event of any Change of Control of Arena during the Non-Compete Period that results in Arena or any of its Affiliates filing an NDA, a BLA or any equivalent thereof for, marketing, promoting, detailing, offering for sale, selling or distributing, or conducting other similar activities related to the commercial sale of, any Competing Product in the Territory, then Eisai shall have final decision-making authority with respect to all decisions regarding each Development Plan, including whether or not to enter into such Development Plan, if Arena and its Affiliates have not divested such Competing Program within six months after such Change of Control, except that Eisai may not (X) obligate Arena to (1) perform any clinical trials or development work other than the Pre-Approval Required U.S. Development and the Post-Approval Required U.S. Development or (2) perform or fund any clinical trials or other development work for which a Development Plan does not exist as of the date of such Change of Control or (Y) amend any existing Development Plan in a manner that imposes additional economic obligations on Arena; and (D) with respect to any dispute as to whether any Cost Overrun (1) is attributable to a Party or (2) represents a Permissible Cost Overrun, either Party may submit such dispute to arbitration pursuant to the procedures set forth in Section 12.7.,
Appears in 1 contract
Sources: Marketing and Supply Agreement (Arena Pharmaceuticals Inc)