Changes for Regulatory Necessity Clause Samples

Changes for Regulatory Necessity. If the applicable Governmental Authorities in the Territory require a Manufacturing Change in order to permit Purchaser to use or sell Drug Product in Licensee Indications in the Territory, Purchaser shall immediately inform Amgen of the same in writing and provide Amgen any related information as reasonably requested by Amgen. Amgen shall use reasonably diligence efforts to implement the Manufacturing Change for Drug Product to be supplied hereunder, and the Parties shall discuss and cooperate in good faith to minimize the time for and disruption of such transition to Drug Product conforming to such Manufacturing Change; provided, however, that Amgen shall have the right to transition Purchaser to an alternate source of supply in accordance with Section 2.14 (Alternate Supply) at any time upon written notice given by Amgen to Purchaser. If Amgen elects to transition Purchaser to an alternate source of supply, the Parties shall cooperate to facilitate such transition so as to minimize disruption to the Parties and shall discuss in good faith the feasibility of Amgen providing transitional supply conforming to the Manufacturing Change until the transition obligations under Section 2.14 have been completed. In any case, Purchaser shall be responsible for all incremental costs incurred by Amgen (including Amgen FTEs at the FTE Rate) in developing and providing Drug Product in accordance with the Manufacturing Change.
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Related to Changes for Regulatory Necessity

  • 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.

  • Mechanisms for Cooperation Pursuant to Article 149 (Objectives), the Parties hereby establish a Committee on Cooperation comprising representatives of each Party.

  • GUIDELINES FOR REVIEWS We may provide you areas on the Site to leave reviews or ratings. When posting a review, you must comply with the following criteria: (1) you should have firsthand experience with the person/entity being reviewed; (2) your reviews should not contain offensive profanity, or abusive, racist, offensive, or hate language; (3) your reviews should not contain discriminatory references based on religion, race, gender, national origin, age, marital status, sexual orientation, or disability; (4) your reviews should not contain references to illegal activity; (5) you should not be affiliated with competitors if posting negative reviews; (6) you should not make any conclusions as to the legality of conduct; (7) you may not post any false or misleading statements; and (8) you may not organize a campaign encouraging others to post reviews, whether positive or negative. We may accept, reject, or remove reviews in our sole discretion. We have absolutely no obligation to screen reviews or to delete reviews, even if anyone considers reviews objectionable or inaccurate. Reviews are not endorsed by us, and do not necessarily represent our opinions or the views of any of our affiliates or partners. We do not assume liability for any review or for any claims, liabilities, or losses resulting from any review. By posting a review, you hereby grant to us a perpetual, non-exclusive, worldwide, royalty-free, fully-paid, assignable, and sublicensable right and license to reproduce, modify, translate, transmit by any means, display, perform, and/or distribute all content relating to reviews.

  • Medical Necessity We Cover benefits described in this Contract as long as the dental service, procedure, treatment, test, device, or supply (collectively, “service”) is Medically Necessary e.g. orthodontia. The fact that a Provider has furnished, prescribed, ordered, recommended, or approved the service does not make it Medically Necessary or mean that We have to Cover it. We may base Our decision on a review of: • Your dental records; • Our dental policies and clinical guidelines; • Dental opinions of a professional society, peer review committee or other groups of Physicians; • Reports in peer-reviewed dental literature; • Reports and guidelines published by nationally-recognized health care organizations that include supporting scientific data; • Professional standards of safety and effectiveness, which are generally-recognized in the United States for diagnosis, care, or treatment; • The opinion of health care professionals in the generally-recognized health specialty involved; • The opinion of the attending Providers, which have credence but do not overrule contrary opinions. Services will be deemed Medically Necessary only if: • They are clinically appropriate in terms of type, frequency, extent, site, and duration, and considered effective for Your illness, injury, or disease; • They are required for the direct care and treatment or management of that condition; • Your condition would be adversely affected if the services were not provided; • They are provided in accordance with generally-accepted standards of dental practice; • They are not primarily for the convenience of You, Your family, or Your Provider; • They are not more costly than an alternative service or sequence of services, that is at least as likely to produce equivalent therapeutic or diagnostic results; • When setting or place of service is part of the review, services that can be safely provided to You in a lower cost setting will not be Medically Necessary if they are performed in a higher cost setting. See the Utilization Review and External Appeal sections of this Contract for Your right to an internal Appeal and external appeal of Our determination that a service is not Medically Necessary.

  • Regulatory Consents The waiting period applicable to the consummation of the Merger under the HSR Act shall have expired or been earlier terminated.