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.
Certification Under Drug Price Competition and Patent Restoration Act. Each of TGTX and CTI shall provide within a reasonable time written notice to the other 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 DFCI Patents covering 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.
Certification Under Drug Price Competition and Patent Restoration Act. Pharmacopeia and Schering each shall immediately give written notice to the other of any certification of which they become aware filed pursuant to 21 U.S.C.§§355(b)(2)(A)(iv) and 355(j)(2)(A)(vii) claiming that Collaboration Patent Rights do not cover the use or sale of any product(s) equivalent to an existing Agreement Product(s) by a Third Party. Schering shall have the right to bring an infringement action, in its sole discretion and at its own expense, in its own name and/or in the name of Pharmacopeia, subject to Section 6.5 above. The provisions of Section 6.5.4 shall apply to any such infringement action.
Certification Under Drug Price Competition and Patent Restoration Act. Amylin and Lilly each will immediately give notice to the other of any certification of which they become aware filed under the U.S. "Drug Price Competition and Patent Term Restoration Act of 1984" claiming that Patents covering Product are invalid or that infringement will not arise from the Manufacture, use or sale of Product by a Third Person. If Amylin or Lilly (depending on which Party is defending the relevant Patents) decides not to bring infringement proceedings against the entity making such a certification, such Party will give notice to the other Party of its decision not to bring suit within twenty (20) days after receipt of notice of such certification. The Party receiving such notice may then, but is not required to, bring suit against the entity that filed the certification. Any suit by Lilly or Amylin will be in the name of Lilly if it involves a Lilly Patent, in the name of Amylin if it involves an Amylin Patent, or in the names of both Parties if it involves a Joint Patent or, collectively, an Amylin Patent and a Lilly Patent. For this purpose, the Party not bringing suit will execute such legal papers necessary for the prosecution of such suit as may be reasonably requested by the Party bringing suit. Each Party shall pay 50% of any expenses (except for the expenses of the non-controlling Party's counsel, if any) and shall receive 50% of any recovery realized as a result of any litigation pursuant to this Section 10.6.
Certification Under Drug Price Competition and Patent Restoration Act. Each of Checkpoint and TGTX shall immediately give written notice to the other of any Paragraph IV Certification.
Certification Under Drug Price Competition and Patent Restoration Act. Each of Licensor and TGTX shall immediately give written notice to the other 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.
Certification Under Drug Price Competition and Patent Restoration Act. Licensor and SPL each shall immediately give written notice to the other of any certification of which they become aware filed pursuant to 21 U.S.C. ss.355(b)(2)(A)(iv) and 355(j)(2)(A)(vii), or any amendment or successor statute thereto, claiming that Patent Rights covering Licensed
Certification Under Drug Price Competition and Patent Restoration Act. Licensor and Schering each shall immediately give written notice to the other of any certification of which they become aware filed pursuant to 21 U.S.C. ss.355(b)(2)(A)(iv) and 355(j)(2)(A)(vii), or any amendment or successor statute thereto, claiming that Patent Rights covering Licensed Compound and/or Licensed Product(s) are invalid or that infringement will not arise from the manufacture, use or sale of a product containing
Certification Under Drug Price Competition and Patent Restoration Act. ISIS and MERCK each shall immediately give notice to the other of any certification of which they become aware filed under the United States "Drug Price Competition and Patent Term Restoration Act of 1984" claiming that ISIS Patent Rights covering Compound or Product are invalid or that infringement will not arise from the manufacture, use or sale of Compound(s) or Product(s) by a third party. If ISIS or MERCK (depending on which party is defending the ISIS Patent Rights) decides not to bring infringement proceedings against the entity making such a certification, such party shall give notice to the other party of its decision not to bring suit within twenty-one (21) days after receipt of notice of such certification. The party receiving such notice may then, but is not required to, bring suit against the party that filed the certification. Any suit by MERCK or ISIS shall either be in the name of MERCK or in the name of ISIS, or jointly by MERCK and ISIS. For this purpose, the party not bringing suit shall execute such legal papers necessary for the prosecution of such suit as may be reasonably requested by the party bringing suit.
Certification Under Drug Price Competition and Patent Restoration Act. If a Party becomes aware of any certification filed pursuant to 21 U.S.C. §355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV), or any notice under any future analogous provisions of United States Law relating to regulation or approval of pharmaceutical products (or any amendment or successor statute thereto), or any comparable Law under any other jurisdiction, claiming that any SYNTA Patent Right, ROCHE Patent Right or Joint Patent Right, in each case Covering a Licensed Product in the Field, is invalid or otherwise unenforceable, or that infringement will not arise from the manufacture, use, import or sale or offer of sale of a product by a Third Party (a “Paragraph IV Certification”), such Party shall promptly notify the other Party in writing within three (3) Business Days after its receipt thereof.
