Required Changes. For changes to the Product Specifications or Manufacturing relating solely to the Products that are required by Laws and other Regulatory Requirements (including, without limitation, cGMP), or by medical or scientific concerns as to the toxicity, safety and/or efficacy of the Products (collectively, “Required Changes”), the Parties shall cooperate in making such changes promptly.
Appears in 6 contracts
Samples: Manufacturing Agreement, Manufacturing Agreement (Reliant Pharmaceuticals, Inc.), Manufacturing Agreement (Reliant Pharmaceuticals, Inc.)
Required Changes. For changes relating solely to the Product Specifications or Manufacturing relating solely to manufacturing of the Products hereunder that are required by Laws laws and other Regulatory Requirements regulatory requirements (including, without limitation, cGMP), or by medical or scientific concerns as to the toxicity, safety and/or efficacy of the Products (collectively, “Required Changes”), the Parties shall cooperate in making such changes promptly.
Appears in 2 contracts
Samples: Api Supply Agreement, Api Supply Agreement (Hospira Inc)
Required Changes. For changes to the Product Specifications or Manufacturing manufacturing relating solely to the Products that are required by Laws laws and other Regulatory Requirements regulatory requirements (including, without limitation, cGMP), or by medical or scientific concerns as to the toxicity, safety and/or efficacy of the Products (collectively, “"Required Changes”"), the Parties shall cooperate in making such changes promptly.
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