Patent Term Extensions. 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 will apply to extend the patent term with 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 shall provide Chiron with the opportunity, at Chiron’s sole discretion and sole cost and expense, to make submissions and filings, and take such other actions as may be reasonably required, on behalf of Cubist to extend within the Territory the patent term of any Cubist Patent or Joint Patent in the Territory with respect to License Products.
Appears in 2 contracts
Sources: License Agreement (Cubist Pharmaceuticals Inc), License Agreement (Cubist Pharmaceuticals Inc)
Patent Term Extensions. Cubist will, in its sole discretion, after discussing its strategy with Chiron and reasonably considering Chiron’s comments, in each country With respect to any system for extending the term of Patent Rights in the TerritoryTerritory due to the time needed to obtain Regulatory Approval of a pharmaceutical product established by any applicable Regulatory Authority in any region in the Territory (a “Patent Term Extension”), determine 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 certificates and any other extensions that are now or become available in the future under Applicable Laws in any region in the Territory (“Other Extensions”), (a) Blueprint will have the right, but not the obligation, and will be solely responsible for whichmaking all decisions regarding Patent Term Extensions, if anyPatent Term Adjustments, or Other Extensions in the 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 Patents within Regulatory Approval of a Licensed Product in the Cubist Patents and Territory or following issuance of a patent included in the Blueprint Patent Rights, Blueprint Manufacturing Patent Rights, or Joint Patents, the Parties Collaboration Patent Rights provided that Blueprint will apply to extend the patent term consult with Zai with respect to Licensed Productssuch decisions and consider [****] the reasonable comments and concerns raised by ▇▇▇; and (b) ▇▇▇ will have the right, as provided but not the obligation, and will be solely responsible for * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION in patent term extension laws or regulations making all decisions regarding Patent Term Extensions, Patent Term Adjustments, and Other Extensions in the Territory similar that are applicable to Zai Collaboration Patent Rights and that become available directly as a result of the Patent Term Restoration Act or other similar laws and regulations affording an extension or restoration Regulatory Approval of patent terms a Licensed Product in the United States, which similar laws and regulations shall include without limitation any Supplementary Protection Certificates. Chiron shall not make any submissions, filings Territory or other communications following issuance of a patent included in the Zai Collaboration Patent Rights; provided that Zai will consult with any governmental agency Blueprint with respect to patent term restoration (such decisions and consider [****] the reasonable comments and concerns raised by Blueprint. The Party 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 similar grant of a monopoly right Other Extensions in the Territory in accordance with respect to any the foregoing sentence. The Party holding the MAA for the applicable Licensed Product) for any Patents within Product in the Cubist Patents or Joint Patents without Cubist’s express consent. Chiron Territory 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 other Party to the extent reasonably requested by the other Party to effectuate the intent of this Section 8.3 14.7 (Patent Term Extensions), including providing to the contraryother Party all documentation, in the event that Cubistcertifications, in its sole discretionand consents necessary to make and prosecute such application and obtain such Patent Term Extension, 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 determinationTerm Adjustment, or reasonable notice if the period for determination is less than thirty (30) days, and shall provide Chiron with the opportunity, at Chiron’s sole discretion and sole cost and expense, to make submissions and filings, and take such other actions as may be reasonably required, on behalf of Cubist to extend within the Territory the patent term of any Cubist Patent or Joint Patent in the Territory with respect to License ProductsOther Extension.
Appears in 1 contract
Patent Term Extensions. Cubist willSellas shall have the first right to make decisions regarding patent term extensions, including supplementary protection certificates, patent linkages and any other extensions that are now or in its sole discretionthe future become available, after discussing its strategy wherever applicable (each, a “Patent Term Extension”), for the Licensed Patent Rights in any country or other jurisdiction within the Territory in connection with Chiron the Products. Prior to selecting any such Licensed Patent Rights for a Patent Term Extension, Sellas shall notify GenFleet of any such selection and, at GenFleet’s request, discuss in good faith any issues or comments GenFleet may have with respect to the selection of such Licensed Patent Rights and reasonably considering ChironSellas shall take into consideration GenFleet’s comments, in each country . Sellas shall have the responsibility of applying for any Patent Term Extension with respect to such Licensed Patent Rights and the Products in the Territory. As reasonably requested by Sellas in writing, determine for which, if any, of the Patents within the Cubist Patents and Joint Patents, the Parties will apply to extend the patent term with 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 GenFleet 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 shall provide Chiron with the opportunityreasonably cooperate, at Chiron’s sole discretion and Sellas’ sole cost and expense, in obtaining such Patent Term Extension. Sellas agrees to make submissions execute and filings, deliver such further authorizations and instruments at least [***] in advance of submission to provide GenFleet with reasonable comment rights and Sellas agrees to take into consideration such other further actions as may be reasonably requiredrequested by GenFleet to implement the foregoing. If Sellas does not exercise its rights to file any Patent Term Extensions on any Licensed Patent Right in the Territory, GenFleet shall have the right, on behalf a country-by-country basis to file a Patent Term Extension for such Licensed Patent Rights at GenFleet’s sole expense; provided, however, that, GenFleet shall not have such right in a country if such filing by GenFleet would preclude Sellas from filing a Patent Term Extension for another Licensed Patent Right of Cubist to extend within Sellas’ choosing in such country. If GenFleet files for and is granted a Patent Term extension, upon such granting, the Territory the patent term of any Cubist corresponding Licensed Patent or Joint Patent Rights in the Territory with respect to License Productscorresponding country shall be included in the Licensed Patent Rights.
Appears in 1 contract
Sources: License Agreement (SELLAS Life Sciences Group, Inc.)
Patent Term Extensions. Cubist will, in its sole discretion, after discussing its strategy with Chiron and reasonably considering Chiron’s '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 will apply to extend the patent term with respect to Licensed Products, as provided for * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION 49 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 's express consent. Chiron will cooperate fully with Cubist in making such filings at Cubist’s '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 shall provide Chiron with the opportunity, at Chiron’s 's sole discretion and sole cost and expense, to make submissions and filings, and take such other actions as may be reasonably required, on behalf of Cubist to extend within the Territory the patent term of any Cubist Patent or Joint Patent in the Territory with respect to License Products.
Appears in 1 contract
Patent Term Extensions. Cubist willSubject to the terms of the In-License Agreements as set forth in Section 7.5, Editas shall reasonably cooperate with Juno, including providing reasonable assistance to Juno (including executing any documents as may reasonably be required), in efforts to seek and obtain patent term restoration or supplemental protection certificates or the like or their equivalents in any country in the Territory, where applicable to Editas Licensed Background Patents (excluding any Editas Licensed Background Patents licensed under an In-License Agreement), Editas Licensed Collaboration Patents, Joint Collaboration Patents or Joint Patents, or any other Patent Rights Controlled by Juno (or any of its Affiliates), including as may be available to the Parties under the provisions of the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 or comparable laws outside the United States, in each case, in connection with any Licensed Product. If elections with respect to obtaining such patent term restoration or supplemental protection certificates or the like or their equivalents are to be made in connection therewith, Juno shall have the right to make the election, and Editas agrees to abide by such election, provided that, with respect to Editas Licensed Collaboration Patents or Editas Licensed Background Patents (excluding any Editas Licensed Background Patents licensed under an In-License Agreement for which Juno shall have no right to make such an election), Juno has (i) given Editas reasonable advance notice of its intention to extend any such Patent Rights; (ii) engaged in good faith discussions with Editas regarding its intention to extend any such Patent Rights and (iii) in good faith considered any argument by Editas to not extend such Patent Rights for business reasons. Without limiting the foregoing, Editas will not (and will cause its Affiliates not to) extend (a) any Editas Licensed Background Patents or Editas Licensed Collaboration Patent, with respect to any Licensed Product or (b) any Joint Collaboration Patent or Joint Patent, in each case ((a) and (b)), without the prior written approval of Juno, 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 will apply to extend the patent term with 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 shall provide Chiron with the opportunity, at Chiron’s sole discretion and sole cost and expense, to make submissions and filings, and take such other actions as may be reasonably required, on behalf of Cubist to extend within the Territory the patent term of any Cubist Patent or Joint Patent in the Territory with respect to License Products.
Appears in 1 contract
Patent Term Extensions. Cubist willImmunomedics and Licensee shall cooperate in good faith in gaining Patent Term Extensions wherever applicable to the Immunomedics Patents, the Licensee Patents and the Joint Collaboration Patents in the Territory. In the event, the Parties cannot reach an agreement for which Immunomedics Patent(s), Licensee Patent(s) or Joint Collaboration Patent(s) to seek Patent Term Extensions for any particular compound, protein, composition, article, product, process or use such dispute will be resolved by the binding recommendation of patent counsel mutually agreed to by both Parties, such recommendation to be ordered within *** in the applicable country. Such patent counsel shall be unaffiliated with either Party and shall not have represented either Party at any time during the previous ***. ***such***. Notwithstanding the forgoing, Licensee shall not object to Immunomedics’ decision with respect to a Patent Term Extension, if Licensee cannot reasonably demonstrate that such decision would have a material adverse effect on the market exclusivity for the Product in the Field in the Territory (it being understood that an extension of the Royalty Term and, if applicable, the Post-Royalty Term, in its sole discretionand of itself shall not constitute such a material adverse effect). For the purpose of registering a Patent Term Extension for the Immunomedics Patent(s) or a Joint Collaboration Patent for which Immunomedics is the Lead Prosecuting Party, after discussing its strategy with Chiron and reasonably considering Chiron’s comments, respect to all applications for Regulatory Approvals for the Product in each country the Field in the Territory, determine Licensee shall provide Immunomedics with written notice of any expected Regulatory *** Portion for whichwhich confidential treatment requested. Approval at least *** prior to the expected date of Regulatory Approval thereof, if any, as well as notice within *** of receiving each Regulatory Approval confirming the Patents within the Cubist Patents and Joint Patents, the Parties will apply to extend the date of such Regulatory Approval. The cost of obtaining such patent term extensions shall be borne by Immunomedics with respect to Licensed Productsall Immunomedics Patents, 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 by Licensee with respect to patent term restoration (or other similar grant of a monopoly right Licensee Patents and equally 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 shall provide Chiron with the opportunity, at Chiron’s sole discretion and sole cost and expense, to make submissions and filings, and take such other actions as may be reasonably required, on behalf of Cubist to extend within the Territory the patent term of any Cubist Patent or Joint Patent in the Territory with respect to License ProductsCollaboration Patents.
Appears in 1 contract
Sources: License and Collaboration Agreement (Immunomedics Inc)
Patent Term Extensions. Cubist will, in its sole discretion, after discussing its strategy Licensee shall provide Pfizer with Chiron notice of each market application and reasonably considering Chiron’s comments, in each country in approval within [***] of such application and approval. Licensee shall have the Territory, determine for which, if any, of the Patents within the Cubist Patents and Joint Patents, the Parties will apply to extend the patent term with 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 first right with respect to making decisions regarding patent term extensions, including supplementary protection certificates, patent linkages and any Licensed Product) for any Patents within the Cubist Patents other extensions that are now 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 future become available, wherever applicable (each, a “Patent Term Extension”), for Licensed Patent Rights in any country or other jurisdiction in connection with the Products. Prior to the contraryselecting any such Patent Rights for a Patent Term Extension, in the event that Cubist, in its sole discretion, makes a determination not to seek an extension within the Territory of the patent term Licensee shall notify Pfizer of any Cubist Patent such selection and, at Pfizer’s request, discuss in good faith any issues or Joint Patent in the Territory comments Pfizer may have with respect to Licensed Products, then Cubist shall provide Chiron with thirty (30) days prior written notice the selection of such determinationPatent Rights and Licensee shall take into consideration Pfizer’s reasonable comments. Licensee shall have the responsibility of applying for any Patent Term Extension with respect to such Patent Rights and the Products in the Territory. Licensee shall consult with Pfizer and keep Pfizer reasonably informed of its efforts to obtain such Patent Term Extension. As reasonably requested by Licensee in writing, or reasonable notice if the period for determination is less than thirty (30) days, and Pfizer shall provide Chiron with the opportunitycooperate, at ChironLicensee’s sole discretion and sole cost and expense, in obtaining such Patent Term Extension. Licensee agrees to make submissions execute and filings, deliver such further authorizations and instruments in advance of submission to provide Pfizer with reasonable comment rights and Licensee agrees to take into consideration such other further actions as may be reasonably requiredrequested by Pfizer to implement the foregoing. If Licensee does not exercise its rights to file Patent Term Extensions on any Licensed Patent Table of Contents Right in the Territory, Pfizer shall have the right, on behalf a country-by-country basis to file a Patent Term Extension for such Licensed Patent Rights at Pfizer’s sole expense; provided, however, that Pfizer shall not have such right in a country if such filing by Pfizer would preclude Licensee from filing a Patent Term Extension for another Patent Right of Cubist Licensee’s choosing in such country. Notwithstanding the foregoing, with respect to extend within the Territory the patent term of [***], if Licensee has not exercised its rights to file a Patent Term Extension on any Cubist Licensed Patent or Joint Patent Right in the Territory with respect and Licensee does not then have a Product directed at the [***], Pfizer shall have a right on a country-by-country basis to License Productsfile a Patent Term Extension for such [***] for any product within the [***].
Appears in 1 contract
Sources: License Agreement (ARYA Sciences Acquisition Corp II)
Patent Term Extensions. Cubist willAs long as ▇▇▇▇▇▇▇ retains Commercialization rights for a Licensed Product under Section 2.1.2, in its sole discretionupon ▇▇▇▇▇▇▇’▇ 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), after discussing its strategy with Chiron and reasonably considering Chiron’s commentsthe Prosecuting Party shall use reasonable efforts, in each country in or jurisdiction where Regulatory Approval for any Licensed Product has been obtained, and if the TerritoryApplicable Law of such country or jurisdiction permits application for a Patent Term Extension, determine to apply, at the reasonable direction of ▇▇▇▇▇▇▇’▇ designated patent counsel, for whicha Patent Term Extension for a patent within the Geron Product Patent Rights including a Valid Claim Covering such Licensed Product, which patent (if any) shall be selected at ▇▇▇▇▇▇▇’▇ reasonable judgment after considering the opinion of ▇▇▇▇▇▇▇’▇ patent counsel regarding its eligibility for a Patent Term Extension. ▇▇▇▇▇▇▇ 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), as ▇▇▇▇▇▇▇ 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 the Patents within the Cubist Patents any Geron Product Patent Right(s) or Development Program Patent Right(s) pertaining to an approved Licensed Product Commercialized by ▇▇▇▇▇▇▇ hereunder. Geron agrees to cooperate with ▇▇▇▇▇▇▇ and Joint Patents, the Parties will apply to extend the patent term with respect to its Affiliate and Third Party sublicensees of Licensed Products, as provided for * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION in patent term extension laws or regulations applicable, upon ▇▇▇▇▇▇▇’▇ reasonable request 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 exercise of the patent term authorizations granted under this Section, and Geron shall execute such documents and take such additional action as ▇▇▇▇▇▇▇ may reasonably request in connection therewith, including, if requested by ▇▇▇▇▇▇▇, permitting Geron to be joined as a party in any suit for Product Infringement brought by ▇▇▇▇▇▇▇ hereunder on the terms and conditions set forth in Section 10.4.2, provided that ▇▇▇▇▇▇▇ shall reimburse Geron all reasonable out-of-pocket costs incurred by Geron in taking such action. Geron agrees to cooperate with ▇▇▇▇▇▇▇ and its Affiliate and Third Party sublicensees of any Cubist Patent or Joint Patent in the Territory with respect to Licensed Products, as applicable, upon ▇▇▇▇▇▇▇’▇ 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 Cubist shall provide Chiron in effect (pursuant to their terms as of the Execution Date, except as such may be amended by Geron with thirty (30) days ▇▇▇▇▇▇▇’▇ prior written notice of consent), Geron shall execute such determination, or reasonable notice if the period for determination is less than thirty (30) days, and shall provide Chiron with the opportunity, at Chiron’s sole discretion and sole cost and expense, to make submissions and filings, documents and take such other actions additional action as ▇▇▇▇▇▇▇ may be reasonably requiredrequest in connection therewith, on behalf including using reasonable efforts to procure the cooperation of Cubist any Inferior Rights Holders, such that ▇▇▇▇▇▇▇ shall have (i) the first and a superior right (in relation to extend any Inferior Rights Holders) to select from all Geron Product Patent Rights and Development Program Patent Rights in a particular country or jurisdiction a particular Patent Right for which it will pursue a Patent Term Extension in such country application, and (ii) the first and a superior right to enforce and defend any patents within the Territory the patent term of any Cubist Geron Product Patent Rights and Development Program Patent Rights against infringement pertaining to a Third Party’s Licensed Product or Joint Patent in the Territory with respect to License Productsa Generic Product.
Appears in 1 contract
Patent Term Extensions. Cubist willDuring the License Term with respect to a Program, in its sole discretionupon 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, after discussing its strategy with Chiron and reasonably considering Chiron’s commentssupplemental protection certificate or their equivalent (each a “Patent Term Extension”)), the Party prosecuting a relevant Patent Right shall use reasonable efforts, in each country in or jurisdiction where Marketing Approval for any such Licensed Product has been obtained, and if the TerritoryApplicable Law of such country or jurisdiction permits application for a Patent Term Extension, determine to apply, at the reasonable direction of Licensee’s Patent Representative, for whicha Patent Term Extension for a patent within the ▇▇▇▇▇▇▇ Program Patents or ▇▇▇▇▇▇▇-Owned Development Program Patents including a Valid Claim Covering such Licensed Product, which patent (if 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 Patents within the Cubist Patents and Joint Patents, the Parties will apply to extend the patent term 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 ▇▇▇▇▇▇▇ Program Patent(s), 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 ▇▇▇▇▇▇▇ Program Patent(s) or ▇▇▇▇▇▇▇-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 ▇▇▇▇▇▇▇ Program Patent(s) or ▇▇▇▇▇▇▇-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. ▇▇▇▇▇▇▇ agrees to cooperate with Licensee and its Affiliate and Third Party sublicensees of Licensed Products, as provided for * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION in patent term extension laws or regulations applicable, upon Licensee’s reasonable request 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 exercise 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) daysauthorizations under this Section, and ▇▇▇▇▇▇▇ shall provide Chiron with the opportunity, at Chiron’s sole discretion and sole cost and expense, to make submissions and filings, execute such documents and take such other actions additional action as Licensee may be reasonably requiredrequest in connection therewith, on behalf of Cubist to extend within the Territory the patent term of any Cubist Patent or Joint Patent provided that Licensee shall reimburse ▇▇▇▇▇▇▇ all reasonable out-of-pocket costs incurred by ▇▇▇▇▇▇▇ in the Territory with respect to License Productstaking such action.
Appears in 1 contract
Sources: License and Option Agreement (Tracon Pharmaceuticals, Inc.)