Common use of Regulatory Submissions Clause in Contracts

Regulatory Submissions. At all times, the Party preparing, filing, and/or maintaining applications for Governmental Approval, or any supplements thereto, in the Territory shall (a) inform the other Party of all material communications with the relevant Competent Authority(ies) in the Territory concerning the Licensed Product and (b) provide copies of proposed material submissions to the relevant Competent Authority(ies) in the Territory concerning the Licensed Product to the other Party prior to their submission to such Competent Authority. To the extent either Party receives material written or material oral communication from the FDA relating to any Governmental Approval or related process in the Territory with respect to any Licensed Product, the Party receiving such communication shall promptly notify the other Party and provide a copy of any written communication as soon as reasonably practicable. In addition, prior to Supplement Approval, Collegium will have a reasonable right, but not the obligation, to participate in or review and comment on, as applicable, any and all filings, meetings, responses, submissions, communications and other interactions between BDSI or any of its Affiliates and the FDA in regards to the Supplement and/or the Current Product generally, including in regards to the Supplement Approval, provided that Collegium shall not (and shall ensure that its representatives participating in any such meetings with the FDA do not) make any statements or take any actions in connection therewith that it knows or reasonably should know will have a material likelihood of adversely affecting BDSI’s efforts to obtain Supplemental Approval or the regulatory status of the Current Product. Except as expressly set forth in the Mfg Transfer Plan, each Party will be responsible for its own costs and expenses incurred in connection with its performance of the activities set forth in this Section 2.03.

Regulatory Submissions. At all timesSubject to Section 5.5, the Party preparing, filing, and/or maintaining applications for Governmental Approval, or any supplements thereto, Company and ARS shall coordinate submission of Regulatory Filings and Regulatory Data to Regulatory Authorities in the Company Territory for obtaining and maintaining Regulatory Approvals for the Commercialization of Products in the Field in the Company Territory. With respect to each Party’s responsibilities regarding Regulatory Filings in the Company Territory for obtaining and maintaining Regulatory Approval for the Commercialization of Products in the Field in the Company Territory, subject to Section 5.5: (i) Company shall fully disclose to ARS all such Regulatory Data that has been incorporated into or relied upon in any such Regulatory Filing. (aii) inform Company shall promptly provide ARS with copies of any material communications (other than routine correspondence, administrative documents and excluding documents related to pricing and reimbursement approval) with a Regulatory Authority in the other Party Company Territory relating to Commercialization of any Composition or Product in the Field. If any such materials are not in the English language, Company shall provide ARS with an English summary at the time of provision, and a true, complete, accurate and certified English translation thereof as soon as practicable. (iii) Company shall provide ARS for review and comment copies in English of all material communications with submissions related to the relevant Competent Authority(ies) Commercialization of Products in the Field to be submitted to a Regulatory Authority in the Company Territory concerning the Licensed Product (other than routine correspondence, administrative documents and (bexcluding documents related to pricing and reimbursement approval) provide copies of proposed material submissions prior to the relevant Competent Authority(iessubmission to allow sufficient time for review, and whenever reasonably possible, at least [***] in advance of their intended date of submission (for clarity, in each case, subject to the timelines set forth in Section 4.2(g)(ii) and Section 4.2(h)). Notwithstanding the foregoing, Company shall not be required to provide ARS local (e.g., country-specific) versions of marketing materials, educational materials or Product labels, so long as such local versions are consistent with a master version of such materials that has been provided pursuant to Section 4.2(e)(ii) or this Section 4.2(e)(iii). (iv) Each Party will provide any comments in due course in order to not delay regulatory activities in the Territory concerning the Licensed Product to Company Territory. Each Party shall in good faith take into account the other Party prior to their submission to such Competent Authority. To the extent either Party receives Party’s comments. (v) Company shall not unreasonably withhold, condition or delay adopting ARS’s comments [***]. (vi) Within [***] after a material written or material oral communication from the FDA relating Regulatory Filing is submitted to any Governmental Approval or related process Regulatory Authority in the Territory Company Territory, Company shall, and shall require its Affiliates and Sublicensees to, provide ARS with an electronic copy thereof. For avoidance of doubt, regulatory submissions also includes communications and submissions with respect to labeling for a Product in the Company Territory. (vii) In order to ensure appropriate coordination of submissions in the Company Territory and outside the Company Territory, within [***] after a material Regulatory Filing for a Product in the Field is submitted to any Licensed ProductRegulatory Authority in the United States, the Party receiving such communication ARS shall, and shall promptly notify the other Party and provide a copy of any written communication as soon as reasonably practicable. In addition, prior to Supplement Approval, Collegium will have a reasonable right, but not the obligation, to participate in or review and comment on, as applicable, any and all filings, meetings, responses, submissions, communications and other interactions between BDSI or any of require its Affiliates and the FDA in regards to the Supplement and/or the Current Product generallyto, including in regards to the Supplement Approval, provided that Collegium shall not (and shall ensure that its representatives participating in any such meetings provide Company with the FDA do not) make any statements or take any actions in connection therewith that it knows or reasonably should know will have a material likelihood of adversely affecting BDSI’s efforts to obtain Supplemental Approval or the regulatory status of the Current Product. Except as expressly set forth in the Mfg Transfer Plan, each Party will be responsible for its own costs and expenses incurred in connection with its performance of the activities set forth in this Section 2.03an electronic copy thereof [***].

Regulatory Submissions. At all times, The Parties acknowledge that the Party preparing, filing, and/or maintaining applications Products have not been reviewed or approved for Governmental sale or use for any purpose by any governmental or regulatory body. Advancis shall prepare any required application(s) for Regulatory Approval, or any supplements thereto, . Advancis shall own in the Territory shall their entirety (a) inform all clinical data and reports related to Product Studies including clinical trials for the other Party of all material communications with the relevant Competent Authority(ies) in the Territory concerning the Licensed Product Products and (b) all NDAs and other Regulatory Approvals for Products. Advancis shall [***] to inform Par of all communications with the FDA and to provide copies of proposed material FDA submissions to the relevant Competent Authority(ies) in the Territory concerning the Licensed Product to the other Party Development and Manufacturing Subcommittee prior to their submission to such Competent AuthorityFDA. The Parties shall cooperate in good faith with respect to, and Advancis shall [***] to enable representatives of Par to attend all formal meetings with the FDA relating to regulatory approval of the Products. The Parties shall cooperate in good faith with [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. respect to the conduct of any inspections by any regulatory authority of a Party’s site and facilities related to the Products. To the extent either Party receives material written or material oral communication from the FDA or any other regulatory authority relating to any Governmental Regulatory Approval or related process in the Territory with respect to any Licensed Productthe Products, the Party receiving such communication shall promptly notify the other Party and provide a copy of any written communication as soon as reasonably practicable. In addition, prior to Supplement Approval, Collegium will have a reasonable right, but not the obligation, to participate in or review and comment on, as applicable, any and all filings, meetings, responses, submissions, communications and other interactions between BDSI or any of its Affiliates and the FDA in regards to the Supplement and/or the Current Product generally, including in regards to the Supplement Approval, provided that Collegium shall not (and shall ensure that its representatives participating in any such meetings with the FDA do not) make any statements or take any actions in connection therewith that it knows or reasonably should know will have a material likelihood of adversely affecting BDSI’s efforts to obtain Supplemental Approval or the regulatory status of the Current Product. Except as expressly set forth in the Mfg Transfer Plan, each Party will be responsible for its own costs and expenses incurred in connection with its performance of the activities set forth in this Section 2.03.

Regulatory Submissions. At all times, The Parties acknowledge that the Party preparing, filing, and/or maintaining applications Products have not been reviewed or approved for Governmental sale or use for any purpose by any governmental or regulatory body. Advancis shall prepare any required application(s) for Regulatory Approval, or any supplements thereto, . Advancis shall own in the Territory shall their entirety (a) inform all clinical data and reports related to Product Studies including clinical trials for the other Party of all material communications with the relevant Competent Authority(ies) in the Territory concerning the Licensed Product Products and (b) all NDAs and other Regulatory Approvals for Products. Advancis shall [***] to inform Par of all communications with the FDA and to provide copies of proposed material FDA submissions to the relevant Competent Authority(ies) in the Territory concerning the Licensed Product to the other Party Development and Manufacturing Subcommittee prior to their submission to such Competent AuthorityFDA. The Parties shall cooperate in good faith with respect to, and Advancis shall [***] to enable representatives of Par to attend all formal meetings with the FDA relating to regulatory approval of the Products. The Parties shall cooperate in good faith with [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 16 -------------------------------------------------------------------------------- respect to the conduct of any inspections by any regulatory authority of a Party's site and facilities related to the Products. To the extent either Party receives material written or material oral communication from the FDA or any other regulatory authority relating to any Governmental Regulatory Approval or related process in the Territory with respect to any Licensed Productthe Products, the Party receiving such communication shall promptly notify the other Party and provide a copy of any written communication as soon as reasonably practicable. In addition, prior to Supplement Approval, Collegium will have a reasonable right, but not the obligation, to participate in or review and comment on, as applicable, any and all filings, meetings, responses, submissions, communications and other interactions between BDSI or any of its Affiliates and the FDA in regards to the Supplement and/or the Current Product generally, including in regards to the Supplement Approval, provided that Collegium shall not (and shall ensure that its representatives participating in any such meetings with the FDA do not) make any statements or take any actions in connection therewith that it knows or reasonably should know will have a material likelihood of adversely affecting BDSI’s efforts to obtain Supplemental Approval or the regulatory status of the Current Product. Except as expressly set forth in the Mfg Transfer Plan, each Party will be responsible for its own costs and expenses incurred in connection with its performance of the activities set forth in this Section 2.03.