Roche as Lead Development Party Sample Clauses

Roche as Lead Development Party. (i) Roche shall be the Lead Development Party and shall have primary operational responsibility for (1) all Non-Clinical Studies and Pre-Approval Trials of any Product for any Additional Program Plan for which Roche exercises its Development Lead Option pursuant to Section 3.6(b)(ii) below, and (2) subject to Section 3.6(a)(i), all Non-Clinical Studies and Pre-Approval Trials of any Product that are conducted primarily to support Regulatory Approval of the applicable Product in the Roche Territory (which shall be deemed to include any Bridging Studies) (each of the foregoing (i) and (ii), a “Roche Lead Study”). (ii) For a period of [****] Business Days after the date on which the JSC approves the first Additional Program Plan for an Additional Indication, and every Additional Program Plan for an Additional Indication thereafter, Roche shall have the right, but not the obligation, to elect to be the Lead Development Party for such Additional Program Plans (the “Development Lead Option”) by providing Alnylam with written notice of such election during such time period. For clarity, upon providing such notice in accordance with the foregoing, Roche shall become the Lead Development Party for the Non-Clinical Studies and Pre-Approval Trials set forth in the applicable Additional Program Plan. For clarity, in the event that Roche does not provide such notice in accordance with the foregoing, Alnylam shall have the right, but not the obligation, to be the Lead Development Party for the applicable Additional Program Plan by providing Roche with written notice thereof.