Changes and Change Control Clause Samples

Changes and Change Control. (a) All changes requiring Apellis prior written consent shall be handled in accordance with the obligations set forth in the Quality Agreement. (b) Any change shall, in each instance, comply with the Applicable Laws (including cGMPs) and shall be made in accordance with the Quality Agreement. In the event that Bachem is required to implement a Major Change (as defined in Section 11.1 of the Quality Agreement) in order to comply with the Applicable Laws (including cGMPs) or such Major Change is otherwise agreed to by Apellis in writing, Bachem shall: (x) immediately notify Apellis of such Major change and use Commercially Reasonable Efforts to implement such Major Change as soon as reasonably practicable or mutually agreed; (y) mutually agree with Apellis on a course of action to ensure that all Drug Substance Manufactured following such Major change meets the Drug Substance Specifications and the Drug Substance quality and yields achieved prior to such change; and (z) provide Apellis with all information with respect to the Manufacture of the Drug Substance in connection with such change reasonably needed to amend any regulatory filings. To the extent permitted by Applicable Laws, Bachem shall continue to supply Apellis with unchanged Drug Substance until such time Apellis informs Bachem that the Drug Substance Manufactured following such change is permitted under the amended regulatory filings therefor. In the event that Bachem intends to implement Major Change, Apellis shall work in a timely fashion to provide any required response to Bachem without undue delay and approval of such changes by Apellis shall not unreasonably be withheld or delayed. It shall be solely the responsibility of Apellis US to evaluate if such a change is in conformance with their regulatory filing and to use at least Commercially Reasonable Efforts to adapt such filing for mutually agreed changes and changes required by Applicable Laws (including cGMPs) or Agencies. (c) Prior to implementing any such Major Change, the Parties shall agree on the reasonable costs thereof; provided that Bachem shall use Commercially Reasonable Efforts to mitigate the costs thereof. Notwithstanding the foregoing, (i) if the change is required by Applicable Laws and such required change solely benefits the Manufacture of the Drug Substance, then Apellis shall be responsible for reimbursing Bachem for the costs of such required change and (ii) in all other cases, Bachem shall bear all costs of such cha...
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Changes and Change Control. (a) All changes requiring ▇▇▇▇▇▇▇▇ prior written consent shall be handled in accordance with the obligations set forth in the Quality Agreement. (b) Notwithstanding anything herein to the contrary or in the Quality Agreement, except as otherwise agreed to by ▇▇▇▇▇▇▇▇ in writing or as may be required to comply with the Applicable Law (including cGMPs), UPM shall not amend, change, or supplement any of the following without ▇▇▇▇▇▇▇▇’▇ prior written consent: (1) the Drug Product Specifications; (2) the Materials; (3) the specifications for Materials that have regulatory impact (e.g., specification is listed in the Regulatory Filing(s)) or the potential for quality impact on the Drug Product; (4) the source of Materials that have regulatory impact (e.g., supplier is listed in the Regulatory Filing(s)) or the potential for quality impact on the Drug Product; (5) the equipment and machinery, other than in-kind replacements, used in the Manufacture of Drug Product that have a direct impact on the quality of the Drug Product; (6) the test methods used in connection with the Manufacture of Drug Product that have regulatory impact (e.g., method is listed in the Regulatory Filing(s)) or the potential for quality impact on the Drug Product; or (7) the process for Manufacturing Drug Product or Materials. (c) Any change in any of the foregoing shall, in each instance, comply with the Applicable Law (including cGMPs) and shall be made in accordance with the Quality Agreement. In the event that UPM is required to change any of the foregoing in order to comply with Applicable Law (including cGMPs) or such change is otherwise agreed to by ▇▇▇▇▇▇▇▇ in writing, UPM shall: (x) immediately notify ▇▇▇▇▇▇▇▇ of such change and use Commercially Reasonable Efforts to implement such change as soon as reasonably practicable; (y) be responsible, at UPM’s expense, for ensuring that all Drug Product Manufactured following such change meets the Drug Product Specifications and the Drug Product quality and yields achieved during the Validation Batches; and (z) provide ▇▇▇▇▇▇▇▇ with all information with respect to the Manufacture of the Drug Product in connection with such change needed to amend any regulatory filings (including NDAs) maintained with respect to the subject Drug Product. To the extent permitted by Applicable Law, UPM shall continue to supply Madrigal with Drug Product approved under any ▇▇▇▇▇▇▇▇’▇ existing regulatory filings (including NDAs), as applicable, for the subject Dr...
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Related to Changes and Change Control

  • AMENDMENT AND CHANGE CONTROL Any amendment or change of any nature made to this Agreement and the Schedule of Requirements thereof shall only be valid if it is in writing, signed by both Parties and added to this Agreement as an addendum hereto. In this regard a Change Notice must first be defined and issued by the requesting Party. A Change Notice Response must then be issued by responding Party. A formal approval of the Change Request will then trigger the issue of the addendum to this Agreement.

  • Change Control All systems processing and/or storing PHI COUNTY discloses to 14 CONTRACTOR or CONTRACTOR creates, receives, maintains, or transmits on behalf of COUNTY 15 must have a documented change control procedure that ensures separation of duties and protects the 16 confidentiality, integrity and availability of data.

  • Service Changes PBI may modify its Service by giving written notice to you (a “Service Change Notice”), which will state whether the change is material. After receiving a Service Change Notice, if the change is material, you may terminate Service by giving us a termination notice at the address indicated in Section 21 or you may create a case at ▇▇▇▇▇▇▇▇▇▇▇.▇▇▇/▇▇/▇▇▇▇▇▇▇-▇▇.▇▇▇▇ (follow the instructions under “how to create a case”).

  • Change Control Procedures (a) No changes or additions may be made to any Work Order without the written agreement of LAUSD as evidenced by a duly executed Change Order. (b) Contractor will not take an action or make a decision which may have a material effect on LAUSD or which adversely affects the function or performance of, or decreases the resource efficiency of, the Services, including implementing changes in technology or equipment and software configuration, without first obtaining LAUSD’s written approval, which approval LAUSD may withhold in its sole discretion as respects any change which may have an adverse effect on LAUSD or the Services.

  • Schedule Changes (a) If, in the course of a posted schedule, the Employer: (i) changes Employees’ scheduled days off without giving 14 days’ notice of the change, they shall be paid 2X their Basic Rate of Pay for all hours worked on what would otherwise have been their off-duty days. (ii) changes Employees’ scheduled Shift, but not their scheduled days off, without giving 14 days’ notice of the change, they shall be paid 2X their Basic Rate of Pay for all hours worked during the first Shift of the changed schedule. (b) Employees shall be notified of such changes in their schedule and such changes shall be recorded on the Shift schedule. (c) An Employee or the Employer may, during the course of a posted schedule, ask to amend scheduled Shifts. Such Employee requests shall be granted where operationally possible without additional cost. Where mutually agreed, the requirements for 14 days’ notice of change and the resultant penalty pay as described in Article 7.04(a) shall not apply. Employees or the Employer should make such requests as far in advance as possible in order to maximize the ability to accommodate the request. Any Shift changes made by mutual agreement shall not violate the scheduling provisions of this Article.