Patent Extensions and Orange Book Listings Sample Clauses

The "Patent Extensions and Orange Book Listings" clause governs how parties handle the extension of patent terms and the listing of patents in the FDA's Orange Book. It typically outlines the responsibilities for seeking patent term extensions, such as those available under the Hatch-Waxman Act, and specifies which patents related to a pharmaceutical product must be listed in the Orange Book. For example, it may require the licensee to notify the licensor of any regulatory filings that could affect patent rights or to cooperate in the process of listing patents. The core function of this clause is to ensure that both parties coordinate to maximize and protect the exclusivity period for a drug product, thereby safeguarding commercial interests and regulatory compliance.
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 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, 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. 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 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. 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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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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Related to Patent Extensions and Orange Book Listings

  • Patent Extensions Subject to the remainder of this Section 6.6, if any election for patent term restoration or extension, supplemental protection certificate or any of their equivalents may be made with respect to any Patent within the Licensed IP, after consultation with Celgene, the Parties will discuss and seek to reach mutual agreement whether or not to take such action. If the Parties are not able to reach mutual agreement, (a) Celgene will have the sole right to make the final decision whether or not to seek such patent term restoration or extension, supplemental protection certificate or any of their equivalents with respect to Specific Patents and Patents within the Collaboration IP licensed to Celgene hereunder and (b) Bluebird will have the sole right to make the final decision whether or not to seek such patent term restoration or extension, supplemental protection certificate or any of their equivalents with respect to all other Patents within the Licensed IP.

  • 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 ▇▇▇▇▇-▇▇▇▇▇▇ 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.

  • Regulatory Applications (a) Summit and GAFC and their respective Subsidiaries shall cooperate and use their respective reasonable best efforts to prepare all documentation, to effect all filings and to obtain all permits, consents, approvals and authorizations of all third parties and Governmental Authorities necessary to consummate the transactions contemplated by this Agreement. Each of Summit and GAFC 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, all material written information submitted to any third party or any Governmental 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 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. (b) Each party agrees, upon request, to furnish the other party with all information concerning itself, its Subsidiaries, directors, officers and stockholders and such other matters as may be reasonably necessary or advisable in connection with any filing, notice or application made by or on behalf of such other party or any of its Subsidiaries to any third party or Governmental Authority.

  • 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 IllumeSys, 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.