Common use of Required Manufacturing Changes Clause in Contracts

Required Manufacturing Changes. Each Party shall give the other Party reasonable written notice prior to any changes to the Specifications, process of Manufacturing, or other change, as applicable, with respect to the Supplied Materials, in each case that are required by cGMPs or Applicable Laws or a Regulatory Authority (collectively, “Required Manufacturing Changes”). PharmaZell shall use commercially reasonable efforts to promptly implement such Required Manufacturing Changes. PharmaZell shall ensure that any change in any of the foregoing shall, in each case, comply with cGMPs and all Applicable Laws. PharmaZell and Intercept will jointly discuss the cost resulting from such changes. ​

Appears in 1 contract

Sources: Manufacturing Agreement (Intercept Pharmaceuticals, Inc.)

Required Manufacturing Changes. Each Party shall give the other Party reasonable written notice prior to any changes to the Specifications, process of Manufacturing, or other change, as applicable, with respect to the Supplied Materials, in each case that are required by cGMPs or Applicable Laws or a Regulatory Authority (collectively, “Required Manufacturing Changes”). PharmaZell shall use commercially reasonable efforts to promptly implement such Required Manufacturing Changes. PharmaZell shall ensure that any change in any of the foregoing shall, in each case, comply with cGMPs and all Applicable Laws. PharmaZell and Intercept will jointly discuss the cost resulting from such changes. ​.

Appears in 1 contract

Sources: Manufacturing Agreement (Intercept Pharmaceuticals Inc)