ACAM 2000 (Acambis Sample Clauses

ACAM 2000 (Acambis. 22.1.1 Acambis, as the holder of BB-IND # 10628, shall amend the CMC (Chemistry, Manufacturing, and Controls) Section of such IND with lot release data from the manufacture of the ACAM 2000 (Acambis) vaccine lot used for the Product while such Product is under IND.
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ACAM 2000 (Acambis. 3.3.1.1 Acambis shall initially have the right to file for any Marketing Authorization(s) with respect to ACAM 2000 (Acambis). Should Acambis decide, in its sole discretion, to apply for and obtain a Marketing Authorization in a country or region, then Acambis will be responsible for filing and maintaining the Marketing Authorization(s) for ACAM 2000 (Acambis) and shall bear all related costs. If (1) Acambis decides to not apply for or obtain a Marketing Authorization in a specific country or region or (2) Baxter or any Baxter affiliate is required by law or government request to apply for a Marketing Authorization in any country, then Acambis and BHSA shall consult to jointly decide if a Marketing Authorization in this particular country is commercially justified from a business perspective. Acambis shall not unreasonably refuse to file and maintain the Marketing Authorization(s) for ACAM 2000 (Acambis) nor shall it unreasonably refuse to allow Baxter or any Baxter affiliate to file for a Marketing Authorization under the circumstances of (2) above.

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