Governmental and Regulatory Inspections Clause Samples
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Governmental and Regulatory Inspections. BMS shall notify the Company immediately by telephone and in writing of any inspections conducted by any Governmental Entity of the premises where the Product is being manufactured, to the extent such inspection relates to the manufacture of the Product, and shall provide to *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. the Company copies of all correspondence, reports, notices, findings and other material pertinent to such inspections and that specifically relate to the Product. BMS may redact portions that do not specifically relate to the Product.
Governmental and Regulatory Inspections. BMSLC shall notify WC of any inspections by any governmental or regulatory authorities of the premises where the Product is being manufactured, to the extent such inspection relates to the manufacture of the Products, promptly after such inspection, and shall provide to WC copies of all correspondence, reports, notices, findings and other material pertinent to such inspections or otherwise relating to the production, use or sale of the Products (including all Form 483s), promptly after they are received or produced by or on behalf of BMSLC from or to the FDA or any other federal, state or foreign governmental or regulatory authority. All notices sent to WC pursuant to this Section shall be sent to the attention of the Senior Vice-President of Regulatory Affairs, Norm▇ ▇▇▇▇▇▇.
Governmental and Regulatory Inspections. The Supplier shall promptly notify the Recipient in accordance with the terms of this Agreement, of the outcome of each inspection conducted by any Governmental Authority of any Facilities to the extent such inspection directly pertains to the Supplied Product in the Territory. The Supplier shall provide any supporting documentation that the Recipient reasonably requires in connection with such outcome; provided that the Supplier may redact portions of any of the foregoing that do not specifically relate to Supplied Products in the Territory. The Recipient shall notify the Supplier within one (1) Business Day of each inspection conducted by a Governmental Authority and the outcome thereof to the extent such inspection directly pertains to the Supplied Products in the Territory.
Governmental and Regulatory Inspections. WSP shall notify WC of any inspections by any governmental or regulatory authorities of the premises where the Product is being manufactured, to the extent such inspection relates to the manufacture of the Products, promptly after such inspection, and shall provide to WC copies of all correspondence, reports, notices, findings and other material pertinent to such inspections or otherwise relating to the production, use or sale of the Products (including all Form 483s), promptly after they are received or produced by or on behalf of WSP from or to the FDA or any other federal, state or foreign governmental or regulatory authority. All notices sent to WC pursuant to this Section shall be sent to the attention of the Senior Vice-President of Regulatory Affairs, Norm▇ ▇▇▇▇▇▇.
Governmental and Regulatory Inspections. ▇▇▇▇ shall promptly notify Kos of any inspections by any Governmental Authorities of the premises where any Processing Activities are taking place, to the extent such inspection relates to the Processing Activities for the Licensed Products in the Territory, and shall provide Kos copies of all correspondence, reports, notices, findings and other material pertinent to such inspections (including all Form 483s) promptly after they are received or produced by or on behalf of ▇▇▇▇ from or to the FDA or any other Governmental Authority.
Governmental and Regulatory Inspections. BMS shall notify the Company of any inspections by any governmental or regulatory authorities of the premises where the Product is being manufactured, to the extent such inspection relates to the manufacture of the Products, promptly after such inspection, and shall provide to the Company copies of all correspondence, reports, notices, findings and other material pertinent to such inspections (including all Form 483s) promptly after they are received or produced by or on behalf of BMS from or to the FDA or any other federal, state or foreign governmental or regulatory authority. All notices sent to Gale▇ ▇▇▇dings PLC, 100 ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ ▇▇▇ention: Vice President Regulatory Affairs.
Governmental and Regulatory Inspections. NTP shall notify LMI of any inspections by a regulatory authority relating to the manufacturing, packaging and testing of Raw Materials supplied to LMI, within five (5) business days of the inspection. When Final Materials supplied to LMI are implicated in regulatory inspection findings, NTP will provide redacted copies of all correspondence, reports, notices, findings and any other material pertinent to such inspections or otherwise relating to the production, use, or sale of the LMI products.
Governmental and Regulatory Inspections. ▇▇▇▇ shall promptly notify ▇▇▇▇▇ of any inspections by any Governmental Authorities of the premises where any Processing Activities are taking place, to the extent such inspection relates to the Processing Activities for the Licensed Product, and shall provide ▇▇▇▇▇ copies of all correspondence, reports, notices, findings and other material pertinent to such inspections (including all Form 483s) promptly after they are received or produced by or on behalf of ▇▇▇▇ from or to the FDA or any other Governmental Authority. All notices shall be sent to ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇, Inc., ▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ Attention: Vice President Regulatory Affairs.
Governmental and Regulatory Inspections. Each Party will notify the other Party of any inspections by any Governmental Authorities of the premises where the Product is being manufactured, tested or stored, to the extent such inspection relates to the manufacture, storage or distribution of the Products, within five Business Days after such inspection, and will provide to the other Party copies of all Forms 483 or other similar notifications of observations relating to the production, testing, storage, use or sale of the Products, redacted as necessary with respect to any portions of the Form 483 not pertaining to the Products, within five Business Days after they are received by or on behalf of a Party from the FDA or any Governmental Authority. All notices sent to a Party pursuant to this Section 9.2 will be sent to such Party in accordance with the Quality Agreement.