Patent Exclusivity Listings Sample Clauses

Patent Exclusivity Listings. Following the License Option Effective Date for a Program, if either Party receives a copy of an application submitted to the FDA under subsection (k) of Section 351 of the PHSA (a “Biosimilar Application”) naming a Product as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (such as in an instance described in Section 351(l)(9)(C) of the PHSA), such Party shall, within [***], notify the other Party so that the other Party may seek permission to view the application and related confidential information from the filer of the Biosimilar Application under Section 351(l)(1)(B)(iii) of the PHSA. If either Party receives any equivalent Biosimilar Application or otherwise becomes aware that such an equivalent Biosimilar Application has been filed in any other jurisdiction in the Territory, then such Party shall, within [***], notify and provide the other Party with copies of such communication. Regardless of the Party that is the “reference product sponsor” for purposes of such Biosimilar Application, (i) Gilead shall have the sole right to designate pursuant to Section 351(l)(1)(B)(ii) of the PHSA the outside counsel and in-house counsel who shall receive confidential access to the Biosimilar Application; (ii) Gilead shall have the right to list any [***] with respect to such lists from the filer of the Biosimilar Application, and to negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange than that specified in Section 351(l) of the PHSA; and (iii) Gilead shall have the sole right to identify such Patents or respond to communications under any equivalent or similar listing in any other jurisdiction in the Territory. If required pursuant to Applicable Law, [***]. At Gilead’s reasonable request and expense, Merus shall cooperate with Gilead in connection therewith, including meeting any submission deadlines, in each case, to the extent required or permitted by Applicable Law. Gilead shall (A) reasonably consult with Merus prior to identifying any [***] to a Third Party as contemplated by this Section 7.4(e), and shall consider in good faith Merus’s advice, requests and suggestions with respect thereto, and (B) notify Merus of any such lists or communications promptly after they are made.
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Patent Exclusivity Listings. If Licensor receives a copy of application or submission filed with a Regulatory Authority for Regulatory Approval of a Biosimilar Product (a “Biosimilar Application”) naming a Licensed Product as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (such as in an instance described in Section 351(l)(9)(C) of the PHSA), Licensor shall, within [ * ], notify and provide AGT with copies of such communication. AGT shall have the sole right to designate the outside counsel and in-house counsel who shall receive confidential access to the Biosimilar Application. AGT shall have the sole right to list any Patents, including Joint Patents and Licensor Patents, insofar as they claim or cover the applicable Licensed Product as required pursuant the PHSA, to respond to any communications with respect to such lists from the filer of the Biosimilar Application, and to negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange than that specified in the PHSA, and AGT shall have the sole right to identify Patents or respond to communications under any equivalent or similar listing in any other jurisdiction in the Territory. AGT shall [ * ] with respect to any such listing of any Licensor Patents or Joint Patents, and shall [ * ] of any such listing of any Licensor Patents or Joint Patents [ * ].
Sample 1

Related to Patent Exclusivity Listings

  • 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 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:

  • Patent Markings Licensee agrees that all Licensed Products Sold by Licensee, Affiliates, and Sublicensees will be marked in accordance with each country’s patent marking laws, including Title 35, U.S. Code, in the United States.

  • Patent Marking LICENSEE shall xxxx all Licensed Products made, used or sold under the terms of this Agreement, or their containers, in accordance with the applicable patent marking laws.

  • Patent Term Extensions The Parties shall use reasonable efforts to obtain all available supplementary protection certificates (“SPC”) and other extensions of the Isconova 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 patent term restorations, extensions or SPCs wherever applicable to Isconova Patent Rights or Joint Patent Rights. The Party first eligible to seek patent term restoration or extension of any such Patent Rights or any SPC related thereto may do so; provided that, if in any country the first Party has an option to extend the patent term for only 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. 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 extension 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 and certificates shall be made by the Party to whom responsibility for Prosecution of the Isconova Patent Rights or Joint Patent Rights are assigned; provided that, in the event that the Party to whom such responsibility is assigned elects not to file for an extension 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 or SPC in the Patent Rights’ owner’s name, and (c) provide all necessary assistance in connection therewith.

  • 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.

  • Licensed Patents Licensee shall be responsible for all further patent prosecution with respect to the Licensed Patents and Licensed Technologies set out in Exhibit “A”. Licensee may select the patent agent for the prosecution of the Licensed Patents, subject to the approval of Licensor as the patent owner, which approval will not be unreasonably withheld. Licensee shall provide Licensor with copies of all relevant documentation related to the filing and prosecution of the Licensed Patents so that Licensor may be informed and apprised of and meaningfully consulted as to the continuing prosecution. Licensor shall keep all such documentation confidential. In the event the Licensee does not agree that any given patent application or patent should be filed, prosecuted or maintained (hereinafter referred to as a “Refused Licensed Patent”) in a particular jurisdiction(s) Licensee shall indicate such disagreement in writing (hereinafter “Refusal Notice”) and upon Licensor’s receipt of such Refusal Notice Licensor shall have the right unilaterally to make, prosecute and maintain such Refused Licensed * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission Patent in such jurisdiction(s) in the name of its owners, at Licensor’s expense, and Licensee shall not have any rights or obligations to such Refused Licensed Patent in such jurisdiction(s); provided, however, that Licensee shall retain all of its ownership rights in any Refused Licensed Patent that is a Co-Owned Technology. In such case Licensor shall provide Licensee with copies of all relevant documentation related to the filing and prosecution of the Refused Licensed Patents so that Licensee may be informed and apprised of and be meaningfully consulted with as to the continuing prosecution. Licensor shall have no obligation to continue prosecution or maintenance of any Refused Licensed Patent and may abandon same without any prior notice or any obligation to Licensee. Both Licensee and Licensor shall make best efforts to respond promptly to any request from the other Party for input or assistance with respect to matters pertaining to the Licensed Patents. Licensee shall use reasonable efforts to amend any patent application to include claims reasonably requested by the other Party and required to protect the Licensed Technology. In addition to Licensee’s obligations pursuant to section 4.1 above, Licensee shall be solely responsible for all patent and legal costs relating to the Licensed Patents and Licensed Technology (excluding Refused Licensed Patents) from the Effective Date onward, including all costs relating to the transfer of the Licensed Patents to the new patent agents selected by Licensee and approved by Licensor. For any patent and legal costs relating to the Licensed Patents and Licensed Technology (excluding Refused Licensed Patents) paid by Licensor after the Effective Date (including, without limitation, those expenses related to patentability assessments and drafting, filing, prosecution, maintenance, and taxes (the “Patent Costs”)), Licensee shall promptly reimburse Licensor for such Patent Costs upon receipt of an invoice from Licensor for such expenses. For any work in progress with respect to the Licensed Patents for which the Patent Costs have not already been paid by Licensor to its patent firm prior to the transfer of the Licensed Patents to Licensee’s patent agent, Licensor will direct its patent firm to copy Licensee on all such invoices from said patent firm and Licensee will promptly pay said invoices directly to Licensor’s patent firm.

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