Common use of Approval of Changes Clause in Contracts

Approval of Changes. IDENIX or NOVARTIS shall prepare a change request in writing. In this document, the following items shall be defined at least: - a comparative description of the change (current versus intended status) - the rational for the change - a GMP assessment - a business (cost/benefit) evaluation For each change, an approval from IDENIX is necessary before implementation. Changes in specifications of material resulting from the update of compendia and pharmacopoeia may be made by NOVARTIS without formal request and are notified to IDENIX through the key-accounts (see Enclosure A) in a timely manner. Registration relevant changes shall only be implemented after obtaining approval from the national health authorities. NOVARTIS shall be informed by IDENIX well in advance.

Approval of Changes. IDENIX or NOVARTIS shall prepare a change request in writing. In this document, the following items shall be defined at least: - a comparative description of the change (current versus intended status) - the rational for the change - a GMP cGMP assessment - a business (cost/benefit) evaluation For each change, change an approval from IDENIX is necessary before implementation. Changes in specifications Specifications of material resulting from the update of compendia and pharmacopoeia may be made by NOVARTIS without formal request and are notified to IDENIX through the key-accounts (see Enclosure A) in a timely mannermanor. Registration relevant changes shall only be implemented after obtaining approval from the national health authorities. NOVARTIS shall be informed by IDENIX well in advance.