Common use of Certificates of Manufacturing Compliance Clause in Contracts

Certificates of Manufacturing Compliance. HMRI shall provide, or cause to be provided, for each lot of Product manufactured pursuant to this Agreement, a certificate of manufacturing compliance, containing the types of information which shall have been approved by mutual agreement of the parties, which will certify that the Product was manufactured in accordance with the Specifications and the GMP. HMRI shall advise Rugby promptly if an authorized agent of the FDA or other governmental regulatory agency visits any of HMRI's manufacturing facilities, or the facilities where the Products are being manufactured, concerning the Products. HMRI shall furnish to Rugby all material information supplied to, or supplied by, the FDA or other governmental regulatory agency, including the Form 483 observations and responses, to the extent that such report relates to Products (or the ability of HMRI to supply such Product), within five (5) business days of HMRI's receipt of such information or delivery of such information, as the case may be.

Certificates of Manufacturing Compliance. HMRI shall provide, or cause to be provided, for each lot of Product manufactured pursuant to this Agreement, a certificate of manufacturing compliance, containing the types of information which shall have been approved by mutual agreement of the parties, which will certify that the Product was manufactured in accordance with the Specifications and the GMP. HMRI shall advise Rugby promptly if an authorized agent of the FDA or other governmental regulatory agency visits any of HMRI's manufacturing facilities, or the facilities where the Products are being manufactured, concerning the Products. HMRI shall furnish to Rugby all material information supplied to, or supplied by, the FDA or other governmental regulatory agency, including the Form 483 observations and responses, to the extent that such report information relates to the Products (or the ability of HMRI to supply such Product), within five (5) business days of HMRI's receipt of such information or delivery of such information, as the case may be.