FDA Authorization Sample Clauses

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 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”) but have not been FDA cleared or approved. 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. 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.

  • 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.

  • Work Authorization By entering into this Agreement, the Judicial Council only authorizes the Criteria Architect to begin its Work on the Phase indicated on the Coversheet of the Agreement. The Judicial Council has the sole and unilateral right to authorize additional Phases, however, those authorizations will be made in the form of an amendment pursuant to this Agreement, authorizing the appropriate Phase and funding specified herein, which must be executed by the Criteria Architect and the Judicial Council. Work for additional Phases added to the Agreement by amendment will be authorized using Notice to Proceed. Criteria Architect is not authorized to begin any work or services marked “NYA” (Not Yet Authorized).

  • Required Authorizations There is no requirement to make any filing with, give any notice to, or obtain any Authorization of, any Governmental Entity as a condition to the lawful completion of the transactions contemplated by this Agreement.

  • Regulatory Authorizations Each Party represents and warrants that it has, or applied for, all regulatory authorizations necessary for it to perform its obligations under this Agreement.

  • Government Authorization No consent, approval, order or authorization of, or registration, declaration or filing with, or notice to, any Governmental Entity, is required by or with respect to Pubco in connection with the execution and delivery of this Agreement by Pubco, or the consummation by Pubco of the transactions contemplated hereby, except, with respect to this Agreement, any filings under the Nevada Statutes, the Securities Act or the Exchange Act.

  • ACH Authorization Merchant authorizes Bank or its agents or designated representatives to initiate debit and credit entries and adjustments to the Settlement Account or the Reserve Account (described in Section 13 of the MPA) through the ACH settlement process for amounts due under the Merchant Agreement. This authorization will remain in full force and effect until termination of the Merchant Agreement and the full and final payment of all obligations of Merchant due under the Merchant Agreement. Merchant acknowledges and agrees that Bank will not be liable for any delays in receipt of funds, any failure by Merchant to receive funds, or errors in debit or credit entries caused by Merchant, or third parties, including but not limited to any Card Association or any financial institution.

  • Authorization; Approvals The issuance of the Policy and the execution, delivery and performance of this Agreement and the Insurance Agreement have been duly authorized by all necessary corporate proceedings. No further approvals or filings of any kind, including, without limitation, any further approvals of or further filings with any governmental agency or other governmental authority, or any approval of the Insurer’s board of directors or stockholders, are necessary for the Policy, this Agreement and the Insurance Agreement to constitute the legal, valid and binding obligations of the Insurer.

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