Common use of Regulatory Approval Activities Clause in Contracts

Regulatory Approval Activities. (a) Subject to, and in accordance with, the terms and conditions of this Agreement and all requirements of applicable laws, rules, and regulations, XTL shall use Commercially Reasonable Efforts to conduct its activities to Obtain Regulatory Approval set forth in the HepeX-B Plan; provided, however, that subject to Section 5.1(b), XTL shall not have any obligation to perform activities to Obtain Regulatory Approval under the HepeX-B Plan or, prior to the first iteration of the HepeX-B Plan, under the guidelines attached as Exhibit C (other than the XTL Activities and such other XTL obligations as are expressly set forth in this Agreement) to which XTL has not consented if (i) prior to the first iteration of the HepeX-B Plan, CUBIST attempts to impose obligations that materially deviate in scope from the guidelines set forth in Exhibit C, (ii) the initial HepeX-B Plan materially deviates in scope from the guidelines attached in Exhibit C, and/or (iii) material changes are made to the HepeX-B Plan without XTL’s prior written consent; provided that in all cases, XTL may not refuse to provide any data or information pursuant to Sections 4.1(a) or 4.2. XTL hereby acknowledges and agrees that it shall not be entitled to engage in any activities to Obtain Regulatory Approval with respect to any Product intended for treatment or prevention of Hepatitis B, unless and until such activities have been incorporated into the HepeX-B Plan and CUBIST shall have provided written consent to XTL engaging in such development activities. The Parties shall use Commercially Reasonable Efforts to minimize the costs and expenses incurred by them as a result of the performance of their obligations under this Section 5. Notwithstanding anything in this Section 5 or elsewhere in this Agreement to the contrary, XTL shall cease any activities to Obtain Regulatory Approval, including any pre-clinical and clinical activity for Products, upon receipt of written notice from CUBIST to cease such activity, or as soon as practicable thereafter.

Regulatory Approval Activities. (a) Subject to, and in accordance with, the terms and conditions of this Agreement and all requirements of applicable laws, rules, and regulations, XTL shall use *Confidential Treatment Requested. Material has been omitted and filed separately with the Commission. Commercially Reasonable Efforts to conduct its activities to Obtain Regulatory Approval set forth in the HepeX-B Plan; provided, however, that subject to Section 5.1(b), XTL shall not have any obligation to perform activities to Obtain Regulatory Approval under the HepeX-B Plan or, prior to the first iteration of the HepeX-B Plan, under the guidelines attached as Exhibit C (other than the XTL Activities and such other XTL obligations as are expressly set forth in this Agreement) [*] to which XTL has not consented has[*] if (i) prior to the first iteration of the HepeX-B Plan, CUBIST attempts to impose obligations that materially deviate in scope from the guidelines set forth in Exhibit C[*], (ii) the initial HepeX-B Plan materially deviates in scope from the guidelines attached in Exhibit C[*], and/or (iii) material changes are made to the HepeX-B Plan without XTL’s prior written consent[*]; provided that in all cases, XTL may not refuse to provide any data or information pursuant to Sections 4.1(a) or 4.2. XTL hereby acknowledges and agrees that it shall not be entitled to engage in any activities to Obtain Regulatory Approval with respect to any Product intended for treatment or prevention of Hepatitis B, unless and until such activities have been incorporated into the HepeX-B Plan and CUBIST shall have provided written consent to XTL engaging in such development activities. The Parties shall use Commercially Reasonable Efforts to minimize the costs and expenses incurred by them as a result of the performance of their obligations under this Section 5. Notwithstanding anything in this Section 5 or elsewhere in this Agreement to the contrary, XTL shall cease any activities to Obtain Regulatory Approval, including any pre-clinical and clinical activity for Products, upon receipt of written notice from CUBIST to cease such activity, or as soon as practicable thereafter.

Regulatory Approval Activities. (a) Subject to, and in accordance with, the terms and conditions of this Agreement and all requirements of applicable laws, rules, and regulations, XTL shall use Commercially Reasonable Efforts to conduct its activities to Obtain Regulatory Approval set forth in the HepeX-B Plan; provided, however, that subject to Section 5.1(b), XTL shall not have any obligation to perform activities to Obtain Regulatory Approval under the HepeX-B Plan or, prior to the first iteration of the HepeX-B Plan, under the guidelines attached as Exhibit C (other than the XTL Activities and such other XTL obligations as are expressly set forth in this Agreement) to which XTL has not consented if (i) prior to the first iteration of the HepeX-B Plan, CUBIST attempts to impose obligations that materially deviate in scope from the guidelines set forth in Exhibit C, (ii) the initial HepeX-B Plan materially deviates in scope from the guidelines attached in Exhibit C, and/or (iii) material changes are made to the HepeX-B Plan without XTL’s prior written consent; provided that in all cases, XTL may not refuse to provide any data or information pursuant to Sections 4.1(a) or 4.2. XTL hereby acknowledges and agrees that it shall not be entitled to engage in any activities to Obtain Regulatory Approval with respect to any Product intended for treatment or prevention of Hepatitis B, unless and until such activities have been incorporated into the HepeX-B Plan and CUBIST shall have provided written consent to XTL engaging in such development activities. The Parties shall use Commercially Reasonable Efforts to minimize the costs and expenses incurred by them as a result of the performance of their obligations under this Section 5. Notwithstanding anything in this Section 5 or elsewhere in this Agreement to the contrary, XTL shall cease any activities to Obtain Regulatory Approval, including any pre-clinical and clinical activity for Products, upon receipt of written notice from CUBIST to cease such activity, or as soon as practicable thereafter. *Confidential Treatment Requested. Material has been omitted and filed separately with the Commission.