Common use of Regulatory Non-Compliance Clause in Contracts

Regulatory Non-Compliance. All information pertaining to notices from Regulatory Authorities whether inside the Territory or outside the Territory controlled by such Party of non-compliance with Laws in connection with the Product in the Field, including receipt of a warning letter or other notice of alleged non-compliance from any Regulatory Authority relating to the Product in the Field whether inside the Territory or outside the Territory; provided, however, that a Party shall be entitled to redact those portions thereof to the extent not related to the Product in the Field.

Appears in 2 contracts

Samples: Development, Commercialization and Supply Agreement (Auxilium Pharmaceuticals Inc), Development, Commercialization and Supply Agreement (Auxilium Pharmaceuticals Inc)

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Regulatory Non-Compliance. All information pertaining to notices from Regulatory Authorities whether inside the Territory or outside the Territory controlled by such Party of non-compliance with Laws in connection with the Bulk Product or Finished Product in the Field, including receipt of a warning letter or other notice of alleged non-compliance from any Regulatory Authority relating to the Bulk Product or Finished Product in the Field whether inside the Territory or outside the Territory; provided, however, that a Party shall be entitled to redact those portions thereof to the extent not related to the Bulk Product or Finished Product in the Field.

Appears in 2 contracts

Samples: Collaboration Agreement (Auxilium Pharmaceuticals Inc), Collaboration Agreement (Auxilium Pharmaceuticals Inc)

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Regulatory Non-Compliance. All information pertaining to notices from Regulatory Authorities Authorities, whether inside the Territory or outside of the Territory controlled by such Party Territory, of non-compliance with Laws in connection with the Product in the FieldProduct, including receipt of a warning letter or other notice of alleged non-compliance from any Regulatory Authority relating to the Product in the Field Product, whether inside the Territory or outside of the Territory; provided, however, that a the disclosing Party shall be entitled to redact those portions thereof to the extent not related to the Product in the FieldProduct.

Appears in 1 contract

Samples: License Agreement (Onyx Pharmaceuticals Inc)

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