Notice of Government Inspections. Each party agrees that, to the extent it becomes aware of the results, observations and/or outcome of any inspections or audits of the facilities or operations involved in the manufacture, processing, testing or packaging of the Products conducted by governmental agencies, including without limitation the FDA, it will notify the other of any such information as it relates to the Products within three (3) days of obtaining the information. Each party will provide the other with copies of reports of quality audits conducted by it and will apprise the other of material manufacturing, marketing, promotion, sales or other issues affecting supply of the Products.
Notice of Government Inspections. Each Party agrees that, to the extent such Party becomes aware of the results, observations or outcome of any inspections or audits of the facilities or operations involved in the Manufacture or Commercialization of the Product conducted by a Regulatory Authority, such Party will notify the other Party of any such information as it directly relates to the Product within [**] Business Days after obtaining the information and shall provide the other Party with a copy of any written materials provided by the Regulatory Authority in connection with such inspection or audit. Each Party will provide the other with copies of reports of quality audits conducted by such Party with respect to the Product and will apprise the other Party of material Manufacture, marketing, promotion, sales, or other issues affecting supply or Commercialization of the Product.
Notice of Government Inspections. (a) NOVAVAX agrees that, to the extent it becomes aware of the results, observations and/or outcome of any inspections or audits of the facilities or operations involved in the manufacture, processing, testing or packaging of the Copromote Products conducted by governmental agencies, including without limitation the FDA, NOVAVAX will notify KING of any such information as it relates to the Copromote Products within three (3) days of obtaining the information. NOVAVAX will provide KING copies of reports of quality audits conducted by NOVAVAX and will apprise KING of material manufacturing issues affecting supply of the Copromote Products.
(b) KING agrees that, to the extent it becomes aware of the results, observations and/or outcome of any inspections or audits of the facilities or operations involved in the manufacture, processing, testing or packaging of the Copromote Products conducted by governmental agencies, including without limitation the FDA, KING will notify NOVAVAX of any such information as it relates to the Copromote Products within three (3) days of obtaining the information. KING will provide NOVAVAX copies of reports of quality audits conducted by KING and will apprise NOVAVAX of material manufacturing issues affecting supply of the Copromote Products.
Notice of Government Inspections. Each party agrees that it will (a) advise the other of any requests by any governmental agency for any inspections with respect to the manufacturing of Products, (b) provide the other with copies of any correspondence related thereto, and, to the extent it becomes aware of the results, observations and/or outcome of any inspections or audits of the facilities or operations involved in the manufacture, processing, testing or packaging of the Products conducted by governmental agencies, including the FDA, and (c) notify the other of any such information as it relates to the Products within three (3) days of obtaining the information.
Notice of Government Inspections. Each Party agrees that it will (a) advise the other Party of any requests by any Regulatory Authority for any inspections with respect to the manufacturing, storing, testing, packaging and labeling of Supplied Product, (b) provide the other Party with copies of any correspondence related thereto, and, to the extent it becomes aware of the results, observations or outcome of any inspections or audits of the facilities or operations involved in the manufacture, storage, testing, packaging or labeling of the Supplied Product conducted by any Regulatory Authority, including providing the other Party an opportunity to review and comment within three (3) Business Days with respect to any correspondence to be provided by such Party to the applicable Regulatory Authority, and (c) notify the other Party of any such information as it relates to the Supplied Product in the Territory within three (3) Business days of obtaining the information.
Notice of Government Inspections. (a) NOMOS agrees that, to the extent it becomes aware of the results, observations and/or outcome of any inspections or audits of the facilities or operations involved in the manufacture, processing, testing or packaging of the Copromote Products conducted by governmental agencies, NOMOS will notify NASI of any such information as it relates to the Copromote Products within three (3) days of obtaining the information. NOMOS will provide NASI copies of reports of quality audits conducted by NOMOS and will apprise NASI of material manufacturing issues affecting supply of the Copromote Products.
(b) NASI agrees that, to the extent it becomes aware of the results, observations and/or outcome of any inspections or audits of the facilities or operations involved in the manufacture, processing, testing or packaging of the Copromote Products conducted by governmental agencies, NASI will notify NOMOS of any such information as it relates to the Copromote Products within three (3) days of obtaining the information. NASI will provide NOMOS copies of reports of quality audits conducted by NASI and will apprise NOMOS of material manufacturing issues affecting supply of the Copromote Products.
Notice of Government Inspections. Each Party agrees that, to the extent such Party becomes aware of the results, observations or outcome of any inspections or audits of the facilities or operations involved in the Manufacture, processing, testing, packaging or commercialization of the Products conducted by a Governmental Authority, including the FDA, such Party will notify the other Party of any such information as it directly relates to the Products within three (3) days after obtaining the information and shall provide the other Party with a copy of any written materials provided by the Governmental Authority in connection with such inspection or audit, including any FDA Form 483s or establishment inspection reports. Each Party will provide the other with copies of reports of quality audits conducted by such Party with respect to the Products and will apprise the other Party of material Manufacture, marketing, promotion, sales, or other issues affecting supply of the Products.
Notice of Government Inspections. KING agrees that, to the extent it becomes aware of the results, observations and/or outcome of any inspections or audits of the facilities or operations involved in the manufacture, processing, testing or packaging of the Product conducted by governmental agencies, including without limitation the FDA, KING will notify AHPC of any such information as it relates to the Product within three (3) days of obtaining the information. KING will provide AHPC copies of reports of quality audits conducted by KING and will apprise AHPC of material manufacturing issues affecting supply of the Product.
Notice of Government Inspections. During the Copromotion Period, King agrees that, to the extent it becomes aware of the results, observations and/or outcome of any inspections or audits of the facilities or operations involved in the manufacture, processing, testing or packaging of the Product conducted by governmental agencies, including without limitation the FDA, King will notify Wyeth of any such information as it relates to the Product within [***] of obtaining the information. During the Copromotion Period, King will provide Wyeth copies of reports of quality audits conducted by King and will apprise Wyeth of material manufacturing issues affecting supply of the Product.
Notice of Government Inspections. Each Party agrees that, to the extent such Party becomes aware of the results, observations or outcome of any inspections or audits of the facilities or operations involved in the Manufacture or Commercialization of the Product conducted by a Regulatory Authority, such Party will notify the other Party of any such information as it directly relates to the Product within [†] Business Days after obtaining the information and shall provide the other Party with a copy of any written [†] DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION materials provided by the Regulatory Authority in connection with such inspection or audit. Each Party will provide the other with copies of reports of quality audits conducted by such Party with respect to the Product and will apprise the other Party of material Manufacture, marketing, promotion, sales, or other issues affecting supply or Commercialization of the Product.
