Changes in Manufacturing Processes. HSL reserves the right to implement reasonable process changes and improvements for manufacturing the Product during the Term, at its cost, but in all instances subject to LMI’s prior written approval (not to be unreasonably withheld, delayed or conditioned). HSL agrees to notify LMI promptly and in advance of any such change or improvement. If any such change or improvement requires, in LMI’s reasonable judgment, regulatory approval, HSL will provide drafts of the proposed filing(s) to LMI for review and LMI will provide its approval or comments within **** (****) days from the date of receipt. In addition, HSL will make any changes to the process for manufacturing the Product requested by LMI, which changes shall be made at LMI’s reasonable cost and expense (including the allocable cost of HSL personnel as evidenced by reasonable documentation made available to LMI). The Parties hereby agree to negotiate in good faith an adjustment to the ****of the Product to reflect any **** caused by the changes described in this Section 2.7. The Parties will in all events reasonably cooperate with the other Party in effecting any process changes or improvements reasonably requested by such Party.
Changes in Manufacturing Processes. JULPHAR shall not make any material changes in the manufacturing processes of the API except as required by Applicable Laws without DANCE’s prior consent. In the event a change in manufacturing process is required, JULPHAR shall provide DANCE with not less than six (6) months’ prior written notice of JULPHAR’s implementation of any intended significant material change(s) to its manufacturing processes for the Active Ingredient, which might affect the quality of the Active Ingredient or any Market Authorization Approvals for the Product (“Change Notice”) (e.g. any change in the Active Ingredient Specifications or Packaging Specifications made by JULPHAR other than pursuant to a DANCE request). If a significant change is implemented by JULPHAR and DANCE provides JULPHAR with demonstrable evidence that the utility (i.e. the conditions of being useful as a pharmaceutical product in connection with the manufacture and performance of the Product) of the Active Ingredient is significantly altered in that there is no similar bioequivalence (to Active Ingredient before the significant change) or similar Product specifications when formulated in the final Product formulation (together, “Utility Loss”), the parties shall exert their reasonable commercial efforts to resolve issues related to the Utility Loss in order to continue operating under this Agreement. In the case of pending specification change, JULPHAR shall allow DANCE ninety (90) days to purchase Active Ingredient supply needed prior of the implementation of specification changes. DANCE shall, over the course of the notice period, have the right to place POs and JULPHAR shall have the obligation to accept such POs and manufacture up to four (4) times the quantity of API reflected in the Rolling Forecast (as defined below).
Changes in Manufacturing Processes. COV reserves the right to implement reasonable process changes and improvements during the Term but in all instances subject to LMI’s prior written approval. COV agrees to notify LMI promptly of any such change or improvement. If any such change or improvement requires, in COV’s reasonable judgment, regulatory approval, COV will provide drafts of the proposed filing(s) to LMI for review and LMI will provide its approval or comments within thirty (30) days from the date of receipt. LMI will in all events reasonably cooperate with COV in effecting any process changes or improvements reasonably requested by COV.
Changes in Manufacturing Processes. Any process changes requested by the CMO after establishment of commercial Product supply under a Proposal shall be made by CMO at its cost, but in all instances subject to LMI’s prior written approval and the other procedures and requirements set forth in the Quality Agreement. CMO agrees to notify LMI in advance of any such change or improvement that it desires to implement pursuant to the Quality Agremeent in order to assess the impact of such change. Process changes requested by LMI after establishment of commercial Product supply under a Proposal shall be subject to CMO fees in accordance with ****. The Parties will in all events reasonably cooperate with the other Party in effecting any process changes or improvements reasonably requested by such Party and, to the extent such changes constitute Intellectual Property, the Parties shall reasonably cooperate in connection with the preparation, filing and prosecution of any patent applications/patents relating thereto, any such changes and any such patents/applications to constitute Improvements to LMI’s Pre-Existing Intellectual Property and Technology pursuant to Section 6.
Changes in Manufacturing Processes. AERO PUMP shall provide DANCE with not less than six (6) months’ prior written notice of AERO PUMP’s implementation of any intended significant material change(s) to its manufacturing processes for the PUMPS (including equipment, packaging, testing, specifications, or any item specifically mentioned in the DMF), which might affect the quality of the PUMPS or any Market Authorization Approvals for the Product (“Change Notice”) (e.g. any change in the PUMPS Specifications or Packaging Specifications made by AERO PUMP other than pursuant to a DANCE request). Any changes that may have impact on quality and/or stability of PUMPS will require written approval by DANCE, and such approval should not be unreasonably withheld. If a significant change is implemented by AERO PUMP and DANCE provides AERO PUMP with demonstrable evidence that the utility (i.e. the conditions of being useful as a pharmaceutical product in connection with the manufacture and performance of the Product) of the PUMPS is significantly altered in that there is no similar bioequivalence (to PUMPS before the significant change) or similar Product specifications when formulated in the final Product formulation (together, “Utility Loss”), the parties shall exert their reasonable commercial efforts to resolve issues related to the Utility Loss in order to continue operating under this Agreement. In the case of pending specification change, AERO PUMP shall allow DANCE ninety (90) days to purchase PUMPS supply needed prior of the implementation of specification changes. DANCE shall, over the course of the notice period, have the right to place POs and AERO PUMP shall have the obligation to accept such POs and manufacture up to four (4) times the quantity of PUMPS reflected in the Rolling Forecast (as defined below).
