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 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.

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 Unless otherwise required by relevant Regulatory Agencies: (i) Subject to Subparagraph (iii) below, BMS shall be the Lead Regulatory Party for all Development activities under the Development Plan, and it shall own all corresponding Regulatory Filings, including INDs. (ii) Zymo shall provide to BMS copies of all Regulatory Filings described in Section 4.2.1(b). (iii) Zymo shall be the Lead Regulatory Party with respect to [ * ], and it shall own all corresponding Regulatory Filings, including INDs, until at least the time of [ * ] clinical trial; provided that, following the earlier of (A) [ * ] and (B) the completion of the [ * ], the JDC shall agree to a plan whereby Zymo shall assign to BMS all Regulatory Filings described in Subparagraph (ii) and this Subparagraph (iii), after which Zymo shall no longer be the Lead Regulatory Party. The parties agree that the target date for such assignment shall be the [ * ], however, the parties agree that the timely [ * ] is of a high priority and the JDC may delay such assignment if necessary to expedite the [ * ]. (b) For each Licensed Product Developed or Commercialized under this Agreement, the Lead Regulatory Party shall promptly provide the other Party party with, as applicable, (i) copies of all material communications Regulatory Filings in the Joint Development Territory; and (ii) reasonable advance notice (to the extent practicable) of scheduled meetings with the FDA or other relevant Regulatory Agency in the Joint Development Territory that pertain to such Licensed Product. Consistent with Applicable Laws, the Lead Regulatory Party shall afford representatives of the other party a reasonable opportunity to comment on such Regulatory Filings, and shall reasonably consider such comments, and, to the extent not prohibited by Applicable Law, shall afford medical, scientific and/or regulatory representatives of the other party an opportunity, at such other party’s option, to attend such meetings with the relevant Competent Authority(ies) Regulatory Agency in the Territory concerning the Licensed Product and (b) provide copies of proposed material submissions Joint Development Territory, to the relevant Competent Authority(ies) in extent reasonably practicable under 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 practicablecircumstances. In addition, if Zymo receives written notice from a Regulatory Agency during the time it is the Lead Regulatory Party that it will become subject to an inspection or audit by such Regulatory Agency with respect to a Licensed Product, Zymo shall notify BMS and shall afford BMS’ regulatory representatives an opportunity, at BMS’ option, to attend such inspection or audit pertaining to such Licensed Product, to the extent reasonably practicable under the circumstances. During the time that Zymo is conducting any clinical trials with a Licensed Product pursuant to the Joint Development Plan, Zymo shall work with BMS to ensure compliance with the clinical trial disclosure obligations as described in the Safety Data Exchange Agreement. (c) The Lead Regulatory Party shall not transfer title or otherwise attempt in any manner to dispose of any Regulatory Filings in the Territory or otherwise impair the other party’s rights in such filings or subsequent Regulatory Approvals. (d) Prior to a Conversion, the content and language of the proposed package insert, and all changes thereto, including all safety-related package insert changes for Licensed Products in the USA, shall be reviewed and approved by the JDC 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 submission to the Supplement and/or the Current Product generally, including in regards to the Supplement Approval, provided that Collegium applicable Regulatory Agency. BMS 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 all content and expenses incurred in connection with its performance language of the activities set forth proposed package insert, and all changes thereto, including all safety-related package insert changes for Licensed Products in the rest of the Territory. (e) If the arrangement described in this Section 2.034.4.2 results in significant logistical difficulties or otherwise causes a material delay, the JEC shall discuss alternatives.