Patent Extensions Orange Book Listings Patent Certifications Sample Clauses

This clause governs the procedures and obligations related to extending patent protection, listing patents in the FDA's Orange Book, and making required patent certifications. It typically outlines how a party must notify the other of any actions taken to extend patent terms, ensure that relevant patents covering a product are properly listed in the Orange Book, and provide certifications regarding the status or validity of such patents, especially in the context of regulatory submissions. The core function of this clause is to ensure compliance with regulatory requirements, protect intellectual property rights, and clarify responsibilities between parties regarding patent-related filings and disclosures.
Patent Extensions Orange Book Listings Patent Certifications. (a) Patent Term Extension. XTL shall have the sole right to make any elections with respect to obtaining patent term extension or supplemental protection certificates or their equivalents in any country with respect to DOV Patent Rights. XTL shall notify DOV in the event XTL determines it will not make such elections or their equivalent. Upon such notice from XTL, DOV may make elections with respect to obtaining patent term extension or supplemental protection certificates or their equivalents in any country with respect to DOV Patent Rights (b) Data Exclusivity. With respect to any data exclusivity periods, such as those periods listed in the FDA’s Orange Book (including any available pediatric exclusivities) or other exclusivity periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 (and all equivalents in any country), XTL shall have the sole right to seek and maintain all such data exclusivity periods available for the Licensed Compound or Licensed Product.
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Patent Extensions Orange Book Listings Patent Certifications. If elections with respect to obtaining patent term extension or supplemental protection certificates or their equivalents in Territory with respect to the Product becomes available, upon NDA Approval for the Product, Pfenex and Alvogen shall mutually agree on the determination of which issued Patent to extend for the Product, and Alvogen shall take such reasonable actions as are necessary to effectuate or assist in such extension. (a) With respect to regulatory exclusivity periods, Pfenex, prior to the transfer of the NDA Approval, and Alvogen or its Affiliate, following such transfer, shall be responsible for seeking and maintaining all such regulatory exclusivity periods that may be available for the Product in the Territory, subject to approval of the Party that is not responsible for seeking and maintaining such exclusivity, such approval not to be unreasonably withheld, delayed or conditioned. The Party that is responsible therefor shall make all filings necessary to list the appropriate exclusivity periods and Pfenex Patents, if any, in the Orange Book with respect to the Product, and the Parties shall mutually agree on which Pfenex Patents, if any, to list in the Orange Book with respect to the Product. (b) Pfenex and Alvogen shall each notify and provide the other Party with copies of any notice of a Paragraph IV Patent Certification (including any associated documents) by a Third Party filing an ANDA or an NDA, or any other similar patent certification by a Third Party in the Territory, in each such case referencing Product. Such notification and copies will [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. be provided to the other Party promptly (but no later than within five (5) Business Days) after receipt of such notification and will be sent to the address set forth in Section 12.2.
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Patent Extensions Orange Book Listings Patent Certifications. On a Program-by-Program basis, from and after [***]:
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Patent Extensions Orange Book Listings Patent Certifications 
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Related to Patent Extensions Orange Book Listings Patent Certifications

  • 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:

  • 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.

  • Patents and Patent Applications To the Company’s knowledge, all patents and patent applications owned by or licensed to the Company or under which the Company has rights have been duly and properly filed and maintained; to the knowledge of the Company, the parties prosecuting such applications have complied with their duty of candor and disclosure to the USPTO in connection with such applications; and the Company is not aware of any facts required to be disclosed to the USPTO that were not disclosed to the USPTO and which could reasonably be expected to preclude the grant of a patent in connection with any such application or could reasonably be expected to form the basis of a finding of invalidity with respect to any patents that have issued with respect to such applications.

  • Filing of Patent Applications Each Party will make timely decisions regarding the filing of Patent Applications on the CRADA Subject Inventions made solely by its employee(s), and will notify the other Party in advance of filing. Collaborator will have the first opportunity to file a Patent Application on joint CRADA Subject Inventions and will notify PHS of its decision within sixty (60) days of an Invention being reported or at least thirty (30) days before any patent filing deadline, whichever occurs sooner. If Collaborator fails to notify PHS of its decision within that time period or notifies PHS of its decision not to file a Patent Application, then PHS has the right to file a Patent Application on the joint CRADA Subject Invention. Neither Party will be obligated to file a Patent Application. Collaborator will place the following statement in any Patent Application it files on a CRADA Subject Invention: “This invention was created in the performance of a Cooperative Research and Development Agreement with the [INSERT into Agency’s model as appropriate: National Institutes of Health, Food and Drug Administration, Centers for Disease Control and Prevention], an Agency of the Department of Health and Human Services. The Government of the United States has certain rights in this invention.” If either Party files a Patent Application on a joint CRADA Subject Invention, then the filing Party will include a statement within the Patent Application that clearly identifies the Parties and states that the joint CRADA Subject Invention was made under this CRADA.

  • Patent Rights The State and the U. S. Department of Transportation shall have the royalty free, nonexclusive and irrevocable right to use and to authorize others to use any patents developed by the Engineer under this contract.