Patent Certification definition

Patent Certification shall have the meaning provided in Section 8.4.

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Patent Certification filed in the United States under 21 U.S.C. §355(b)(2) or 21 U.S.C. §355(j)(2) or similar provisions in other jurisdictions, or (iii) declaratory judgment, opposition or similar action alleging the invalidity, unenforceability or non-infringement of any such intellectual property rights (collectively “Third Party Infringement”).

Patent Certification has the meaning set forth in Section 1.27.

Examples of Patent Certification in a sentence

• Penn shall notify and provide Company with copies of any allegations of alleged patent invalidity, unenforceability or non-infringement of a Penn Patent Right pursuant to a Paragraph IV Patent Certification by a third party filing an Abbreviated New Drug Application, an application under §505(b)(2) or any other similar patent certification by a third party, and any foreign equivalent thereof.

• Bayer shall notify and provide Aegerion with copies of any allegations of alleged patent invalidity, unenforceability or non-infringement of a Bayer Patent Right pursuant to a Paragraph IV Patent Certification by a Third Party filing an Abbreviated New Drug Application, an application under §505(b)(2) of the United States Federal Food, Drug, and Cosmetic Act, as amended, or any other similar patent certification by a Third Party, and any foreign equivalent thereof.

• Kayla shall notify and provide Codiak with copies of any allegations of alleged patent invalidity, unenforceability or non-infringement of a Licensed Patent pursuant to a Paragraph IV Patent Certification by a Third Party filing an Abbreviated New Drug Application, an application under §505(b)(2) or any other similar patent certification by a Third Party, and any foreign equivalent thereof.

• PDL shall notify and provide BMS with copies of any allegations of alleged patent invalidity, unenforceability or non-infringement of any PDL Licensed Patent pursuant to a certification by a Third Party under any applicable law governing the filing of an expedited new drug application for a biological product (similar to a Paragraph IV Patent Certification by a Third Party filing an Abbreviated New Drug Application).

• Such notification and copies shall be provided to BMS within [***] days after Company receives such certification, and shall be sent to the address set forth in Section 10.4. Notwithstanding the foregoing, any such Paragraph IV Patent Certification shall be deemed to be an act of infringement hereunder of the BMS Patent Rights by a Third Party in the Field subject to the enforcement provisions of Section 10.4.

• Upon written notification of either party to the other party indicatingthat the grievance mediation is terminated, the timelines in the grievance procedure shall continue the point at which they were frozen.

• Each party shall notify and provide the other with copies of any allegations of alleged patent invalidity, unenforceability or non-infringement of a Licensed Patent pursuant to the FDA’s Paragraph IV Patent Certification procedure by a third party filing an Abbreviated New Drug Application, an application under §505(b)(2) of the Federal Food, Drug and Cosmetics Act, or any other similar patent certification by a third party, and any foreign equivalent thereof.

• Exelixis shall notify and provide Sanofi-Aventis with copies of any allegations of alleged patent invalidity, unenforceability or non-infringement of an Exelixis Patent licensed hereunder pursuant to a Paragraph IV Patent Certification by a third Party filing an Abbreviated New Drug Application, an application under §505(b)(2) or other similar patent certification by a Third Party, and any foreign equivalent thereof.

• UHN shall notify and provide Avro with copies of any allegations of alleged patent invalidity, unenforceability or non-infringement of a Patent Right pursuant to a Paragraph IV Patent Certification by a Third Party filing an Abbreviated New Drug Application, an application under §505(b)(2) or any other similar patent certification by a third party, and any foreign equivalent thereof.

• Each Party will notify and provide the other Party with copies of any allegations of alleged patent invalidity, unenforceability or non-infringement of an Aerpio Patent Right pursuant to a Paragraph IV Patent Certification by a Third Party filing an Abbreviated New Drug Application, an application under §505(b)(2) of the FD&C Act, or any other similar patent certification by a Third Party, and any foreign equivalent thereof.

More Definitions of Patent Certification

Patent Certification means any certification filed in the U.S. under 21 U.S.C. § 355(b)(2) or 21 U.S.C. § 355(j)(2) or similar provisions in other jurisdictions in connection with an ANDA (an Abbreviated New Drug Application in the U.S. or a comparable application for Marketing Approval under Applicable Law in any country other than the U.S.) or other Marketing Approval Application for a Third Party Competitive Product.

Patent Certification has the meaning set forth in Section 10.3. 1.96 “Payment Shares” has the meaning set forth in Section 7.6. 1.97 “Patents” means (a) all national, regional and international patents and patent applications filed in any country or jurisdiction, including without limitation provisional patent applications, (b) all patent applications filed either from such patents and patent applications or from a patent application claiming priority from either of these, including any continuation, continuation-in-part, division, provisional, converted provisional and continued prosecution applications, or any substitute applications, (c) any patent issued with respect to or in the future issued from any such patent applications including utility models, ▇▇▇▇▇ patents and design patents and certificates of invention, and (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, reexaminations and extensions (including any supplementary protection certificates, patent term extensions and the like) of the foregoing patents or patent applications. 1.98 “Person” means an individual, corporation, partnership, limited liability company, trust, business trust, association, joint stock company, joint venture, pool, syndicate, sole proprietorship, unincorporated organization, Governmental Authority or any other form of entity not specifically listed herein. 1.99 “Phase 2 Clinical Study” means a human clinical trial of a Compound or Product, the primary endpoint of which is a measure of efficacy in the target patient population, which is prospectively designed to generate sufficient data that may permit commencement of pivotal clinical trials, or a similar clinical study prescribed by the Regulatory Authorities, from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(b), as amended. 1.100 “Phase 3 Clinical Study” means a human clinical trial of a Compound or Product on a sufficient number of subjects in an indicated patient population that is designed to establish that a Compound or Product is safe and efficacious for its intended use and to determine the benefit/risk relationship, warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Marketing Authorization of such Compound or Product, including all tests and studies that are required by the FDA fro...