Common use of Interactions Clause in Contracts

Interactions. (a) To the extent permitted by the relevant regulatory authority and by Law, Iovance shall be solely and exclusively responsible for all interactions and communications with and reports to the applicable regulatory authorities related to the Products and/or Services. (b) To the extent that the relevant regulatory authority will not or is not permitted by Law to directly interact with Iovance, copies of (or summaries in the case of oral communications, interactions, and reports) all interactions and communications with, and reports to, the applicable regulatory authority related to the Products and/or Services (whether written or oral) shall be submitted to Iovance by Company, in reasonable and sufficient time prior to submission to the applicable regulatory authority, for Iovance’s prior review and approval. For clarity, this may include Iovance providing on-site, but indirect, assistance to Company in connection with a regulatory interaction. Company will incorporate all of Iovance’s comments in good faith that are factually accurate and not contrary to Company’s responsibility under Law. (c) Company shall be responsible for all interactions and communications with and reports to the applicable regulatory authorities that are not related to the Products and/or Services, but that could reasonably be expected to impact the Products and/or Services. Company, however, shall provide copies of all communications, interactions, and reports proposed for submission (or summaries in the case of oral communications, interactions, and reports) that could reasonably be expected to impact the Product and/or Services, to Iovance, in reasonable and sufficient time prior to submission to the applicable regulatory authority, for Iovance’s prior comment. Company will consider all of Iovance’s comments in good faith. (d) In addition to the requirements of the foregoing subsections (b) and (c), Company shall furnish Iovance with final copies (or summaries or minutes in the case of oral communications, interactions, and reports) of all communications and interactions with, and reports to any applicable regulatory authority that relate to or could reasonably be expected to otherwise impact the Products and/or Services. (e) After any of the foregoing interactions, communications, or reports, Company shall notify Iovance and provide Iovance with copies (or summaries or minutes in the case of oral communications, reports, and interactions) of any further communications with or received from, or reports to such regulatory agency relating to the subject matter of the response to the extent such response relates to the Products and/or Services or could reasonably be expected to impact the Products and/or Services. Any further interactions and communications with, or reports to the applicable regulatory authority to the extent related to the Products and/or Services or could reasonably be expected to impact the Products and/or Services shall be governed by the terms of this Section 10.2.2 (including with respect to Iovance’s right to comment on and/or approve the interaction, communication, or report prior to any submission to a regulatory authority), applied mutatis mutandis. Company shall further keep Iovance promptly and fully informed of the steps taken by Company to resolve any outstanding issues with such regulatory agency and the anticipated timetable of resolution of such issues to the extent that they do not involve interactions and communications with, or reports to an applicable regulatory authority, which shall be subject to Iovance’s prior written approval to the extent such steps relate to the Products and/or Services, or which shall be subject to Iovance’s comment prior to implementation to the extent such steps could reasonably be expected to impact the Products and/or Services. In the former case, Company shall incorporate all of Iovance’s comments in good faith. In the latter case, Company will consider all of Iovance’s comments in good faith.

Interactions. (a) To the extent permitted by the relevant regulatory authority and by Law, Iovance LBIO shall be solely and exclusively responsible for all interactions and communications with and reports to the applicable regulatory authorities related to the Products and/or Services. (b) To the extent that the relevant regulatory authority will not or is not permitted by Law to directly interact with IovanceLBIO, copies of (or summaries in the case of oral communications, interactions, and reports) all interactions and communications with, and reports to, the applicable regulatory authority related to the Products and/or Services (whether written or oral) shall be submitted to Iovance LBIO by Company, in reasonable and sufficient time prior to submission to the applicable regulatory authority, for IovanceLBIO’s prior review and approval. For clarity, this may include Iovance LBIO providing on-site, but indirect, assistance to Company in connection with a regulatory interaction. Company will incorporate all of IovanceLBIO’s comments in good faith that are factually accurate and not contrary to Company’s responsibility under Law. (c) Company shall be responsible for all interactions and communications with and reports to the applicable regulatory authorities that are not related to the Products and/or Services, but that could reasonably be expected to impact the Products and/or Services. Company, however, shall provide copies of all communications, interactions, and reports proposed for submission (or summaries in the case of oral communications, interactions, and reports) that could reasonably be expected to impact the Product and/or Services, to IovanceLBIO, in reasonable and sufficient time prior to submission to the applicable regulatory authority, for IovanceLBIO’s prior comment. Company will consider all of IovanceLBIO’s comments in good faith. (d) In addition to the requirements of the foregoing subsections (b) and (c), Company shall furnish Iovance LBIO with final copies (or summaries or minutes in the case of oral communications, interactions, and reports) of all communications and interactions with, and reports to any applicable regulatory authority that relate to or could reasonably be expected to otherwise impact the Products and/or Services. (e) After any of the foregoing interactions, communications, or reports, Company shall notify Iovance LBIO and provide Iovance LBIO with copies (or summaries or minutes in the case of oral communications, reports, and interactions) of any further communications with or received from, or reports to such regulatory agency relating to the subject matter of the response to the extent such response relates to the Products and/or Services or could reasonably be expected to impact the Products and/or Services. Any further interactions and communications with, or reports to the applicable regulatory authority to the extent related to the Products and/or Services or could reasonably be expected to impact the Products and/or Services shall be governed by the terms of this Section 10.2.2 (including with respect to IovanceLBIO’s right to comment on and/or approve the interaction, communication, or report prior to any submission to a regulatory authority), applied mutatis mutandis. Company shall further keep Iovance LBIO promptly and fully informed of the steps taken by Company to resolve any outstanding issues with such regulatory agency and the anticipated timetable of resolution of such issues to the extent that they do not involve interactions and communications with, or reports to an applicable regulatory authority, which shall be subject to IovanceLBIO’s prior written approval to the extent such steps relate to the Products and/or Services, or which shall be subject to IovanceLBIO’s comment prior to implementation to the extent such steps could reasonably be expected to impact the Products and/or Services. In the former case, Company shall incorporate all of IovanceLBIO’s comments in good faith. In the latter case, Company will consider all of IovanceLBIO’s comments in good faith.