Common use of Regulatory correspondence and Inspections Clause in Contracts

Regulatory correspondence and Inspections. Catalytica shall promptly inform ORPHAN of any regulatory correspondence or inspection with respect to Catalytica’s manufacture of the Product as follows: (a) Catalytica shall provide ORPHAN with copies of any correspondence and other documentation received or prepared by Catalytica in connection with the manufacture and testing of the Product in the Territory, including, but not limited to, copies of the proposed NDA (but only of those portions for which Catalytica is responsible) and of the potential DMF for the Product and of annual submissions to the FDA and other regulatory authorities in the Territory. Copies of all such correspondence or other documentation prepared by Catalytica shall be reviewed and approved by ORPHAN prior to its submission, such approval not to be unreasonably withheld. (b) If Catalytica receives any regulatory correspondence or comments from any federal, state, or local regulatory agency related to its manufacture of the Product, or affecting the Product, requiring a response or action by Catalytica, including, without limitation, receipt of an FDA Form 483 (Inspectional Observations) or an FDA “Warning Letter”, Catalytica shall immediately provide ORPHAN with a copy of each such regulatory correspondence or comment and a copy of Catalytica’s proposed response thereto for ORPHAN’S review and approval (such approval not to be unreasonably withheld or delayed) prior to its submission if Catalytica’s manufacture of additional products are not involved. In cases where Catalytica’s manufacture of additional products are involved, a good faith effort will be made to reach joint approval within an appropriate timeframe. (c) If Catalytica’s manufacturing facility is inspected by representatives of any federal, state, or local regulatory agency in connection with Catalytica’s manufacture of the Product, including, but not limited to, any pre-NDA approval inspection by the FDA, Catalytica shall notify ORPHAN within one (1) working day (by telephone and, if possible, by fax or letter) upon learning of such inspection, and shall supply ORPHAN with copies of any correspondence or portions of correspondence which relate to such regulatory inspection. ORPHAN may send representatives to Catalytica’s manufacturing facility to observe any portion of such regulatory inspection relating to the Product.

Regulatory correspondence and Inspections. Catalytica Supplier shall promptly inform ORPHAN of any regulatory correspondence or inspection with respect to CatalyticaSupplier’s manufacture of the Product Drug as follows: (a) Catalytica Supplier shall provide ORPHAN with copies of any correspondence and other documentation received or prepared by Catalytica Supplier in connection with the manufacture and testing of the Product Drug in the Territory, including, but not limited to, copies of the proposed NDA (but only of those portions for which Catalytica Supplier is responsible) and of the potential DMF for the Product Drug and of annual submissions to the FDA and other regulatory authorities in the Territory. Copies of all such correspondence or other documentation prepared by Catalytica Supplier shall be reviewed and approved by ORPHAN prior to its submission, such approval not to be unreasonably withheld. (b) If Catalytica Supplier receives any regulatory correspondence or comments from any federal, state, or local regulatory agency related to in connection with its manufacture of the Product, or affecting the Product, Drug requiring a response or action by CatalyticaSupplier, including, without limitation, receipt of an FDA Form 483 (Inspectional Observations) or an FDA “Warning Letter”, Catalytica Supplier shall immediately provide ORPHAN with a copy of each such regulatory correspondence or comment and a copy of CatalyticaSupplier’s proposed response thereto for ORPHAN’S review and approval (such approval not to be unreasonably withheld or delayed) prior to its submission if CatalyticaSupplier’s manufacture of additional products are not involved. In cases where CatalyticaSupplier’s manufacture of additional products are involved, a good faith effort will be made to reach joint approval within an appropriate timeframe. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. (c) If CatalyticaSupplier’s manufacturing facility is inspected by representatives of any federal, state, or local regulatory agency in connection with CatalyticaSupplier’s manufacture of the ProductDrug, including, but not limited to, any pre-NDA approval inspection by the FDA, Catalytica Supplier shall notify ORPHAN within one (1) working day [ * ] (by telephone and, if possible, by fax or letter) upon learning of such inspection, and shall supply ORPHAN with copies of any correspondence or portions of correspondence which relate to such regulatory inspection. ORPHAN may send representatives to CatalyticaSupplier’s manufacturing facility to observe any portion of such regulatory inspection relating to the ProductDrug.

Regulatory correspondence and Inspections. Catalytica shall promptly inform ORPHAN of any regulatory correspondence or inspection with respect to Catalytica’s manufacture of the Product as follows: (a) Catalytica shall provide ORPHAN with copies of any correspondence and other documentation received or prepared by Catalytica in connection with the manufacture and testing of the Product in the Territory, including, but not limited to, copies of the proposed NDA (but only of those portions for which Catalytica is responsible) and of the potential DMF for the Product and of annual submissions to the FDA and other regulatory authorities in the Territory. Copies of all such correspondence or other documentation prepared by Catalytica shall be reviewed and approved by ORPHAN prior to its submission, such approval not to be unreasonably withheld. (b) If Catalytica receives any regulatory correspondence or comments from any federal, state, or local regulatory agency related to its manufacture of the Product, or affecting the Product, requiring a response or action by Catalytica, including, without limitation, receipt of an FDA Form 483 (Inspectional Observations) or an FDA “Warning Letter”, Catalytica shall immediately provide ORPHAN with a copy of each such regulatory correspondence or comment and a copy of Catalytica’s proposed response thereto for ORPHAN’S review and approval (such approval not to be unreasonably withheld or delayed) prior to its submission if Catalytica’s manufacture of additional products are not involved. In cases where Catalytica’s manufacture of additional products are involved, a good faith effort will be made to reach joint approval within an appropriate timeframe. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. (c) If Catalytica’s manufacturing facility is inspected by representatives of any federal, state, or local regulatory agency in connection with Catalytica’s manufacture of the Product, including, but not limited to, any pre-NDA approval inspection by the FDA, Catalytica shall notify ORPHAN within one (1) working day (by telephone and, if possible, by fax or letter) upon learning of such inspection, and shall supply ORPHAN with copies of any correspondence or portions of correspondence which relate to such regulatory inspection. ORPHAN may send representatives to Catalytica’s manufacturing facility to observe any portion of such regulatory inspection relating to the Product.

Regulatory correspondence and Inspections. Catalytica Supplier shall promptly inform ORPHAN of any regulatory correspondence or inspection with respect to CatalyticaSupplier’s manufacture of the Product Drug as follows: (a) Catalytica Supplier shall provide ORPHAN with copies of any correspondence and other documentation received or prepared by Catalytica Supplier in connection with the manufacture and testing of the Product Drug in the Territory, including, but not limited to, copies of the proposed NDA (but only of those portions for which Catalytica Supplier is responsible) and of the potential DMF for the Product Drug and of annual submissions to the FDA and other regulatory authorities in the Territory. Copies of all such correspondence or other documentation prepared by Catalytica Supplier shall be reviewed and approved by ORPHAN prior to its submission, such approval not to be unreasonably withheld. (b) If Catalytica Supplier receives any regulatory correspondence or comments from any federal, state, or local regulatory agency related to in connection with its manufacture of the Product, or affecting the Product, Drug requiring a response or action by CatalyticaSupplier, including, without limitation, receipt of an FDA Form 483 (Inspectional Observations) or an FDA “Warning Letter”, Catalytica Supplier shall immediately provide ORPHAN with a copy of each such regulatory correspondence or comment and a copy of CatalyticaSupplier’s proposed response thereto for ORPHAN’S review and approval (such approval not to be unreasonably withheld or delayed) prior to its submission if CatalyticaSupplier’s manufacture of additional products are not involved. In cases where CatalyticaSupplier’s manufacture of additional products are involved, a good faith effort will be made to reach joint approval within an appropriate timeframe. (c) If CatalyticaSupplier’s manufacturing facility is inspected by representatives of any federal, state, or local regulatory agency in connection with CatalyticaSupplier’s manufacture of the ProductDrug, including, but not limited to, any pre-NDA approval inspection by the FDA, Catalytica Supplier shall notify ORPHAN within one (1) working day (by telephone and, if possible, by fax or letter) upon learning of such inspection, and shall supply ORPHAN with copies of any correspondence or portions of correspondence which relate to such regulatory inspection. ORPHAN may send representatives to CatalyticaSupplier’s manufacturing facility to observe any portion of such regulatory inspection relating to the ProductDrug.