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.
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.
FDA Reports. Promptly upon receipt from FDA, a copy of each inspection report received from FDA and responses from and to FDA.
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.
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.
