Process Performance Qualification Sample Clauses

Process Performance Qualification. If made part of the Scope of Work as part of Passage Bio’s pre-Commercialization activities of a Passage Bio Product, Catalent shall perform Process Performance Qualification in support of Passage Bio’s BLA submission to the FDA for such Passage Bio Product in accordance with cGMPs, the Specifications, the Quality Agreement, any applicable Laws, and otherwise in accordance with this Agreement. Such Process Performance Qualification may include, but is not limited to, the following tasks which are more fully described in the Scope of Work: [*]. Catalent agrees to use commercially reasonable efforts to meet the timelines set forth in the Scope of Work. Unless otherwise agreed by the Parties in the Scope of Work, the Process Performance Qualification will be completed upon Catalent’s completion of [*]. The date upon which a final report confirming the completion of these PPQ activities has been submitted by Catalent and approved by Passage Bio shall be referred to herein as the “PPQ Completion Date.” Passage Bio’s approval of the completion of the PPQ activities shall not be unreasonably withheld or delayed.
Sample 1
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Process Performance Qualification. Catalent shall perform Process Performance Qualification in support of Sarepta’s BLA submission to the FDA for the Lead DMD Product in accordance with cGMPs, the Specifications, the Quality Agreement, any applicable Laws, and otherwise in accordance with this Agreement. Such Process Performance Qualification includes, [**]. Catalent agrees to use commercially reasonable efforts to meet the timelines set forth in the Scope of Work. The Process Performance Qualification will be completed upon Catalent’s completion of the number of lots of Bulk Drug Substance and Drug Product specified in the Scope of Work, as the same may be amended as provided herein, that each conform to the Product Requirements (collectively, the “PPQ Lots”), along with corresponding documentation, Certificate of Analysis, Certificate of Compliance and validation reports for each such lot. The date upon which a final report confirming the completion of these PPQ activities has been submitted by Catalent and approved by Sarepta shall be referred to herein as the “PPQ Completion Date.” Sarepta’s approval of the completion of the PPQ activities shall not be unreasonably withheld or delayed.
Sample 1

Related to Process Performance Qualification

  • Ongoing Performance Measures The Department intends to use performance-reporting tools in order to measure the performance of Contractor(s). These tools will include the Contractor Performance Survey (Exhibit H), to be completed by Customers on a quarterly basis. Such measures will allow the Department to better track Vendor performance through the term of the Contract(s) and ensure that Contractor(s) consistently provide quality services to the State and its Customers. The Department reserves the right to modify the Contractor Performance Survey document and introduce additional performance-reporting tools as they are developed, including online tools (e.g. tools within MFMP or on the Department's website).

  • Registry Performance Specifications Registry Performance Specifications for operation of the TLD will be as set forth in Specification 10 attached hereto (“Specification 10”). Registry Operator shall comply with such Performance Specifications and, for a period of at least one (1) year, shall keep technical and operational records sufficient to evidence compliance with such specifications for each calendar year during the Term.

  • Records Created as Part of Consultant’s Performance All reports, data, maps, models, charts, studies, surveys, photographs, memoranda, plans, studies, specifications, records, files, or any other documents or materials, in electronic or any other form, that Consultant prepares or obtains pursuant to this Agreement and that relate to the matters covered hereunder shall be the property of the City. Consultant hereby agrees to deliver those documents to the City at any time upon demand of the City. It is understood and agreed that the documents and other materials, including but not limited to those described above, prepared pursuant to this Agreement are prepared specifically for the City and are not necessarily suitable for any future or other use. Failure by Consultant to deliver these documents to the City within the time period specified by the City shall be a material breach of this Agreement. City and Consultant agree that, until final approval by City, all data, plans, specifications, reports and other documents are preliminary drafts not kept by the City in the ordinary course of business and will not be disclosed to third parties without prior written consent of both parties.

  • Excuse for Nonperformance or Delayed Performance Except with respect to defaults of subcontractors, Contractor/Vendor shall not be in default by reason of any failure in performance of this contract in accordance with its terms (including any failure by Contractor/Vendor to make progress in the prosecution of the work hereunder which endangers such performance) if Contractor/Vendor has notified the Commission or designee within 15 days after the cause of the delay and the failure arises out of causes such as: acts of God; acts of the public enemy; acts of the State and any other governmental entity in its sovereign or contractual capacity; fires; floods; epidemics; quarantine restrictions; strikes or other labor disputes; freight embargoes; or unusually severe weather. If the failure to perform is caused by the failure of a subcontractor to perform or to make progress, and if such failure arises out of causes similar to those set forth above, Contractor/Vendor shall not be deemed to be in default, unless the services to be furnished by the subcontractor were reasonably obtainable from other sources in sufficient time to permit Contractor to meet the contract requirements. Upon request of Contractor, the Commission or designee shall ascertain the facts and extent of such failure, and, if such officer determines that any failure to perform was occasioned by any one or more of the excusable causes, and that, but for the excusable cause, Contractor’s progress and performance would have met the terms of the contract, the delivery schedule shall be revised accordingly, subject to the rights of the State under the clause entitled (in fixed-price contracts, “Termination for Convenience,” in cost-reimbursement contracts, “Termination”). (As used in this Paragraph of this clause, the term “subcontractor” means subcontractor at any tier).

  • Distribution and Pool Performance Information Item 1121(a) - Distribution and Pool Performance Information

  • Annual Performance Evaluation On either a fiscal year or calendar year basis, (consistently applied from year to year), the Bank shall conduct an annual evaluation of Executive’s performance. The annual performance evaluation proceedings shall be included in the minutes of the Board meeting that next follows such annual performance review.

  • Employee Performance Review When a formal review of an employee’s performance is made, the employee concerned shall be given an opportunity to discuss, sign and make written comments on the review form in question and the employee is to receive a signed copy to indicate that its contents have been read. An employee shall be entitled to a minimum of two (2) work days to review the performance review prior to providing any response to the Employer, verbally or in writing, with respect to the evaluation.

  • Covenants of Performance Measurement No interference. Registry Operator shall not interfere with measurement Probes, including any form of preferential treatment of the requests for the monitored services. Registry Operator shall respond to the measurement tests described in this Specification as it would to any other request from an Internet user (for DNS and RDDS) or registrar (for EPP). ICANN testing registrar. Registry Operator agrees that ICANN will have a testing registrar used for purposes of measuring the SLRs described above. Registry Operator agrees to not provide any differentiated treatment for the testing registrar other than no billing of the transactions. ICANN shall not use the registrar for registering domain names (or other registry objects) for itself or others, except for the purposes of verifying contractual compliance with the conditions described in this Agreement. PUBLIC INTEREST COMMITMENTS Registry Operator will use only ICANN accredited registrars that are party to the Registrar Accreditation Agreement approved by the ICANN Board of Directors on 27 June 2013 in registering domain names. A list of such registrars shall be maintained by ICANN on ICANN’s website. (Intentionally omitted. Registry Operator has not included commitments, statements of intent or business plans provided for in its application to ICANN for the TLD.) Registry Operator agrees to perform the following specific public interest commitments, which commitments shall be enforceable by ICANN and through the Public Interest Commitment Dispute Resolution Process established by ICANN (posted at xxxx://xxx.xxxxx.xxx/en/resources/registries/picdrp), which may be revised in immaterial respects by ICANN from time to time (the “PICDRP”). Registry Operator shall comply with the PICDRP. Registry Operator agrees to implement and adhere to any remedies ICANN imposes (which may include any reasonable remedy, including for the avoidance of doubt, the termination of the Registry Agreement pursuant to Section 4.3(e) of the Agreement) following a determination by any PICDRP panel and to be bound by any such determination. Registry Operator will include a provision in its Registry-Registrar Agreement that requires Registrars to include in their Registration Agreements a provision prohibiting Registered Name Holders from distributing malware, abusively operating botnets, phishing, piracy, trademark or copyright infringement, fraudulent or deceptive practices, counterfeiting or otherwise engaging in activity contrary to applicable law, and providing (consistent with applicable law and any related procedures) consequences for such activities including suspension of the domain name. Registry Operator will periodically conduct a technical analysis to assess whether domains in the TLD are being used to perpetrate security threats, such as pharming, phishing, malware, and botnets. Registry Operator will maintain statistical reports on the number of security threats identified and the actions taken as a result of the periodic security checks. Registry Operator will maintain these reports for the term of the Agreement unless a shorter period is required by law or approved by ICANN, and will provide them to ICANN upon request. Registry Operator will operate the TLD in a transparent manner consistent with general principles of openness and non-discrimination by establishing, publishing and adhering to clear registration policies.

  • CONTRACTOR PERFORMANCE AUDIT The Contractor shall allow the Authorized User to assess Contractor’s performance by providing any materials requested in the Authorized User Agreement (e.g., page load times, response times, uptime, and fail over time). The Authorized User may perform this Contractor performance audit with a third party at its discretion, at the Authorized User’s expense. The Contractor shall perform an independent audit of its Data Centers, at least annually, at Contractor expense. The Contractor will provide a data owner facing audit report upon request by the Authorized User. The Contractor shall identify any confidential, trade secret, or proprietary information in accordance with Appendix B, Section 9(a), Confidential/Trade Secret Materials.

  • Performance Measure Grantee will adhere to the performance measures requirements documented in

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