Idenix Responsibilities Clause Samples

Idenix Responsibilities. Idenix shall be responsible for: (i) Manufacturing and supplying the Idenix Compound for the Collaboration Trials, as further described in Article 4 above; (ii) with the cooperation of ▇▇▇▇▇▇▇, and as necessary or reasonably expected to be necessary and described in Section 5.1(b), preparing and filing all necessary Collaboration Trial Regulatory Documentation (including the 2-DAA Combined Therapy IND and the 3-DAA Combined Therapy IND, if necessary, but excluding any IND for a ▇▇▇▇▇▇▇ Compound) and acting as liaison for all communication with the Regulatory Authorities in any country in the Territory for the purpose of conducting the Collaboration Trial(s) in such country; and maintaining and acting as the sponsor of record for each Collaboration Trial; (iii) with the cooperation of ▇▇▇▇▇▇▇ as reasonably required, and subject to the provisions of Section 9.6, listing any Collaboration Trial on ▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇ or other public registry agreed upon by the JDC in any county in the Territory in which a Collaboration Trial is being conducted in accordance with Applicable Law; (iv) providing ▇▇▇▇▇▇▇ with, to the extent possible, not less than [**] business days advance notice of scheduled meetings or other non-written communications with a Regulatory Authority and the opportunity to participate in each such meeting or other non-written communications to the extent that it relates to the 2-DAA Combined Therapy, 3-DAA Combined Therapy, the 435 Compound or 055 Compound; provided, however, in no event shall Idenix or any Idenix Affiliate communicate with any Regulatory Authority solely with respect to the 435 Compound or 055 Compound without the prior written consent of ▇▇▇▇▇▇▇, and provided that ▇▇▇▇▇▇▇ shall step out of any portions of such meetings or other non-written communications with a Regulatory Authority that relate solely to the Idenix Compound and Idenix shall step out of any portions of such meetings or other non-written communications with a Regulatory Authority that relate solely to the 435 Compound or 055 Compound; (v) providing to ▇▇▇▇▇▇▇ (x) a written executive high-level summary of meetings or other non-written communications with a Regulatory Authority within [**] business days of such meeting or communication and a copy of the Sponsor meeting minutes submitted to the Regulatory Authority no later than [**] business days after submission of such minutes to the Regulatory Authority, and (y) copies of any official correspondence from a Regul...