Common use of Conduct of Clinical Trials Clause in Contracts

Conduct of Clinical Trials. 5.3.1 Novartis may conduct the activities set forth in any development plan with respect to a Dose Ranging Clinical Trial, a Drug-Drug Interaction Study or an HCV Combination Clinical Trial involving an Idenix HCV Product described in Section 5.2 (and any ancillary activities reasonably related thereto), and Novartis shall be solely responsible for such activities and all costs and expenses associated therewith; provided, that (a) if permitted by applicable Law, at Novartis’ election, a separate IND may be filed by Novartis to conduct such study(ies) or if not so permitted or Novartis does not so elect, Novartis shall be entitled to rely on and reference any IND held by Idenix or its Affiliates with respect to the applicable Idenix HCV Product and only for the purposes of conducting the relevant study(ies); (b) without limiting the foregoing clause (a), Idenix hereby grants Novartis a right of reference to its regulatory filings made in connection with the applicable Idenix HCV Product, solely for purposes of Novartis’ regulatory filings in connection with such study(ies) and the Development, Manufacture and/or Commercialization of any Novartis HCV Product which is the subject of such study(ies), and Idenix agrees to use Commercially Reasonable Efforts to assist Novartis, at Novartis’ reasonable request and expense, with respect to such regulatory filings; (c) Idenix, at its sole expense, shall provide Novartis with analytical support in any Drug-Drug Interaction Study(ies) of the relevant Idenix HCV Product with the relevant Novartis HCV Product; (d) Idenix shall provide Novartis with copies of the investigator brochure for such Idenix HCV Product; (e) Idenix shall promptly, on request, provide Novartis with copies of all correspondence with Regulatory Authorities (other than (i) commercially sensitive information, (ii) trade secrets and (iii) other information which is not applicable or relevant to the use of the relevant Idenix HCV Product) relating to such Idenix HCV Product; (f) Idenix shall promptly, upon request, provide Novartis with relevant data from prior clinical trials involving the relevant Idenix HCV Product (other than (i) commercially sensitive information, (ii) trade secrets and (iii) other information which is not applicable or relevant to the use of such Idenix HCV Product), including reports sent to any data and safety monitoring board; (g) Idenix shall otherwise use Commercially Reasonable Efforts to assist Novartis, at Novartis’ reasonable request and expense, with respect to such study(ies); and (h) Novartis shall promptly (within no more than [**] days) after the completion of each material activity set forth in the applicable development plan or the completion of any pre-clinical study conducted under Section 4.1.1, share with Idenix the material results of such activity or study. 5.3.2 Notwithstanding anything herein to the contrary, in the event that any pre-clinical study(ies), Dose Ranging Clinical Trials or Drug-Drug Interaction Study conducted by Novartis pursuant to Section 4.1.1 above or any HCV Combination Clinical Trial(s) produces unexpected negative results, Novartis shall share such results with Idenix immediately. 5.3.3 Neither Party may make any submission of any clinical data of the other Party to any Regulatory Authority, any data and safety monitoring board or any clinical investigators, without, to the extent possible, providing prior notice of such submission to the other Party and offering to include such other Party in the relevant interactions with such Regulatory Authority, data and safety monitoring board or clinical investigator, and each Party shall be responsible for any submissions of its clinical data as may be required by applicable law.

Conduct of Clinical Trials. 5.3.1 Novartis may Under the auspices of, and subject to review and approval by, the Joint Development Committee, the Parties shall have the following responsibilities relating to the Clinical Trials (as defined below): (a) BMS shall be responsible for the preparation of all protocols and the conduct of all studies for Phase III and Phase IV commenced after the activities Effective Date and all other studies proposed to be conducted or required to be conducted by any regulatory authority in any country in the Territory in connection with the registration process for the Product in accordance with the Clinical Plan set forth in any development plan with respect as ANNEX C attached hereto, as amended from time to a Dose Ranging time by the Joint Development Committee (the "Clinical TrialPlan") (all of the foregoing studies, a Drug-Drug Interaction Study or an HCV Combination collectively, the "Clinical Trial involving an Idenix HCV Product described in Section 5.2 (and any ancillary activities reasonably related theretoTrials"), and Novartis shall be solely responsible including, without limitation, payment for such activities and all costs and expenses associated therewith; providedwith all of the foregoing, that except as provided in Section 3.3(b). BMS shall (aabsent reasonable cause for delay, as determined by the Joint Development Committee) if permitted by applicable Lawcommence each of the Clinical Trials on or before the scheduled commencement date for such Clinical Trial set forth on ANNEX C attached hereto. BMS shall submit all protocols for Clinical Trials to Sano for its approval, at Novartis’ electionwhich shall not be unreasonably withheld. If Sano has any objections to any protocol submitted, a separate IND may be filed by Novartis it shall notify BMS of such objections within 15 days after its receipt of such protocol and the Joint Development Committee shall meet immediately to conduct such study(ies) or if not so permitted or Novartis resolve any disagreement within the following 15 day period. If Sano does not so electnotify BMS of any objections to such protocol within such 15 day period, Novartis Sano shall be entitled deemed to rely on and reference any IND held by Idenix or its Affiliates with respect have not objected to the applicable Idenix HCV Product and only for the purposes of conducting the relevant study(ies); such protocol. (b) without limiting the foregoing clause (a), Idenix hereby grants Novartis a right of reference Sano shall provide to its regulatory filings made in connection with the applicable Idenix HCV Product, solely for purposes of Novartis’ regulatory filings in connection with such study(ies) and the Development, Manufacture and/or Commercialization of any Novartis HCV Product which is the subject of such study(ies), and Idenix agrees to use Commercially Reasonable Efforts to assist NovartisBMS, at Novartis’ reasonable request a price of [*****] per patch, all clinical supplies of Finished Product and expense, with respect matching placebos reasonably requested by BMS for the conduct of all Clinical Trials. Sano shall use its best efforts to supply such regulatory filings; requested amounts. (c) IdenixBMS shall provide to Sano, at its sole expense, shall provide Novartis with analytical support in any Drug-Drug Interaction Study(ies) of the relevant Idenix HCV Product with the relevant Novartis HCV Product; (d) Idenix shall provide Novartis with copies of the investigator brochure for such Idenix HCV Product; (e) Idenix shall promptly, on request, provide Novartis with copies of all correspondence with Regulatory Authorities (other than (i) commercially sensitive information, (ii) trade secrets and (iii) other information which is not applicable or relevant to the use of the relevant Idenix HCV Product) relating to such Idenix HCV Product; (f) Idenix shall promptly, upon request, provide Novartis with relevant data from prior clinical trials involving the relevant Idenix HCV Product (other than (i) commercially sensitive information, (ii) trade secrets and (iii) other information which is not applicable or relevant to the use of such Idenix HCV Product), including reports sent to any data and safety monitoring board; (g) Idenix shall otherwise use Commercially Reasonable Efforts to assist Novartis, at Novartis’ reasonable request and expense, with respect to such study(ies); and (h) Novartis shall promptly (within no more than [**] days) after the completion ***], all supplies of each material activity set forth Bulk Materials reasonably required by Sano in the applicable development plan or the completion order for Sano to provide clinical supplies of any pre-clinical study conducted under Section 4.1.1, share with Idenix the material results of such activity or study. 5.3.2 Notwithstanding anything herein Finished Product to the contrary, in the event that any pre-clinical study(ies), Dose Ranging Clinical Trials or Drug-Drug Interaction Study conducted by Novartis BMS pursuant to Section 4.1.1 above or any HCV Combination 3.3(b). In addition, BMS shall provide to Sano, no later than the end of each calendar quarter during the period that the Clinical Trial(sTrials are being conducted, a non-binding, good faith rolling forecast of estimated quantities (by dosage size) produces unexpected negative resultsand anticipated delivery schedules for clinical supplies of Finished Product and matching placebos, Novartis shall share for the two calendar quarters commencing at least six months after the date of each such results with Idenix immediately. 5.3.3 Neither Party may make any submission of any clinical data of the other Party to any Regulatory Authority, any data and safety monitoring board or any clinical investigators, without, to the extent possible, providing prior notice of such submission to the other Party and offering to include such other Party in the relevant interactions with such Regulatory Authority, data and safety monitoring board or clinical investigator, and each Party forecast. Such forecasts shall be responsible for any submissions of its clinical data as may be required by applicable lawrevised and updated quarterly.

Conduct of Clinical Trials. 5.3.1 Novartis may Use of Clinical Trial Data. In the course of Acutus conducting Clinical Trials as required under this ARTICLE 4 for the purpose of obtaining Marketing Authorization Approval for the First FS US Product and the First FS EU Product, and for the purpose of enabling the BIO Parties to seek Marketing Authorization Approval for the External Products in the US, Acutus shall incorporate and use the BIO Parties’ External Products together with the FS Product Line in the conduct the activities of such Clinical Trials, as further set forth in the Development Plan. The BIO Parties shall supply Acutus with the External Products for the foregoing purpose free of charge to Acutus, and Acutus shall provide the BIO Parties with the needed quantities of the External Products well in advance to any development plan with respect to requested delivery date. For clarity, the Parties assume that for each of the three (3) External Products approximately twenty- five (25) units are needed. Acutus shall be responsible for the costs of supplying the FS Product Line for the foregoing purpose. Acutus shall generate a Dose Ranging Clinical Trial, a Drug-Drug Interaction Study or an HCV Combination Clinical Trial involving an Idenix HCV Data package from such Clinical Trials that includes data pertaining to administration of the External Products with the FS Product described in Section 5.2 (and any ancillary activities reasonably related thereto)Line, and Novartis shall be solely responsible for such activities and all costs and expenses associated therewith; provided, that (a) if permitted by applicable Law, at Novartis’ election, a separate IND may be filed by Novartis to conduct such study(ies) or if not so permitted or Novartis does not so elect, Novartis shall be entitled to rely on and reference any IND held by Idenix or its Affiliates with respect to the applicable Idenix HCV Product and only for the purposes of conducting the relevant study(ies); (b) without limiting the foregoing clause (a), Idenix hereby grants Novartis a right of reference to its regulatory filings made in connection with the applicable Idenix HCV Product, solely for purposes of Novartis’ regulatory filings in connection with such study(ies) and the Development, Manufacture and/or Commercialization of any Novartis HCV Product which is the subject of such study(ies), and Idenix agrees to use Commercially Reasonable Efforts to assist Novartisensure that such Clinical Trial Data package as well as any related information submitted (including, if applicable, pre-clinical data) and testing (and results thereof) undertaken in support of the Regulatory Filings made hereunder are sufficient to enable the BIO Parties to seek Marketing Authorization Approval for the External Products in at Novartis’ reasonable request least the US. Reasonably in advance of the First Commercial Sale of the First FS US Product or the First FS EU Product, whichever is sooner, Acutus shall create a Clinical Trial register. The BIO Parties shall have the right to publish the results and/or summaries of results of all Clinical Trials, observational studies, and expense, other studies such as meta analyses conducted by the Parties with respect to such regulatory filings; (c) Idenixthe FS Product Line in the Field in the Territory under this Agreement, at its sole expense, shall provide Novartis with analytical support in any Drug-Drug Interaction Study(ies) of including the relevant Idenix HCV Product with the relevant Novartis HCV Product; (d) Idenix shall provide Novartis with copies of the investigator brochure for such Idenix HCV Product; (e) Idenix shall promptly, on request, provide Novartis with copies protocols of all correspondence with Regulatory Authorities (other than (i) commercially sensitive informationsuch Clinical Trials, (ii) trade secrets and (iii) other information after obtaining the prior written approval of Acutus, which is approval shall not applicable be unreasonably conditioned, withheld, or relevant to the use of the relevant Idenix HCV Product) relating to such Idenix HCV Product; (f) Idenix shall promptly, upon request, provide Novartis with relevant data from prior clinical trials involving the relevant Idenix HCV Product (other than (i) commercially sensitive information, (ii) trade secrets and (iii) other information which is not applicable or relevant to the use of such Idenix HCV Product), including reports sent to any data and safety monitoring board; (g) Idenix shall otherwise use Commercially Reasonable Efforts to assist Novartis, at Novartis’ reasonable request and expense, with respect to such study(ies); and (h) Novartis shall promptly (within no more than [**] days) after the completion of each material activity set forth in the applicable development plan or the completion of any pre-clinical study conducted under Section 4.1.1, share with Idenix the material results of such activity or study. 5.3.2 Notwithstanding anything herein to the contrary, in the event that any pre-clinical study(ies), Dose Ranging Clinical Trials or Drug-Drug Interaction Study conducted by Novartis pursuant to Section 4.1.1 above or any HCV Combination Clinical Trial(s) produces unexpected negative results, Novartis shall share such results with Idenix immediately. 5.3.3 Neither Party may make any submission of any clinical data of the other Party to any Regulatory Authority, any data and safety monitoring board or any clinical investigators, without, to the extent possible, providing prior notice of such submission to the other Party and offering to include such other Party in the relevant interactions with such Regulatory Authority, data and safety monitoring board or clinical investigator, and each Party delayed. Acutus shall be responsible for hosting and maintaining such Clinical Trial register at its sole cost and expense and shall own all data collected and hosted on the Clinical Trial register. The BIO Parties shall reasonably cooperate with Acutus to collect all applicable Clinical Trial results and/or summaries thereof and Clinical Trial protocols for publishing on the Clinical Trial register. Notwithstanding the foregoing, each Party’s rights to use any submissions data provided under this Section 4.4 shall be limited to uses in accordance with the licenses and rights granted to each of its clinical data as may be required by applicable lawthe Parties under ARTICLE 2.