1.25 “Commercially Reasonable Efforts” shall mean:
(a) With respect to efforts of Sanofi as measured on a country by country basis: that measure of efforts and resources consistent with Sanofi’s and its Affiliates’ own efforts and resources applied to its and their own compounds, devices and products of a similar value, stage of development, life cycle and commercial potential, taking into account all relevant factors including issues of safety and efficacy, product profile, difficulty in developing or manufacturing the applicable Product or sourcing raw materials necessary therefor, competitiveness of alternative third party products in the marketplace, regulatory approvals (including pricing approvals), pricing and reimbursement, the patent or other proprietary position of the applicable Product, the regulatory requirements involved and the potential profitability of the applicable Product for Sanofi and its Affiliates as compared to the expected profitability of other products of its then current or in development product portfolios; and
www.sec.gov/Archives/edgar/data/899460/000119312514406347/d783199dex101.htmIt's not reasonable effort until some months after international launch.
12.2 Termination by the Parties.
(a) Termination for Material Breach. In the event that either Party shall be in material breach in the performance of any of its obligations under this Agreement (the “Breaching Party”), in addition to any other right and remedy the other Party (the “Complaining Party”) may have, the Complaining Party may terminate this Agreement by giving notice in writing specifying the breach and its claim of right to terminate; provided, however, that if the breach is remediable, the Breaching Party shall have ninety (90) days (or forty-five (45) days for any payment breach) (the “Notice Period”) to rectify the breach and termination shall become effective at the end of the Notice Period only if the Breaching Party fails to cure the breach complained about during (i) the Notice Period or, (ii) if such breach (other than any payment breach) has not been cured within such 90-day period, if the Breaching Party has commenced actions to cure such breach within the Notice Period and thereafter uses reasonable efforts to cure such breach, such longer period as is reasonably required to cure such breach, but in any event, not to exceed ninety (90) days following expiration of the Notice Period; provided further, that, if Sanofi is the Breaching Party and the breach is with respect to Sanofi’s failure to comply with its obligation to use Commercially Reasonable Efforts with respect to (x) the United States, MannKind may terminate this Agreement in its entirety, and (y) any Major Market (other than the United States) or […***…] Country, MannKind may terminate this Agreement only with respect to such Major Market or […***…] Country (as applicable) and not in its entirety. If the Breaching Party disputes in good faith that it has materially breached one of
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its obligations under this Agreement, termination shall not take effect pending resolution of such dispute pursuant to Article 14. If, as a result of the application of such dispute resolution procedures, the Breaching Party is determined to be in material breach of one or more of its obligations under this Agreement (an “Adverse Ruling”), then if the Breaching Party fails to complete the actions specified by the Adverse Ruling to cure such breach within ninety (90) days (or forty five (45) days for any payment breach) after such Adverse Ruling, then the Complaining Party may terminate this Agreement upon written notice to the Breaching Party.
(b) Termination Upon Insolvency. Either Party will be entitled to terminate this Agreement with immediate effect by notice in writing if the other Party files for protection under bankruptcy or insolvency laws, makes an assignment for the benefit of creditors, appoints or suffers appointment of a receiver, administrator, manager, trustee or like official over its property that is not discharged within 90 days, proposes a written agreement of composition or extension of its debts, is a party to any dissolution, winding-up or liquidation or has any such petition filed against it which involuntary petition is not discharged within 60 days of the filing thereof.
12.3 Additional Sanofi Termination Rights.
(a) If, at any time on or after January 1, 2016, Sanofi determines in good faith that Commercialization of Product is no longer economically viable in the United States, then Sanofi may terminate this Agreement in its entirety upon delivery of at least ninety (90) days’ prior written notice to MannKind. In addition, at any time on or after January 1, 2016, upon delivery of at least six (6) months’ prior written notice to MannKind, Sanofi shall have the right to terminate this Agreement for any reason (a) in its entirety, or (b) on a country-by-country basis other than with respect to the United States; provided, however, that if Sanofi terminates this Agreement under this Section 12.3(a) in each of […***…], then Sanofi shall terminate this Agreement with respect to all countries of the European Union. For purposes of clarity, Sanofi shall have no right to terminate this Agreement with respect to only the United States under this Section 12.3(a).
(b) Termination for Safety or Regulatory Reasons. On a country-by-country basis, Sanofi shall have the right in its sole discretion to terminate this Agreement in such country immediately upon thirty (30) days’ written notice to MannKind in the event:
(i) of withdrawal or indefinite suspension of any MAA for a Product in such country; or
(ii) that Sanofi determines in good faith that pursuing the Development or Commercialization of a Product in the Territory or any part thereof poses an unacceptable medical risk to patients.
12.4 Additional MannKind Termination Right. MannKind shall have the right to terminate this Agreement immediately upon written notice to Sanofi if Sanofi or any of its Affiliates or sublicensees directly, or indirectly through any Third Party, commences any interference or opposition proceeding with respect to, challenges the validity or enforceability of,
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or opposes any extension of or the grant of a supplementary protection certificate with respect to, any MannKind Patent; provided that MannKind shall not have such right to terminate this Agreement for a proceeding, challenge or opposition of the type described above (in each case, a “Challenge”) by a sublicensee if (a) the sublicense agreement with such sublicensee includes a right of the applicable sublicensor (Sanofi, its Affiliate or another sublicensee, as applicable) to terminate the sublicense following written notice to such sublicensee and, if applicable, a cure period not to exceed sixty (60) days if such sublicensee directly, or indirectly through any Third Party, institutes a Challenge of any MannKind Patent and (b) either (i) the applicable sublicensor diligently enforces its rights to cause the sublicensee to withdraw or dismiss such Challenge including, if applicable, exercise of such termination right promptly following the expiration of any applicable cure period or (ii) such Challenge is withdrawn or dismissed within thirty (30) days after a request by the applicable sublicensor or by MannKind to do.
12.5 Termination Not Sole Remedy. Termination is not the sole remedy under this Agreement and, whether or not termination is effected and notwithstanding anything contained in this Agreement to the contrary, all other remedies will remain available except as agreed to otherwise herein. Notwithstanding the foregoing, termination of this Agreement in the applicable […***…] Country in accordance with Section 12.2(a) shall be MannKind’s sole remedy for Sanofi’s failure to comply with its obligations under Section 4.2(c) to use Commercially Reasonable Efforts to file for, obtain or maintain Marketing Approvals for Product in the Field in any […***…] Country.