Regulatory Patent Listing Sample Clauses
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Regulatory Patent Listing. 9.5.1 To the extent required by or permitted by Law, at all times prior to transfer of the Regulatory Filings to Takeda during the Term, Orexigen will use Commercially Reasonable Efforts to promptly, accurately and completely provide to the applicable Regulatory Authorities, all applicable Patents for any Product that has become the subject of a marketing application owned by Orexigen and submitted to FDA, for listing in FDA’s Approved Products with Therapeutic Equivalence Determinations (“Orange Book”) in accordance with the ▇▇▇▇▇-▇▇▇▇▇▇ Act and all so called “Patent Register” listings as required in Canada. *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
9.5.2 To the extent required by or permitted by Law, at all times after transfer of the Regulatory Filings to Takeda during the Term, Takeda will use Commercially Reasonable Efforts to promptly, accurately and completely provide to the applicable Regulatory Authorities, all applicable Patents for any Product that has become the subject of a marketing application owned by Takeda and submitted to FDA, for listing in the Orange Book in accordance with the ▇▇▇▇▇-▇▇▇▇▇▇ Act and all so called “Patent Register” listings as required in Canada.
9.5.3 Prior to any listing under Section 9.5.1 or 9.5.2, the Parties will meet to evaluate, identify all applicable Patents to be listed. Orexigen shall have the right to finally determine the Patents to be listed under Section 9.5.1 and Takeda shall have the right to finally determine the Patents to be listed under Section 9.5.2.
Regulatory Patent Listing. Takeda shall be solely responsible for: (i) filing appropriate information with the FDA in the U.S. listing any TBIL Patents and Takeda Patents in the Orange Book; and (ii) with respect to other countries in the Territory, filing appropriate information with the applicable Regulatory Authority listing any TBIL Patents and Takeda Patents in the Patent listing source in such country in the Territory that is equivalent to the Orange Book, if any. Upon the reasonable request of Takeda, TBIL shall reasonably assist Takeda with its efforts in filing the appropriate information to have a TBIL Patent listed in the Orange Book or its equivalent, and Takeda shall reimburse TBIL for fifty percent (50%) of its and its Affiliates’ Third Party Expenses incurred to conduct such assistance requested by Takeda. Takeda shall provide TBIL with a reasonable opportunity to review and comment (which Takeda shall reasonably consider in good faith) on the information proposed for submission with respect to a TBIL Patent or Takeda Patent that Covers any Products.
