Common use of Post-Effective Date Clinical Programs and Supplemental Approval Clause in Contracts

Post-Effective Date Clinical Programs and Supplemental Approval. Except as otherwise provided in Section 4.5, after the Effective Date, Distributor shall be responsible at its sole cost and expense for conducting any clinical Testing that Distributor chooses to conduct, if any, at its sole choice and discretion, for the continued and successful Marketing of the Product in the Territory as well as the associated regulatory costs. Distributor shall provide any clinical protocols at least forty-five (45) days before such clinical work begins for Cipher’s review and approval, which shall not be unreasonably withheld, conditioned or delayed. Cipher shall provide any comments or approval within fifteen (15) days so that Distributor can implement an approved clinical protocol without undue delay. To the extent Cipher, in its sole discretion, believes it would be beneficial to conduct certain post-regulatory approval clinical Testing, and Distributor does not wish to undertake such Testing, Cipher shall be free to undertake such Testing at its own cost and expense; provided, however, that prior to Cipher undertaking such Tests, the Parties will negotiate in good faith additional consideration to be paid to Cipher in the event such Testing results in successful outcomes.