Patent Extensions and Orange Book Listings Sample Clauses

Patent Extensions and Orange Book Listings. If elections with respect to obtaining patent term extensions (including any available pediatric extensions) or supplemental protection certificates or their equivalents in any country with respect to Penn Patent Rights are available, Company will have the exclusive right to make any such elections based on Licensed Products. With respect to data exclusivity periods (such as those periods listed in the FDA’s Orange Book (including any available pediatric extensions) or periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or orphan exclusivity periods, and all equivalents in any country), Company will have the sole right to seek and maintain all such data exclusivity periods available for the Licensed Products. With respect to all of the rights and activities identified in this Section 7.4, Penn hereby appoints Company as its agent for such purposes with the authority to act on Penn’s behalf with respect to the Penn Patent Rights, provided that such actions are consistent with this Agreement and provided further that Company’s actions, in Company’s reasonable judgment, are not likely to harm Penn’s reputation or good standing.
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Patent Extensions and Orange Book Listings. If elections with respect to obtaining patent term extensions (including, without limitation, any available pediatric extensions) or supplemental protection certificates or their equivalents in any country with respect to Field Patent Rights are available, Avro shall have the sole and exclusive right to make any such elections based on Licensed Products. With respect to data exclusivity periods (such as those periods listed in the FDA’s Orange Book (including, without limitation, any available pediatric extensions) or periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or orphan exclusivity periods, and all equivalents in any country), Avro shall have the sole and exclusive right to seek and maintain all such data exclusivity periods available for the Licensed Products. With respect to all of the rights and activities identified in this Section 8.2, UHN hereby appoints Avro as its agent for such purposes with the authority to act on UHN’s behalf with respect to the Field Patent Rights in a manner consistent with this Agreement.
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Patent Extensions and Orange Book Listings. If elections with respect to obtaining patent term extensions (including, without limitation, any available pediatric extensions) or supplemental protection certificates or their equivalents in any country with respect to Patent Rights are available, Surface shall have the sole and exclusive right to make any such elections based on Licensed Products. With respect to data exclusivity periods (such as those periods listed in the FDA’s Orange Book (including, without limitation, any available pediatric extensions) or periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or orphan exclusivity periods, and all equivalents in any country), Surface shall have the sole and exclusive right to seek and maintain all such CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. EXCLUSIVE LICENSE AGREEMENT data exclusivity periods available for the Licensed Products. With respect to all of the rights and activities identified in this Section 6.3, Harbour hereby appoints Surface as its agent for such purposes with the authority to act on Harbour’s behalf with respect to the Patent Rights in a manner consistent with this Agreement.
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Patent Extensions and Orange Book Listings. If elections with respect to obtaining patent term extensions (including any available pediatric extensions) or supplemental protection certificates or their equivalents in any country with respect to the Licensed Patents are available, Codiak, after consulting with Kayla, shall have the sole and exclusive right to make any such reasonable elections based on Licensed Products. With respect to data exclusivity periods (such as those periods listed in the FDA’s Orange Book (including any available pediatric extensions) or periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or orphan exclusivity periods, and all equivalents in any country), Codiak shall have the sole and exclusive right to seek and maintain all such data exclusivity periods available for the Licensed Products. With respect to all of the rights and activities identified in this Section 6.3, Kayla hereby appoints Codiak as its agent for such purposes with the authority to act on Kayla’s behalf with respect to such Licensed Patents in a manner consistent with this Agreement.
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Patent Extensions and Orange Book Listings. If elections with respect to obtaining patent term extensions (including any available pediatric extensions) or supplemental protection certificates or their equivalents in any country with respect to the Licensed Patents are available, Codiak, after consulting with Kayla, shall have the sole and exclusive right to make any such reasonable elections based on Licensed Products. With respect to data exclusivity [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED periods (such as those periods listed in the FDA’s Orange Book (including any available pediatric extensions) or periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or orphan exclusivity periods, and all equivalents in any country), Codiak shall have the sole and exclusive right to seek and maintain all such data exclusivity periods available for the Licensed Products. With respect to all of the rights and activities identified in this Section 6.3, Kayla hereby appoints Codiak as its agent for such purposes with the authority to act on Kayla’s behalf with respect to such Licensed Patents in a manner consistent with this Agreement.
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Patent Extensions and Orange Book Listings. If elections with respect to obtaining patent term extensions (including, without limitation, any available pediatric extensions) or supplemental protection certificates or their equivalents in any country with respect to the relevant Patent Rights are available, Spitfire shall have the sole and exclusive right to make any such elections based on Licensed Products. With respect to data exclusivity periods such as those periods listed in the FDA’s Orange Book (including, without limitation, any available pediatric extensions, and all equivalents in any country), Spitfire shall have the sole and exclusive right to seek and maintain all such data exclusivity periods available for the Licensed Products. With respect to all of the rights and activities identified in this Section 5.2, Mederis hereby appoints Spitfire as its agent for such purposes with the authority to act on Mederis’s behalf with respect to the relevant Patent Rights in a manner consistent with this Agreement.
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Patent Extensions and Orange Book Listings. The Existing Agreement is hereby amended to include a new Section 9.7 titled “PATENT EXTENSIONS AND ORANGE BOOK LISTINGS”, which new Section 9.7 shall read in its entirety as follows: “The Parties shall cooperate in obtaining patent term extensions (including any available pediatric extensions) or supplemental protection certificates or their equivalents available in any country.”
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Patent Extensions and Orange Book Listings. If elections with respect to obtaining patent term extensions (including, without limitation, any available pediatric extensions) or supplemental protection certificates or their equivalents in any country with respect to Licensed Patents are available, Company shall have the sole and exclusive right to make any such elections based on Licensed Products. With respect to data exclusivity periods (such as those periods listed in the FDA’s Orange Book (including, without limitation, any available pediatric extensions) or periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or orphan exclusivity periods, and all equivalents in any country), Company shall have the sole and exclusive right to seek and maintain all such data exclusivity periods available for the Licensed Products. With respect to all of the rights and activities identified in this Section 9.5, MDACC will, to the extent approved by System, appoint Company as its agent for such purposes with the authority to act on MDACC’s behalf with respect to the Licensed Patents in a manner consistent with this Agreement.
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Patent Extensions and Orange Book Listings. If elections with respect to obtaining patent term extensions or supplemental protection certificates or their equivalents in any country arising from the Exploitation of a Licensed Product, Clementia will have the sole and exclusive right in good faith to make any such elections with respect to a Blueprint Product-Specific Patent. With respect to Regulatory Exclusivity Periods, such as those periods listed in the FDA’s Orange Book (including any available pediatric extensions) or periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or orphan exclusivity periods, and all equivalents in any country, Clementia will have the sole and exclusive right in good faith to seek and maintain all such Regulatory Exclusivity Periods available for the Licensed Products.
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Related to Patent Extensions and Orange Book Listings

  • Patent Extensions (a) The Parties shall cooperate in obtaining patent term restoration (under but not limited to Drug Price Competition and Patent Term Restoration Act), supplemental protection certificates or their equivalents, and patent term extensions with respect to the Intrexon Patents and/or ARES TRADING Patents in any country and/or region where applicable.

  • Patent Listings Licensee shall have the right and responsibility to make all filings with Regulatory Authorities in the Territory with respect to the AstraZeneca Patents, including as required or allowed (i) in the United States, in the FDA’s Orange Book and (ii) in the European Union, under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents; provided that Licensee shall consult with AstraZeneca to determine the course of action with respect to such filings.

  • 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 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. 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.

  • Patent Term Extension and Supplementary Protection Certificate Upon receiving Marketing Approval for a POZEN Product, the Parties agree to coordinate the application for any patent term extension or supplementary protection certificates that may be available. The primary responsibility of applying for any extension or supplementary protection certificate will be the Party having the right to make the application under the Applicable Law. The Party responsible for filing the application will keep the other Party fully informed of its efforts to obtain such extension or supplementary protection certificate. Each Party will provide prompt and reasonable assistance, without additional compensation, to obtain such patent extension or supplementary protection certificate. The Party filing such request will pay all expenses in regard to obtaining the extension or supplementary protection certificate.

  • Regulatory Applications (a) Sky and SBI and their respective Subsidiaries shall cooperate and use their respective reasonable best efforts to prepare, within 45 days of the execution of this Agreement, all documentation and requests for regulatory approval, to timely effect all filings and to obtain all permits, consents, approvals and authorizations of all third parties and Governmental Authorities and Regulatory Authorities necessary to consummate the transactions contemplated by this Agreement. Each of Sky and SBI shall have the right to review in advance, and to the extent practicable each will consult with the other, in each case subject to applicable laws relating to the exchange of information, with respect to, and shall be provided in advance so as to reasonably exercise its right to review in advance, all material written information submitted to any third party or any Governmental Authority or Regulatory Authority in connection with the transactions contemplated by this Agreement. In exercising the foregoing right, each of the parties hereto agrees to act reasonably and as promptly as practicable. Each party hereto agrees that it will consult with the other party hereto with respect to the obtaining of all material permits, consents, approvals and authorizations of all third parties and Governmental Authorities or Regulatory Authorities necessary or advisable to consummate the transactions contemplated by this Agreement and each party will keep the other party apprised of the status of material matters relating to completion of the transactions contemplated hereby.

  • Patent Applications It is understood by the parties that, pursuant to the Baylor Technology Transfer Agreement, MAS has the initial responsibility for filing, prosecution and maintenance of Patents and Patent Applications covering the Baylor Technology. The parties agree that, as between MAS and CTI, MAS shall be responsible for deciding whether and how to file, prosecute and maintain the Patents and Patent Applications, provided that:

  • Reporting Obligations and Regulatory Approvals Applicable laws and regulations may require holders and beneficial owners of Shares, including the Holders and Beneficial Owners of ADSs, to satisfy reporting requirements and obtain regulatory approvals in certain circumstances. Holders and Beneficial Owners of ADSs are solely responsible for determining and complying with such reporting requirements and obtaining such approvals. Each Holder and each Beneficial Owner hereby agrees to make such determination, file such reports, and obtain such approvals to the extent and in the form required by applicable laws and regulations as in effect from time to time. Neither the Depositary, the Custodian, the Company or any of their respective agents or affiliates shall be required to take any actions whatsoever on behalf of Holders or Beneficial Owners to determine or satisfy such reporting requirements or obtain such regulatory approvals under applicable laws and regulations.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

  • Research Reports Distributor acknowledges that Dealer may prepare research reports relating to the Fund that are not to be used for marketing purposes (“Research Reports”). Distributor hereby authorizes Dealer to use the name of the Fund, Distributor and BREDS in Research Reports.

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