Common use of Captisol Information Submitted for Regulatory Review Clause in Contracts

Captisol Information Submitted for Regulatory Review. Except as otherwise set forth herein, Company shall be solely responsible for all communications with regulatory agencies in connection with the Licensed Product. Notwithstanding the foregoing, Company shall provide CyDex with copies of the portions of all regulatory submissions related to Captisol data alone (and not in conjunction with any product formulation) thirty (30) days prior to submission and shall allow CyDex to review and comment upon said submissions. If CyDex reasonably determines that any data on Captisol alone included in such submission would materially adversely affect another product utilizing Captisol, CyDex shall notify Company within thirty (30) days of receipt of such submission, and the parties shall discuss and attempt to resolve the matter in good faith. If the parties cannot resolve such matter within thirty (30) days after CyDex notifies Company of such a determination, then the dispute shall be presented to the Chief Executive Officer of each party, or his or her respective designee, for resolution. If the parties’ Chief Executive Officers, or their respective designees, cannot resolve the dispute within thirty (30) days of being requested by a party to resolve such dispute, either party may initiate a short-form arbitration proceeding pursuant to Section 14.4(b) below. Company shall inform CyDex of meetings with the FDA (or other regulatory agencies in the Territory) regarding the Licensed Product, a reasonable period of time prior to such event (with reasonableness determined by how much notice Company has of such meeting) and shall allow CyDex to participate in any FDA (or other regulatory agency) review that might reasonably include inquiries regarding Captisol. If Company submits written responses to the FDA that include data on Captisol alone, CyDex shall be permitted to review such written materials prior to submission. If CyDex reasonably objects to the contents of such written responses relating to Captisol alone, the parties agree to cooperate in working toward a reasonable and mutually agreeable response.

Captisol Information Submitted for Regulatory Review. Except as otherwise set forth herein, Company shall be solely responsible for all communications with regulatory agencies in connection with the Licensed Product. Notwithstanding the foregoing, Company shall provide CyDex with copies of the portions of all regulatory submissions related to Captisol data alone (and not in conjunction with any product formulation) thirty (30) days prior to submission and shall allow CyDex to review and comment upon said submissions. If CyDex reasonably determines that any data on Captisol alone included in such submission would materially adversely affect another product utilizing Captisol, CyDex shall notify Company within thirty (30) days of receipt of such submission, and the parties shall discuss and attempt to resolve the matter in good faith. If the parties cannot resolve such matter within thirty (30) days after CyDex notifies Company of such a determination, then the dispute shall be presented to the Chief Executive Officer of each party, or his or her respective designee, for resolution. If the parties’ Chief Executive Officers, or their respective designees, cannot resolve the dispute within thirty (30) days of being requested by a party to resolve such dispute, either party may initiate a short-form arbitration proceeding pursuant to Section 14.4(b) below. Company shall inform CyDex of meetings with the FDA (or other regulatory agencies in the Territory) regarding the [***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO THE RULES APPLICABLE TO SUCH CONFIDENTIAL TREATMENT REQUEST. Licensed Product, a reasonable period of time prior to such event (with reasonableness determined by how much notice Company has of such meeting) and shall allow CyDex to participate in any FDA (or other regulatory agency) review that might reasonably include inquiries regarding Captisol. If Company submits written responses to the FDA that include data on Captisol alone, CyDex shall be permitted to review such written materials prior to submission. If CyDex reasonably objects to the contents of such written responses relating to Captisol alone, the parties agree to cooperate in working toward a reasonable and mutually agreeable response.

Captisol Information Submitted for Regulatory Review. Except as otherwise set forth herein, Company shall be solely responsible for all communications with regulatory agencies LICENSE AND SUPPLY AGREEMENT PAGE 16 in connection with the Licensed Product. Notwithstanding the foregoing, CyDex agrees to provide proprietary technical information relating to Captisol directly to global health authorities as reasonably requested by Company during development and/or new product registration. Company shall provide CyDex with copies of the portions of all regulatory submissions related to containing Captisol data alone (and not in conjunction with any product formulation) thirty (30) days [***] prior to submission and shall allow CyDex to review and comment upon said submissions. If CyDex reasonably determines that any data on Captisol alone included in such submission would materially adversely affect another product utilizing Captisol, CyDex shall notify Company within thirty (30) days [***] of receipt of such submission, and the parties shall discuss and attempt to resolve the matter in good faith. If the parties cannot resolve such matter within thirty (30) days after CyDex notifies Company of such a determination, then the dispute shall be presented to the Chief Executive Officer of each party, or his or her respective designee, for resolution. If the parties’ Chief Executive Officers, or their respective designees, cannot resolve the dispute within thirty (30) days of being requested by a party to resolve such dispute, either party may initiate a short-form arbitration proceeding pursuant to Section 14.4(b) below. Company shall inform CyDex of meetings with the FDA (or other regulatory agencies in the Territory) regarding the Licensed Product, a reasonable period of time Product [***] prior to such event (with reasonableness determined by how much notice Company has of such meeting) and shall allow CyDex to participate in any FDA (or other regulatory agency) review that might reasonably include inquiries regarding Captisol. If Company submits written responses to the FDA that include data on Captisol alone, CyDex shall be permitted to review such written materials prior to submission. If CyDex reasonably objects to the contents of such written responses relating to Captisol aloneCaptisol, the parties agree to cooperate in working toward a reasonable and mutually agreeable response.

Captisol Information Submitted for Regulatory Review. Except as otherwise set forth herein, Company shall be solely responsible for all communications with regulatory agencies in connection with the Licensed Product and CyDex shall not, without Company's consent, correspond or communicate with any regulatory agency regarding the Licensed Product. CyDex shall, as soon as practicable after any contact with or receipt of any communication from any regulatory authority regarding Licensed Product, forward a copy or description of the same to Company. Notwithstanding the foregoing, Company shall provide CyDex with copies of the portions of all regulatory submissions related to Captisol containing CAPTISOL data alone (and not in conjunction with any product formulation) thirty (30) [**] days prior to submission and shall allow CyDex to review and comment upon said submissions. If CyDex reasonably determines in its reasonable good faith determination that any data on Captisol alone included in such submission would materially adversely affect another a product utilizing CaptisolCAPTISOL, CyDex shall notify Company within thirty (30) [**] days of receipt of such submission, and the parties shall discuss and attempt to resolve the matter in good faith. If the parties cannot resolve such matter within thirty (30) [**] days after CyDex notifies Company of such a determination, then the dispute shall be presented to the Chief Executive Officer chief executive officer of each party, or his or her respective designee, for resolution. If the parties’ Chief Executive Officers' chief executive officers, or their respective designees, cannot resolve the dispute within thirty (30) [**] days of being requested by a party to resolve such dispute, either party may initiate a short-form arbitration proceeding pursuant to Section 14.4(bSECTION 14.4(B) below. Company shall inform CyDex of meetings with the FDA (or other regulatory agencies in the Territory) regarding the Licensed Product, a reasonable period of time Product [**] days prior to such event (with reasonableness determined by how much notice Company has of such meeting) and shall allow CyDex to participate in any FDA (event, or as soon as possible if the FDA, or other regulatory agency) review that might reasonably include inquiries regarding Captisolbody, requests a meeting with less than [**] days notice, and shall provide CyDex a detailed summary of the minutes of any such meeting to the extent such minutes relate to CAPTISOL. If Company submits written responses to the FDA that include data on Captisol CAPTISOL alone, CyDex shall be permitted to review such written materials prior to submission. Such responses shall be provided by the Company to CyDex [**] days prior to submission. CyDex shall respond with comments to Company within [**] days. If CyDex does not provide comments within [**] business days, Company will interpret such non-response as agreement to the proposed response by Company. If CyDex reasonably objects to the contents of such written responses relating to Captisol aloneCAPTISOL, the parties agree to cooperate in working toward a reasonable and mutually agreeable response; provided, however, that Company shall have final decision-making authority with respect to the content of any IND or NDA for Licensed Products (subject to the limitations set forth in this SECTION 7.1 concerning data solely concerning CAPTISOL), and with respect to the submission of such IND or NDA.

Captisol Information Submitted for Regulatory Review. Except as otherwise set forth herein, Company shall be solely responsible for all communications with regulatory agencies in connection with the Licensed Product. Notwithstanding the foregoing, CyDex agrees to provide proprietary technical information relating to Captisol directly to global health authorities as reasonably requested by Company during development and/or new product registration. Company shall provide CyDex with copies of the portions of all regulatory submissions related to containing Captisol data alone (and not in conjunction with any product formulation) thirty (30) days [***] prior to submission and shall allow CyDex to review and comment upon said submissions. If CyDex reasonably determines that any data on Captisol alone included in such submission would materially adversely affect another product utilizing Captisol, CyDex shall notify Company within thirty (30) days [***] of receipt of such submission, and the parties shall discuss and attempt to resolve the matter in good faith. If the parties cannot resolve such matter within thirty (30) days after CyDex notifies Company of such a determination, then the dispute shall be presented to the Chief Executive Officer of each party, or his or her respective designee, for resolution. If the parties’ Chief Executive Officers, or their respective designees, cannot resolve the dispute within thirty (30) days of being requested by a party to resolve such dispute, either party may initiate a short-form arbitration proceeding pursuant to Section 14.4(b) below. Company shall inform CyDex of meetings with the FDA (or other regulatory agencies in the Territory) regarding the Licensed Product, a reasonable period of time Product [***] prior to such event (with reasonableness determined by how much notice Company has of such meeting) and shall allow CyDex to participate in any FDA (or other regulatory agency) review that might reasonably include inquiries regarding Captisol. If Company submits written responses to the FDA that include data *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. on Captisol alone, CyDex shall be permitted to review such written materials prior to submission. If CyDex reasonably objects to the contents of such written responses relating to Captisol aloneCaptisol, the parties agree to cooperate in working toward a reasonable and mutually agreeable response.

Captisol Information Submitted for Regulatory Review. Except as otherwise set forth herein, Company Proteolix shall be solely responsible for all communications with regulatory agencies in connection with the Licensed Product. Notwithstanding the foregoing, Company Proteolix shall provide CyDex with copies of the portions of all regulatory submissions related to Captisol containing CAPTISOL data alone (and not in conjunction with any product formulation) thirty (30) [ ** ] days prior to submission and shall allow CyDex to review and comment upon said submissions. If CyDex reasonably determines in its reasonable good faith determination that any data on Captisol alone included in such submission would materially adversely affect another a product utilizing CaptisolCAPTISOL, CyDex shall notify Company Proteolix within thirty (30) [ ** ] days of after receipt of such submission, and the parties shall discuss and attempt to resolve the matter in good faith. If the parties cannot resolve such matter within thirty (30) [ ** ] days after CyDex notifies Company Proteolix of such a determination, then the dispute shall be presented to the Chief Executive Officer chief executive officer of each party, or his or her respective designee, for resolution. If the parties’ Chief Executive Officerschief executive officers, or their respective designees, cannot resolve the dispute within thirty (30) [ ** ] days of after being requested by a party to resolve such dispute, either party may initiate a short-form arbitration proceeding pursuant to Section 14.4(b) below. Company Proteolix shall inform CyDex of meetings with the FDA (or other regulatory agencies in the Territory) regarding the Licensed Product, a reasonable period of time Product [ ** ] days prior to such event (with reasonableness determined by how much notice Company has of such meeting) and shall allow CyDex to participate in any FDA (or other regulatory agency) review that might reasonably include inquiries regarding CaptisolCAPTISOL. If Company Proteolix submits written responses to the FDA that include data on Captisol CAPTISOL alone, CyDex shall be permitted to review such written materials prior to submission. If CyDex reasonably objects to the contents of such written responses relating to Captisol aloneCAPTISOL, the parties agree to cooperate in working toward a reasonable and mutually agreeable response.