Changes and Change Control Sample Clauses

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 
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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 xxxxxxxxxxx.xxx/xx/xxxxxxx-xx.xxxx (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.

  • Change Control Procedure 34.1 In the event that either Party desires any change the terms of this Agreement or any Contract which may materially impact on the timings, scope, Specification or Charges of the Goods or Services, or the scope of either parties’ obligations under this Agreement or the relevant Contract, or which the relevant Party otherwise reasonably determines warrants the use of this change control procedure, the following procedures will apply: (a) the Party requesting the change will deliver a “Change Request” (in the form (or substantially in the same form) contained in Schedule 5 to this Agreement) which describes: (i) the nature of the change; (ii) the reason for the change; (iii) the effect that the requested change will have on the scope or Specification for the Goods or Services; and (iv) any change to the Charges and the Term. (b) Upon receipt of a Change Request, the receiving Party’s authorised representative will contact his/ her counterpart within 5 working days to discuss and agree the Change Request. The parties will negotiate the proposed changes to the Agreement and/or affected Contract in good faith and agree a timeline in which to finalise the Change Notice. (c) Neither party is obliged to agree to a Change Request, but if the parties do agree to implement such a Change Request, the appropriate authorised representatives of both parties will sign the Change Request which will be effective from the date set out in the Change Request. (d) If there is any conflict between the terms and conditions set out in the Agreement or any Contract and the Change Request, then the terms and conditions set out in the most recent fully executed Change Request will apply. (e) The Supplier shall neither be relieved of its obligations to supply the Goods and/or Services in accordance with the terms and conditions of this Agreement or any Contract, nor be entitled to an increase in the Charges as the result of: (i) a General Change in Law; or (ii) a Specific Change in Law where the effect of that Specific Change in Law on the Goods and/or Services is reasonably foreseeable at the Commencement Date of this Agreement, or, where the Change Request relates to a Contract, the applicable Contract Commencement Date. 34.2 The Parties agree that any variations to the Agreement or any Contract to reflect non- material changes (including for example a change to the name/contact details of a Party’s representative) may be agreed in writing and shall not be required to be made in accordance with the procedure in this clause 34, provided always that UKRI shall, in their absolute discretion, decide whether a proposed change is non-material for these purposes.

  • Amendments and Changes The Contracting Parties may make amendments and changes to this Agreement by mutual consent Such amendments and changes shall be made in the form of additional protocols which, upon entry into force in the manner prescribed in Article 15, shall constitute an integral and inseparable part of this Agreement

  • Changes, etc This instrument and the provisions hereof may be changed, waived, discharged or terminated only by an instrument in writing signed by the party against which enforcement of the change, waiver, discharge or termination is sought.

  • Program Changes Contractor agrees to inform the County of any alteration in program or service delivery at least thirty (30) days prior to the implementation of the change, or as soon as reasonably feasible.

  • Business Changes Change in any material respect the nature of the business of the Borrower or its Subsidiaries as conducted on the Effective Date.

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