Common use of Specification Changes Clause in Contracts

Specification Changes. SMI shall not make any change to the Modified Starch (including materials, packaging, and directions for use), Modified Starch Specifications, the raw materials, suppliers of starch, manufacturing process for the Modified Starch or the Products Specifications (collectively, “Specification Changes”), unless approved by CryoLife in writing in advance, which approval may not be unreasonably denied (with the Parties understanding that any such changes that would require new, or change to any Regulatory Approval may be denied by CryoLife due to the cost or time involved in that change). 4.2.1 Without limiting the foregoing, all Specification Changes (including changes required by law) shall be submitted to CryoLife in writing no later than one hundred eighty (180) days prior to SMI’s proposed date of implementation for such change. Unless CryoLife notifies SMI in writing that it disapproves of such change during the thirty (30) calendar day period following the notification of such change or if such a proposed change is otherwise required by law, regulation, or directive, SMI shall be authorized to implement such change and shall be responsible for properly communicating and implementing such change, including with respect to any of SMI’s vendors. 4.2.2 Without limiting the foregoing, the following changes shall be deemed governed by this Section: (i) use of any nonconforming material in the Manufacturing of the Modified Starch in variance with the Modified Starch Specifications or the Products Specifications; (ii) implementation of any deviation that could affect the handling, sterility, safety, or efficacy of any of the Modified Starch or the Products or be at variance with the Modified Starch Specifications or the Products Specifications; or (iii) implementation of any corrective action that could affect the safety or efficacy of the Modified Starch or the Products. Notwithstanding the foregoing, SMI shall not make any Specification Changes that disqualify Products for sale under any Regulatory Approval respecting the Products within any portion of the Territory. 4.2.3 SMI shall be responsible for all costs and expenses associated with developing and implementing any Specification Changes including, without limitation, any and all cost associated with obtaining regulatory approval to incorporate Specification Changes into Products or to Manufacture or Distribute Products that incorporate Specification Changes throughout the Territory.