Quality Control and Regulatory Compliance Sample Clauses

Quality Control and Regulatory Compliance. Each Licensee agrees that it will make no use of the Marks that would tend to reflect adversely upon the Purchasing Agent, its business reputation, the GTN business and/or market, or would violate or reflect adversely upon the Purchasing Agent with regard to the Commission, the NASD or any other governmental authority or securities association or other regulatory matters. The common law understanding of the reasonable man standard, given the facts and circumstances then facing such Licensee, its agents and employees, shall apply when making a determination pursuant to this paragraph (e). Any proposed use of the Marks outside of the terms contemplated by this Paragraph shall be submitted to the Purchasing Agent for its written approval prior to said proposed use.
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Quality Control and Regulatory Compliance. (a) During the Term, Bovie shall establish and maintain a quality assurance control program to be maintained by its Quality Control Team. Bovie shall enter into Arthrex's Contract Manufacturers/Suppliers/Vendors Agreement with respect to quality assurance, a copy of which is attached hereto as Appendix D. Arthrex shall maintain its Quality Control Department, which shall provide technical and other assistance to Bovie in order for Bovie to better understand and meet the Product Specifications and manufacturing requirements. Bovie's Quality Control Team and Arthrex's Quality Control Department shall work together in an effort to establish total quality assurance.
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Quality Control and Regulatory Compliance. (a) Supplier shall manufacture, test and supply the Products in accordance with (i) the Product Specifications; (ii) Supplier’s standard manufacturing practices; and (iii) current Good Manufacturing Practices as required by the Federal Food, Drug and Cosmetic Act, as amended (the “Act”) and the pertinent rules and regulations of the FDA, ISO 13485:2012 or current version, SOR 98/282 (Canada), the Medical Device Directive (Council Directive 00/00 XXX and 2007/47/EC), Active Implantable Medical Devices (AIMD 90/385/EEC) (collectively, “GMP”). [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Quality Control and Regulatory Compliance. 7.1 Each delivery of Commercial Product shall be accompanied by KNC’s Certificate of Conformance, as mutually agreed to by the parties.
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Quality Control and Regulatory Compliance. 6.1 No Product shall be released for shipment by BIOVECTRA unless and until SyntheMed shall have been notified by BIOVECTRA of completion of Product manufacture and has reviewed and approved the BIOVECTRA testing results. SyntheMed will be afforded full opportunity to test the Product to ensure compliance with the Product Specifications. Notwithstanding the above, such testing shall take place within thirty (30) days of completion of Product manufacture and BIOVECTRA’s Certificate of Conformance and Certification to SyntheMed. Such testing may be accomplished either by SyntheMed directly or by a third party designated by SyntheMed, which designee may be an independent testing laboratory. Each delivery of Product manufactured by BIOVECTRA shall be accompanied by BIOVECTRA's Certificate of Conformance and Certificate of Analysis, the generic form of which is attached as Schedule 4.
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Quality Control and Regulatory Compliance. 6.1 No Product shall be released for shipment by STI unless and until SyntheMed shall have been notified by STI of completion of Product manufacture and SyntheMed has reviewed and approved the testing results. SyntheMed will be afforded full opportunity to test the Product to ensure compliance with the Product Specifications and to confirm the results submitted to SyntheMed by STI. Such testing may be accomplished either by SyntheMed directly or by a third party designated by SyntheMed, which designee may be an independent testing laboratory. Each lot of Product manufactured by STI shall have STI's Certificate of Conformance and Certificate of Analysis, the generic form of which is attached as Schedule 4.
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Quality Control and Regulatory Compliance. 7.1 Each delivery of Product or Commercial Product manufactured by KNC shall be accompanied by KNC's Certificate of Conformance and Certificate of Analysis, the generic form of which is attached as Schedule F.
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Quality Control and Regulatory Compliance. 6.1 No Product shall be released for shipment by CDI unless and until SyntheMed shall have been notified by CDI of completion of Product manufacture and afforded full opportunity to test the Product to ensure compliance with the Product Specifications. Such testing may be accomplished either by SyntheMed directly or by a third party designated by SyntheMed, which designee may be an independent testing laboratory. Each lot of Product manufactured by CDI shall have CDI's Certificate of Conformance and Certificate of Analysis, the form of which is attached as Schedule 4_.
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Quality Control and Regulatory Compliance 
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Related to Quality Control and Regulatory Compliance

  • Legal and Regulatory Compliance The issuance of Shares shall be subject to compliance with all applicable requirements of federal, state or foreign law with respect to such securities. If at any time the Company determines, in its discretion, that the listing, registration or qualification of the Shares upon any securities exchange or under any state or federal law, or the consent or approval of any governmental regulatory authority is necessary as a condition to the issuance of Shares to Participant (or his or her estate), such issuance will not occur unless and until such listing, registration, qualification, consent or approval will have been effected or obtained free of any conditions not acceptable to the Company. If the Company determines that the issuance of any Shares will violate federal securities laws or other applicable laws or regulations or the requirements of any exchange or market system upon which the Shares are listed, the Company may defer issuance until the earliest date at which the Company reasonably anticipates that the issuance of Shares will no longer cause such violation. The Company will make all reasonable efforts to meet the requirements of any such state or federal law or securities exchange and to obtain any such consent or approval of any such governmental authority, but the inability of the Company to obtain from any regulatory body having jurisdiction the authority, if any, deemed by the Company’s legal counsel to be necessary to the lawful issuance of any Shares shall relieve the Company of any liability in respect of the failure to issue such Shares as to which such requisite authority shall not have been obtained. As a condition to the issuance of Shares, the Company may require Participant to satisfy any qualifications that may be necessary or appropriate, to evidence compliance with any applicable law or regulation and to make any representation or warranty with respect thereto as may be requested by the Company.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials conducted by the Company, and to the knowledge of the Company, the preclinical tests and clinical trials conducted on behalf of or sponsored by the Company, that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such Permits as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

  • Regulatory Compliance a. Monitor compliance with the 1940 Act requirements, including:

  • Regulatory Compliance Cooperation (a) CIT/VC agrees to use commercially reasonable best efforts to avoid the occurrence of a Regulatory Problem. In the event that CIT/VC determines that it has a Regulatory Problem, the Company agrees to use commercially reasonable efforts to take all such actions as are reasonably requested by CIT/VC in order (A) to effectuate and facilitate any transfer by CIT/VC of any Securities of the Company then held by CIT/VC to any Person designated by CIT/VC (subject, however, to compliance with Section 3 of this Agreement), (B) to permit CIT/VC (or any Affiliate of CIT/VC) to exchange all or any portion of the voting Securities of the Company then held by such Person on a share-for-share basis for shares of a class of non-voting Securities of the Company, which non-voting Securities shall be identical in all respects to such voting Securities, except that such new Securities shall be non-voting and shall be convertible into voting Securities on such terms as are requested by CIT/VC in light of regulatory considerations then prevailing, and (C) to continue and preserve the respective allocation of the voting interests with respect to the Company arising out of CIT/VC's ownership of voting Securities of the Company and/or provided for in this Agreement before the transfers and amendments referred to above (including entering into such additional agreements as are requested by CIT/VC to permit any Person(s) designated by CIT/VC to exercise any voting power which is relinquished by CIT/VC upon any exchange of voting Securities for nonvoting Securities of the Company); and the Company shall enter into such additional agreements, adopt such amendments to this Agreement, the Company's Charter and the Company's By-laws and other relevant agreements and taking such additional actions, in each case as are reasonably requested by CIT/VC in order to effectuate the intent of the foregoing. If CIT/VC elects to transfer Securities of the Company to a Regulated Holder in order to avoid a Regulatory Problem, the Company shall enter into such agreements with such Regulated Holder as it may reasonably request in order to assist such Regulated Holder in complying with applicable laws, and regulations to which it is subject. Such agreements may include restrictions on the 39. redemption, repurchase or retirement of Securities of the Company that would result or be reasonably expected to result in such Regulated Holder holding more voting securities or total securities (equity and debt) than it is permitted to hold under such laws and regulations.

  • Quality Control A. Controlled Affiliate agrees to use the Licensed Marks and Name only in connection with the licensed services and further agrees to be bound by the conditions regarding quality control shown in attached Exhibit A as they may be amended by BCBSA from time-to-time.

  • FDA Compliance The Company: (A) is and at all times has been in material compliance with all statutes, rules or regulations of the FDA and other comparable governmental entities applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”); (B) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any governmental entity alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such Authorizations; (D) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA or any governmental entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) has not received notice that the FDA or any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity is considering such action; and (F) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).

  • Information for Regulatory Compliance Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities.

  • Compliance Control Services (1) Support reporting to regulatory bodies and support financial statement preparation by making the Fund's accounting records available to the Trust, the Securities and Exchange Commission (the “SEC”), and the independent accountants.

  • General Compliance This Agreement is intended to comply with Section 409A or an exemption thereunder and shall be construed and administered in accordance with Section 409A. Notwithstanding any other provision of this Agreement, payments provided under this Agreement may only be made upon an event and in a manner that complies with Section 409A or an applicable exemption. Any payments under this Agreement that may be excluded from Section 409A either as separation pay due to an involuntary separation from service or as a short-term deferral shall be excluded from Section 409A to the maximum extent possible. For purposes of Section 409A, each installment payment provided under this Agreement shall be treated as a separate payment. Any payments to be made under this Agreement upon a termination of employment shall only be made upon a “separation from service” under Section 409A. Notwithstanding the foregoing, the Company makes no representations that the payments and benefits provided under this Agreement comply with Section 409A, and in no event shall the Company be liable for all or any portion of any taxes, penalties, interest, or other expenses that may be incurred by the Executive on account of non-compliance with Section 409A.

  • SAFE Compliance The Company shall comply with the SAFE Rules and Regulations, and shall use commercially reasonable efforts to cause its shareholders and option holders that are, or that are directly or indirectly owned or controlled by, PRC residents or PRC citizens, to comply with the SAFE Rules and Regulations applicable to them in connection with the Company, including without limitation, requesting each shareholder and option holder, that is, or is directly or indirectly owned or controlled by, a PRC resident or PRC citizen to complete any registration and other procedures required under applicable SAFE Rules and Regulations.

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