Common use of Generic Competition Clause in Contracts

Generic Competition. Notwithstanding the foregoing, if either Party (a) reasonably believes that a Third Party may be filing or preparing or seeking to file a generic or abridged Drug Approval Application in the Licensee Territory that refers to or relies on Regulatory Documentation submitted by either Party to any Regulatory Authority whether or not such a filing may be in violation of any Regulatory Exclusivity Period or infringe the Licensor Patents, the Licensee Patents or the Joint Patents or (b) receives any notice of certification regarding the Licensor Patents, Joint Patents or Licensee Patents pursuant to the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 (21 United States Code §355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV)) claiming that any such Patents are invalid or unenforceable or claiming that any such Patents will not be infringed by the Manufacture, use, marketing or sale of a product for which an ANDA is filed or (c) receives any equivalent or similar certification or notice in any other jurisdiction, it shall notify the other Party in writing, identifying the alleged applicant or potential applicant and furnishing the information upon which such determination is based, and provide the other Party a copy of any such notice of certification within ten (10) days of receipt and the Parties’ rights and obligations with respect to any legal action as a result of such certification shall be as set forth in Section 8.3.1; provided, however, that if the enforcing Party elects not to bring suit against the Third Party providing notice of such certification within thirty (30) days of receipt of such notice with respect to any Licensor Patent, Joint Patent or Licensee Patent, then the other Party shall have the right, but shall not the obligation, to bring suit against such Third Party and to join the enforcing Party as a Party plaintiff if necessary to bring such a suit, in which event the other Party shall hold the enforcing Party harmless from and against any and all costs and expenses of such litigation, including reasonable attorney’s fees and expenses.

Generic Competition. Notwithstanding the foregoing, if either Party (a) reasonably believes that a Third Party may be filing or preparing or seeking to file a generic or abridged Drug Approval Application in the Licensee Territory that refers to or relies on Regulatory Documentation submitted by either Party to any Regulatory Authority whether or not such a filing may be in violation of any Regulatory Exclusivity Period or infringe the Licensor GPC Biotech Patents, the Licensee Patents or the Joint Patents or (b) receives any notice of certification regarding the Licensor GPC Biotech Patents, Joint Patents or Licensee Patents pursuant to the U.S. “Drug Price Competition and Patent Term Restoration Act Act” of 1984 (21 United States Code §355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV)) (“ANDA Act”) claiming that any such Patents are invalid or unenforceable or claiming that the any such Patents will not be infringed by the Manufacture, use, marketing or sale of a product for which an application under the ANDA Act is filed or (c) receives any equivalent or similar certification or notice in any other jurisdiction, it shall notify the other Party in writing, identifying the alleged applicant or potential applicant and furnishing the information upon which such determination is based, and provide the other Party a copy of any such notice of certification within ten (10) days of receipt and the Parties’ rights and obligations with respect to any legal action as a result of such certification shall be as set forth in Section 8.3.1; provided, however, that if the enforcing Party elects not to bring suit against the Third Party providing notice of such certification within thirty (30) days of receipt of such notice with respect to any Licensor Patent, (y) GPC Biotech Patent or Joint Patent in the Licensee Territory or (z) Licensee PatentPatent in the Territory, then the other Party shall have the right, but shall not the obligation, to bring suit against such Third Party and to join the enforcing Party as a Party plaintiff if necessary to bring such a suit, in which event the other Party shall hold the enforcing Party harmless from and against any and all costs and expenses of such litigation, including reasonable attorney’s fees and expenses.

Generic Competition. Notwithstanding the foregoing, if either Party (ai) reasonably believes that a Third Party may be filing or preparing or seeking to file a generic or abridged Drug Approval Application in the Licensee Territory that refers to or relies on Regulatory Documentation submitted by either Party to any Regulatory Authority Authority, whether or not such a filing may be in violation of any Regulatory Exclusivity Period or infringe the Licensor Galapagos Patents, the Licensee Patents or the Joint Patents or ; (bii) receives any notice of certification regarding the Licensor Patents, Joint Galapagos Patents or Licensee the Joint Patents pursuant to the U.S. “Drug Price Competition and Patent Term Restoration Act Act” of 1984 (21 United States Code §355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV)) (“ANDA Act”) claiming that any such Patents are invalid or unenforceable or claiming that any such Patents will not be infringed by the Manufacture, use, marketing or sale of a product for which an application under the ANDA Act is filed filed; or (ciii) receives any equivalent or similar certification or notice in any other jurisdiction, it shall (A) notify the other Party in writing, writing identifying the alleged applicant or potential applicant and furnishing the information upon which such determination is based, based and (B) provide the other Party with a copy of any such notice of certification within ten […***…] (10[…***…]) days of the date of receipt and the Parties’ rights and obligations with respect to any legal action as a result of such certification shall be as set forth in Section 8.3.17.3.1, 7.3.2, or 7.3.4, as applicable; provided, however, that if the enforcing Party Xxxxxx elects not to bring suit against the Third Party providing notice of such certification within thirty […***…] (30[…***…]) days of receipt of such notice with respect to any Licensor Patentnotice, Joint Patent or Licensee Patent, then the other Party Galapagos shall have the right, but shall not the obligationbe obligated, to bring suit against such Third Party and to join the enforcing Party Xxxxxx as a Party party plaintiff if necessary to bring such a suit, in which event the other Party Galapagos shall hold the enforcing Party Xxxxxx harmless from and against any and all costs and expenses of such litigation, including reasonable attorney’s attorneys’ fees and expenses.

Generic Competition. Notwithstanding the foregoing, if either Party (ai) reasonably believes that a Third Party may be filing or preparing or seeking to file a generic or abridged Drug Approval Application in the Licensee Territory that refers to or relies on Regulatory Documentation submitted by either Party to any Regulatory Authority Authority, whether or not such a filing may be in violation of any Regulatory Exclusivity Period or infringe the Licensor Galapagos Patents, the Licensee AbbVie Patents or the Joint Patents or Patents, (bii) receives any notice of certification regarding the Licensor Galapagos Patents, Joint AbbVie Patents or Licensee Joint Patents pursuant to the U.S. “Drug Price Competition and Patent Term Restoration Act Act” of 1984 (21 United States Code §355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV)) (“ANDA Act”) claiming that any such Patents are invalid or unenforceable or claiming that any such Patents will not be infringed by the Manufacture, use, marketing or sale of a product for which an application under the ANDA Act is filed filed, or (ciii) receives any equivalent or similar certification or notice in any other jurisdiction, it shall (a) notify the other Party in writing, writing identifying the alleged applicant or potential applicant and furnishing the information upon which such determination is based, and (b) provide the other Party with a copy of any such notice of certification within ten […***…] (10[…***…]) days of the date of receipt and the Parties’ rights and obligations with respect to any legal action as a result of such certification shall be as set forth in Section 8.3.1Sections 7.3.1, 7.3.2, or 7.3.4, as applicable; provided, however, that if the enforcing Party AbbVie elects not to bring suit against the Third Party providing notice of such certification within thirty […***…] (30[…***…]) days of receipt of such notice with respect to any Licensor Patentnotice, Joint Patent or Licensee Patent, then the other Party Galapagos shall have the right, but shall not the obligation, to bring suit against such Third Party and to join the enforcing Party AbbVie as a Party party plaintiff if necessary to bring such a suit, in which event the other Party Galapagos shall hold the enforcing Party AbbVie harmless from and against any and all costs and expenses of such litigation, including reasonable attorney’s attorneys’ fees and expenses.

Generic Competition. Notwithstanding the foregoing, if either Party (ai) reasonably believes that a Third Party may be filing or preparing or seeking to file a generic or abridged Drug Approval Application in the Licensee Territory that refers to or relies on Regulatory Documentation submitted by either Party to any Regulatory Authority Authority, whether or not such a filing may be in violation of any Regulatory Exclusivity Period or infringe the Licensor Galapagos Patents, the Licensee AbbVie Patents or the Joint Patents or Patents, (bii) receives any notice of certification regarding the Licensor Galapagos Patents, Joint AbbVie Patents or Licensee Joint Patents pursuant to the U.S. “Drug Price Competition and Patent Term Restoration Act Act” of 1984 (21 United States Code §355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV)) (“ANDA Act”) claiming that any such Patents are invalid or unenforceable or claiming that any such Patents will not be infringed by the Manufacture, use, marketing or sale of a product for which an application under the ANDA Act is filed filed, or (ciii) receives any equivalent or similar certification or notice in any other jurisdiction, it shall (a) notify the other Party in writing, writing identifying the alleged applicant or potential applicant and furnishing the information upon which such determination is based, and (b) provide the other Party with a copy of any such notice of certification within ten (10) [...***...] days of the date of receipt and the Parties’ rights and obligations with respect to any legal action as a result of such certification shall be as set forth in Section 8.3.1Sections 7.3.1, 7.3.2, or 7.3.4, as applicable; provided, however, that if the enforcing Party AbbVie elects not to bring suit against the Third Party providing notice of such certification within thirty (30) [...***...] days of receipt of such notice with respect to any Licensor Patentnotice, Joint Patent or Licensee Patent, then the other Party Galapagos shall have the right, but shall not the obligation, to bring suit against such Third Party and to join the enforcing Party AbbVie as a Party party plaintiff if necessary to bring such a suit, in which event the other Party Galapagos shall hold the enforcing Party AbbVie harmless from and against any and all costs and expenses of such litigation, including reasonable attorney’s attorneys’ fees and expenses.

Generic Competition. Notwithstanding the foregoing, if either Party or its Patent Liaison (a) reasonably believes that a Third Party may be filing or preparing or seeking to file a generic or abridged Drug Approval Application in the Licensee Territory that refers to or relies on Regulatory Documentation regulatory documentation submitted by either Party to any Regulatory Authority whether or not such a filing may be in violation of any Regulatory Exclusivity Period or infringe the Licensor PatentsAuthority, the Licensee Patents or the Joint Patents or (b) receives any notice of certification regarding the Licensor Epizyme Patents, Joint BII Patents or Licensee the Joint Patents pursuant to the U.S. “Drug Price Competition and Patent Term Restoration Act Act” of 1984 (21 United States Code §355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV)) (“ANDA Act”) claiming that any such Patents are invalid or unenforceable or claiming that any such Patents will not be infringed by the Manufacture, use, marketing or sale of a product for which an application under the ANDA Act is filed or (c) receives any equivalent or similar certification or notice in any other jurisdiction, it shall (i) notify the other Party (or its Patent Liaison) in writing, writing identifying the alleged applicant or potential applicant and furnishing the information upon which such determination is based, based and (ii) provide the other Party (or its Patent Liaison) with a copy of any such notice of certification within ten (10) days [**] of the date of receipt and the Parties’ rights and obligations with respect to any legal action as a result of such certification shall be as set forth in Section Sections 8.3.1, 8.3.2, 8.3.3 or 8.3.5, as applicable; providedprovided that, however, that if the enforcing Party entitled to first enforce the Patents pursuant to the foregoing Sections elects not to bring suit against the Third Party providing notice of such certification within thirty (30) days [**] of receipt of such notice with respect to any Licensor Patentnotice, Joint Patent or Licensee Patent, then the other Party shall have the right, but shall not the obligationbe obligated, to bring suit against such Third Party Party. Notwithstanding the foregoing, Epizyme shall not, and to join the enforcing Party as a Party plaintiff if necessary to agrees not to, bring such suit against the Third Party if it is not in connection with a suitGeneric Product (as defined in Section 1.84 (Definition of “Generic Product”) absent prior written consent from BII, which may be withheld in which event the other Party shall hold the enforcing Party harmless from and against any and all costs and expenses of such litigation, including reasonable attorneyBII’s fees and expensessole discretion.