FDA Reports Sample Clauses

FDA Reports. The Company and Gemini shall have received a report(s) from the U.S. Department of Health and Human Services Food and Drug Administration ("FDA") consultants selected by them regarding the FDA approval of certain products of Isolagen and such report(s) shall be satisfactory to them in their sole discretion.
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FDA Reports. Beginning on the date of this Agreement, each party ----------- shall provide to the other the same information that is required to be submitted to FDA pursuant to 21 CFR 314.80 so that the other party may meet the time frames for reporting such information set forth therein. Moreover, within sixty (60) days after the end of every calendar quarter during the term of this Agreement, each party shall also provide the other with a summary of safety data, including, but not limited to, clinical safety data and reports of adverse drug reactions, if any.
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FDA Reports. Both ICU and BBM shall comply with all Medical ----------- Device Reporting requirements of the Safe Medical Devices Act of 1990 and the regulations promulgated thereunder. The parties shall consult with each other prior to the submission of any Medical Device Report and unless restricted by applicable law, each party shall use its reasonable efforts to provide the other with a copy of each Medical Device Report related to the CLAVE Product to be submitted by a party to the FDA at least two business days prior to the submission. [*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
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FDA Reports. Together with the delivery of any Financial Statements delivered pursuant to Section 6.1(b) or (c) (Financial Statements), the Borrower agrees to provide summaries to the Administrative Agent regarding the regulatory status of the Borrower’s and each of its Subsidiaries’ medical device products and a Responsible Officer of the Borrower shall certify to the Administrative Agent that the quality system of the Borrower and its Subsidiaries complies with all applicable Requirements of Law of the FDA and that no material adverse finding resulted from any inspection or audit conducted by the Borrower or any of its Subsidiaries regarding their quality systems. Such summaries will contain information regarding the status of PMA and 510(k) submissions; the status of agency actions regarding such submissions (denial, withdrawal, etc.); the termination or suspension of marketing of any of the Borrower’s or any of its Subsidiaries’ medical device products; the results of FDA inspections of the Borrowers’ and each of its Subsidiaries’ manufacturing facilities. The Borrower shall, and shall cause each of its Subsidiaries to, provide the Administrative Agent timely access to all available documentation relating to any of the foregoing information, including summaries containing information regarding the results of any internal inspections and audits conducted by the Borrower or any of its Subsidiaries regarding its medical device products.
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FDA Reports. Promptly upon receipt from FDA, a copy of each inspection report received from FDA and responses from and to FDA.
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Related to FDA Reports

  • Progress Reports 8. Within 30 days after the end of each calendar quarter following the date of this Agreement, the board of directors shall submit to the Reserve Bank written progress reports detailing the form and manner of all actions taken to secure compliance with the provisions of this Agreement and the results thereof, and a parent company only balance sheet, income statement, and, as applicable, report of changes in stockholders’ equity. Approval and Implementation of Plan

  • ERISA Reports Upon request by Lender, copies of any annual report to be filed pursuant to the requirements of ERISA in connection with each plan subject thereto; and

  • Research Reports Distributor acknowledges that Dealer may prepare research reports relating to the Fund that are not to be used for marketing purposes (“Research Reports”). Distributor hereby authorizes Dealer to use the name of the Fund, Distributor and BAAM in Research Reports.

  • Reports The Depositary shall make available for inspection by Owners at its Office any reports and communications, including any proxy solicitation material, received from the Company which are both (a) received by the Depositary as the holder of the Deposited Securities and (b) made generally available to the holders of those Deposited Securities by the Company. The Company shall furnish reports and communications, including any proxy soliciting material to which this Section applies, to the Depositary in English, to the extent those materials are required to be translated into English pursuant to any regulations of the Commission.

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

  • Final Reports Within ninety (90) days of receipt of the Required Documents, the Asset Representations Reviewer shall publish its findings to the Sponsor and the Indenture Trustee. The Asset Representations Reviewer shall provide the Sponsor and the Indenture Trustee with the following reports as a result of the Asset Representations Review (collectively, the “Final Reports”):

  • Inspection; Reports (a) The Shipowner will at all reasonable times afford the Mortgagee or its authorized representatives full and complete access to the Vessel for the purpose of inspecting the Vessel and her cargo and papers, including without limitation all records pertaining to the Vessel’s maintenance and repair, and, at the request of the Mortgagee, the Shipowner will deliver for inspection copies of any and all contracts and documents relating to the Vessel, whether on board or not.

  • Records Reports To maintain records and to prepare and file reports required by law to be filed by the Trustee or required by agreement with the Company or by this Trust Agreement;

  • Sales Reports (a) After the First Commercial Sale of a Drug Product, Vertex shall furnish or cause to be furnished to CFFT on a quarterly basis a written report or reports covering each calendar quarter (each such calendar quarter being sometimes referred to herein as a “reporting period”) within sixty days after the close of each quarter showing, for Net Sales in the Field and, separately, for Net Sales outside the Field, (i) the Net Sales of each Drug Product in each country in the world during the reporting period by Vertex and each Affiliate, licensee and sublicensee; (ii) the royalties, payable in U.S. dollars (“Dollars”), which shall have accrued under Section 5.3 hereof in respect of such sales and the basis of calculating those royalties; (iii) withholding taxes, if any, required by law to be deducted from any royalties payable in respect of any such sales; (iv) the exchange rates used in converting into Dollars, from the currencies in which sales were made, any payments due which are based on Net Sales; and (v) dispositions of Drug Products other than pursuant to sale for cash. With respect to sales of Drug Products invoiced in Dollars, the Net Sales amounts and the amounts due to CFFT hereunder shall be expressed in Dollars. With respect to sales of Drug Products invoiced in a currency other than Dollars, the Net Sales and amounts due to CFFT hereunder shall be expressed in the domestic currency of the party making the sale, together with the Dollar equivalent of the amount payable to CFFT, calculated by translating foreign currency sales into U.S. dollars based on the average of the exchange rates reported in The Wall Street Journal or comparable publication over the period covered by the royalty report. If any licensee or sublicensee makes any sales invoiced in a currency other than its domestic currency, the Net Sales shall be converted to its domestic currency in accordance with the licensee’s or sublicensee’s normal accounting principles. Vertex shall furnish to CFFT appropriate evidence of payment of any tax or other amount required by applicable laws or regulations to be deducted from any royalty payment payable by Vertex to CFFT pursuant to this Agreement, including any tax or withholding levied by a foreign taxing authority in respect of the payment or accrual of any royalty. Reports shall be due on the thirtieth (30th) day following the close of each reporting period, although Vertex shall also provide CFFT with a “flash” report of Net Sales, only, within ten (10) business days after the end of each month. Vertex shall keep accurate records in sufficient detail to enable the amounts due hereunder to be determined and to be verified by CFFT.

  • Financial Statements, Reports Provide Bank with the following by submitting to the Financial Statement Repository or otherwise submitting to Bank:

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