Common use of Regulatory Inspections Clause in Contracts

Regulatory Inspections. Licensee shall permit the Regulatory Authority(ies) in the Exelixis Territory to conduct inspections of Licensee, its Affiliates, and acting reasonably and in good faith of Sublicensees or subcontractors (including Clinical Trial sites) relating to the Development of the Product under the GDP, and shall ensure that such Affiliates, and acting reasonably and on good faith, such Sublicensees and subcontractors permit such inspections. In addition, Licensee shall promptly notify Exelixis of any such inspection and shall supply Exelixis with all information pertinent thereto. Licensee shall use Commercially Reasonable Efforts to allow an Exelixis representative to attend any such inspection with the presence of Licensee. Exelixis shall permit the Regulatory Authority(ies) in the Licensee Territory to conduct inspections of Exelixis, its Affiliates, and acting reasonably and in good faith of Sublicensees or subcontractors (including Clinical Trial sites) relating to the Development of the Product under the GDP for the Licensee Territory, and shall ensure that such Affiliates, and acting reasonably and on good faith, such Sublicensees and subcontractors permit such inspections. In addition, Exelixis shall promptly notify Licensee of any such inspection and shall supply Licensee with all information pertinent thereto. Exelixis shall use Commercially Reasonable Efforts to allow a Licensee representative to attend any such inspection with the presence of Exelixis.

Appears in 3 contracts

Samples: Collaboration and License Agreement (Exelixis, Inc.), Collaboration and License Agreement (Exelixis, Inc.), Collaboration and License Agreement (Exelixis, Inc.)

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Regulatory Inspections. Licensee shall permit the Regulatory Authority(ies) in the Exelixis Ovid Territory to conduct inspections of Licensee, its Affiliates, and acting reasonably its Sublicensees and in good faith of Sublicensees or subcontractors (including Clinical Trial sites) relating to the Development of the Product under the GDPDevelopment Plan, and shall ensure that such Affiliates, Affiliates and acting reasonably and on good faith, such Sublicensees and subcontractors permit such inspections. In addition, Licensee shall promptly notify Exelixis Ovid of any such inspection and shall supply Exelixis Ovid with all information pertinent thereto. Licensee Ovid shall use Commercially Reasonable Efforts have the right to allow an Exelixis have a representative to attend any such inspection with the presence of Licenseeinspection. Exelixis Ovid shall permit the Regulatory Authority(ies) in the Licensee Territory to conduct inspections of ExelixisLicensee, its Affiliates, and acting reasonably its Sublicensees and in good faith of Sublicensees or subcontractors (including Clinical Trial sites) relating to the Development of the Product in the Licensee Territory under the GDP for the Licensee TerritoryDevelopment Plan, and shall ensure that such Affiliates, Affiliates and acting reasonably and on good faith, such Sublicensees and subcontractors permit such inspections. In addition, Exelixis Ovid shall promptly notify the Licensee of any such inspection in the Licensee Territory and shall supply the Licensee with Certain identified information marked with [***] has been excluded from the exhibit because it is both not material and is the type that the registrant treats as private or confidential. all information pertinent thereto. Exelixis The Licensee shall use Commercially Reasonable Efforts have the right to allow have a Licensee representative to attend any such inspection with the presence of Exelixisinspection.

Appears in 1 contract

Samples: Collaboration and License Agreement (Ovid Therapeutics Inc.)

Regulatory Inspections. Licensee shall permit the Regulatory Authority(ies) in the Exelixis Territory to conduct inspections of Licensee, its Affiliates, and acting reasonably and in good faith of Sublicensees or subcontractors (including Clinical Trial sites) relating to the Development of the Product under the GDP, and shall ensure that such Affiliates, and acting reasonably and on good faith, such Sublicensees and subcontractors permit such inspections. In addition, Licensee shall promptly notify Exelixis of any such inspection and shall supply Exelixis with all information pertinent thereto. Licensee shall use Commercially Reasonable Efforts to allow an Exelixis representative to attend any such inspection with the presence of Licensee. Exelixis shall permit the Regulatory Authority(ies) in the Licensee Territory to conduct inspections of Exelixis, its Affiliates, and acting reasonably and in good faith of Sublicensees or subcontractors (including Clinical Trial sites) relating to the Development of the Product under the GDP for the Licensee Territory, and shall ensure that such Affiliates, and acting reasonably and on good faith, such Sublicensees and subcontractors permit such inspections. In addition, Exelixis shall promptly notify Licensee of any such inspection and shall supply Licensee with all information pertinent thereto. Exelixis shall use Commercially Reasonable Efforts to allow a Licensee representative to attend any such inspection with the presence of Exelixis.. 5.5

Appears in 1 contract

Samples: Collaboration and License Agreement

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Regulatory Inspections. Licensee shall permit the Regulatory Authority(ies) in the Exelixis Ovid Territory to conduct inspections of Licensee, its Affiliates, and acting reasonably its Sublicensees and in good faith of Sublicensees or subcontractors (including Clinical Trial sites) relating to the Development of the Product under the GDPDevelopment Plan, and shall ensure that such Affiliates, Affiliates and acting reasonably and on good faith, such Sublicensees and subcontractors permit such inspections. In addition, Licensee shall promptly notify Exelixis Ovid of any such inspection and shall supply Exelixis Ovid with all information pertinent thereto. Licensee Ovid shall use Commercially Reasonable Efforts have the right to allow an Exelixis have a representative to attend any such inspection with the presence of Licenseeinspection. Exelixis Ovid shall permit the Regulatory Authority(ies) in the [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. Licensee Territory to conduct inspections of ExelixisLicensee, its Affiliates, and acting reasonably its Sublicensees and in good faith of Sublicensees or subcontractors (including Clinical Trial sites) relating to the Development of the Product in the Licensee Territory under the GDP for the Licensee TerritoryDevelopment Plan, and shall ensure that such Affiliates, Affiliates and acting reasonably and on good faith, such Sublicensees and subcontractors permit such inspections. In addition, Exelixis Ovid shall promptly notify the Licensee of any such inspection in the Licensee Territory and shall supply the Licensee with all information pertinent thereto. Exelixis The Licensee shall use Commercially Reasonable Efforts have the right to allow have a Licensee representative to attend any such inspection with the presence of Exelixisinspection.

Appears in 1 contract

Samples: Collaboration and License Agreement (Ovid Therapeutics Inc.)

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