Additional Development Considerations Sample Clauses

Additional Development Considerations. (i) Eisai (or the Eisai Related Party in the applicable country) shall hold the IND and be responsible for executing the Regulatory Strategy for the Products in all countries in the Territory. (ii) Eisai (or the Eisai Related Party in the applicable country) will be responsible for all NDA and other filings for Regulatory Approval (including deciding whether an NDA shall be filed, subject to Section 5.2(a)) for all Products in all countries in the Territory. Eisai (or the Eisai Related Party in the applicable country) shall hold all NDAs and all Regulatory Approvals for all Products in all countries in the Territory. (iii) Eisai (or the Eisai Related Party in the applicable country) shall be responsible for obtaining pricing and reimbursement approvals, as applicable, for all Products in all countries in the Territory at its expense.

Additional Development Considerations. (i) Arena has the right, during a “review period” for each filing of up to three months beginning when a final or substantially mature draft filing is provided to Arena by Eisai, to review and comment on each final or substantially mature draft IND or NDA filing prior to submission by Eisai in a country in the Territory where Eisai has the right to make such filing. After such review period (or earlier if agreed by Arena), Eisai may move forward with the intended filing after good faith consideration of any reasonable Arena comments. (ii) Eisai has the right, during a “review period” for each filling of up to three months beginning when a final or substantially mature draft filing is provided to Eisai by Arena, to review and comment on each final or substantially mature draft IND filing prior to submission by Arena in a country in the Territory where Arena has the right to make such filing. After such review period (or earlier if agreed by Eisai), Arena may move forward with the intended filing after good faith consideration of any reasonable Eisai comments. (iii) Eisai, unless otherwise agreed by the Parties, will use Commercially Reasonable Efforts to obtain any CPP issuable by FDA, EMA or Swissmedic (or other Regulatory Authority) necessary to obtain regulatory approval of the Initial Product in a country in the Additional Territory or New Territory. (iv) The Parties agree to coordinate a joint meeting, and to use Commercially Reasonable Efforts to seek to hold such meeting, with the Committee for Medicinal Products for Human Use in Europe within [...***...] of the 2nd Amendment Effective Date. Eisai agrees to use Commercially Reasonable Efforts to seek to hold a meeting with the Ministry of Health, Labour and Welfare of Japan within [...***...] after such meeting with the Committee for Medicinal Products for Human Use in Europe. (v) The Parties shall discuss in good faith at the JDC, after consideration of the Development Plans for Additional Products, which Party (or its Affiliate or Sub-distributor) should be the Responsible Party to hold an IND and to execute the Regulatory Strategy in a particular country in the Territory relating to the applicable Development Plan for the Initial Product or any Additional Product. Unless otherwise agreed by the JDC (or the JSC or the Senior Executives in accordance with Section 4.1(f)), (A) the Party (or its Affiliate or Sub-distributor) that has final decision-making authority with respect to the Regulatory Strat...