Common use of Regulatory Assistance Clause in Contracts

Regulatory Assistance. Aerogen shall be responsible for creating and maintaining design history files for the Device and for obtaining and maintaining all applicable regulatory and safety certifications for the Device including those set forth in the Product Requirements (e.g., CE Xxxx) for the Device at Dance’s cost. In the event that Aerogen uses the Device outside of the Field, Aerogen will be responsible for the cost of maintaining regulatory and safety certifications from the Device for so long as it continues to use the Device outside of the Field. In addition, Aerogen shall, at Dance’s expense, cooperate with Dance in providing all information (including Information) and reasonable assistance, and taking all actions reasonably requested by Dance, that are necessary or desirable to enable Dance to comply with its obligations under this Agreement including those obligations relating to obtaining Regulatory Approvals for the Drug Device Combination in the Territory. Without limiting the generality of the foregoing, Aerogen shall (i) provide Dance with copies of correspondence received from and to be provided to Regulatory Authorities concerning the Device, including XX xxxxx and manufacturing inspections; (ii) consider in good faith all reasonable suggestions and comments provided by Dance with respect to such correspondence and other communications with Regulatory Authorities; and (iv) not voluntarily take any action or fail to take any action which would be reasonable likely to have an adverse effect on the development of the Drug Device Combination or Dance’s ability to obtain Regulatory Approvals for the Drug Device Combination, including with respect to the milestones and timelines set forth in the Device Development Plan. In addition to the foregoing, Aerogen shall (a) assist Dance with and accompany Dance in its interactions with Regulatory Authorities as requested by Dance and at Dance’s expense and (b) obtain and maintain all applicable regulatory and safety certifications for the Device including those set forth in the Product Requirements. Dance shall provide Aerogen with copies of all correspondence received from and to be provided to Regulatory Authorities concerning the Device and access to all regulatory documentation relating to the Drug Device Combination if so requested.

Regulatory Assistance. Aerogen All Regulatory Approvals with respect to Licensed Products in the Field in the Territory shall be in the name of Licensee or its Sublicensee. Licensee shall have exclusive control and authority over, and responsibility for, the regulatory strategies relating to the development and commercialization of all Licensed Products in the Field in the Territory, including, without limitation: (a) the preparation of all documents submitted to Regulatory Authorities and the filing of all submissions relating to Regulatory Approval of Licensed Products in the Field in the Territory (including each IND); and (b) all regulatory actions, communications and meetings with any governmental authority with respect to any Licensed Product in the Field in the Territory. Upon the request of Licensee, SGI shall use Commercially Reasonable Efforts to provide to Licensee on a timely basis such information as may be required or useful for the foregoing regulatory activities, and otherwise provide reasonable assistance to Licensee in complying with all regulatory obligations, including certifications and product approvals. Licensee shall be responsible for creating interfacing, corresponding and maintaining design history files for the Device and for obtaining and maintaining meeting with all applicable regulatory and safety certifications for the Device including those set forth Regulatory Authorities with respect to any Licensed Product in the Field in the Territory. Except as required [***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. by applicable law or in response to a request of Licensee, SGI shall not communicate directly with the FDA or any other governmental authority relating to any Licensed Product Requirements (e.g., CE Xxxx) for without the Device at Dance’s costprior written consent of Licensee. In the event that Aerogen uses the Device outside of the Fieldfurtherance thereof, Aerogen will be responsible for the cost of maintaining regulatory and safety certifications from the Device for so long as it continues SGI shall refer all FDA communications relating to use the Device outside of the Fieldany Licensed Product to Licensee. In addition, Aerogen shall, at Dance’s expense, SGI shall cooperate with Dance in providing Licensee to provide all information (including Information) reasonable assistance and reasonable assistance, and taking take all actions reasonably requested by Dance, Licensee that are necessary or desirable to enable Dance to comply with its obligations under this Agreement including those obligations any law in the Territory applicable to any Licensed Product in the Field. SGI hereby [***] required to support the filing of all submissions relating to obtaining Regulatory Approval of a Licensed Product in the Field in the Territory, solely for purposes of allowing Licensee to obtain and maintain submissions relating to Regulatory Approvals for Licensed Products in the Drug Device Combination Field in the Territory. Without limiting the generality In furtherance of the foregoing, Aerogen shall (i) provide Dance with copies SGI shall, promptly upon request of correspondence received from Licensee, deliver a letter to the FDA, in form and substance reasonably acceptable to Licensee, authorizing Licensee to reference the drug master files of SGI. SGI will inform Licensee of all changes to drug master files that will or might be provided to Regulatory Authorities concerning the Device, including XX xxxxx and manufacturing inspections; (ii) consider in good faith all reasonable suggestions and comments provided by Dance with respect to such correspondence and other communications with Regulatory Authorities; and (iv) not voluntarily take any action or fail to take any action which would be reasonable reasonably likely to have affect the regulatory filings of Licensee. Licensee shall reimburse SGI for any out of pocket costs incurred by SGI in providing any such information plus an adverse effect on the development of the Drug Device Combination or Danceamount equal to SGI’s ability to obtain Regulatory Approvals then current Personnel Fee for the Drug Device CombinationSGI’s personnel engaged in such activities, including with respect to the milestones and timelines as set forth in the Device Development Plan. In addition to the foregoing, Aerogen shall (a) assist Dance with and accompany Dance in its interactions with Regulatory Authorities as requested by Dance and at Dance’s expense and (b) obtain and maintain all applicable regulatory and safety certifications for the Device including those set forth in the Product Requirements. Dance shall provide Aerogen with copies of all correspondence received from and to be provided to Regulatory Authorities concerning the Device and access to all regulatory documentation relating to the Drug Device Combination if so requestedSection 6.1.2.

Regulatory Assistance. Aerogen All Regulatory Approvals with respect to Licensed Products in the Field in the Territory shall be in the name of Licensee or its Sublicensee. Licensee shall have exclusive control and authority over, and responsibility for, the regulatory strategies relating to the development and commercialization of all Licensed Products in the Field in the Territory, including, without limitation: (a) the preparation of all documents submitted to Regulatory Authorities and the filing of all submissions relating to Regulatory Approval of Licensed Products in the Field in the Territory (including each IND); and (b) all regulatory actions, communications and meetings with any governmental authority with respect to any Licensed Product in the Field in the Territory. Upon the request of Licensee, SGI shall use Commercially Reasonable Efforts to provide to Licensee on a timely basis such information as may be required or useful for the foregoing regulatory activities, and otherwise provide reasonable assistance to Licensee in complying with all regulatory obligations, including certifications and product approvals. Licensee shall be responsible for creating interfacing, corresponding and maintaining design history files for the Device and for obtaining and maintaining meeting with all applicable regulatory and safety certifications for the Device including those set forth Regulatory Authorities with respect to any Licensed Product in the Field in the Territory. Except as required by applicable law or in response to a request of Licensee, SGI shall not communicate directly with the FDA or any other governmental authority relating to any Licensed Product Requirements (e.g., CE Xxxx) for without the Device at Dance’s costprior written consent of Licensee. In the event that Aerogen uses the Device outside of the Fieldfurtherance thereof, Aerogen will be responsible for the cost of maintaining regulatory and safety certifications from the Device for so long as it continues SGI shall refer all FDA communications relating to use the Device outside of the Fieldany Licensed Product to Licensee. In addition, Aerogen shall, at Dance’s expense, SGI shall cooperate with Dance in providing Licensee to provide all information (including Information) reasonable assistance and reasonable assistance, and taking take all actions reasonably requested by Dance, Licensee that are necessary or desirable to enable Dance to comply with its obligations under this Agreement including those obligations any law in the Territory applicable to any Licensed Product in the Field. SGI hereby [*] required to support the filing of all submissions relating to obtaining Regulatory Approval of a Licensed Product in the Field in the Territory, solely for purposes of allowing Licensee to obtain and maintain submissions relating to Regulatory Approvals for Licensed Products in the Drug Device Combination Field in the Territory. Without limiting the generality In furtherance of the foregoing, Aerogen shall (i) provide Dance with copies SGI shall, promptly upon request of correspondence received from Licensee, deliver a letter to the FDA, in form and substance reasonably acceptable to Licensee, authorizing Licensee to reference the drug master files of SGI. SGI will inform Licensee of all changes to drug master files that will or might be provided to Regulatory Authorities concerning the Device, including XX xxxxx and manufacturing inspections; (ii) consider in good faith all reasonable suggestions and comments provided by Dance with respect to such correspondence and other communications with Regulatory Authorities; and (iv) not voluntarily take any action or fail to take any action which would be reasonable reasonably likely to have affect the regulatory filings of Licensee. Licensee shall reimburse SGI for any out of pocket costs incurred by SGI in providing any such information plus an adverse effect on the development of the Drug Device Combination or Danceamount equal to SGI’s ability to obtain Regulatory Approvals then current Personnel Fee for the Drug Device CombinationSGI’s personnel engaged in such activities, including with respect to the milestones and timelines as set forth in the Device Development Plan. In addition to the foregoing, Aerogen shall (a) assist Dance with and accompany Dance in its interactions with Regulatory Authorities as requested by Dance and at Dance’s expense and (b) obtain and maintain all applicable regulatory and safety certifications for the Device including those set forth in the Product Requirements. Dance shall provide Aerogen with copies of all correspondence received from and to be provided to Regulatory Authorities concerning the Device and access to all regulatory documentation relating to the Drug Device Combination if so requestedSection 6.1.2.