Monitoring and Recordkeeping; Operating Procedures Sample Clauses

Monitoring and Recordkeeping; Operating Procedures. Throughout the Term and for so long thereafter as is required by Laws, Innocoll shall monitor and maintain reasonable records confirming its compliance with cGMPs, including through the establishment and implementation of such operating procedures as are reasonably necessary to assure such compliance. Innocoll shall notify EUSA in writing of any significant trend changes in the statistical process control data and/or quality testing results for Batches Manufactured hereunder.
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Monitoring and Recordkeeping; Operating Procedures. Throughout the term of this Agreement, and for so long thereafter as is required by applicable Laws, Supplier shall monitor and maintain reasonable records respecting its compliance with cGMPs, including through the establishment and implementation of such operating procedures as are reasonably necessary to assure such compliance. Supplier shall notify Adolor in writing of any significant trend changes in the statistical process control data and/or quality testing results for batches of the BX7, Validation Batches and/or the API Compound manufactured hereunder.
Monitoring and Recordkeeping; Operating Procedures. Throughout the term of this AGREEMENT, and for so long thereafter as is reasonably necessary, GENTA shall monitor and maintain, and shall use COMMERCIALLY REASONABLE EFFORTS to cause its Subcontractors to monitor and maintain, reasonable records respecting their compliance with cGMPs, including through the establishment and implementation of such operating procedures as are reasonably necessary to assure such compliance. GENTA shall use COMMERCIALLY REASONABLE EFFORTS to cause its Subcontractors to notify it in writing, and will itself notify the SUPPLY CHAIN TEAM in writing, of any significant trend changes in the statistical process control data and/or quality testing results for batches of API, BULK DRUG PRODUCT or FINISHED PRODUCT manufactured for supply to AVENTIS hereunder.
Monitoring and Recordkeeping; Operating Procedures. During any period Mylan is manufacturing the Product and for so long thereafter as is required by Law, Mylan shall maintain records evidencing its compliance with GMPs, GCPs and GLPs to the extent such records are required by Law but in no event for less than three years. Mylan shall provide Forest with reasonable access to such documentation promptly upon Forest's request.
Monitoring and Recordkeeping; Operating Procedures. Throughout the term of this Agreement, and for so long thereafter as is required by applicable Laws, CRL shall monitor and maintain reasonable records respecting its compliance with cGMPs, including through the establishment and implementation of such operating procedures as are reasonably necessary to assure such compliance. [***]
Monitoring and Recordkeeping; Operating Procedures. Throughout the term of this Agreement, and for so long thereafter as is required by applicable Laws, PII shall monitor and maintain reasonable records respecting its compliance with cGMPs, including through the establishment and implementation of such operating procedures as are reasonably necessary to assure such compliance. PII shall notify Adolor in writing of any significant trend changes in the statistical process control data and/or quality testing results for batches of Drug Product manufactured hereunder.

Related to Monitoring and Recordkeeping; Operating Procedures

  • Testing Procedures Testing will be conducted by an outside certified Agency in such a way to ensure maximum accuracy and reliability by using the techniques, chain of custody procedures, equipment and laboratory facilities which have been approved by the U.S. Department of Health and Human Services. All employees notified of a positive controlled substance or alcohol test result may request an independent test of their split sample at the employee’s expense. If the test result is negative the Employer will reimburse the employee for the cost of the split sample test.

  • Billing Procedures The Supporting Party will xxxx the Protecting Party for actual costs incurred for Assistance by Hire. Reimbursements will be limited to the provisions of the Agreement and the applicable OP, regardless of whether or not it is authorized on the Resource Order or other documentation produced by the incident. Reimbursable costs may include transportation, salary, overtime, per diem and other approved expenses of Supporting agency personnel. Rates and conditions of use for the equipment and personnel are documented in the OP. Parties shall submit a xxxx within 90 days of the incident. Parties must use their own invoice form for billing under this Agreement to avoid any confusion with other services that may have been ordered under other agreements. Invoices must identify Supporting Party’s name, address, and Taxpayer Identification Number (Department only), fire name, order and request number, and xxxx number and amount. Invoice supporting documentation must include description of services performed, period of services performed, and any applicable cost share agreements. Supporting documentation will itemize details of billing, listing personnel, equipment, travel and per diem, aircraft, supplies and purchases as approved in the attached AOP. It will also include itemized deductions for maintenance and repair of equipment. Department invoices will include “Record of Activities” (FSLA-5) and U.S. Forest Service invoices will include transaction register. Invoices for services under this agreement must be sent to: Name: Xxxx Xxxxxx-Xxxxx, ECC Manager Address: 0000 Xxxxxxxxx Xxxxx Xxxx, Xxxxx, Xxx: Xxxxxxxxxx, XX 00000 Telephone: (000) 000-0000 FAX: (000) 000-0000 Email: xxxxxxxxxxxx@xx.xxx.xx Name: Spalding Community Service District Address: 000-000 Xxxxxxxx Xxx Xxxx, Xxxxx, Xxx: Xxxxxxxxxx, XX 00000 Telephone: (000) 000-0000 FAX: (000) 000-0000 Email: xxxxxxxxxxxxx@xxxxxxx.xxx All bills will have a payment due date 30 days upon receipt. Contested Xxxxxxxx: Written notice that a xxxx is contested will be mailed to the Party within 30 days of receipt of the invoice and will fully explain the contested items. Contested items should be resolved no later than 60 days following receipt of the written notice. Parties are responsible for facilitating resolution of contested xxxxxxxx. Billing requirements and rates are documented in the attached OP.

  • Reporting Procedures Enter in the XXX Entity Management area the information that XXX requires about each proceeding described in paragraph 2 of this award term and condition. You do not need to submit the information a second time under assistance awards that you received if you already provided the information through XXX because you were required to do so under Federal procurement contracts that you were awarded.

  • Operating Procedures Company shall observe and comply with the Operating Procedures. Company shall ensure that Company's Stores personnel are trained regarding the Operating Procedures and shall ensure their compliance with them. The Operating Procedures may be supplemented, amended or modified by Bank from time to time in its reasonable discretion; provided, however, a copy of any such supplement, amendment or modification shall be provided to Company at least ninety (90) days before its effective date (the "Notice Date") unless otherwise required by Applicable Law, and for those changes required by Applicable Law, notice shall be given as soon as practicable. For changes that are (A) required by Applicable Law, or (B) determined by Bank in good faith to be necessary from the standpoint of safe and sound banking practices (both (A) and (B) being referred to herein as the "Required Changes"), where Bank implements such Required Changes with all of its other clients that are also affected by such change in Applicable Law or operate in circumstances similarly requiring changes from the standpoint of safe and sound banking practices, Bank shall identify the changes as Required Changes in the notice to Company. Unless such change is a Required Change, Company shall have the right within thirty (30) days after the Notice Date to object to such change and the parties' representatives will promptly thereafter meet to discuss such change in good faith in order to agree upon such change or a mutually agreeable alternative to such change. In the event the parties are unable to agree upon such change or an alternative within sixty (60) days after the Notice Date, then a senior executive from both Company and Bank shall meet to negotiate in good faith in order to agree upon such change or a mutually agreeable alternative to such change. If the parties' senior executives are unable to mutually agree within ninety (90) days after the Notice Date, then Bank shall have the right to implement the initially proposed change so long as (i) Bank implements such change with all or substantially all of its other similar clients, (ii) such change does not change the chargebacks section of the Operating Procedures, and (iii) such change does not impose a material adverse financial or operational burden on Company.

  • Standard Operating Procedures Standard Operating Procedures shall not contravene the Canada Labour Code, the Canadian Human Rights Code, or the Collective Agreement, and an allegation of such contravention is subject to the grievance procedure.

  • Quality Management System Supplier hereby undertakes, warrants and confirms, and will ensue same for its subcontractors, to remain certified in accordance with ISO 9001 standard or equivalent. At any time during the term of this Agreement, the Supplier shall, if so instructed by ISR, provide evidence of such certifications. In any event, Supplier must notify ISR, in writing, in the event said certification is suspended and/or canceled and/or not continued.

  • Accounting Procedures 7.3.1. Principal and Interest Computation.......................... 7.3.2.

  • Program Monitoring and Evaluation The Recipient shall prepare, or cause to be prepared, and furnish to the Association not later than six months after the Closing Date, a report of such scope and in such detail as the Association shall reasonably request, on the execution of the Program, the performance by the Recipient and the Association of their respective obligations under the Legal Agreements and the accomplishment of the purposes of the Financing.”

  • Project Monitoring Reporting and Evaluation The Recipient shall furnish to the Association each Project Report not later than forty-five (45) days after the end of each calendar semester, covering the calendar semester.

  • Performance of Services in Accordance with Regulatory Requirements; Furnishing of Books and Records In performing the services set forth in this Agreement, the Manager: A. shall conform with the 1940 Act and all rules and regulations thereunder, with all other applicable federal, state and foreign laws and regulations, with any applicable procedures adopted by the Trust’s Board of Trustees, and with the provisions of the Trust’s Registration Statement filed on Form N-1A as supplemented or amended from time to time; B. will make available to the Trust, promptly upon request, any of the Fund’s books and records as are maintained under this Agreement, and will furnish to regulatory authorities having the requisite authority any such books and records and any information or reports in connection with the Manager’s services under this Agreement that may be requested in order to ascertain whether the operations of the Trust are being conducted in a manner consistent with applicable laws and regulations.

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