Provision Language
Definitions
“NDA Response Date” means the date that the FDA first provides either a complete response letter or approval of the NDA for the Licensed Product.
IV. JOINT PRODUCT COMMITTEE, PRODUCT DEVELOPMENT, CLINICAL TRIALS AND REGULATORY APPROVALS
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4.2 Licensed Product Development
4.2.1 Prior to the NDA Response Date, the Council in reasonable consultation with LICENSEE will use Commercially Reasonable Efforts to undertake the development and regulatory approval efforts toward obtaining a first approval of the NDA for the Licensed Product in the United States, at Council’s cost and expense.
4.2.2 Phase 4 Studies Required upon Regulatory Approval.
(a) To the extent required by the FDA upon Regulatory Approval of the Licensed Product, Council will perform and pay the associated costs and expenses for the four post-approval studies described on Schedule 4.2.2(a).
(b) The Parties anticipate that in order to obtain and/or maintain Regulatory Approval for the Licensed Product a post-approval study may be required by the FDA on such Regulatory Approval to measure risk for venous thromboembolism (VTE) (“VTE Study”), and that as of the Effective Date the scope of the study the FDA has requested is described on Schedule 4.2.2(b). The Parties agree to cooperate in good faith to provide that the scope and cost of a VTE Study is appropriate. To the extent required by the FDA upon Regulatory Approval of the Licensed Product, LICENSEE will perform the VTE Study, provided that (i) fifty percent (50%) of the reasonable and direct costs and expenses incurred by LICENSEE for performance of such Phase IV Study in excess of twenty million United States Dollars ($20,000,000), after payment thereof by LICENSEE, will be deductible by LICENSEE from the royalties or other payments owed to the Council hereunder to the extent actually paid and not previously deducted by LICENSEE as of the time that the applicable royalty or other payment is owed to Council, and (ii) any costs and expenses below such twenty million United States Dollars ($20,000,000) will be the sole responsibility of LICENSEE and will not be deductible from royalties or other payments owed by LICENSEE to Council.
4.2.3 Subject to Section 4.2.2, LICENSEE (itself or through an Affiliate or permitted Third Party sublicensee) will use Commercially Reasonable Efforts to maintain the NDA for the Licensed Product in the Territory. Without limiting the obligation of LICENSEE in the previous sentence, in the event that LICENSEE determines that LICENSEE will not maintain the NDA for the Licensed Product, LICENSEE will promptly notify COUNCIL of such determination and will provide the Council a reasonable opportunity within five (5) Business Days of such notification to discuss such determination and to offer suggestions regarding potential avenues to maintain the NDA, and if the Parties cannot agree within ten (10) Business Days after such notification on a pathway reasonably likely to permit the LICENSEE to maintain the NDA, then such notification will constitute a notice of Termination by LICENSEE under Section 12.3.1(a) (termination for reason other than for Council’s material breach), provided that the one hundred eighty (180) day notice period for effectiveness of such termination may be shortened by mutual agreement of the Parties to any lesser time period down to an immediate termination as of the expiration of such ten (10) day period following such notification.
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4.4 Regulatory Activities
4.4.1 Transfer to LICENSEE.
(a) Council will continue to hold the Investigational New Drug Application (“IND”) prior to Regulatory Approval by the FDA
(b) Upon Regulatory Approval by the FDA and payment of the associated milestone set forth in Section 3.1.1, LICENSEE will own and hold the NDA and all other Applications for Regulatory Approval, licenses, and authorizations from the FDA, provided that (i) all data and information in the NDA will be owned solely by Council and licensed to LICENSEE in the Territory pursuant to the terms of this Agreement, and (ii) Council and its other licensees will have an irrevocable and perpetual a Right of Reference to such Applications for Regulatory Approval, licenses, and authorizations for (A) purposes of obtaining Regulatory Approval and Commercialization of the Licensed Product and other products outside the Territory, and (B) for all purposes with respect to products other than the Licensed Product (but not including any Generic Equivalent of the Licensed Product) within the Territory. Upon approval by the FDA of the NDA, Council will promptly transfer the NDA to LICENSEE and LICENSEE will accept such transfer from Council. Council agrees to use Commercially Reasonable Efforts in agreements related to licensing the Licensed Product outside the Territory to obtain a Right of Reference for LICENSEE similar to that described for Council above with respect to applications for Regulatory Approval outside the Territory. LICENSEE will not transfer any rights under the Licensed Product NDA to any Affiliate or Third Party (including by granting any Right of Reference thereto) under any circumstance other than as expressly permitted under this Agreement, including (x) in conjunction with an assignment to such Third Party or Affiliate of this Agreement as permitted under Section 14.4, and (y) under a sublicense pursuant to Section 2.2.
(c) Following payment by LICENSEE of the full payment set forth in Section 3.1.1, on an ongoing basis at LICENSEE’s expense, Council will provide LICENSEE, in the form specified by the Joint Product Committee, with material relevant information and data that is part of the Council Know-How, including upon approval an electronic copy of the Licensed Product NDA as filed with the FDA. Each Party will provide the other Party with a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate the Right of Reference described in this Section 4.1.1.
V. COMMERCIALIZATION
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5.9 Global Coordination. LICENSEE will reasonably cooperate with Council and Council’s other licensees of Nestorone®-containing products other than the Licensed Product with respect to safety, and pharmacovigilance, and will enter into one or more safety and pharmacovigilance agreements as may be necessary or useful to effect such cooperation, and Council will require its other licensees of Nestorone®-containing products other than the Licensed Product to cooperate with LICENSEE, or its permitted sublicensees, as the case may be, with respect to safety and pharmacovigilance, including safety data.
X. COVENANTS
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10.1.2 Each of Council and LICENSEE will promptly notify the Joint Product Committee if it becomes aware of any Other Information from sources other than LICENSEE. If any such Other Information relates to fatal, life threatening, or other serious adverse events (as defined in ICH-E2A, Section II.B.), the Party first becoming aware of it will promptly advise the Joint Product Committee by telephone, fax, email, or other instantaneous method of communication and will within fifteen (15) days thereafter provide written confirmation of such Other Information. Council will allow LICENSEE to comply (and LICENSEE will be responsible for complying) with the adverse reaction reporting requirements of the Act, and other comparable applicable Laws outside the United States with respect to the Licensed Product. Prior to the first commercial sale of the Licensed Product by LICENSEE or its designee, the Parties or their designees will enter into a pharmacovigilance and safety agreement concerning their respective reporting and investigation responsibilities.