Common use of Certification Under Drug Price Competition and Patent Restoration Act Clause in Contracts

Certification Under Drug Price Competition and Patent Restoration Act. Each Party shall immediately give written notice to the other Party of any certification of which they become aware filed pursuant to 21 U.S.C. Section 355(b)(2)(A) (or any amendment or successor statute thereto) claiming that any Licensor Patents Covering a Compound or a Licensed Product, or the manufacture or use of each of the foregoing, are invalid or unenforceable, or that infringement will not arise from the manufacture, use or sale in the US of a Licensed Product by a Third Party.

Appears in 5 contracts

Samples: Master License Agreement (Viking Therapeutics, Inc.), License Agreement (Apricus Biosciences, Inc.), License Agreement (Apricus Biosciences, Inc.)

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Certification Under Drug Price Competition and Patent Restoration Act. Each Party shall immediately give written notice to the other Party of any certification of which they become aware filed pursuant to 21 U.S.C. Section Article 355(b)(2)(A) (or any amendment or successor statute thereto) claiming that any Licensor Patents Covering a covering Compound or a Licensed Product, or the manufacture or use of each of the foregoing, are invalid or unenforceable, or that infringement will not arise from the manufacture, use or sale in the US of a Licensed Product product by a Third Party.

Appears in 3 contracts

Samples: Development Agreement, License and Co Development Agreement (Threshold Pharmaceuticals Inc), License and Co Development Agreement (Threshold Pharmaceuticals Inc)

Certification Under Drug Price Competition and Patent Restoration Act. Each Party shall immediately give written notice to the other Party of any certification of which they become aware filed pursuant to 21 U.S.C. Section 355(b)(2)(A) or 21 U.S.C. Section 355(j)(2)(A) (or any amendment amendments or successor statute statutes thereto) claiming that any Licensor Patents Covering a Compound or a Licensed Product, or the manufacture or use of each of the foregoing, are invalid or unenforceable, or that infringement will not arise from the manufacture, use or sale in the US of a Licensed Product product by a Third Party.

Appears in 2 contracts

Samples: License Agreement (Liquidia Corp), License Agreement (Liquidia Corp)

Certification Under Drug Price Competition and Patent Restoration Act. Each Party shall immediately give written notice to the other Party of any certification of which they become aware filed pursuant to 21 U.S.C. Section 355(b)(2)(A) (or any amendment or successor statute thereto) claiming that any Licensor Novacea Background Patents Covering a Compound covering Compound, Formulation or a Licensed Product, or the manufacture or use of each of the foregoing, Product are invalid or unenforceable, or that infringement will not arise from the manufactureManufacture, use or sale in the US of a Licensed Product product by a Third Party.

Appears in 2 contracts

Samples: Development, and Commercialization Agreement, License, Development, and Commercialization Agreement (Novacea Inc)

Certification Under Drug Price Competition and Patent Restoration Act. Each Party A party shall immediately promptly give written notice to the other Party party of any certification of which they become such party becomes aware filed pursuant to 21 U.S.C. Section 355(b)(2)(A) (or any amendment or successor statute thereto) claiming that any Licensor Licensed Patents Covering a Compound or covering a Licensed Product, or the manufacture or use of each of the foregoingthereof, are invalid or unenforceable, or that infringement will not arise from the manufacture, use or sale in the US of a Licensed Product by a Third Party.

Appears in 2 contracts

Samples: License Agreement (Ligand Pharmaceuticals Inc), License Agreement (Ligand Pharmaceuticals Inc)

Certification Under Drug Price Competition and Patent Restoration Act. Each Party party shall immediately give written notice to the other Party party of any certification of which they become aware filed pursuant to 21 U.S.C. Section 355(b)(2)(A) (or any amendment or *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. successor statute thereto) claiming that any Licensor Patents Covering a Compound or a Licensed Product, or the manufacture or use of each of the foregoing, Cell-Matrix Patent Rights are invalid or unenforceable, or that infringement will shall not arise from the manufacture, use or sale in the US of a Licensed Product product by a Third Party.

Appears in 1 contract

Samples: License Agreement (Micromet, Inc.)

Certification Under Drug Price Competition and Patent Restoration Act. Each Party shall immediately give written notice to the other Party of any certification of which they become aware filed pursuant to 21 U.S.C. Section 355(b)(2)(A) (or any amendment or successor statute thereto) claiming that any Licensor Patents Covering covering a Compound or a Licensed Product, or the manufacture or use of each of the foregoing, are invalid or unenforceable, or that infringement will not arise from the manufacture, use or sale in the US of a Licensed Product by a Third Party.

Appears in 1 contract

Samples: License Agreement (Ligand Pharmaceuticals Inc)

Certification Under Drug Price Competition and Patent Restoration Act. Each Party shall immediately give written notice to the other Party of any certification of which they become aware filed pursuant to 21 U.S.C. Section 355(b)(2)(A) (or any amendment or successor statute thereto) claiming that any Licensor Lpath Patents Covering a covering Compound or a Licensed Product, or the manufacture or use of each of the foregoingforegoing in or for the Field, are invalid or unenforceable, or that infringement will not arise from the manufacture, use or sale in the US of a Licensed Product product by a Third Party.

Appears in 1 contract

Samples: License Agreement (Lpath, Inc)

Certification Under Drug Price Competition and Patent Restoration Act. Each Party shall immediately give written notice to the other Party of any certification of which they become aware filed pursuant to 21 U.S.C. Section 355(b)(2)(A§ 355(j)(2)(A) (or any amendment or successor statute thereto) or equivalent Law of a Country claiming that any Licensor TaiMed Patents Covering a Compound or a Licensed Product, covering the Antibody or the manufacture or use of each of the foregoing, Product are invalid or unenforceable, or that infringement will not arise from be infringed by the manufacture, use or sale in the US of a Licensed Product product by a Third Party.

Appears in 1 contract

Samples: Distribution and Marketing Agreement (Theratechnologies Inc.)

Certification Under Drug Price Competition and Patent Restoration Act. Each Party shall immediately give written notice to the other Party of any certification of which they become aware filed pursuant to 21 U.S.C. U.S. Code Section 355(b)(2)(A) and applicable patent laws or regulations within the Territory (or any amendment or successor statute thereto) claiming that any Licensor Sublicensor Patents Covering a Compound covering Sublicensed Compounds or a Licensed ProductSublicensed Products, or the manufacture or use of each of the foregoing, are invalid or unenforceable, or that infringement will not arise from the manufacture, use or sale in the US of a Licensed Product product by a Third Party.

Appears in 1 contract

Samples: Sublicense Agreement (ObsEva SA)

Certification Under Drug Price Competition and Patent Restoration Act. Each Party of Licensor and Omthera shall immediately give written notice to the other Party of any certification of which they become aware filed pursuant to 21 U.S.C. Section 355(b)(2)(A) (or any amendment or successor statute thereto) claiming that any Licensor Patents Covering covering a Compound or a Licensed Product, or the manufacture or use of each of the foregoing, are invalid or unenforceable, or that infringement will not arise from the manufacture, use or sale in the US of a Licensed Product by a Third Party.

Appears in 1 contract

Samples: Research and License Agreement (Ligand Pharmaceuticals Inc)

Certification Under Drug Price Competition and Patent Restoration Act. Each Party shall immediately give written notice to the other Party of any certification of which they become aware filed pursuant to 21 U.S.C. Section 355(b)(2)(A) (or any amendment or successor statute thereto) claiming that any Licensor Anacor Background Patents, Anacor Program Patents Covering a or Joint Program Patents covering Licensed Compound or a Licensed Product, or the manufacture or use of each of the foregoing, Product are invalid or unenforceable, or that infringement will not arise from the manufacture, use or sale in the US of a Licensed Product product by a Third Party.

Appears in 1 contract

Samples: And Commercialization Agreement (Anacor Pharmaceuticals Inc)

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Certification Under Drug Price Competition and Patent Restoration Act. Each Party shall immediately give written notice to the other Party of any certification of which they become aware filed pursuant to 21 U.S.C. Section 355(b)(2)(A) (or any amendment or successor statute thereto) claiming that any Licensor Presage Patents Covering a Compound or a Licensed Product, or the manufacture Development, manufacture, use or use Commercialization of each of the foregoingCompound or Product, are invalid or unenforceable, or that infringement will not arise from the research, development, manufacture, use use, commercialization or sale in the US of a Licensed Product by a Third Party.

Appears in 1 contract

Samples: License Agreement (MEI Pharma, Inc.)

Certification Under Drug Price Competition and Patent Restoration Act. Each Party shall immediately give written notice to the other Party of any certification of which they become aware filed pursuant to 21 U.S.C. Section U.S. CFR § 355(b)(2)(A) (or any amendment or successor statute thereto) claiming that any Licensor Selecta Patents Covering a Compound covering Xork or a Licensed Xork Product, or the manufacture Manufacture or use of each of the foregoing, are invalid or unenforceable, or that infringement will shall not arise from the manufactureManufacture, use or sale in the US of a Licensed Product product by a Third Party.

Appears in 1 contract

Samples: License and Development Agreement (Cartesian Therapeutics, Inc.)

Certification Under Drug Price Competition and Patent Restoration Act. Each Party shall immediately give written notice to the other Party of any certification of which they become aware filed pursuant to 21 U.S.C. Section 355(b)(2)(A) (or any amendment or successor statute thereto) claiming that any Licensor Patents Covering a Compound or a Licensed Product, or the manufacture or use of each of the foregoing, are Collaboration Patent is invalid or unenforceable, or that infringement will not arise from the manufacture, use use, importation or sale in the US of a Licensed Product product containing a Collaboration Compound by a Third Party.

Appears in 1 contract

Samples: Collaboration and License Agreement (PTC Therapeutics, Inc.)

Certification Under Drug Price Competition and Patent Restoration Act. Each Party shall immediately give written notice to the other Party of any certification of which they become aware filed pursuant to 21 U.S.C. Section 355(b)(2)(A) (or any amendment or successor statute thereto) claiming that any Licensor Patents Covering a Compound, Follow-On Compound or a Licensed Product, or the manufacture or use of each of the foregoing, are invalid or unenforceable, or that infringement will not arise from the manufacture, use or sale in the US of a Licensed Product in or outside the Field by a Third Party.

Appears in 1 contract

Samples: License Agreement (Idera Pharmaceuticals, Inc.)

Certification Under Drug Price Competition and Patent Restoration Act. Each Party shall immediately give written notice to the other Party of any certification of which they become aware filed pursuant to 21 U.S.C. Section 355(b)(2)(A) (or any amendment or successor statute thereto) claiming ), of which it becomes aware and which claims either that any Licensor Patents Covering a Compound or a Licensed ProductARES Patent, any Product or the manufacture Development, manufacture, use or use Commercialization, of each of the foregoing, are invalid or unenforceable, or that no infringement will not arise from the Development, manufacture, use or sale in the US Commercialization of a Licensed Product any similar product by a Third Party.

Appears in 1 contract

Samples: License Agreement (Chanticleer Holdings, Inc.)

Certification Under Drug Price Competition and Patent Restoration Act. Each Party shall immediately give written notice to the other Party of any certification of which they become it becomes aware filed pursuant to 21 U.S.C. Section 355(b)(2)(A) (or any amendment or successor statute thereto) claiming that any Licensor Licensed Patents Covering a covering the Compound or a Licensed Product, or the manufacture or use of each of the foregoing, are invalid or unenforceable, or that infringement will not arise from the manufacture, use or sale in the US United States of a Licensed Product or Competing Product by a Third Party.

Appears in 1 contract

Samples: License Agreement (Marinus Pharmaceuticals Inc)

Certification Under Drug Price Competition and Patent Restoration Act. Each Party shall immediately give written notice to the other Party of any certification of which they become aware filed pursuant to 21 U.S.C. Section U.S. CFR § 355(b)(2)(A) (or any amendment or successor statute thereto) or corresponding Applicable Laws in other countries claiming that any Licensor ATSA Patents Covering covering a Compound or a Licensed Product, or the manufacture or use of each of the foregoing, are invalid or unenforceable, or that infringement will not arise from the manufacture, use or sale in the US of a Licensed Product product by a Third Party.

Appears in 1 contract

Samples: License Agreement (Vera Therapeutics, Inc.)

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