Cardiovascular Sealant Sample Clauses

Cardiovascular Sealant. (A) Focal shall, at its own expense and with the cooperation and reasonable assistance of Ethicon, conduct those animal studies (the "Cardiovascular Studies") as shall be necessary to evaluate the effectiveness [*] * Confidential treatment has been requested for marked portion [*] (B) Within sixty (60) days after the completion of the Cardiovascular Studies, the Advisory Board shall review such studies and determine whether further development work in connection with the Cardiovascular Sealant Candidate should be undertaken. In the event that the members of the Advisory Board agree that further development work in connection with the Cardiovascular Sealant Candidate should be undertaken, the Advisory Board shall determine (1) which additional studies should be undertaken in order to obtain sufficient information to initiate Clinical Trials in the E.U. and in Japan, and (2) how to proceed with the seeking of Regulatory Approval for the Cardiovascular Sealant Candidate as a Product in the Territory. Ethicon, at its own expense, shall have the responsibility for conducting the requisite development work and for obtaining Regulatory Approval for the Cardiovascular Sealant Candidate in the Territory; provided, however, that Ethicon may, upon agreement by Focal, utilize Focal's services for the performance of selected development work, such development work to be provided at cost by Focal. In the event that the members of the Advisory Board agree that further development in connection with the Cardiovascular Sealant Candidate should not be undertaken but that the parties should consider a program to develop a New Product for use as an intraoperative surgical sealant in cardiovascular surgery (an "Alternate Cardiovascular Sealant Candidate"), then the parties shall discuss in good faith the initiation of such program in accordance with the provisions set forth in Section 4(b)(vii). In the event that the parties have not agreed to initiate a development program with respect to the Cardiovascular Sealant Candidate or an Alternate Cardiovascular Sealant Candidate within [*] after completion of the Cardiovascular Studies, then Ethicon shall be entitled, in its sole and unfettered discretion and at its own expense, to undertake its own preclinical development, clinical development, Regulatory Approval and/or commercialization program with respect to the Cardiovascular Sealant Candidate in the Territory, and Focal shall be under no obligation to participate in such pro...
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