Common use of CUBIST Diligence Clause in Contracts

CUBIST Diligence. (a) Subject to, and in accordance with, the terms and conditions of this Agreement and all requirements of applicable laws, rules and regulations, CUBIST shall use Commercially Reasonable Efforts to Obtain Regulatory Approval for HepeX-B in each of the Major Markets, and subsequent to obtaining Regulatory Approval in a Major Market, to Commercialize HepeX-B in such Major Market. The sole remedy of XTL for any breach by CUBIST of its obligations under this Section 2.2 with respect to any Major Market is to terminate CUBIST’s rights and licenses under this Agreement with respect to such Major Market pursuant to Section 13.4. In the event CUBIST breaches its obligations under Section 2.2 with respect to ***** or more Major Market countries, XTL shall also have the right pursuant to Section 13.4 to terminate CUBIST’s rights and licenses under this Agreement with respect to each country that is not a Major Market country in which CUBIST is not then using Commercially Reasonable Efforts to Obtain Regulatory Approval for HepeX-B, and subsequent to obtaining Regulatory Approval in such country, to Commercialize HepeX-B in such country. For the avoidance of doubt, CUBIST shall not be considered to be in violation of its diligence obligations under this Section 2.2 if the failure to use Commercially Reasonable Efforts as required under this Section 2.2 is caused in material part by the wrongful acts or omissions of XTL or any breach of this Agreement by XTL. (b) CUBIST shall be deemed to have used Commercially Reasonable Efforts for all purposes of this Section 2.2 at all times following such time as CUBIST (and its Affiliates and Sublicensees) has achieved worldwide Net Sales and Sublicensee Revenues which, combined, exceed the aggregate amount of $50,000,000. Notwithstanding anything to the contrary in this Agreement, the “safe harbor” provisions of this Section 2.2(b) are not intended to set minimum standards of performance by CUBIST, and CUBIST shall be entitled to demonstrate that other efforts with respect to the Product should be deemed to be Commercially Reasonable Efforts. (c) As set forth in Section 2.2(a), the parties agree that XTL’s sole and exclusive remedy with respect to a material breach by CUBIST of its obligations set forth in Section 2.2(a) shall be to terminate the rights and licenses granted by XTL to CUBIST under this Agreement with respect to those jurisdictions within the Territory in which CUBIST shall have failed to use Commercially Reasonable Efforts; provided that within sixty (60) days after receipt of any report provided by CUBIST under Section 4.1(b), XTL shall have delivered to CUBIST written notice (a “Disagreement Notice”) of such failure, which notice shall set forth in reasonable detail the nature of the alleged failure; provided further that such failure has not been cured or waived within 60 calendar days following delivery of such notice. If XTL does not deliver a Disagreement Notice under this Section 2.2(c) within such sixty (60) day period, CUBIST shall be deemed to be in full compliance with the terms of Section 2.2(a) with respect to the time period covered by such CUBIST report. XTL shall not bring, commence, continue or prosecute any claim, legal action or proceeding under, in relation to, arising out of or in connection with a breach of Section 2.2(a), except as set forth in Section 2.2(d). (d) If XTL and CUBIST are not able to resolve their disagreement with respect to CUBIST’s compliance with Section 2.2(a) within sixty (60) days after CUBIST’s receipt of a Disagreement Notice, then either XTL or CUBIST, acting alone, may at any time following receipt of such Disagreement Notice by delivery to the other party of a written notice indicating such party’s election to have the disagreement resolved by arbitration (a “Marketing Inquiry”), cause the matter to be submitted to binding arbitration under Section 14.2; provided that (i) the arbitrators shall be entitled to review and resolve only whether or not CUBIST failed to materially comply with its obligations under Section 2.2(a) during the applicable reporting period of time that is the subject of the Marketing Inquiry, and (ii) the arbitrators shall be individuals who are knowledgeable in the field of the development, manufacture, and sale of drugs and drug products, and shall have no current or prior business relationships with any of XTL, CUBIST, or any of their respective Affiliates.

CUBIST Diligence. (a) Subject to, and in accordance with, the terms and conditions of this Agreement and all requirements of applicable laws, rules and regulations, CUBIST shall use Commercially Reasonable Efforts to Obtain Regulatory Approval for HepeX-B in each of the Major Markets, and subsequent to obtaining Regulatory Approval in a Major Market, to Commercialize HepeX-B in such Major Market. The sole remedy of XTL for any breach by CUBIST of its obligations under this Section 2.2 with respect to any Major Market is to terminate CUBIST’s rights and licenses under this Agreement with respect to such Major Market pursuant to Section 13.4. In the event CUBIST breaches its obligations under Section 2.2 with respect to [***** ] or more Major Market countries, XTL shall also have the right pursuant to Section 13.4 to terminate CUBIST’s rights and licenses under this Agreement with respect to each country that is not a Major Market country in which CUBIST is not then using Commercially Reasonable Efforts to Obtain Regulatory Approval for HepeX-B, and subsequent to obtaining Regulatory Approval in such country, to Commercialize HepeX-B in such country. For the avoidance of doubt, CUBIST shall not be considered to be in violation of its diligence obligations under this Section 2.2 if the failure to use Commercially Reasonable Efforts as required under this Section 2.2 is caused in material part by the wrongful acts or omissions of XTL or any breach of this Agreement by XTL. (b) CUBIST shall be deemed to have used Commercially Reasonable Efforts for all purposes of this Section 2.2 at all times following such time as CUBIST (and its Affiliates and Sublicensees) has achieved worldwide Net Sales and Sublicensee Revenues [*] which, combined, exceed the aggregate amount of $50,000,000[*]. Notwithstanding anything to the contrary in this Agreement, the “safe harbor” provisions of this Section 2.2(b) are not intended to set minimum standards of performance by CUBIST, and CUBIST shall be entitled to demonstrate that other efforts with respect to the Product should be deemed to be Commercially Reasonable Efforts. (c) As set forth in Section 2.2(a), the parties agree that XTL’s sole and exclusive remedy with respect to a material breach by CUBIST of its obligations set forth in Section 2.2(a) shall be to terminate the rights and licenses granted by XTL to CUBIST under this Agreement with respect to those jurisdictions within the Territory in which CUBIST shall have failed to use Commercially Reasonable Efforts; provided that within sixty (60) days after receipt of any report provided by CUBIST under Section 4.1(b), XTL shall have delivered to CUBIST written notice (a “Disagreement Notice”) of such failure, which notice shall set forth in reasonable detail the nature of the alleged failure; provided further that such failure has not been cured or waived within 60 calendar days following delivery of such notice. If XTL does not deliver a Disagreement Notice under this Section 2.2(c) within such sixty (60) day period, CUBIST shall be deemed to be in full compliance with the terms of Section 2.2(a) with respect to the time period covered by such CUBIST report. XTL shall not bring, commence, continue or prosecute any claim, legal action or proceeding under, in relation to, arising out of or in connection with a breach of Section 2.2(a), except as set forth in Section 2.2(d). (d) If XTL and CUBIST are not able to resolve their disagreement with respect to CUBIST’s compliance with Section 2.2(a) within sixty (60) days after CUBIST’s receipt of a Disagreement Notice, then either XTL or CUBIST, acting alone, may at any time following receipt of such Disagreement Notice by delivery *Confidential Treatment Requested. Material has been omitted and filed separately with the Commission. to the other party of a written notice indicating such party’s election to have the disagreement resolved by arbitration (a “Marketing Inquiry”), cause the matter to be submitted to binding arbitration under Section 14.2; provided that (i) the arbitrators shall be entitled to review and resolve only whether or not CUBIST failed to materially comply with its obligations under Section 2.2(a) during the applicable reporting period of time that is the subject of the Marketing Inquiry, and (ii) the arbitrators shall be individuals who are knowledgeable in the field of the development, manufacture, and sale of drugs and drug products, and shall have no current or prior business relationships with any of XTL, CUBIST, or any of their respective Affiliates.

CUBIST Diligence. (a) Subject to, and in accordance with, the terms and conditions of this Agreement and all requirements of applicable laws, rules and regulations, CUBIST shall use Commercially Reasonable Efforts to Obtain Regulatory Approval for HepeX-B in each of the Major Markets, and subsequent to obtaining Regulatory Approval in a Major Market, to Commercialize HepeX-B in such Major Market. The sole remedy of XTL for any breach by CUBIST of its obligations under this Section 2.2 with respect to any Major Market is to terminate CUBIST’s rights and licenses under this Agreement with respect to such Major Market pursuant to Section 13.4. In the event CUBIST breaches its obligations under Section 2.2 with respect to [***** ] or more Major Market countries, XTL shall also have the right pursuant to Section 13.4 to terminate CUBIST’s rights and licenses under this Agreement with respect to each country that is not a Major Market country in which CUBIST is not then using Commercially Reasonable Efforts to Obtain Regulatory Approval for HepeX-B, and subsequent to obtaining Regulatory Approval in such country, to Commercialize HepeX-B in such country. For the avoidance of doubt, CUBIST shall not be considered to be in violation of its diligence obligations under this Section 2.2 if the failure to use Commercially Reasonable Efforts as required under this Section 2.2 is caused in material part by the wrongful acts or omissions of XTL or any breach of this Agreement by XTL. (b) CUBIST shall be deemed to have used Commercially Reasonable Efforts for all purposes of this Section 2.2 at all times following such time as CUBIST (and its Affiliates and Sublicensees) has achieved worldwide Net Sales and Sublicensee Revenues which, combined, exceed the aggregate *Confidential Treatment Requested. Material has been omitted and filed separately with the Commission. amount of $50,000,000. Notwithstanding anything to the contrary in this Agreement, the “safe harbor” provisions of this Section 2.2(b) are not intended to set minimum standards of performance by CUBIST, and CUBIST shall be entitled to demonstrate that other efforts with respect to the Product should be deemed to be Commercially Reasonable Efforts. (c) As set forth in Section 2.2(a), the parties agree that XTL’s sole and exclusive remedy with respect to a material breach by CUBIST of its obligations set forth in Section 2.2(a) shall be to terminate the rights and licenses granted by XTL to CUBIST under this Agreement with respect to those jurisdictions within the Territory in which CUBIST shall have failed to use Commercially Reasonable Efforts; provided that within sixty (60) days after receipt of any report provided by CUBIST under Section 4.1(b), XTL shall have delivered to CUBIST written notice (a “Disagreement Notice”) of such failure, which notice shall set forth in reasonable detail the nature of the alleged failure; provided further that such failure has not been cured or waived within 60 calendar days following delivery of such notice. If XTL does not deliver a Disagreement Notice under this Section 2.2(c) within such sixty (60) day period, CUBIST shall be deemed to be in full compliance with the terms of Section 2.2(a) with respect to the time period covered by such CUBIST report. XTL shall not bring, commence, continue or prosecute any claim, legal action or proceeding under, in relation to, arising out of or in connection with a breach of Section 2.2(a), except as set forth in Section 2.2(d). (d) If XTL and CUBIST are not able to resolve their disagreement with respect to CUBIST’s compliance with Section 2.2(a) within sixty (60) days after CUBIST’s receipt of a Disagreement Notice, then either XTL or CUBIST, acting alone, may at any time following receipt of such Disagreement Notice by delivery to the other party of a written notice indicating such party’s election to have the disagreement resolved by arbitration (a “Marketing Inquiry”), cause the matter to be submitted to binding arbitration under Section 14.2; provided that (i) the arbitrators shall be entitled to review and resolve only whether or not CUBIST failed to materially comply with its obligations under Section 2.2(a) during the applicable reporting period of time that is the subject of the Marketing Inquiry, and (ii) the arbitrators shall be individuals who are knowledgeable in the field of the development, manufacture, and sale of drugs and drug products, and shall have no current or prior business relationships with any of XTL, CUBIST, or any of their respective Affiliates.