Common use of Regulatory Communications Clause in Contracts

Regulatory Communications. As between the Parties, Legend shall have the sole responsibility to maintain all INDs necessary to perform the Legend Phase 1 Clinical Trial Activities under the Legend Development Plan and Budget, and to conduct communications with the applicable Regulatory Authorities with respect to such INDs; provided that [***] shall be subject to review and comment by Novartis at least [***] (unless an earlier response is required by the applicable Regulatory Authority, in which case the Parties shall work in good faith to provide a response within such timeframe) prior to their submission to the applicable Regulatory Authorities. Subject to Section 3.3(e), Legend shall, and shall cause its Affiliates to, [***] such comments of Novartis on such Regulatory Materials. Subject to the immediately following sentence, Legend shall provide Novartis with (i) access to or copies of all material written or electronic correspondence to the extent pertaining to its [***] Legend or its Affiliates ([***]) from, or forwarded by Legend or its Affiliates ([***]) to, the Regulatory Authorities in the Territory, and (ii) copies of all meeting minutes and summaries of all meetings, conferences, and discussions held by Legend or its Affiliates [***] with the Regulatory Authorities to extent relating to [***], including copies of all contact reports produced by Legend or its Affiliates [***] regarding the same, in each case ((i) and (ii)) within [***]. If such written or electronic correspondence so received from any such Regulatory Authority relates to [***], Legend shall notify Novartis and provide Novartis with copies of such written or electronic correspondence as soon as practicable, but not later than [***] after receipt of such correspondence. Legend shall provide Novartis with prior written notice, to the extent Legend or its Affiliates has advance knowledge, of [***], within [***] after [***]. Novartis shall have the right to [***]; provided that, (A) [***], and (B) [***]