Common use of Amendments and/or Modifications Clause in Contracts

Amendments and/or Modifications. 3.1 Either Party may at any time recommend an amendment and/or modification to this Agreement or the Appendices, including the Specifications. Amendments and/or modifications to this Agreement or the Appendices shall only be effective upon a signed written agreement between the Parties. The Appendices shall be subject to version control to document any changes made to them. Amendments and/or modifications to the Specifications shall be made in accordance with the change control provisions of the Quality Agreement. 3.2 Neither Party shall unreasonably withhold, condition or delay its consent to any amendments and/or modifications recommended in good faith by the other Party in relation to compliance with changes in Applicable Laws, including, without limitation, cGMP, or changes in the regulatory environment. In the event Ypsomed modifies the YpsoMate and determines in good faith that corresponding modifications to any Component is necessary or beneficial, then AMAG shall approve such modifications, provided that such modifications are made in accordance with the change control provisions of the Quality Agreement. Notwithstanding the foregoing, with respect to each proposed amendment and/or modification to the Agreement or the Appendices, the Parties shall discuss in good faith the cost and time implications associated therewith. The requirements and the procedure for change control are set out in the Quality Agreement. 3.3 In the event that the Parties agree to change the Specifications in accordance with the change control provisions of the Quality Agreement, Ypsomed shall: (x) use commercially reasonable efforts to implement such change as soon as reasonably practicable; (y) be responsible for ensuring that all Components manufactured following such change meets the Specifications as amended; and (z) provide AMAG with all information and reasonable assistance with respect to the manufacture of the Components in connection with such change needed to amend any regulatory filings maintained with respect to the Bremelanotide Device. To the extent such change is a result of a change in Applicable Law or a discretionary change requested by [***], AMAG shall [***] of implementing the changes, otherwise, Ypsomed shall [***]. 3.4 The Specifications are not physically attached to this Agreement, since they are kept in the Design History File (DHF) which is maintained at Ypsomed's premises. Ypsomed shall provide AMAG with a copy of the Specifications.