FDA Authorization Clause Samples

FDA Authorization. The Cue Products have not been FDA cleared or approved, but the Cue COVID-19 Test for Home and Over The Counter (OTC) Use and the Cue COVID-19 Test for Professional Use have been authorized by the FDA under an Emergency Use Authorization (“EUA”). Such products have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of such products is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
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FDA Authorization. 6.1 Softheart shall have full responsibility for obtaining FDA 510(k) authorization of the use of the Windows Upgrade as part of or in connection with ART products, if necessary. It is presently contemplated that a "letter to file" and the associated documentation will be adequate to retain the current FDA authorization. However, in the event that a new 510(k) becomes necessary, Softheart will prepare the application and provide whatever further information the FDA may require. All out-of-pocket expenses shall be paid or reimbursed by ART upon presentation of adequate documentation. To the extent that FDA compliance requires a commitment of time by Softheart beyond that which is necessary for 510(k) authorization, the parties shall negotiate a new fee arrangement for the FDA aspect of this Agreement only and ART shall be entitled to recoup its fees and expenses at the rate of $2,000 per unit for products sold, other than Coronary Reporting and Inventory programs, as provided in Paragraph 3 of Exhibit B of the License Agreement. 6.2 Softheart shall indemnify ART to the extent described in this Paragraph 6.2 for any and all liability, loss, expenses (including, but not limited to, attorneys' fees), actions or damages of any kind or nature incurred by ART as a result of any claim or proceeding against ART by any person not a party to this Agreement or any governmental authority (including the FDA) which claim or proceeding is based in whole or in part on an allegation that the use of the Windows Upgrade violates the Medical Device Amendments to the Food, Drug and Cosmetic Act, or any rules, regulations or orders promulgated or issued thereunder, but only to the extent that such claim or proceeding is based on a finding by the FDA that the sale or marketing of the Windows Upgrade violates such Medical Device Amendments; provided ART promptly notifies Softheart of any such claim or proceeding in writing and gives Softheart the opportunity to defend or settle any such claim or proceeding. If Softheart successfully defends or settles such claim, it shall have no further liability under this Paragraph 6.
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FDA Authorization. The Company and its subsidiaries (i) have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other written notice from the U.S. Food and Drug Administration (the “FDA”) or any other similar federal, state, local or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Health Care Laws (defined below) or with respect to any licenses, certificates approvals, clearances, authorizations, exemptions, permits or supplements or amendments thereto required by any Health Care Laws to conduct the business of the Company and its subsidiaries as described in Pricing Disclosure Package (collectively, “Authorizations”); (ii) possess all applicable Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor its subsidiaries is in violation of any such Authorizations except where such violation would not, singly or in the aggregate, have a Material Adverse Effect; (iii) have not received written notice of any pending or completed claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other federal, state, local or foreign governmental or regulatory authority or third party alleging that any product, operation, or activity of the Company is in material violation of any Health Care Laws or Authorizations and neither the Company nor its subsidiaries has any knowledge that the FDA or any other federal, state, local or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (iv) have not received written notice that the FDA or any other federal, state, local or foreign governmental or regulatory authority has taken, is taking or intends to take action to suspend, or revoke any material Authorizations and has no knowledge that the FDA or any other federal, state, local or foreign governmental or regulatory authority is considering such action; and (v) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions, information and supplements or amendments as required by any Health Care Laws or Authorizations and all such reports, documents, forms, notices, applications, records, claims, submissions, information and supplements or amendments were materially true, complete and correct on the date filed (o...
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FDA Authorization. The Company and its subsidiaries (i) have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other written notice from the U.S. Food and Drug Administration (the “FDA”) or any other similar federal, state, local or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Health Care Laws (defined below) or with respect to any licenses, certificates approvals, clearances, authorizations, exemptions, permits or supplements or amendments thereto required by any Health Care Laws to conduct the business of the Company and its subsidiaries as described in Pricing Disclosure Package (collectively, “Authorizations”); (ii) possess all applicable Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor its subsidiaries is in violation of any such Authorizations except where such violation would not, singly or in the aggregate, have a Material Adverse Effect; (iii) have not received written notice of any pending or completed claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other federal, state, local or foreign governmental or regulatory authority or third party alleging that any product, operation, or activity of the Company is in material violation of any Health Care Laws or Authorizations and neither the Company nor its subsidiaries has any knowledge that the FDA or any other federal, state, local or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (iv) have not received written notice that the FDA or any other federal, state, local or foreign governmental or regulatory authority has taken, is taking or intends to take action to suspend, or revoke any material Authorizations and has no knowledge that the FDA or any other federal, state, local or foreign governmental or regulatory authority is considering such action; and (v) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions, information and supplements or amendments as required by any Health Care Laws or Authorizations and all such reports, documents, forms, notices, applications, records, claims, submissions, information and supplements or amendments were materially true, complete and correct on the date filed (o...
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Related to FDA Authorization

  • Power; Authorization Such Investor has all requisite power and authority to execute and deliver this Agreement. This Agreement, when executed and delivered by such Investor, will constitute a valid and legally binding obligation of such Investor, enforceable in accordance with its respective terms, except as: (a) limited by applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally; and (b) limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies.

  • Prior Authorization A determination to authorize a Provider’s request, pursuant to services covered in the MississippiCAN Program, to provide a service or course of treatment of a specific duration and scope to a Member prior to the initiation or continuation of the service.

  • Network Authorization For services that cannot be provided by a network provider, you can request a network authorization to seek services from a non-network provider. With an approved network authorization, the network benefit level will apply to the authorized covered healthcare service. If we approve a network authorization for you to receive services from a non- network provider, our reimbursement will be based on the lesser of our allowance, the non-network provider’s charge, or the benefit limit. For more information, please see the How Non-Network Providers Are Paid section.

  • LEGAL AUTHORIZATION (a) The Sub-Recipient certifies that it has the legal authority to receive the funds under this Agreement and that its governing body has authorized the execution and acceptance of this Agreement. The Sub-Recipient also certifies that the undersigned person has the authority to legally execute and bind Sub-Recipient to the terms of this Agreement.

  • WORK AUTHORIZATIONS The State will issue work authorizations using the form included in Attachment D (Work Authorizations and Supplemental Work Authorizations) to authorize all work under this contract. The Engineer must sign and return a work authorization within seven (7) working days after receipt. Refusal to accept a work authorization may be grounds for termination of the contract. The State shall not be responsible for actions by the Engineer or any costs incurred by the Engineer relating to work not directly associated with or prior to the execution of a work authorization. Terms and conditions governing the use of work authorizations are set forth in Attachment A, General Provisions, Article 1.