Changes by Regulatory Authorities. The parties agree that any changes required by regulatory authority, shall be incorporated into the Product as evidenced by the written approval of COMPANY via a CCR prior to such incorporation. At the time of such incorporation, such changes shall become part of the Specifications. If DPT is required by regulatory authority to perform validation studies for purposes of validating new manufacturing process or cleaning procedures or new material and finished Product assay procedures with respect to Product in order to continue to engage in the manufacture of said Product for COMPANY, such studies shall be conducted in accordance with paragraph 5.3 herein. Any costs to DPT resulting from the operation of this paragraph shall be reimbursed by COMPANY.
Changes by Regulatory Authorities. If BLP is required by a regulatory authority to perform validation studies for purposes of validating new manufacturing procedures, new Raw Material or finished Product assay procedures with respect to a Product, in each case which are unique to the manufacture of the Product, in order to continue to engage in the manufacture of the Product for ISTA, BLP shall promptly provide ISTA with notice that such validation studies are required, such notice to include an estimate of all related validation study expenses. ISTA shall notify BLP whether it desires BLP to continue manufacturing the Product, and all direct expenses borne by BLP and pre-approved by ISTA in writing in the conduct of any such validation study shall be reimbursed to BLP by ISTA as incurred.
Changes by Regulatory Authorities. The parties agree that any changes required by regulatory authority, shall be incorporated into the Product as evidenced by the written approval of Connetics via a PCR prior to such incorporation. At the time of such incorporation, such changes shall become part of the Specifications. If DPT is required by regulatory authority to perform validation studies for purposes of validating new manufacturing process or cleaning procedures or new material and finished Product assay procedures with respect to Product in order to continue to engage in the manufacture of said Product for Connetics, such studies shall be conducted in accordance with SECTION 6.3 in this Agreement. Any costs to DPT resulting from the operation of this Section shall be reimbursed by Connetics.
Changes by Regulatory Authorities. DPT agrees that any changes required by regulatory authority, shall be incorporated into the Product as evidenced by the written approval of COMPANY via a PCR prior to such incorporation. At the time of such incorporation, such changes shall become part of the Specifications and such revised Specifications ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. must be approved in writing by COMPANY before they are implemented. If, as a result of such change, DPT is required by a regulatory authority to perform validation studies for purposes of validating new manufacturing process or cleaning procedures or new raw material and finished Product assay procedures with respect to Product in order to continue to engage in the manufacture of said Product for COMPANY, such studies shall be conducted in accordance with paragraph 5.3 herein. Due to said changes the parties shall mutually agree upon an adjustment to the price of Product, if necessary, and Schedule A shall be amended accordingly.
Changes by Regulatory Authorities. Upshxx-Xxxxx xxxees that any changes required by any regulatory authority shall be incorporated into the Product as evidenced by the written approval of Ascent via a PCR prior to such incorporation. At the time of such incorporation, such changes shall become part of the Specifications. If Upshxx-Xxxxx xx required by any regulatory authority to perform validation studies for purposes of validating a new manufacturing process or cleaning procedures or new raw material and finished Product assay procedures with respect to Product in order to continue to engage in the manufacture of such Product for Ascent, such studies shall be conducted in accordance with Section 5.3 herein. In the event of such changes, Upshxx-Xxxxx xxxll adjust the price of Product, if necessary, and Schedule D shall be amended accordingly.
Changes by Regulatory Authorities. The parties agree that any changes required by a regulatory authority, shall be incorporated into the Product as evidenced by the written approval of AUXILIUM via a change control prior to such incorporation. At the time of such incorporation, such changes shall become part of the Specifications. If DPT is required by a regulatory authority to perform validation studies for purposes of validating new manufacturing process or cleaning procedures or new material and finished Product assay procedures with respect to Product in order to continue to engage in the manufacture of said Product for AUXILIUM, DPT and AUXILIUM will enter into good faith negotiations regarding how such studies will be conducted. In the event the parties cannot come to an agreement, such matter will be resolved in accordance with paragraph 12.6. In the event a regulatory authority required change is (i) specific to Product, AUXILIUM shall be responsible for the costs associated with such change; or (ii) not specific to Product, DPT shall be responsible for the costs associated with such change.
Changes by Regulatory Authorities. If B&L is required by a regulatory authority to perform validation studies for purposes of validating new manufacturing procedures or new raw material and finished product assay procedures with respect to a Product in order to continue to engage in the manufacture of the Product for AERIE (and AERIE, after notice that such validation studies are required, and upon notice to AERIE of an estimate of all related validation study expenses, desires B&L to continue manufacturing the Product), all direct expenses borne by B&L in the conduct of any such validation study shall be reimbursed to B&L by AERIE as incurred. D. Regulatory Responsibility. AERIE will responsible for all regulatory submissions and correspondence with the FDA related to the Product. B&L will be responsible for providing AERIE, as needed, with documentation typically included in the Chemistry, Manufacturing & Controls (CMC) section of regulatory submissions, for the preparation of regulatory submissions. 6. Inspections and Manufacturing Compliance A. Inspections by AERIE. Representatives from AERIE shall be permitted access, at reasonable times during B&L’s normal business hours and upon reasonable advance notice to B&L, to visit, in the company of a B&L representative, the manufacturing and/or packaging facility or facilities where AERIE’s Product will be or are being manufactured and/or packaged for the purposes of auditing B&L’s processes to ensure that AERIE’s Product are being manufactured, packaged, stored and handled in accordance with the mutually agreed upon product specifications, cGMP’s and applicable laws, rules and regulations.
Changes by Regulatory Authorities. If BLP is required by a regulatory authority to perform validation studies for purposes of validating new manufacturing procedures or new raw material and finished product assay procedures with respect to a Product in order to continue to engage in the manufacture of the Product for AHC (and AHC, after notice that such validation studies are required, and upon notice to AHC of an estimate of all related validation study expenses, desires BLP to continue manufacturing the Product), all direct expenses borne by BLP in the conduct of any such validation study shall be reimbursed to BLP by AHC as incurred.
6. Inspections and Manufacturing Compliance
A. Inspections by AHC. Representatives from AHC shall be permitted access, at reasonable times during BLP's normal business hours and upon reasonable advance notice to BLP, to visit, in the company of a BLP representative, the manufacturing and/or packaging facility or facilities where AHC's Product will be or are being manufactured and/or packaged for the purposes of auditing BLP's processes to ensure that AHC's Product are being manufactured, packaged, stored and handled in accordance with the mutually agreed upon product specifications, cGMP's and applicable laws, rules and regulations.
B. Inspection by Regulatory Agencies. Duly authorized representative(s) from the FDA or other applicable regulatory agencies shall be permitted access, at reasonable times during BLP's normal business hours, to visit, in the company of a BLP representative, the manufacturing and/or packaging facility or facilities where the Product will be or are being manufactured and/or packaged for the purposes of auditing BLP's processes to ensure that the Product are being manufactured, packaged, stored and handled in accordance with the Product Specifications, cGMP's and applicable laws, rules and regulations. BLP shall, at its own expense, promptly respond to AMERXSA.DOC 11/21/97 -4- all inquiries and questions resulting from such visits and inspections and, at its own expense, promptly correct any deficiencies reported as a result of such inspections. BLP shall immediately notify AHC if an authorized agent of the FDA or other governmental agency visits BLP's manufacturing facility for the purposes of inspecting the manufacturing and testing of Amerx. Health Care Corporation's Products.
Changes by Regulatory Authorities. If B&L is required by a regulatory authority to perform validation studies for purposes of validating new manufacturing procedures or new raw material and finished product assay procedures with respect to a Product in order to continue to engage in the manufacture of the Product for AERIE (and AERIE, after notice that such validation studies are required, and upon notice to AERIE of an estimate of all related validation study expenses, desires B&L to continue manufacturing the Product), all direct expenses borne by B&L in the conduct of any such validation study shall be reimbursed to B&L by AERIE as incurred.
Changes by Regulatory Authorities. HARMONY agrees that any changes required by regulatory authority, shall be incorporated into the Product as evidenced by the written approval of SIRIUS via a PCR prior to such incorporation. At the time of such incorporation, such changes shall become part of the Specifications. If HARMONY is required by regulatory authority to perform validation studies for purposes of validating new manufacturing process or cleaning procedures or new raw material and finished Product assay procedures with respect to Product in order to continue to engage in the manufacture of said Product for SIRIUS, such studies shall be conducted in accordance with paragraph 5.3 herein. Due to said changes, HARMONY shall [c.i.]. Such [c.i.] shall be [c.i.] which shall not be [c.i.] and, if necessary, Schedule A shall be amended accordingly.
