Provision Language
IV. JOINT PRODUCT COMMITTEE, PRODUCT DEVELOPMENT, CLINICAL TRIALS AND REGULATORY APPROVALS
4.2 Licensed Product Development.
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4.2.2 Phase 4 Studies Required upon Regulatory Approval.
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(c) If (x) a complete response letter or continuance of greater than ninety (90) days is received by Council with respect to the Licensed Product, (y) post-marketing requirements or commitments in addition to the studies set forth on Schedule 4.2.2(a) or the VTE Study are required by the FDA upon the initial Regulatory Approval of the Licensed Product (“Additional Requirements”), or (z) the shelf life for the Licensed Product permitted by the FDA upon the initial Regulatory Approval thereof is less than eighteen (18) months, then in each case the Joint Product Committee will meet promptly to determine the strategy to be implemented to address any such issue, provided that:
i. If a complete response letter or continuance of greater than ninety (90) days is received by Council with respect to the Licensed Product, to the extent that, within thirty (30) days following the notification and sharing by Council to LICENSEE of the complete response letter or notice of continuance, as applicable, the Parties, acting reasonably, are unable to agree on a strategy to address such response or continuance, as applicable (including with respect to each Party’s share of the costs and expenses associated with any such required studies), then each Party will have the right to terminate this Agreement immediately upon written notice by such Party to the other Party delivered not later than the last day of such thirty (30) day period;
ii. If (A) Additional Requirements are required by the FDA upon Regulatory Approval of the Licensed Product that would involve a Clinical Study or, in the good faith judgment of either Party, would require expenditures in excess of one million United States Dollars ($1,000,000) in the aggregate, and (B) within thirty (30) days following the notification and sharing by Council to LICENSEE of the Regulatory Approval letter from the FDA, the Parties, acting reasonably, are unable to agree on a strategy to address such additional post-marketing requirements (including with respect to each Party’s share of the costs and expenses associated with any such required additional requirements), then each Party will have the right to terminate this Agreement immediately upon written notice by such Party to the other Party delivered not later than the last day of such thirty (30) day period;
iii.If the FDA permitted shelf life is less than eighteen (18) months in the Regulatory Approval for the Licensed Product, then LICENSEE shall have the right to terminate the Agreement with immediate effect on written notice to Council made not later than five (5) Business Days following the notification and sharing by Council to LICENSEE of the Regulatory Approval letter from the FDA; and
iv. If neither Party terminates the Agreement in accordance with Section 4.2.2(c)i above, then LICENSEE shall promptly make a one- time non-refundable, non-creditable (except as set forth in Section 3.1.1) and no-recourse payment to Council of five million United States Dollars (US $5,000,000).
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.
4.2.4 Except as provided in Sections 4.2.1 and 4.2.2, as between the Parties, LICENSEE will be responsible for all development costs with respect to the Licensed Product incurred after the Effective Date by or on behalf of LICENSEE, provided that any costs incurred by Council for development activities under this Agreement shall only be reimbursable by LICENSEE to the extent agreed to by LICENSEE in advance in writing.
4.2.5 Except as provided in Sections 4.2.1 and 4.2.2, LICENSEE will use Commercially Reasonable Efforts to perform the development activities related to the Licensed Product in the Territory. Without limiting the foregoing or Council’s other remedies, if Council notifies LICENSEE that it believes LICENSEE is not using Commercially Reasonable Efforts to develop the Licensed Product: (i) the Joint Product Committee will meet within fifteen(15) days of any such notice and, at such meeting, Council will provide its rationale to the Joint Product Committee regarding why it believes LICENSEE has not been using Commercially Reasonable Efforts and LICENSEE will provide its rationale regarding why it believes it has been using Commercially Reasonable Efforts; and (ii) the Parties will use good faith efforts for a period of up to thirty (30) days following such Joint Product Committee meeting to attempt to resolve any such disputes after which time Council may pursue resolution pursuant to the terms of Section 14.3.
XII. TERM AND TERMINATION
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12.2 Termination by Council.
12.2.1 Subject to this Section 12.2.1, Council may terminate this Agreement upon written notice as follows:
(a) in the event of a material breach by LICENSEE of this Agreement (other than a failure to pay an undisputed material amount or a disputed material amount due under Section 3.1.1 or 3.1.2).
(b) if LICENSEE shall have failed to pay an undisputed material amount, or
(c) if LICENSEE shall have failed to pay a disputed material amount due under Section 3.1.1 or 3.1.2 within seven (7) days of the date payment was due, immediately upon expiration of the foregoing seven (7) day period; provided that in the case of 12.2.1(a) and 12.2.1(b) above, LICENSEE has received written notice from Council of such breach, specifying in reasonable detail the particulars of the alleged breach, and such breach in the case of (a) above, if curable, has not been cured within sixty (60) calendar days of the date of notice or such longer period as may reasonably be required to cure such breach, or in the case of (b) above within seven (7) Business Days, after the date of the relevant notice.
12.2.2
12.2.2 Notwithstanding the foregoing Section 12.2.1:
(a) other than with respect to a disputed material payment amount, if LICENSEE in good faith disputes a purported material breach referred to in 12.2.1(a) , or the failure to cure or remedy such material breach and elects by written notice to Council within seven (7) Business Daysafter notice to LICENSEE of such breach to resolve the dispute in accordance with the dispute resolution provisions in Section 14.3, then Council may not terminate this Agreement until the date on which it has been, determined under Section 14.3that LICENSEE is in material breach of this Agreement;
(b) if LICENSEE elects by written notice given within seven (7) Business Days of the payment date therefore to resolve a dispute regarding a material payment due under Section 3.1.1 or 3.1.2 pursuant to Section 14.3 and has made payment of such disputed amount to Council within such seven (7) Business Day period as provided above, then Council may not terminate this Agreement on account of failure to make such payment and LICENSEE will be entitled to recover from Council all or such portion of such payment as may be determined to be owing to it pursuant to Section 14.3; and
(c) for a disputed material payment amount, either Party may submit such dispute to an audit procedure as set forth inSection 3.2.4 upon written notice to the other Party, with the Party whose position in the applicable dispute is farthest away from what the auditors determine to bear the costs of such audit, and any such dispute so resolved shall not be subject to further dispute resolution pursuant to Section 14.3.
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12.3 Termination by LICENSEE
12.3.1 LICENSEE may terminate this Agreement upon written notice to Council (a) for any reason, upon one-hundred eighty (180) days’ written notice to Council, (b) in the event of a material breach by Council or its Affiliates of this Agreement, provided that Council has received written notice from LICENSEE of such breach, specifying in reasonable detail the particulars of the alleged breach, such breach is continuing for sixty (60) calendar days after such notice and such breach has not been cured within such sixty (60) day period (except that, in the event such breach is curable but may not reasonably be cured in sixty (60) calendar days, then such cure period will be extended for an additional period during which Council is making good faith attempts to cure such breach); (c) immediately in the event (i) that Council becomes insolvent or is unable to pay its debts when due; (ii) Council files a petition in bankruptcy, reorganization or similar proceeding, or, if such a petition is filed against Council, such petition is not dismissed within ninety (90) days; (iii) Council discontinues its business; or (iv) a receiver is appointed or there is an assignment for the benefit of Council’s creditors, and (d) on fifteen (15) days written notice following the NDA Response Date if the FDA indicates that the Licensed Product does not qualify as employing an NCE that is entitled to five years regulatory exclusivity in the United States.
12.4 Automatic Termination. This Agreement will terminate automatically, without notice or opportunity to cure, upon the occurrence of any of the following events:
12.4.1 LICENSEE being authorized (whether by its board of directors or such other Person having authority to direct LICENSEE) to commence or institute any bankruptcy, receivership, insolvency, reorganization or other similar proceedings under any bankruptcy, insolvency, or other similar law now or hereinafter in effect, including any section or chapter of the United States Bankruptcy Code (as may be amended, the “Bankruptcy Code”) or under any similar laws or statutes of the United States or any state thereof or of any jurisdiction (whether or not in the United States) having authority or jurisdiction over the assets of LICENSEE or in which LICENSEE may operate or have assets;
12.4.2 the commencement or institution of any bankruptcy, receivership, insolvency, reorganization or other similar proceedings by or against LICENSEE under any bankruptcy, insolvency, or other similar law now or hereinafter in effect, including any section or chapter of the Bankruptcy Code or under any similar laws or statutes of the United States or any state thereof or of any jurisdiction (whether or not in the United States) having authority or jurisdiction over the assets of LICENSEE or in which LICENSEE may operate or have assets; and
12.4.3 the appointment of a receiver, trustee, or similar party with respect to any material asset of LICENSEE.