ACAM definition
Examples of ACAM in a sentence
Manufacturer shall demonstrate consistency of its fill, finish and lyopholization process by manufacturing three (3) consecutive conformance lots of ACAM 2000 vaccine that conform to subcontract requirements.
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.
Baxter shall market the ACAM 2000 (Acambis) vaccine as Acambis vaccine and not represent or otherwise give the appearance to a Customer that the ACAM 2000 (Acambis) vaccine is a Baxter vaccine.
Such materials shall include, but not be limited to, the master virus seed, the production virus seed, and any other Acambis-proprietary materials and/or documents used in the manufacture of ACAM 2000 (Acambis) or ACAM 2000 (******).
Baxter and Acambis Research shall jointly create a document that shall be provided to each Customer which outlines the differences of ACAM 2000 (Acambis) compared to ACAM 2000 (******).
If Baxter applies for and obtains a Marketing Authorization for Product that includes the ACAM 2000 (******) vaccine, Baxter shall develop and provide all documentation required to obtain and maintain such Marketing Authorization.
Baxter shall not sell Product to Customers as ACAM 2000 (Acambis) unless Acambis agrees and such Product conforms to Acambis’ IND and/or BLA on file with the US FDA.
Baxter shall market the ACAM 2000 (Acambis) vaccine only for the indications authorised by the US FDA and, if applicable, may market the ACAM 2000 (******) vaccine only for those indications as authorized by the competent Regulatory Authority(ies) in the Customer’s territory.
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.
The ACAM consists of a computer based system responsible for the monitoring and control of alarms and access control points.