Common use of Patent Term Extensions Clause in Contracts

Patent Term Extensions. The Parties shall use reasonable efforts to obtain all available supplementary protection certificates, patent term restorations, and other extensions (collectively, “Extensions”) of the Acceleron Patent Rights and Joint Patent Rights (including those available under the Xxxxx-Xxxxxx Act). Each Party shall execute such authorizations and other documents and take such other actions as may be reasonably requested by the other Party to obtain such Extensions. The Parties shall cooperate with each other in gaining Extensions wherever applicable to Acceleron Patent Rights or Joint Patent Rights. The holder of the applicable NDA may determine what Extensions of any such Patent Rights shall be made; provided that, if in any country such holder has an option to extend the patent term for only one of several patents, the first Party shall consult with the other Party before making the election. If more than one patent is eligible for such an Extension, the Parties shall select in good faith a strategy that shall maximize patent protection and commercial value for each Licensed Product. All filings for such Extensions, as determined by the holder of the applicable NDA, shall be made by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are assigned, and the owner of record of the applicable Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Extension, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file for such Extension in the Patent Rights’ owner’s name, and (c) provide all necessary assistance in connection therewith. The Parties acknowledge and agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term with respect to “Licensed Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world other than those of North America with respect to such “Licensed Products” under the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Patent Rights under the Shire Agreement, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Agreement that affect Acceleron Patent Rights, and, to the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 if, after using such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by Shire.

Appears in 5 contracts

Samples: Collaboration, License and Option Agreement (Acceleron Pharma Inc), Collaboration, License and Option Agreement (Acceleron Pharma Inc), Collaboration, License and Option Agreement (Acceleron Pharma Inc)

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Patent Term Extensions. The Cubist will, in its sole discretion, after discussing its strategy with Chiron and reasonably considering Chiron’s comments, in each country in the Territory, determine for which, if any, of the Patents within the Cubist Patents and Joint Patents, the Parties shall use reasonable efforts will apply to obtain all available supplementary protection certificates, extend the patent term restorationswith respect to Licensed Products, as provided for * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION in patent term extension laws or regulations in the Territory similar to the Patent Term Restoration Act or other similar laws and regulations affording an extension or restoration of patent terms in the United States, which similar laws and regulations shall include without limitation any Supplementary Protection Certificates. Chiron shall not make any submissions, filings or other communications with any governmental agency with respect to patent term restoration (or other similar grant of a monopoly right with respect to any Licensed Product) for any Patents within the Cubist Patents or Joint Patents without Cubist’s express consent. Chiron will cooperate fully with Cubist in making such filings at Cubist’s sole expense which may include without limitation, making available regulatory data and information for such purpose. Notwithstanding anything in the foregoing provisions of this Section 8.3 to the contrary, in the event that Cubist, in its sole discretion, makes a determination not to seek an extension within the Territory of the patent term of any Cubist Patent or Joint Patent in the Territory with respect to Licensed Products, then Cubist shall provide Chiron with thirty (30) days prior written notice of such determination, or reasonable notice if the period for determination is less than thirty (30) days, and other extensions (collectivelyshall provide Chiron with the opportunity, “Extensions”) of the Acceleron Patent Rights at Chiron’s sole discretion and Joint Patent Rights (including those available under the Xxxxx-Xxxxxx Act). Each Party shall execute such authorizations sole cost and other documents expense, to make submissions and filings, and take such other actions as may be reasonably requested by required, on behalf of Cubist to extend within the other Party to obtain such Extensions. The Parties shall cooperate with each other in gaining Extensions wherever applicable to Acceleron Territory the patent term of any Cubist Patent Rights or Joint Patent Rights. The holder of the applicable NDA may determine what Extensions of any such Patent Rights shall be made; provided that, if in any country such holder has an option to extend the patent term for only one of several patents, the first Party shall consult with the other Party before making the election. If more than one patent is eligible for such an Extension, the Parties shall select in good faith a strategy that shall maximize patent protection and commercial value for each Licensed Product. All filings for such Extensions, as determined by the holder of the applicable NDA, shall be made by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are assigned, and the owner of record of the applicable Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Extension, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file for such Extension in the Patent Rights’ owner’s name, and (c) provide all necessary assistance in connection therewith. The Parties acknowledge and agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term Territory with respect to “Licensed License Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world other than those of North America with respect to such “Licensed Products” under the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Patent Rights under the Shire Agreement, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Agreement that affect Acceleron Patent Rights, and, to the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 if, after using such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by Shire.

Appears in 2 contracts

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

Patent Term Extensions. The Parties shall: (a) notify each other of the issuance of each patent where extension is possible included within the Nerviano Patents or Joint Patents, giving the date of issue and patent number for each such patent; and (b) advise each other in a timely manner of NDA Approval by the FDA, EMA, or MHLW for any Product and any other governmental approval that is pertinent to any patent term extension or restoration. The Parties shall use reasonable efforts to obtain all available supplementary protection certificates, patent term restorations, and other extensions (collectively, “Extensions”) or restorations of the Acceleron Patent Rights and such Nerviano Patents or Joint Patent Rights Patents (including those available under the Xxxxx-Xxxxxx Act). Each To that end, each Party shall shall: (c) supply the other Party, in a timely manner, with any information in its possession or control pertaining to, or desirable for, the extension of any Nerviano Patents or Joint Patent; (d) execute such authorizations and deliver to the other Party, in a timely manner, any authorizations, supporting affidavits and other documents required in connection with the extension of any Nerviano Patent or Joint Patent; and (e) take such other actions as may be reasonably requested by the other Party to obtain such Extensionsextensions. The Parties shall cooperate with each other in seeking or gaining Extensions patent term restorations or extensions wherever applicable to Acceleron Patent Rights such Nerviano Patents or Joint Patent RightsPatents, and in determining which Nerviano Patents or Joint Patents the Parties should seek and obtain patent term extension or restoration. The holder of the applicable NDA may determine what Extensions Party first eligible to seek patent term restoration or extension of any such Patent Rights Nerviano Patents or Joint Patents related thereto shall be madehave the right to do so; provided thatprovided, that if in any country such holder the first Party has an option to extend the patent term for only one of several patents, the first Party shall will consult with the other Party before making the election. If more than one patent Nerviano Patents or Joint Patents (or other patents) is eligible for such an Extensionextension or patent term restoration, the Parties shall select in good faith agree upon a strategy that shall will maximize patent protection and commercial value for each Licensed the Product. All filings for such Extensions, as determined by the holder of the applicable NDA, shall be made by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are assigned, and the owner of record of the applicable Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Extension, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file for such Extension in the Patent Rights’ owner’s name, and (c) provide all necessary assistance in connection therewith. The Parties acknowledge and agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term with respect to “Licensed Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world other than those of North America with respect to such “Licensed Products” under the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Patent Rights under the Shire Agreement, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Agreement that affect Acceleron Patent Rights, and, to the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 if, after using such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by Shire.

Appears in 2 contracts

Samples: License Agreement (Ignyta, Inc.), License Agreement (Ignyta, Inc.)

Patent Term Extensions. The Parties As long as Xxxxxxx retains Commercialization rights for any Licensed Product, upon Xxxxxxx’x written request (which shall be by a notice identifying the date of the applicable Regulatory Approval of a Licensed Product and the deadline for filing a Patent Term Extension), the Prosecuting Party shall use reasonable efforts to obtain all available supplementary protection certificatesefforts, patent term restorationsin each country or jurisdiction where Regulatory Approval for any such Licensed Product has been obtained, and other extensions if the Applicable Law of such country or jurisdiction permits application for a Patent Term Extension, to apply, at the reasonable direction of Xxxxxxx’x designated patent counsel, for a Patent Term Extension for a patent within the Arrowhead Patent Rights including a Valid Claim Covering such Licensed Product, which patent (collectivelyif any) shall be selected at Xxxxxxx’x reasonable judgment after considering the opinion of Xxxxxxx’x patent counsel regarding its eligibility for a Patent Term Extension. Xxxxxxx shall have the right to: (a) identify in any list of patents in a Drug Application the applicable Arrowhead Patent Right(s) as Xxxxxxx reasonably believes is appropriate; (b) commence suit for any Product Infringement of any such Arrowhead Patent Right(s) under Applicable Law as permitted under Section 10.4.2 and 10.4.3; and (c) exercise any rights that may be exercisable by a patent owner, “Extensions”including applying for a Patent Term Extension, of any Arrowhead Patent Right(s) pertaining to an approved Licensed Product Commercialized by Xxxxxxx hereunder. Arrowhead agrees to cooperate with Xxxxxxx and its Affiliate and Third Party sublicensees of Licensed Products, as applicable, upon Xxxxxxx’x reasonable request in the exercise of the Acceleron Patent Rights authorizations granted under this Section, and Joint Patent Rights (including those available under the Xxxxx-Xxxxxx Act). Each Party Arrowhead shall execute such authorizations and other documents and take such other actions additional action as Xxxxxxx may be reasonably requested by the other Party to obtain such Extensions. The Parties shall cooperate with each other in gaining Extensions wherever applicable to Acceleron Patent Rights or Joint Patent Rights. The holder of the applicable NDA may determine what Extensions of any such Patent Rights shall be made; provided that, if in any country such holder has an option to extend the patent term for only one of several patents, the first Party shall consult with the other Party before making the election. If more than one patent is eligible for such an Extension, the Parties shall select in good faith a strategy that shall maximize patent protection and commercial value for each Licensed Product. All filings for such Extensions, as determined by the holder of the applicable NDA, shall be made by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are assigned, and the owner of record of the applicable Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Extension, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file for such Extension in the Patent Rights’ owner’s name, and (c) provide all necessary assistance request in connection therewith. The Parties acknowledge , including, if requested by Xxxxxxx, permitting Arrowhead to be joined as a party in any suit for Product Infringement brought by Xxxxxxx hereunder on the terms and agree that (i) pursuant to the Shire Agreementconditions set forth in Section 10.4.2 and 10.4.3, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term with respect to “Licensed Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world other than those of North America with respect to such “Licensed Products” under the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Patent Rights under the Shire Agreement, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Agreement that affect Acceleron Patent Rights, and, to the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be Xxxxxxx shall reimburse Arrowhead all reasonable Out-of-Pocket Costs incurred by Arrowhead in breach of its obligations under this Section 8.9 if, after using taking such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by Shireaction.

Appears in 2 contracts

Samples: Research Collaboration and Option Agreement (Arrowhead Pharmaceuticals, Inc.), License Agreement (Arrowhead Pharmaceuticals, Inc.)

Patent Term Extensions. The Parties i. Novartis shall be responsible for determining the strategy for applying for the extension of the term of any [*] Patents with respect to Canakinumab, such as under the “U.S. Drug Price Competition and Patent Term Restoration Act of 1984” (the “Act”), the Supplementary Certificate of Protection of the Member States of the European Union and other similar measures in any other country. If requested by Novartis, and at Novartis’ cost, XOMA shall apply for and use its reasonable efforts to obtain all available supplementary protection certificatessuch an extension or, patent term restorations, and other extensions should the Law permit or require Novartis (collectively, “Extensions”or one (1) of its respective Affiliates, subcontractors or sublicensees hereunder) to so apply, XOMA hereby gives permission to Novartis to do so (in which case XOMA agrees to cooperate with Novartis in the Acceleron Patent Rights exercise of such authorization and Joint Patent Rights (including those available under the Xxxxx-Xxxxxx Act). Each Party shall execute such authorizations and other documents and take such other actions additional action as Novartis may reasonably request in connection therewith). Novartis and XOMA agree to cooperate with one another in obtaining any patent extension hereunder as directed by Novartis, and [*]. ii. Novartis shall be responsible for determining the strategy with respect to certifications, notices and patent enforcement procedures regarding [*] Patents under the Act and the Biologics Price Competition and Innovation Act of 2009 (the “BPCIA”). XOMA shall cooperate, as reasonably requested by the other Party to obtain such Extensions. The Parties shall cooperate with each other in gaining Extensions wherever applicable to Acceleron Patent Rights or Joint Patent Rights. The holder of the applicable NDA may determine what Extensions of any such Patent Rights shall be made; provided thatNovartis, if in any country such holder has an option to extend the patent term for only one of several patents, the first Party shall consult with the other Party before making the election. If more than one patent is eligible for such an Extension, the Parties shall select in good faith a strategy that shall maximize patent protection and commercial value for each Licensed Product. All filings for such Extensions, as determined by the holder of the applicable NDA, shall be made by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are assigned, and the owner of record of the applicable Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Extension, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file for such Extension in the Patent Rights’ owner’s name, and (c) provide all necessary assistance in connection therewith. The Parties acknowledge and agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term with respect to “Licensed Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world other than those of North America with respect to such “Licensed Products” under the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Patent Rights under the Shire Agreement, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Agreement that affect Acceleron Patent Rights, and, to the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 if3.d.ii. XOMA hereby authorizes Novartis to: (a) provide in any BLA or in connection with the BPCIA, after using a list of XOMA IL-1 Patents as required under the BPCIA; (b) except as otherwise expressly provided in this Agreement, exercise any rights exercisable by Novartis as Patent owner under the Act or the BPCIA; and (c) exercise any rights that may be exercisable by Novartis as reference product sponsor under the BPCIA, including (1) engaging in the Patent resolution provisions of the BPCIA with regard to [*] Patents; and (2) determining which Patents will be the subject of immediate Patent infringement action under § 351(l)(6) of the BPCIA; provided, that with respect to Novartis’ exercise of rights under the BPCIA, Novartis shall consult with a representative of XOMA designated by XOMA in writing and qualified to receive confidential information pursuant to § 365(l) of the BPCIA with respect to Novartis’ exercise of any rights exercisable as reference product sponsor, including providing such commercially reasonable effortsrepresentative with timely copies of material correspondence relating to such matters, it is unable providing such representative the opportunity, reasonably in advance of any related Novartis action, to comply comment thereon and to consult with and consider in good faith the requests and suggestions of XOMA with respect to such obligations because of actions taken or not taken by Shire.matters

Appears in 2 contracts

Samples: Il 1 Target License Agreement (XOMA Corp), License Agreement

Patent Term Extensions. The Parties shall use reasonable efforts to obtain all available supplementary protection certificates, patent term restorations, and other extensions (collectively, “Extensions”) will confer regarding the desirability of the Acceleron Patent Rights and Joint Patent Rights (including those available under the Xxxxx-Xxxxxx Act). Each Party shall execute such authorizations and other documents and take such other actions as may be reasonably requested by the other Party to obtain such Extensions. The Parties shall cooperate with each other in gaining Extensions wherever applicable to Acceleron Patent Rights or Joint Patent Rights. The holder of the applicable NDA may determine what Extensions of any such Patent Rights shall be made; provided that, if seeking in any country such holder has an option to extend the any patent term for only one of several patentsextension, the first Party shall consult with the other Party before making the election. If more than one patent is eligible for such an Extension, the Parties shall select in good faith a strategy that shall maximize supplemental patent protection and commercial value for each Licensed Product. All filings for such Extensions, as determined by the holder or related extension of the applicable NDA, shall be made by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are assigned, and the owner of record of the applicable Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Extension, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file for such Extension in the Patent Rights’ owner’s name, and (c) provide all necessary assistance in connection therewith. The Parties acknowledge and agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term rights with respect to “Licensed Products” under the Shire AgreementProduct Specific Patents. BMS shall have the sole right, but not the obligation, to apply for any such extension or protection. Neither Party will proceed with such an extension until the Parties have consulted with one another and Shire shall make agreed to a strategy therefor, provided that in the decision in all countries of case where the world other than those of North America Parties are unable to reach consensus, BMS will have the final decision-making authority with respect to such “Licensed Products” under the Shire Agreement, and the filings for Extensions with respect thereto decision; provided further that such decision will be made by in accordance with Applicable Law so as to maximize marketing exclusivity for the party who is responsible Product in the Field. Without limiting the foregoing, CytomX covenants that it will not seek patent term extensions, supplemental protection certificates, or similar rights or extensions for Prosecuting Patent Rights the Product Specific Patents without the prior written consent of BMS, not to be unreasonably withheld. Each Party will cooperate fully with and provide all reasonable assistance to the other Party and use all commercially reasonable efforts consistent with its obligations under Applicable Law (including any applicable consent order or decree) in connection with obtaining any such extensions for the Shire AgreementProduct Specific Patents consistent with such strategy. To the extent reasonably and legally required in order to obtain any such extension in a particular country, andeach Party will make available to the other a copy of the necessary documentation to enable such other Party to use the same for the purpose of obtaining the extension in such country. If BMS seeks a patent term extension, as such, Celgene’s supplemental patent protection or related extension of rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron shall keep Celgene informed of all elections with respect to Extensions made pursuant any BMS Patent covering a Product, then for the purpose of calculating the Royalty Term, the last-to-expire Patent among the CytomX Patent Rights or Product Specific Patent will be deemed to be extended by the Shire Agreement that affect Acceleron Patent Rights, and, to same amount of time as the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 if, after using such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by ShireBMS Patent.

Appears in 2 contracts

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

Patent Term Extensions. The Parties Each Party shall use reasonable efforts have the sole right and authority, in consultation with the other Party, to apply for and obtain all available any Patent term extension or related extension of rights, including supplementary protection certificates, patent term restorations, certificates and other extensions similar rights (collectively, “Patent Term Extensions”) of ), for any Galapagos Patent, Gilead Collaboration Patent or Joint Collaboration Patent, in each case, in its Respective Territory. If the Acceleron Parties disagree on the appropriate strategy with respect to any Patent Rights Term Extension for any Galapagos Patent, Gilead Collaboration Patent or Joint Collaboration Patent, then such dispute shall be subject to resolution by the JSC; provided that if the JSC is unable to reach consensus on the strategy, then each Party shall have final decision-making authority with respect to such strategy in its Respective Territory and Joint Patent Rights (including those available under neither Party shall have the Xxxxxright to escalate such dispute beyond the JSC. In exercising such final decision-Xxxxxx Act)making authority after consideration by the JSC, each Party shall consider, reasonably and in good faith, all input received from the other Party. Each Party shall execute such authorizations and other documents and take such other actions as may be reasonably requested by provide reasonable assistance to the other Party in connection with applying for and obtaining any Patent Term Extensions for any Galapagos Patent, Gilead Collaboration Patent or Joint Collaboration Patent. To the extent reasonably and legally required in order to obtain any Patent Term Extension in any country, each Party shall make available to the other a copy of the necessary documentation Controlled by such ExtensionsParty to enable such other Party to use the same for the purpose of obtaining such Patent Term Extension in such country. The Parties shall cooperate Any Patent Costs incurred in connection with each other in gaining Extensions wherever applicable to Acceleron any Patent Rights Term Extension for any Galapagos Patent, Gilead Collaboration Patent or Joint Collaboration Patent Rights. The holder of the applicable NDA may determine what Extensions of any such Patent Rights shall be made; provided that, if in any country such holder has an option to extend the patent term for only one of several patents, the first Party shall consult with the other Party before making the election. If more than one patent is eligible for such an Extension, the Parties shall select in good faith a strategy that shall maximize patent protection and commercial value for each Licensed Product. All filings for such Extensions, as determined by the holder of the applicable NDA, shall be made borne by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are assigned, and the owner of record of the applicable Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Extension, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file applying for such Extension in the Patent Rights’ owner’s name, and (c) provide all necessary assistance in connection therewith. The Parties acknowledge and agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term with respect to “Licensed Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world other than those of North America with respect to such “Licensed Products” under the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Patent Rights under the Shire Agreement, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Agreement that affect Acceleron Patent Rights, and, to the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 if, after using such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by ShireTerm Extension.

Appears in 2 contracts

Samples: Option, License and Collaboration Agreement (Gilead Sciences Inc), Option, License and Collaboration Agreement (Galapagos Nv)

Patent Term Extensions. The Parties During the Term, upon Xxxxxxx’x written request (which shall be by a written notice identifying the date of the applicable Marketing Approval of a Licensed Product and the deadline for filing a patent term extension, supplemental protection certificate or their equivalent (each a “Patent Term Extension”)), the Party prosecuting a relevant Patent Right shall use reasonable efforts to obtain all available supplementary protection certificatesefforts, patent term restorationsin each country or jurisdiction where Marketing Approval for any such Licensed Product has been obtained, and other extensions if the Applicable Law of such country or jurisdiction permits application for a Patent Term Extension, to apply, at the reasonable direction of Xxxxxxx’x Patent Representative, for a Patent Term Extension for a patent within the TRACON Program Patents or TRACON-Owned Development Program Patents including a Valid Claim Covering such Licensed Product, which patent (collectivelyif any) shall be selected at Xxxxxxx’x reasonable judgment after considering the opinion of Xxxxxxx’x patent counsel regarding its eligibility for a Patent Term Extension. Xxxxxxx shall have the right to: (a) identify in any list of patents in a Drug Approval Application for a Licensed Product with respect to such Program the applicable Xxxxxxx Program Patent(s), “Extensions”TRACON Program Patent(s) and Development Program Patent(s), as Xxxxxxx reasonably believes is appropriate; (b) for clarity, commence an Action for any Product Infringement of any such TRACON Program Patent(s) or TRACON-Owned Development Program Patent(s) under Applicable Law as permitted under Section 6.2.2; and (c) subject to specific limitations of this Agreement, exercise any rights that may be exercisable by a patent owner, including applying for a Patent Term Extension, of any TRACON Program Patent(s) or TRACON-Owned Development Program Patent(s) pertaining to an approved Licensed Product licensed to Xxxxxxx and Commercialized by Xxxxxxx during the Term. TRACON agrees to cooperate with Xxxxxxx and its Affiliate and Third Party (sub)licensees of Licensed Products, as applicable, upon Xxxxxxx’x reasonable request in the exercise of the Acceleron Patent Rights authorizations under this Section, and Joint Patent Rights (including those available under the Xxxxx-Xxxxxx Act). Each Party TRACON shall execute such authorizations and other documents and take such other actions additional action as Xxxxxxx may be reasonably requested by the other Party to obtain such Extensions. The Parties shall cooperate with each other in gaining Extensions wherever applicable to Acceleron Patent Rights or Joint Patent Rights. The holder of the applicable NDA may determine what Extensions of any such Patent Rights shall be made; provided that, if in any country such holder has an option to extend the patent term for only one of several patents, the first Party shall consult with the other Party before making the election. If more than one patent is eligible for such an Extension, the Parties shall select in good faith a strategy that shall maximize patent protection and commercial value for each Licensed Product. All filings for such Extensions, as determined by the holder of the applicable NDA, shall be made by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are assigned, and the owner of record of the applicable Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Extension, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file for such Extension in the Patent Rights’ owner’s name, and (c) provide all necessary assistance request in connection therewith. The Parties acknowledge and agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term with respect to “Licensed Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world other than those of North America with respect to such “Licensed Products” under the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Patent Rights under the Shire Agreement, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Agreement that affect Acceleron Patent Rights, and, to the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be Xxxxxxx shall reimburse TRACON all reasonable out-of-pocket costs incurred by TRACON in breach of its obligations under this Section 8.9 if, after using taking such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by Shireaction.

Appears in 2 contracts

Samples: License Agreement (Tracon Pharmaceuticals, Inc.), License and Option Agreement (Tracon Pharmaceuticals, Inc.)

Patent Term Extensions. The Parties shall use reasonable efforts With respect to any system for extending the term of Patent Rights in the Territory or supplementary protection certificates and any other extensions that are now or become available in the future under Applicable Laws in any country or region in the Territory, in each case, due to the time needed to obtain all available supplementary protection certificatesRegulatory Approval of a pharmaceutical product established by any applicable Regulatory Authority or other Governmental Authority in any region in the Territory (a “Patent Term Extension”), patent or adjusting the term restorationsof Patent Rights in the Territory due to the time needed to prosecute and obtain a grant of a Patent Right under Applicable Laws in any region in the Territory (a “Patent Term Adjustment”), (a) Kiniksa will have the right, but not the obligation, and other extensions (collectivelywill be solely responsible for making all decisions regarding Patent Term Extensions or Patent Term Adjustments in the Territory that are applicable to Kiniksa Patent Rights, “Extensions”) of the Acceleron or Joint Collaboration Patent Rights and that become available for a patent included in the Kiniksa Patent Rights, or Joint Collaboration Patent Rights provided that Kiniksa will consult with Partner with respect to such decisions and consider the reasonable comments and concerns raised by ​ Partner; and (including those b) Partner will have the right, but not the obligation, and will be solely responsible for making all decisions regarding Patent Term Extensions, and Patent Term Adjustments in the Territory that are applicable to Partner Collaboration Patent Rights and that become available under for the Xxxxx-Xxxxxx Act)Licensed Product in the Territory or following issuance of a patent included in the Partner Collaboration Patent Rights; provided that Partner will consult with Kiniksa with respect to such decisions and consider the reasonable comments and concerns raised by Kiniksa. The Party holding the MAA for the Licensed Product in the Territory will make the appropriate filings and applications in the Territory in order to effectuate each Party’s decisions regarding Patent Term Extensions, or Patent Term Adjustments in the Territory in accordance with the foregoing sentence. Each Party shall execute such authorizations and will cooperate with the other documents and take such other actions as may be Party to the extent reasonably requested required by the other Party to obtain such effectuate the intent of this Section 14.7 (Patent Term Extensions. The Parties shall cooperate with each other in gaining Extensions wherever applicable ), including providing to Acceleron Patent Rights or Joint Patent Rights. The holder of the applicable NDA may determine what Extensions of any such Patent Rights shall be made; provided that, if in any country such holder has an option to extend the patent term for only one of several patents, the first Party shall consult with the other Party before making the election. If more than one patent is eligible for such an Extensionall documentation, the Parties shall select in good faith a strategy that shall maximize patent protection and commercial value for each Licensed Product. All filings for such Extensions, as determined by the holder of the applicable NDA, shall be made by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are assignedcertifications, and the owner of record of the applicable consents necessary to make and prosecute such application and obtain such Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Extension, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file for such Term Extension in the or Patent Rights’ owner’s name, and (c) provide all necessary assistance in connection therewith. The Parties acknowledge and agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term with respect to “Licensed Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world other than those of North America with respect to such “Licensed Products” under the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Patent Rights under the Shire Agreement, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Agreement that affect Acceleron Patent Rights, and, to the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 if, after using such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by ShireTerm Adjustment.

Appears in 1 contract

Samples: Collaboration and License Agreement (Kiniksa Pharmaceuticals, Ltd.)

Patent Term Extensions. The ESC will discuss and recommend for which, if any, of the Patents within the Chroma Patents and Joint Patents the Parties should seek Patent Term Extensions. Chroma, in the case of the Chroma Patents, and CTI in the case of the Joint Patents, shall use have the final decision-making authority with respect to applying for any such Patent Term Extensions, and will act with reasonable promptness in light of the development stage of Products to apply for any such Patent Term Extensions, where it so elects; provided, however, that if in a particular country or jurisdiction only one such Patent can obtain a Patent Term Extension, then the Parties will consult in good faith to determine which such Patent should be the subject of efforts to obtain all available supplementary protection certificates, patent term restorationsa Patent Term Extension, and other extensions (collectively, “Extensions”) in any event CTI’s decision on such matter will control in the case of a disagreement with regard to the Acceleron Patent Rights Licensed Territory and Joint Patent Rights (including those available under Chroma’s decision on such matters will control in the Xxxxx-Xxxxxx Act). Each Party shall execute such authorizations and other documents and take such other actions as may be reasonably requested by case of disagreement with regard to the other Party to obtain such ExtensionsROW Territory. The Parties shall Party that does not apply for an extension hereunder will cooperate with each other in gaining Extensions wherever applicable to Acceleron Patent Rights or Joint Patent Rights. The holder of the applicable NDA may determine what Extensions of any such Patent Rights shall be made; provided that, if in any country such holder has an option to extend the patent term for only one of several patents, the first Party shall consult fully with the other Party before in making the election. If more than one patent is eligible such filings or actions, for example and without limitation, making available all required regulatory data and information and executing any required authorizations to apply for such an Patent Term Extension, the Parties shall select in good faith a strategy that shall maximize patent protection and commercial value for each Licensed Product. All filings for such Extensions, as determined by the holder of the applicable NDA, shall be made by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are assigned, and the owner of record of the applicable Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Extension, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file for such Extension in the Patent Rights’ owner’s name, and (c) provide all necessary assistance expenses incurred in connection therewith. The Parties acknowledge and agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term with activities of each Party with respect to “Licensed Products” under the Shire Agreement, and Shire Patent(s) for which such Party seeks Patent Term Extensions pursuant to this Section 9.5 shall make be entirely borne by such Party. Chroma shall only be obliged to comply with the decision in all countries provisions of the world other than those of North America this Section 9.5 with respect to such “Licensed Products” any Chroma Patent which is licensed to Chroma under the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Patent Rights under the Shire Agreement, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Vernalis Agreement that affect Acceleron Patent Rights, and, to the extent that Shire Chroma is making not prohibited to do so pursuant to the terms of the Vernalis Agreement, provided that in any such elections, Acceleron event Chroma shall use commercially reasonable efforts to cause Shire Vernalis to take the actions specified by this Section 8.9 in a manner consistent comply with the Shire Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 ifthese provisions. If, after using such despite Chroma’s commercially reasonable efforts, it Chroma is unable not able to comply cause Vernalis to so comply, CTI’s commercial diligence obligations under Section 6.4 shall be equitably adjusted in light of such lack of compliance. CTI’s rights under this Section 9.5 will ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such obligations because of actions taken or not taken information has been filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. be correspondingly limited by Shirethe rights which Chroma is able to exercise pursuant to the Vernalis Agreement.

Appears in 1 contract

Samples: Co Development and License Agreement (Cell Therapeutics Inc)

Patent Term Extensions. The Parties During the License Term with respect to a Program, upon Licensee’s written request (which shall be by a written notice identifying the date of the applicable Marketing Approval of a Licensed Product with respect to such Program and the deadline for filing a patent term extension, supplemental protection certificate or their equivalent (each a “Patent Term Extension”)), the Party prosecuting a relevant Patent Right shall use reasonable efforts to obtain all available supplementary protection certificatesefforts, patent term restorationsin each country or jurisdiction where Marketing Approval for any such Licensed Product has been obtained, and other extensions if the Applicable Law of such country or jurisdiction permits application for a Patent Term Extension, to apply, at the reasonable direction of Licensee’s Patent Representative, for a Patent Term Extension for a patent within the Xxxxxxx Program Patents or Xxxxxxx-Owned Development Program Patents including a Valid Claim Covering such Licensed Product, which patent (collectivelyif any) shall be selected at Licensee’s reasonable judgment after considering the opinion of Licensee’s patent counsel regarding its eligibility for a Patent Term Extension. Licensee shall have the right to: (a) identify in any list of patents in a Drug Approval Application for a Licensed Product with respect to such Program the applicable Xxxxxxx Program Patent(s), “Extensions”Licensee Program Patent(s) and Development Program Patent(s), as Licensee reasonably believes is appropriate; (b) for clarity, commence an Action for any Product Infringement of any such Xxxxxxx Program Patent(s) or Xxxxxxx-Owned Development Program Patent(s) under Applicable Law as permitted under Section 7.4.2; and (c) subject to specific limitations of this Agreement, exercise any rights that may be exercisable by a patent owner, including applying for a Patent Term Extension, of any Xxxxxxx Program Patent(s) or Xxxxxxx-Owned Development Program Patent(s) pertaining to an approved Licensed Product with respect to such Program licensed to Licensee and Commercialized by Licensee during the License Term with respect to such Program. Xxxxxxx agrees to cooperate with Licensee and its Affiliate and Third Party sublicensees of Licensed Products, as applicable, upon Licensee’s reasonable request in the exercise of the Acceleron Patent Rights authorizations under this Section, and Joint Patent Rights (including those available under the Xxxxx-Xxxxxx Act). Each Party Xxxxxxx shall execute such authorizations and other documents and take such other actions additional action as Licensee may be reasonably requested by the other Party to obtain such Extensions. The Parties shall cooperate with each other in gaining Extensions wherever applicable to Acceleron Patent Rights or Joint Patent Rights. The holder of the applicable NDA may determine what Extensions of any such Patent Rights shall be made; provided that, if in any country such holder has an option to extend the patent term for only one of several patents, the first Party shall consult with the other Party before making the election. If more than one patent is eligible for such an Extension, the Parties shall select in good faith a strategy that shall maximize patent protection and commercial value for each Licensed Product. All filings for such Extensions, as determined by the holder of the applicable NDA, shall be made by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are assigned, and the owner of record of the applicable Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Extension, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file for such Extension in the Patent Rights’ owner’s name, and (c) provide all necessary assistance request in connection therewith. The Parties acknowledge and agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term with respect to “Licensed Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world other than those of North America with respect to such “Licensed Products” under the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Patent Rights under the Shire Agreement, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Agreement that affect Acceleron Patent Rights, and, to the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be Licensee shall reimburse Xxxxxxx all reasonable out-of-pocket costs incurred by Xxxxxxx in breach of its obligations under this Section 8.9 if, after using taking such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by Shireaction.

Appears in 1 contract

Samples: License and Option Agreement (Tracon Pharmaceuticals, Inc.)

Patent Term Extensions. The Parties shall use reasonable efforts to obtain all available supplementary protection certificates, patent term restorations, certificates ("SPC") and other extensions (collectively, “Extensions”) of the Acceleron Patent Rights and Joint Patent Rights (including those available under the XxxxxHatch-Xxxxxx Waxman Act)) Covering or claiming RNAi Therapeutic Products. Each Party Eacx Xxxty shall execute such authorizations and other documents and take such other actions as may be reasonably requested by the other Party to obtain such Extensionsextensions. The Parties shall cooperate with each other in gaining Extensions patent term restorations, extensions and/or SPCs wherever applicable to Acceleron Patent Rights or Joint such Patent Rights. The holder of the applicable NDA may determine what Extensions Party first eligible to seek patent term restoration or extension of any such Patent Rights or any SPC related thereto shall be madehave the right to do so; provided thatprovided, that if in any country such holder the first Party has an option to extend the patent term for only one of several patents, the first Party shall consult with the other Party before making the election. If more than one patent is eligible for such an Extensionextension or patent term restoration, the Parties shall select in good faith agree upon a strategy that shall maximize patent protection and commercial value for each Licensed ProductRNAi Therapeutic Products. All filings for such Extensions, as determined by the holder of the applicable NDA, extensions and certificates shall be made by the Party to whom responsibility for Prosecution prosecution and maintenance of the Acceleron Patent Rights or Joint such Patent Rights are assigned, and the owner of record of the applicable Patent Right shall assist with such filings; provided thatprovided, that in the event that the Party to whom such responsibility is assigned elects not to file for an Extensionextension or SPC, such Party shall (ai) inform the other Party of its intention not to file, file and (bii) grant the other Party the right to file for such Extension extension or SPC in the Patent Rights’ owner’s name, patentee's name and (c) such Party shall provide all necessary assistance in connection therewith. The Parties acknowledge and agree that (i) pursuant provisions of this Section 11.9 shall also apply to Patent Rights Covering or claiming a MERCK Development Product to the Shire Agreement, Shire and Acceleron will consult in selecting extent such Patent Rights are included in ALNYLAM Technology licensed to extend the patent term with respect to “Licensed Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world other than those of North America MERCK with respect to such “Licensed Products” under MERCK Development Product pursuant to Section 7.1 and to a [**] Product to the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting extent such Patent Rights under the Shire Agreement, and, as such, Celgene’s rights under this Section 8.9 are subject included in MERCK Technology licensed to Shire’s prior rights; and (ii) Acceleron shall keep Celgene informed of all elections ALNYLAM with respect to Extensions made such [**] Product pursuant to the Shire Agreement that affect Acceleron Patent Rights, and, to the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 if, after using such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by Shire7.1.

Appears in 1 contract

Samples: Research Collaboration and License Agreement (Alnylam Pharmaceuticals, Inc.)

Patent Term Extensions. The Parties shall use reasonable efforts to obtain all available supplementary protection certificates, patent term restorations, certificates (“SPC”) and other extensions (collectively, “Extensions”) of the Celgene Patent Rights, Acceleron Patent Rights and Joint Patent Rights (including those available under the Xxxxx-Xxxxxx Act). Each Party shall execute such authorizations and other documents and take such other actions as may be reasonably requested by the other Party to obtain such Extensionsextensions. The Parties shall cooperate with each other in gaining Extensions patent term restorations, extensions or SPCs wherever applicable to Celgene Patent Rights, Acceleron Patent Rights or Joint Patent Rights. The holder of the applicable NDA may determine what Extensions Party first eligible to seek patent term restoration or extension of any such Patent Rights shall be madeor any SPC related thereto may do so; provided thatprovided, that if in any country such holder the first Party has an option to extend the patent term for only one of several patents, the first Party shall consult with the other Party before making the election; provided, further that, notwithstanding the foregoing, if, at the time the first Party becomes eligible to seek patent term restoration or extension of any such Patent Rights or any SPC related thereto, the other Party is Developing or Commercializing a Licensed Product in their respective Subfield, then the decisions to seek any such patent term restoration or extension of any such Patent Rights or any SPC related thereto and, if applicable, elect one of several patents for which to extend the patent term shall require the mutual consent of both Parties. If more than one patent is eligible for such an Extensionextension or patent term restoration, the Parties shall select in good faith a strategy that shall maximize patent protection and commercial value for each Licensed Product. All filings for such Extensions, as determined by the holder of the applicable NDA, extensions and certificates shall be made by the Party to whom responsibility for Prosecution of the Celgene Patent Rights, Acceleron Patent Rights or Joint Patent Rights are assigned, and the owner of record of the applicable Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Extensionextension or SPC, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file for such Extension extension or SPC in the Patent Rights’ owner’s name, and (c) provide all necessary assistance in connection therewith. The Parties acknowledge and agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term with respect to “Licensed Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world other than those of North America with respect to such “Licensed Products” under the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Patent Rights under the Shire Agreement, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Agreement that affect Acceleron Patent Rights, and, to the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 if, after using such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by Shire.

Appears in 1 contract

Samples: Collaboration, License and Option Agreement (Acceleron Pharma Inc)

Patent Term Extensions. The Parties shall use reasonable efforts With respect to any system for extending the term of Patent Rights in the Territory due to the time needed to obtain all available Regulatory Approval of a pharmaceutical product established by any applicable Regulatory Authority in any region in the Territory (a “Patent Term Extension”), adjusting the term of Patent Rights in the Territory due to the time needed to prosecute and obtain a grant of a Patent Right under Applicable Laws in any region in the Territory (a “Patent Term Adjustment”), or supplementary protection certificatescertificates and any other extensions that are now or become available in the future under Applicable Laws in any region in the Territory (“Other Extensions”), patent term restorations(a) Blueprint will have the right, but not the obligation, and other extensions (collectivelywill be solely responsible for making all decisions regarding Patent Term Extensions, “Extensions”) of Patent Term Adjustments, or Other Extensions in the Acceleron Territory that are applicable to Blueprint Patent Rights, Blueprint Manufacturing Patent Rights, or Joint Collaboration Patent Rights and that become available directly as a result of the Regulatory Approval of a Licensed Product in the Territory or following issuance of a patent included in the Blueprint Patent Rights, Blueprint Manufacturing Patent Rights, or Joint Collaboration Patent Rights provided that Blueprint will consult with Zai with respect to such decisions and consider [****] the reasonable comments and concerns raised by Xxx; and (including those b) Xxx will have the right, but not the obligation, and will be solely responsible for making all decisions regarding Patent Term Extensions, Patent Term Adjustments, and Other Extensions in the Territory that are applicable to Zai Collaboration Patent Rights and that become available under directly as a result of the Xxxxx-Xxxxxx Act)Regulatory Approval of a Licensed Product in the Territory or following issuance of a patent included in the Zai Collaboration Patent Rights; provided that Zai will consult with Blueprint with respect to such decisions and consider [****] the reasonable comments and concerns raised by Blueprint. Each The Party shall execute such authorizations holding the MAA for the applicable Licensed Product in the Territory will make the appropriate filings and applications in the Territory in order to effectuate each Party’s decisions regarding Patent Term Extensions, Patent Term Adjustments, or Other Extensions in the Territory in accordance with the foregoing sentence. The Party holding the MAA for the applicable Licensed Product in the Territory will cooperate with the other documents and take such other actions as may be Party to the extent reasonably requested by the other Party to obtain such effectuate the intent of this Section 14.7 (Patent Term Extensions. The Parties shall cooperate with each other in gaining Extensions wherever applicable ), including providing to Acceleron Patent Rights or Joint Patent Rights. The holder of the applicable NDA may determine what Extensions of any such Patent Rights shall be made; provided that, if in any country such holder has an option to extend the patent term for only one of several patents, the first Party shall consult with the other Party before making the election. If more than one patent is eligible for all documentation, certifications, and consents necessary to make and prosecute such an application and obtain such Patent Term Extension, the Parties shall select in good faith a strategy that shall maximize patent protection and commercial value for each Licensed Product. All filings for such ExtensionsPatent Term Adjustment, as determined by the holder of the applicable NDA, shall be made by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are assigned, and the owner of record of the applicable Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Other Extension, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file for such Extension in the Patent Rights’ owner’s name, and (c) provide all necessary assistance in connection therewith. The Parties acknowledge and agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term with respect to “Licensed Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world other than those of North America with respect to such “Licensed Products” under the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Patent Rights under the Shire Agreement, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Agreement that affect Acceleron Patent Rights, and, to the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 if, after using such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by Shire.

Appears in 1 contract

Samples: License and Collaboration Agreement (Zai Lab LTD)

Patent Term Extensions. The Parties As long as Xxxxxxx retains Commercialization rights for a Licensed Product under Section 2.1.2, upon Xxxxxxx’x written request (which shall be by a notice identifying the date of the applicable Regulatory Approval of a Licensed Product and the deadline for filing a Patent Term Extension), the Prosecuting Party shall use reasonable efforts to obtain all available supplementary protection certificatesefforts, patent term restorationsin each country or jurisdiction where Regulatory Approval for any Licensed Product has been obtained, and other extensions if the Applicable Law of such country or jurisdiction permits application for a Patent Term Extension, to apply, at the reasonable direction of Xxxxxxx’x designated patent counsel, for a Patent Term Extension for a patent within the Geron Product Patent Rights including a Valid Claim Covering such Licensed Product, which patent (collectivelyif any) shall be selected at Xxxxxxx’x reasonable judgment after considering the opinion of Xxxxxxx’x patent counsel regarding its eligibility for a Patent Term Extension. Xxxxxxx shall have the right to: (a) identify in any list of patents in a Drug Application the applicable Geron Product Patent Right(s) and Development Program Patent Right(s), “Extensions”as Xxxxxxx reasonably believes is appropriate; (b) commence suit for any Product Infringement of any such Geron Product Patent Right(s) or Development Program Patent Right(s) under Applicable Law as permitted under Section 10.4.2; and (c) exercise any rights that may be exercisable by a patent owner, including applying for a Patent Term Extension, of any Geron Product Patent Right(s) or Development Program Patent Right(s) pertaining to an approved Licensed Product Commercialized by Xxxxxxx hereunder. Geron agrees to cooperate with Xxxxxxx and its Affiliate and Third Party sublicensees of Licensed Products, as applicable, upon Xxxxxxx’x reasonable request in the exercise of the Acceleron Patent Rights authorizations granted under this Section, and Joint Patent Rights (including those available under the Xxxxx-Xxxxxx Act). Each Party Geron shall execute such authorizations and other documents and take such other actions additional action as Xxxxxxx may be reasonably requested by the other Party to obtain such Extensions. The Parties shall cooperate with each other in gaining Extensions wherever applicable to Acceleron Patent Rights or Joint Patent Rights. The holder of the applicable NDA may determine what Extensions of any such Patent Rights shall be made; provided that, if in any country such holder has an option to extend the patent term for only one of several patents, the first Party shall consult with the other Party before making the election. If more than one patent is eligible for such an Extension, the Parties shall select in good faith a strategy that shall maximize patent protection and commercial value for each Licensed Product. All filings for such Extensions, as determined by the holder of the applicable NDA, shall be made by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are assigned, and the owner of record of the applicable Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Extension, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file for such Extension in the Patent Rights’ owner’s name, and (c) provide all necessary assistance request in connection therewith, including, if requested by Xxxxxxx, permitting Geron to be joined as a party in any suit for Product Infringement brought by Xxxxxxx hereunder on the terms and conditions set forth in Section 10.4.2, provided that Xxxxxxx shall reimburse Geron all reasonable out-of-pocket costs incurred by Geron in taking such action. The Parties acknowledge Geron agrees to cooperate with Xxxxxxx and agree its Affiliate and Third Party sublicensees of Licensed Products, as applicable, upon Xxxxxxx’x reasonable request in the exercise of the authorizations granted under this Section, and subject to any surviving rights granted by Geron to any Third Party and Geron’s obligations remaining under applicable Existing Third Party Agreements then in effect (pursuant to their terms as of the Execution Date, except as such may be amended by Geron with Xxxxxxx’x prior written consent), Geron shall execute such documents and take such additional action as Xxxxxxx may reasonably request in connection therewith, including using reasonable efforts to procure the cooperation of any Inferior Rights Holders, such that Xxxxxxx shall have (i) pursuant the first and a superior right (in relation to the Shire Agreement, Shire and Acceleron will consult in selecting any Inferior Rights Holders) to select from all Geron Product Patent Rights to extend the patent term with respect to “Licensed Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world other than those of North America with respect to such “Licensed Products” under the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Development Program Patent Rights under the Shire Agreementin a particular country or jurisdiction a particular Patent Right for which it will pursue a Patent Term Extension in such country application, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron shall keep Celgene informed of all elections with respect the first and a superior right to Extensions made pursuant enforce and defend any patents within the Geron Product Patent Rights and Development Program Patent Rights against infringement pertaining to the Shire Agreement that affect Acceleron Patent Rights, and, to the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 if, after using such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken Third Party’s Licensed Product or not taken by Shirea Generic Product.

Appears in 1 contract

Samples: Collaboration and License Agreement (Geron Corp)

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Patent Term Extensions. The Parties shall: (a) notify each other of the issuance of each patent where extension is possible included within the Nerviano Patents or Joint Patents, giving the date of issue and patent number for each such patent; and (b) advise each other in a timely manner of approval by the FDA, EMA, or MHLW to use or market any Product and any other governmental approval that is pertinent to any patent term extension or restoration. The Parties shall use reasonable efforts to obtain all available supplementary protection certificates, patent term restorations, and other extensions (collectively, “Extensions”) or restorations of the Acceleron Patent Rights and such Nerviano Patents or Joint Patent Rights Patents (including those available under the Xxxxx-Xxxxxx Act). Each To that end, each Party shall shall: (c) supply the other Party, in a timely manner, with any information in its possession or control pertaining to, or desirable for, the extension of any Nerviano Patents or Joint Patent; (d) execute such authorizations and deliver to the other Party, in a timely manner, any authorizations, supporting affidavits and other documents required in connection with the extension of any Nerviano Patent or Joint Patent; and (e) take such other actions as may be [*] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portion. reasonably requested by the other Party to obtain such Extensionsextensions. The Parties shall cooperate with each other in seeking or gaining Extensions patent term restorations or extensions wherever applicable to Acceleron Patent Rights such Nerviano Patents or Joint Patents, and in determining which Nerviano Patents or Joint Patent Rightsthe Parties should seek and obtain patent term extension or restoration. The holder of the applicable NDA may determine what Extensions Party first eligible to seek patent term restoration or extension of any such Nerviano Patents or Joint Patent Rights related thereto shall be madehave the right to do so; provided thatprovided, that if in any country such holder the first Party has an option to extend the patent term for only one of several patents, the first Party shall will consult with the other Party before making the election. If more than one patent Nerviano Patents or Joint Patent is eligible for such an Extensionextension or patent term restoration, the Parties shall select in good faith agree upon a strategy that shall will maximize patent protection and commercial value for each Licensed the Product. All filings for such Extensions, as determined by the holder Notwithstanding any of the applicable NDAforegoing, shall where consensus cannot be made by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are assignedreached, and the owner of record of the applicable Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Extension, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file for such Extension in the Patent Rights’ owner’s name, and (c) provide all necessary assistance in connection therewith. The Parties acknowledge and agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term with respect to “Licensed Products” under the Shire Agreement, and Shire Trovagene shall make the decision final determination after consultation with Nerviano and considering Nerviano’ position in all countries of the world other than those of North America with respect to such “Licensed Products” under the Shire Agreementgood faith; provided, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Patent Rights under the Shire Agreementhowever, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron that Trovagene shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Agreement not make any final determination that affect Acceleron Patent Rights, and, to the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent conflicts with the Shire terms and conditions of this Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 if, after using such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by Shire.

Appears in 1 contract

Samples: License Agreement (Trovagene, Inc.)

Patent Term Extensions. (a) The Parties shall will use reasonable efforts to obtain all available supplementary protection certificates, patent term restorations, and other extensions (collectively, “Extensions”) of the Acceleron Patent Rights POZEN Patents and Joint Patent Rights Patents (including those available under 35 U.S.C. Section 156 et seq. (the Xxxxx“Hxxxx-Xxxxxx Act)) in the Territory. Each The Parties will cooperate with each other in gaining Patent term restorations and extensions for POZEN Patents and Joint Patents in the Territory. The Parties will notify each other of the issuance of each Patent included within the POZEN Patents or Joint Patents where extension is possible, giving the date of issue and Patent number for each such patent. (b) The Party shall first eligible to seek patent term restoration or extension of any such POZEN Patent or Joint Patent will have the right to do so; provided, that if the first Party has an option to extend the patent term for only one of several Patents, the first Party will consult with the other Party before making such election. If more than one POZEN Patent or Joint Patent is eligible for extension or patent term restoration, the Parties will agree upon a strategy that will maximize patent protection for the Collaboration Products. (c) All filings for such extensions of POZEN Patents will be made by POZEN, and all filings for such extensions of a Joint Patent will be made by the Party which prosecuted such Joint Patent; provided, that in the event that a Party elects not to file for an extension of a Patent which it prosecuted, such Party will (i) promptly inform the other Party of its intention not to file and (ii) file for such extension on the other Party’s behalf, if so instructed, or, in the case of a Joint Patent, grant to the other Party the right to file such extension and cooperate in such filing. The Party which is the sponsor of record of the NDA, at the time that applications for extension are submitted, will execute such authorizations and other documents and take such other actions as may be reasonably requested by the other Party to obtain such Extensions. The Parties shall cooperate with each other in gaining Extensions wherever applicable to Acceleron Patent Rights or Joint Patent Rights. The holder of the applicable NDA may determine what Extensions of any such Patent Rights shall be made; provided thatextensions, if in any country such holder has an option to extend the patent term for only one of several patents, the first Party shall consult with including designating the other Party before making the election. If more than one patent is eligible as its agent for such an Extension, purpose as provided in the Parties shall select in good faith Hxxxx-Xxxxxx Act. (d) Any such extension of a strategy that shall maximize patent protection and commercial value for each Licensed Product. All filings for such Extensions, as determined by POZEN Patent or a Joint Patent will be included within the holder definition of the applicable NDA, shall be made by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights POZEN Patents or Joint Patent Rights are assignedPatents, and the owner of record of the applicable Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Extension, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file for such Extension in the Patent Rights’ owner’s name, and (c) provide all necessary assistance in connection therewith. The Parties acknowledge and agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term with respect to “Licensed Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world other than those of North America with respect to such “Licensed Products” under the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Patent Rights under the Shire Agreement, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Agreement that affect Acceleron Patent Rights, and, to the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 if, after using such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by Shirerespectively.

Appears in 1 contract

Samples: Product Development and Commercialization Agreement (Pozen Inc /Nc)

Patent Term Extensions. The Parties Each party shall notify the other party of the issuance of each patent included within the Curis Patent Rights, P&G Patent Rights or Joint Patent Rights that claim any Product, including the composition of any ingredient, its manufacture or use, where extension is possible, giving the date of issue and patent number for each such patent. Subject to Curis’ obligations [**], the parties shall use reasonable efforts Commercially Reasonable Efforts to obtain all available supplementary protection certificates, patent term restorations, certificates and other extensions (collectively, “Extensions”) of the Acceleron Patent Rights and Joint such Patent Rights (including those available under the Xxxxx-Xxxxxx Act). Each Party party shall execute such authorizations and other documents and take such other actions as may be reasonably requested by the other Party party to obtain such Extensionsextensions. The Parties parties shall cooperate with each other in gaining Extensions patent term restorations, extensions and/or supplementary protection certificates (“SPC”) wherever applicable to Acceleron Curis Patent Rights, P&G Patent Rights or Joint Patent RightsRights covering Products to the extent practicable in light of Curis’ obligations [**]. The holder of the applicable NDA may determine what Extensions party first eligible to seek patent term restoration or extension of any such Patent Rights patent or any SPC related thereto shall be madehave the right to do so; provided thatprovided, that if in any country such holder the first party has an option to extend the patent term for only one of several patents, the first Party shall party will consult with the other Party party before making the election. If more than one patent is eligible for such an Extensionextension or patent term restoration, the Parties RSC shall select in good faith agree upon a strategy that shall will maximize patent protection and commercial value for each Licensed ProductProducts. All filings for such Extensions, as determined by the holder of the applicable NDA, extensions and certificates shall be made by the Party party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are patent is assigned, and the owner of record of the applicable Patent Right shall assist with such filings; provided thatprovided, that in the event that the Party party to whom such responsibility the patent is assigned elects not to file for an Extensionextension or SPC, such Party party shall (ai) inform the other Party party of its intention not to file, file and (bii) grant the other Party party the right to file for such Extension in the Patent Rights’ owner’s name, and (c) provide all necessary assistance in connection therewithextension or certificate on behalf of such party. The Parties parties acknowledge and that Curis’ patent obligations [**] may take precedence over P&G’s rights, but the parties agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights use diligent efforts to extend the patent term with respect to “Licensed Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world keep each other than those of North America with respect to such “Licensed Products” under the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Patent Rights under the Shire Agreement, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Agreement that affect Acceleron Patent Rights, and, to the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 if, after using such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by Shireprecedence as they arise.

Appears in 1 contract

Samples: Collaboration, Research and License Agreement (Curis Inc)

Patent Term Extensions. The Parties shall notify each other of the issuance of each patent included within the Durect, Endo and Joint Patents where a patent term extension, adjustment or restoration, or supplementary protection certificate (an “SPC,” and together with patent term extensions, adjustments and restorations, “Patent Term Extensions”) is possible in the Licensed Territory, giving the date of issue and patent number for each such patent. Endo shall use reasonable efforts Commercially Reasonable Efforts to obtain all available supplementary protection certificatesPatent Term Extensions of such Durect, patent term restorations, and other extensions (collectively, “Extensions”) of the Acceleron Patent Rights and Endo or Joint Patent Rights Patents (including those available under the Xxxxx-Xxxxxx Act). Each Party Durect shall execute such authorizations and other documents and take such other actions as may be reasonably requested by the other Party Endo to obtain such Patent Term Extensions. The Parties shall cooperate with each other in gaining obtaining Patent Term Extensions wherever applicable to Acceleron Patent Rights such Durect, Endo or Joint Patent RightsPatents. The holder of the applicable NDA may determine what Extensions of any such Patent Rights shall be made; provided that, if If in any country such holder in the Licensed Territory Endo has an option to extend the patent term for only one of several patents, the first Party shall Endo will consult with the other Party Durect before making the election. If more than one patent Durect, Endo or Joint Patent is eligible for such an ExtensionPatent Term Extension in the Licensed Territory, the Parties shall select in good faith agree upon a strategy that shall will maximize patent protection and commercial value for each Licensed the Product. All filings for such Extensions, as determined by Patent Term Extensions in the holder of the applicable NDA, Licensed Territory shall be made by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are assignedEndo at its sole cost and expense; provided, and the owner of record of the applicable Patent Right shall assist with such filings; provided that, that in the event that the Party to whom such responsibility is assigned Endo elects not to file for an Extensiona Patent Term Extension in the Licensed Territory, such Party Endo shall (a) promptly inform the other Party Durect of its intention not to file, file and (b) grant the other Party Durect the right to file for such Extension in the Patent Rights’ owner’s name, and (c) provide all necessary assistance in connection therewith. The Parties acknowledge and agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term with respect to “Licensed Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world other than those of North America with respect to such “Licensed Products” under the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Patent Rights under the Shire Agreement, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Agreement that affect Acceleron Patent Rights, and, to the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 if, after using such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by ShireTerm Extension.

Appears in 1 contract

Samples: License Agreement (Durect Corp)

Patent Term Extensions. The Parties shall use reasonable efforts to obtain all available supplementary protection certificates, patent term restorations, and other extensions (collectively, “Extensions”) of the Acceleron Patent Rights and Joint Patent Rights (including those available under the Xxxxx-Xxxxxx Act). Each Party shall execute such authorizations and other documents and take such other actions as may be reasonably requested by the other Party to obtain such Extensions. The Parties shall cooperate with each other in gaining Extensions wherever applicable to Acceleron Patent Rights or Joint Patent Rights. The holder of the 67 THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. applicable NDA may determine what Extensions of any such Patent Rights shall be made; provided that, if in any country such holder has an option to extend the patent term for only one of several patents, the first Party shall consult with the other Party before making the election. If more than one patent is eligible for such an Extension, the Parties shall select in good faith a strategy that shall maximize patent protection and commercial value for each Licensed Product. All filings for such Extensions, as determined by the holder of the applicable NDA, shall be made by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are assigned, and the owner of record of the applicable Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Extension, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file for such Extension in the Patent Rights’ owner’s name, and (c) provide all necessary assistance in connection therewith. The Parties acknowledge and agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term with respect to “Licensed Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world other than those of North America with respect to such “Licensed Products” under the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Patent Rights under the Shire Agreement, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Agreement that affect Acceleron Patent Rights, and, to the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 if, after using such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by Shire.. Article 9 CONFIDENTIALITY 9.1

Appears in 1 contract

Samples: Collaboration, License and Option Agreement

Patent Term Extensions. The Parties shall use reasonable efforts to obtain all available supplementary protection certificates, patent term restorations, consult and other extensions (collectively, “Extensions”) of the Acceleron Patent Rights and Joint Patent Rights (including those available under the Xxxxx-Xxxxxx Act). Each Party shall execute such authorizations and other documents and take such other actions as may be reasonably requested by the other Party to obtain such Extensions. The Parties shall cooperate with each other in gaining Extensions wherever applicable obtaining patent term extensions, adjustments, or restorations or supplemental protection certificates or their equivalents (each a “Patent Extension” and collectively “Patent Extensions”) in the Territory for the Licensed Patents and Joint Patents to Acceleron Patent Rights the extent they Cover Licensed Compounds, Licensed Products, or Joint Patent Rights. The holder of the applicable NDA may determine what Extensions of any such Patent Rights shall be madeMonotherapy Regimen; provided that, if (a) Incyte shall have the primary right and authority to seek and apply for Patent Extensions with respect to Licensed Patents and Joint Patents that [**] claim Monoclonal Antibodies, subject to review and comment by MacroGenics, which Incyte shall consider in good faith; (b) MacroGenics shall have the primary right and authority to seek and apply for Patent Extensions with respect to Licensed Patents and Joint Patents that [**] claim bi- or multi-specific antibodies, subject to review and comment by Incyte, which MacroGenics shall consider in good faith; and (c) the Parties shall discuss in good faith and shall mutually agree upon whether to seek and apply for Patent Extensions with respect to any country Patents [**] Monoclonal Antibodies and [**]. In the event that a Party does not intend to seek a Patent Extension that is or will become available for a Licensed Patent or Joint Patent, it shall so inform the other Party in writing in sufficient time to permit the other Party to seek such holder has an option to extend the patent term Patent Extension. The Party that does not apply for only one of several patents, the first Party shall consult a Patent Extension hereunder will cooperate fully with the other Party before in making the election. If more than one patent is eligible such filings or actions, including making available all required regulatory data and Information and executing any required authorizations to apply for such an Patent Extension, the Parties shall select in good faith a strategy that shall maximize patent protection and commercial value for each Licensed Product. All filings for such Extensions, as determined by the holder of the applicable NDA, shall be made by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are assigned, and the owner of record of the applicable Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Extension, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file for such Extension in the Patent Rights’ owner’s name, and (c) provide all necessary assistance out-of-pocket expenses incurred in connection therewith. The Parties acknowledge and agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term with activities of each Party with respect to the Licensed Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world other than those of North America with respect to such “Licensed Products” under the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Patent Rights under the Shire Agreement, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (iiPatent(s) Acceleron shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Agreement that affect Acceleron Patent Rights, and, to the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 if, after using such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by Shire.Joint Patent(s)

Appears in 1 contract

Samples: Global Collaboration and License Agreement (Incyte Corp)

Patent Term Extensions. The Parties Subject to the terms of each In-License Agreement, Agios shall use reasonable efforts have the first right to obtain all available supplementary protection certificates, patent term restorations, and other extensions (collectively, “Extensions”) of select the Acceleron appropriate Agios Patent Rights and Licensee shall have the first right to select the appropriate Joint Combination Therapy Patent Rights (including those available under the Xxxxx-Xxxxxx Act). Each Party shall execute such authorizations and other documents and take such other actions as may be reasonably requested by the other Party for filing to obtain such Extensions. The Parties shall cooperate with each other in gaining Extensions wherever applicable to Acceleron Patent Rights or Joint Patent Rights. The holder of the applicable NDA may determine what Extensions of any such Patent Rights shall be made; provided that, if in any country such holder has an option to extend the patent term extensions, including supplementary protection certificates and any other extensions that are now available or become available in the future, based on Regulatory Approvals for only one of several patentsLicensed Products in the Field in the Territory, and the first selecting Party shall consult with the other Party before making the election. If more than one patent is eligible for such an Extension, the Parties shall select in good faith a strategy that shall maximize patent protection and commercial value for each Licensed Product. All filings for such Extensions, as determined by the holder of the applicable NDA, shall be made by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are assigned, and the owner of record of the applicable Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Extension, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file for such Extension in the Patent Rights’ owner’s name, and (c) provide all necessary assistance in connection therewith. The Parties acknowledge and agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term with respect to “Licensed Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world other than those of North America with respect to such “Licensed Products” under decisions and shall consider the Shire Agreementcomments and concerns of the other Party in good faith. Each Party shall cooperate with the other Party in gaining any such patent term extensions, and the filings for Extensions with respect thereto will be made including by the party who signing all necessary papers. If Licensee elects not to, or is responsible for Prosecuting unable to, file to obtain any patent term extension described in this Section 9.05 (Patent Rights under the Shire AgreementTerm Extensions), it shall give Agios prompt notice thereof, and, as suchin such cases, Celgene’s rights under shall permit Agios at Agios’ own expense to take such actions itself. If Agios elects not, or is unable to, to file to obtain any patent term extension described in this Section 8.9 9.05 (Patent Term Extensions), it shall give Licensee prompt notice thereof, and, in such cases, Licensee may, with Agios’ prior written consent (which may not be unreasonably withheld), take such actions itself at its own expense. In such case, such first Party shall execute such documents and perform such acts as may be reasonably necessary for such other Party to perform such actions. In seeking or obtaining patent term extensions (including supplementary protection certificates and any other extensions that are subject to Shire’s prior rights; and (iinow available or become available in the future) Acceleron shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Agreement that affect Acceleron Agios Patent Rights, and, in no event shall Licensee take any position that is contrary to or detrimental to the extent that Shire is making scope or enforceability of any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 if, after using such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by Shireother Agios Patent Right.

Appears in 1 contract

Samples: License Agreement (Agios Pharmaceuticals Inc)

Patent Term Extensions. The Parties shall use reasonable efforts With respect to any system for extending the term of Patent Rights in the Territory or supplementary protection certificates and any other extensions that are now or become available in the future under Applicable Laws in any country or region in the Territory, in each case, due to the time needed to obtain all available supplementary protection certificatesRegulatory Approval of a pharmaceutical product established by any applicable Regulatory Authority or other Governmental Authority in any region in the Territory (a “Patent Term Extension”), patent or adjusting the term restorationsof Patent Rights in the Territory due to the time needed to prosecute and obtain a grant of a Patent Right under Applicable Laws in any region in the Territory (a “Patent Term Adjustment”), (a) Kiniksa will have the right, but not the obligation, and other extensions (collectivelywill be solely responsible for making all decisions regarding Patent Term Extensions or Patent Term Adjustments in the Territory that are applicable to Kiniksa Patent Rights, “Extensions”) of the Acceleron Kiniksa Manufacturing Patent Rights, or Joint Collaboration Patent Rights and that become available for a patent included in the Kiniksa Patent Rights, Kiniksa Manufacturing Patent Rights, or Joint Collaboration Patent Rights provided that Kiniksa will consult with Partner with respect to such decisions and consider the reasonable comments and concerns raised by Partner; and (including those b) Partner will have the right, but not the obligation, and will be solely responsible for making all decisions regarding Patent Term Extensions, and Patent Term Adjustments in the Territory that are applicable to Partner Collaboration Patent Rights and that become available under for the Xxxxx-Xxxxxx Act)Licensed Product in the Territory or following issuance of a patent included in the Partner Collaboration Patent Rights; provided that Partner will consult with Kiniksa with respect to such decisions and consider the reasonable comments and concerns raised by Kiniksa. The Party holding the MAA for the Licensed Product in the Territory will make the appropriate filings and applications in the Territory in order to effectuate each Party’s decisions regarding Patent Term Extensions, or Patent Term Adjustments in the Territory in accordance with the foregoing sentence. Each Party shall execute such authorizations and will cooperate with the other documents and take such other actions as may be Party to the extent reasonably requested required by the other Party to obtain such effectuate the intent of this Section 14.7 (Patent Term Extensions. The Parties shall cooperate with each other in gaining Extensions wherever applicable ), including providing to Acceleron Patent Rights or Joint Patent Rights. The holder of the applicable NDA may determine what Extensions of any such Patent Rights shall be made; provided that, if in any country such holder has an option to extend the patent term for only one of several patents, the first Party shall consult with the other Party before making the election. If more than one patent is eligible for such an Extensionall ​ ​ documentation, the Parties shall select in good faith a strategy that shall maximize patent protection and commercial value for each Licensed Product. All filings for such Extensions, as determined by the holder of the applicable NDA, shall be made by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are assignedcertifications, and the owner of record of the applicable consents necessary to make and prosecute such application and obtain such Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Extension, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file for such Term Extension in the or Patent Rights’ owner’s name, and (c) provide all necessary assistance in connection therewith. The Parties acknowledge and agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term with respect to “Licensed Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world other than those of North America with respect to such “Licensed Products” under the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Patent Rights under the Shire Agreement, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Agreement that affect Acceleron Patent Rights, and, to the extent that Shire is making any such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 if, after using such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by ShireTerm Adjustment.

Appears in 1 contract

Samples: Collaboration and License Agreement (Kiniksa Pharmaceuticals, Ltd.)

Patent Term Extensions. The Parties shall use reasonable efforts to obtain all available supplementary protection certificates, patent term restorations, consult and other extensions (collectively, “Extensions”) of the Acceleron Patent Rights and Joint Patent Rights (including those available under the Xxxxx-Xxxxxx Act). Each Party shall execute such authorizations and other documents and take such other actions as may be reasonably requested by the other Party to obtain such Extensions. The Parties shall cooperate with each other in gaining Extensions wherever applicable obtaining patent term extensions, adjustments, or restorations or supplemental protection certificates or their equivalents (each a “Patent Extension” and collectively “Patent Extensions”) in the Territory for the Licensed Patents and Joint Patents to Acceleron Patent Rights the extent they Cover Licensed Compounds, Licensed Products, or Joint Patent Rights. The holder of the applicable NDA may determine what Extensions of any such Patent Rights shall be madeMonotherapy Regimen; provided that, if (a) Incyte shall have the primary right and authority to seek and apply for Patent Extensions with respect to Licensed Patents and Joint Patents that [**] claim Monoclonal Antibodies, subject to review and comment by MacroGenics, which Incyte shall consider in good faith; (b) MacroGenics shall have the primary right and authority to seek and apply for Patent Extensions with respect to Licensed Patents and Joint Patents that [**] claim bi- or multi-specific antibodies, subject to review and comment by Incyte, which MacroGenics shall consider in good faith; and (c) the Parties shall discuss in good faith and shall mutually agree upon whether to seek and apply for Patent Extensions with respect to any country Patents [**] Monoclonal Antibodies and [**]. In the event that a Party does not intend to seek a Patent Extension that is or will become available for a Licensed Patent or Joint Patent, it shall so inform the other Party in writing in sufficient time to permit the other Party to seek such holder has an option to extend the patent term Patent Extension. The Party that does not apply for only one of several patents, the first Party shall consult a Patent Extension hereunder will cooperate fully with the other Party before in making the election. If more than one patent is eligible such filings or actions, including making available all required regulatory data and Information and executing any required authorizations to apply for such an Patent Extension, the Parties shall select in good faith a strategy that shall maximize patent protection and commercial value for each Licensed Product. All filings for such Extensions, as determined by the holder of the applicable NDA, shall be made by the Party to whom responsibility for Prosecution of the Acceleron Patent Rights or Joint Patent Rights are assigned, and the owner of record of the applicable Patent Right shall assist with such filings; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an Extension, such Party shall (a) inform the other Party of its intention not to file, (b) grant the other Party the right to file for such Extension in the Patent Rights’ owner’s name, and (c) provide all necessary assistance out-of-pocket expenses incurred in connection therewith. The Parties acknowledge and agree that (i) pursuant to the Shire Agreement, Shire and Acceleron will consult in selecting Patent Rights to extend the patent term with activities of each Party with respect to the Licensed Products” under the Shire Agreement, and Shire shall make the decision in all countries of the world other than those of North America with respect Patent(s) or Joint Patent(s) for which such Party seeks a Patent Extension pursuant to such “Licensed Products” under the Shire Agreement, and the filings for Extensions with respect thereto will be made by the party who is responsible for Prosecuting Patent Rights under the Shire Agreement, and, as such, Celgene’s rights under this Section 8.9 are subject to Shire’s prior rights; and (ii) Acceleron 9.4 shall keep Celgene informed of all elections with respect to Extensions made pursuant to the Shire Agreement that affect Acceleron Patent Rights, and, to the extent that Shire is making any be entirely borne by such elections, Acceleron shall use commercially reasonable efforts to cause Shire to take the actions specified by this Section 8.9 in a manner consistent with the Shire Agreement; provided that Acceleron will not be in breach of its obligations under this Section 8.9 if, after using such commercially reasonable efforts, it is unable to comply with such obligations because of actions taken or not taken by ShireParty.

Appears in 1 contract

Samples: Global Collaboration and License Agreement (Macrogenics Inc)

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