Common use of Facilities and Inspections Clause in Contracts

Facilities and Inspections. Without limiting CyDex’s responsibility under this Agreement, CyDex shall have the right at any time to satisfy its supply obligations to Company hereunder either in whole or in part through arrangements with third parties engaged to perform services or supply facilities or goods in connection with the manufacture or testing of Captisol (each, a “Third-Party Manufacturer”). CyDex shall give Company at least sixty (60) days prior written notice of any such arrangement. The parties hereby agree that [***] is a Third-Party Manufacturer as of the Effective Date of this Agreement. CyDex shall permit no more than two (2) of Company’s authorized representatives, during normal working hours and upon reasonable prior notice to CyDex but in no event less than sixty (60) days’ prior notice, to inspect that portion of all CyDex facilities utilized for the manufacture, preparation, processing, storage or quality control of Captisol or such facilities of any Third-Party Manufacturer, once per calendar year per facility for existing facilities (unless the inspection reveals material deficiencies or concerns which require additional follow-up inspections, including without limitation, noncompliance with GMP, Specifications or any applicable law). In addition, CyDex shall permit any such inspection of a new facility (one time per new facility) upon not less than sixty (60) days’ prior notice and such initial inspection shall not count as a yearly inspection under the preceding sentence. If any such inspection is of a facility of a Third Party Manufacturer, Company shall pay, on a pass through basis, the amount charged to CyDex by its Third Party Manufacturer specifically by reason of Company’s participation in such inspection. Company’s authorized representatives shall be accompanied by CyDex personnel at all times, shall be qualified to conduct such manufacturing audits, shall comply with all applicable rules and regulations relating to facility security, health and safety, and shall execute a written confidentiality agreement with terms at least as restrictive as those set forth in Section 8 hereof. In no event shall any such manufacturing audit exceed two (2) days in duration. Company shall ensure that its authorized representatives conduct each manufacturing audit in such a manner as to not interfere with the normal and ordinary operations of CyDex or its Third-Party Manufacturer. CyDex shall inform Company of any regulatory inspection that may impact Captisol or the Licensed Product and shall provide Company with a summary of the outcome of such inspection and a copy of any Form 483 or other letter of deficiency received from a regulatory agency inspection, subject to confidentiality obligations of CyDex to Third Parties related to matters other than Captisol alone. Except as expressly set forth in this Section 3.6, neither Company nor its Affiliates, Sublicensees or their respective employees or representatives shall have access to CyDex’s facilities or the facilities of any Third-Party Manufacturer.

Facilities and Inspections. Without limiting CyDex’s responsibility under this Agreement, CyDex shall have the right at any time to satisfy its supply obligations to Company hereunder either in whole or in part through arrangements with third parties engaged to perform services or supply facilities or goods in connection with the manufacture or testing of Captisol (each, a “Third-Party Manufacturer”). CyDex shall give Company at least sixty (60) days prior written notice of any such arrangement. The parties hereby agree that [***] * is a Third-Party Manufacturer as of the Effective Date of this Agreement. CyDex shall permit no more than two (2) **** of Company’s authorized representatives, during normal working hours and upon reasonable prior notice to CyDex but in no event less than sixty (60) days’ ****prior notice, to inspect that portion of all CyDex facilities utilized for the manufacture, preparation, processing, storage or quality control of Captisol or such facilities of any Third-Party Manufacturer, once per calendar year per facility for existing facilities (unless the inspection reveals material deficiencies or concerns which require additional follow-up inspections, including without limitation, noncompliance with GMP, Specifications or any applicable law). In addition, CyDex shall permit any such inspection of a new facility (one time per new facility) upon not less no more frequently than sixty (60) days’ prior notice and such initial inspection shall not count as a yearly inspection under the preceding sentence**** . If any such inspection is of a facility the facilities of a Third Third-Party Manufacturer, Company shall pay, on a pass through basis, the amount charged to CyDex by its Third Party Manufacturer specifically by reason of Company’s participation in such inspection****. Company’s authorized representatives shall be accompanied by CyDex personnel at all times, shall be qualified to conduct such manufacturing audits, shall comply with all applicable rules and regulations relating to facility security, health and safety, and shall execute a written confidentiality agreement with terms at least as restrictive as those set forth in Section 8 hereof. In no event shall any such manufacturing audit exceed two (2) days **** in duration. Company shall ensure that its authorized representatives conduct each manufacturing audit in such a manner as to not interfere with the normal and ordinary operations of CyDex or its Third-Party Manufacturer. CyDex shall inform Company of any regulatory inspection that may impact Captisol or the Licensed Product and shall provide Company with a summary of the outcome of such inspection and a copy of any Form 483 or other letter of deficiency received from a regulatory agency inspection, subject to confidentiality obligations of CyDex to Third Parties related to matters other than Captisol alone. Except as expressly set forth in this Section 3.6, neither Company nor its Affiliates, Sublicensees or their respective employees or representatives shall have access to CyDex’s facilities or the facilities of any Third-Party Manufacturer.

Facilities and Inspections. Without limiting CyDex’s responsibility under this Agreement, CyDex shall have the right at any time permit, and shall use reasonable commercial efforts to satisfy its supply obligations to Company hereunder either in whole or in part through arrangements with third parties engaged to perform services or supply facilities or goods in connection with the manufacture or testing of Captisol (each, a “Third-Party Manufacturer”). CyDex shall give Company at least sixty (60) days prior written notice of any such arrangement. The parties hereby agree that [***] is a induce each Third-Party Manufacturer as to permit, a reasonable number of Company and the Effective Date of this Agreement. CyDex shall permit no more than two (2) of CompanyPermitted Purchaser’s authorized representatives, during normal working hours and upon reasonable prior notice to CyDex but in no event less than sixty (60) 20 days’ prior noticenotice (subject to Third-Party Manufacturer’s consent to be reasonably sought by CyDex), to confidentially inspect for a reasonable number of days that portion of all CyDex facilities utilized for the manufacture, preparation, processing, storage or quality control of Captisol or and/or such facilities of any Third-Party Manufacturer, no more frequently than once per calendar year per facility for existing facilities (unless the inspection reveals material deficiencies or concerns which require additional follow-up inspections, including without limitation, noncompliance with GMP, Specifications or any applicable law). In addition, CyDex shall permit any such inspection of more frequently if a new facility (one time per new facility) upon not less than sixty (60) days’ prior notice and such initial inspection shall not count as a yearly inspection under the preceding sentence. If any such inspection is of a facility of a Third Party Manufacturer, Company shall pay, on a pass through basis, the amount charged to CyDex by its Third Party Manufacturer specifically by reason of Company’s participation in such inspectionDefect has been identified. Company’s authorized representatives shall be accompanied by CyDex personnel (and, if Third-Party Manufacturer so requests, Third-Party Manufacturer personnel) at all times, shall be qualified to conduct such manufacturing audits, shall comply with all applicable rules and regulations relating to facility security, health and safety, and shall execute a written confidentiality agreement with terms at least as restrictive as those set forth in Section 8 hereof. In no event shall any such manufacturing audit exceed two (2) days in duration. Company shall ensure that its authorized representatives conduct each manufacturing audit in such a manner as to not unreasonably interfere with the normal and ordinary operations of CyDex or its Third-Party Manufacturer. CyDex shall inform Company of any regulatory inspection that may impact Captisol or the Licensed Product and shall provide Company with a summary of the outcome of such inspection and a copy of any Form 483 or other letter of deficiency received from a regulatory agency inspection, subject to confidentiality obligations of CyDex to Third Parties related to matters other than Captisol alone. Except as expressly set forth in this Section 3.63.7, neither Company nor its AffiliatesCompany, Sublicensees or Permitted Purchasers and their respective employees or representatives shall not have access to CyDex’s facilities or the facilities of any Third-Party Manufacturer. To the extent that a governmental authority requests the ability to inspect CyDex or any Third Party Manufacturing facility, CyDex will use reasonable efforts to promptly support and facilitate such request.

Facilities and Inspections. Without limiting CyDex’s responsibility under this Agreement, CyDex shall have the right at any time permit, and shall use reasonable commercial efforts to satisfy its supply obligations to Company hereunder either in whole or in part through arrangements with third parties engaged to perform services or supply facilities or goods in connection with the manufacture or testing of Captisol (each, a “Third-Party Manufacturer”). CyDex shall give Company at least sixty (60) days prior written notice of any such arrangement. The parties hereby agree that [***] is a induce each Third-Party Manufacturer as of the Effective Date of this Agreement. CyDex shall permit no more than two (2) to permit, a reasonable and limited number of Company’s authorized representatives, during normal working hours and upon reasonable prior notice to CyDex but in no event less than sixty (60) 30 days’ prior noticenotice (subject to the Third-Party Manufacturer’s consent to be reasonably sought by CyDex), to confidentially inspect for a reasonable and limited number of days that portion of all CyDex facilities utilized for the manufacture, preparation, processing, storage or quality control of Captisol or such facilities of any Third-Party Manufacturer, no more frequently than once per calendar year per facility for existing facilities (unless the inspection reveals material deficiencies or concerns which require additional follow-up inspections, including without limitation, noncompliance with GMP, Specifications or any applicable law). In addition, CyDex shall permit any such inspection of a new facility (one time per new facility) upon not less than sixty (60) days’ prior notice and such initial inspection shall not count as a yearly inspection under the preceding sentence. If any such inspection is of a facility of a Third Party Manufacturer, Company shall pay, on a pass through basis, the amount charged to CyDex by its Third Party Manufacturer specifically by reason of Company’s participation in such inspectionyear. Company’s authorized representatives shall be accompanied by CyDex personnel (and, if the Third-Party Manufacturer so requests, Third-Party Manufacturer personnel) at all times, shall be qualified to conduct such manufacturing audits, and shall CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. comply with all applicable rules and regulations relating to facility security, health and safety, and shall execute a written confidentiality agreement with terms at least as restrictive as those set forth in Section 8 hereof. In no event shall any such manufacturing audit exceed two (2) days in duration. Company shall ensure that its authorized representatives conduct each manufacturing audit in such a manner as to not interfere with the normal and ordinary operations of CyDex or its Third-Party Manufacturer. CyDex shall inform Company of any regulatory inspection that may impact Captisol or the Licensed Product and shall provide Company with a summary of the outcome of such inspection and a copy of any Form 483 or other letter of deficiency received from a regulatory agency inspection, subject to confidentiality obligations of CyDex to Third Parties related to matters other than Captisol alone. Except as expressly set forth in this Section 3.63.7, neither Company nor its AffiliatesCompany, Sublicensees or Permitted Purchasers and their respective employees or representatives shall not have access to CyDex’s facilities or the facilities of any Third-Party Manufacturer.

Facilities and Inspections. Without limiting CyDex’s responsibility under this Agreement, CyDex shall have the right at any time to satisfy its supply obligations to Company hereunder either in whole or in part through arrangements with third parties engaged to perform services or supply facilities or goods in connection with the manufacture or testing of Captisol (each, a “Third-Party Manufacturer”). CyDex shall give Company at least sixty (60) days prior written notice of any such arrangement. The parties hereby agree that [***] is a Third-Party Manufacturer as of the Effective Date of this Agreement. CyDex shall permit no more than two (2) [***] of Company’s authorized representatives, during normal working hours and upon reasonable prior notice to CyDex but in no event less than sixty (60) days’ [***] prior notice, to inspect that portion of all CyDex facilities utilized for the manufacture, preparation, processing, storage or quality control of Captisol or such facilities of any Third-Party Manufacturer, once no more frequently than [***] per calendar year per facility for existing facilities (unless the inspection reveals material deficiencies or concerns which require additional follow-up inspections, including without limitation, noncompliance with GMP, Specifications or any applicable law). In addition, CyDex shall permit any such inspection of a new facility (one time per new facility) upon not less than sixty (60) days’ prior notice and such initial inspection shall not count as a yearly inspection under the preceding sentenceyear. If any such inspection is of a facility the facilities of a Third Third-Party Manufacturer, Company shall pay, on a pass through basis, the amount charged to CyDex by its Third Party Manufacturer specifically by reason of Company’s participation in such inspectionpay [***]. Company’s authorized representatives shall be accompanied by CyDex personnel at all times, shall be qualified to conduct such manufacturing audits, shall comply with all applicable rules and regulations relating to facility security, health and safety, and shall execute a written confidentiality agreement with terms at least as restrictive as those set forth in Section 8 hereof. In no event shall any such manufacturing audit exceed two (2) days [***] in duration. Company shall ensure that its authorized representatives conduct each manufacturing audit in such a manner as to not interfere with the normal and ordinary operations of CyDex or its Third-Party Manufacturer. CyDex shall inform Company of any regulatory inspection that may impact Captisol or the Licensed Product and shall provide Company with a summary of the outcome of such inspection and a copy of any Form 483 or other letter of deficiency received from a regulatory agency inspection, subject to confidentiality obligations of CyDex to Third Parties related to matters other than Captisol alone. Except as expressly set forth in this Section 3.6, neither Company nor its Affiliates, Sublicensees or their respective employees or representatives shall have access to CyDex’s facilities or the facilities of any Third-Party Manufacturer.

Facilities and Inspections. Without limiting CyDex’s responsibility under this Agreement, CyDex shall have the right at any time to satisfy its supply obligations to Company hereunder either in whole or in part through arrangements with third parties engaged to perform services or supply facilities or goods in connection with the manufacture or testing of Captisol (each, a “Third-Party Manufacturer”). CyDex shall give Company at least sixty (60) days prior written notice of any such arrangement. The parties hereby agree that [***] The Hovione Group is a Third-Party Manufacturer as of the Effective Date of this Agreement. CyDex shall permit no more than two (2) **** of Company’s authorized representatives, during normal working hours and upon reasonable prior notice to CyDex but in no event less than sixty (60) days’ ****prior notice, to inspect that portion of all CyDex facilities utilized for the manufacture, preparation, processing, storage or quality control of Captisol or such facilities of any Third-Party Manufacturer, once per calendar year per facility for existing facilities (unless the inspection reveals material deficiencies or concerns which require additional follow-up inspections, including without limitation, noncompliance with GMP, Specifications or any applicable law). In addition, CyDex shall permit any such inspection of a new facility (one time per new facility) upon not less no more frequently than sixty (60) days’ prior notice and such initial inspection shall not count as a yearly inspection under the preceding sentence**** . If any such inspection is of a facility the facilities of a Third Third-Party Manufacturer, Company shall pay, on a pass through basis, the amount charged to CyDex by its Third Party Manufacturer specifically by reason of Company’s participation in such inspection****. Company’s authorized representatives shall be accompanied by CyDex personnel at all times, shall be qualified to conduct such manufacturing audits, shall comply with all applicable rules and regulations relating to facility security, health and safety, and shall execute a written confidentiality agreement with terms at least as restrictive as those set forth in Section 8 hereof. In no event shall any such manufacturing audit exceed two (2) days **** in duration. Company shall ensure that its authorized representatives conduct each manufacturing audit in such a manner as to not interfere with the normal and ordinary operations of CyDex or its Third-Party Manufacturer. CyDex shall inform Company of any regulatory inspection that may impact Captisol or the Licensed Product and shall provide Company with a summary of the outcome of such inspection and a copy of any Form 483 or other letter of deficiency received from a regulatory agency inspection, subject to confidentiality obligations of CyDex to Third Parties related to matters other than Captisol alone. Except as expressly set forth in this Section 3.6, neither Company nor its Affiliates, Sublicensees or their respective employees or representatives shall have access to CyDex’s facilities or the facilities of any Third-Party Manufacturer.

Facilities and Inspections. Without limiting CyDex’s responsibility under this Agreement, CyDex shall have the right at any time to satisfy its supply obligations to Company hereunder either in whole or in part through arrangements with third parties engaged to perform services or supply facilities or goods in connection with the manufacture or testing of Captisol (each, a “Third-Party Manufacturer”). CyDex shall give Company at least sixty (60) days prior written notice of any such arrangement. The parties hereby agree that [***] is a Third-Party Manufacturer as of the Effective Date of this Agreement. CyDex shall permit no more than two (2) of Company’s authorized representatives, during normal working hours and upon reasonable prior notice to CyDex but in no event less than sixty (60) days’ prior notice, to inspect that portion of all CyDex facilities utilized for the manufacture, preparation, processing, storage or quality control of Captisol or such facilities of any Third-Party Manufacturer, once per calendar year per facility for existing facilities (unless the inspection reveals material deficiencies or concerns which require additional follow-up inspections, including without limitation, noncompliance with GMP, Specifications or any applicable law). In addition, CyDex shall permit any such inspection of a new facility (one time per new facility) upon not less than sixty (60) days’ prior notice and such initial inspection shall not count as a yearly inspection under the preceding sentence. If any such inspection is of a facility of a Third Party Manufacturer, Company shall pay, on a pass through basis, the amount charged to CyDex by its Third Party Manufacturer specifically by reason of Company’s participation in such inspection. Company’s authorized representatives shall be accompanied by CyDex personnel at all times, shall be qualified to conduct such manufacturing audits, shall comply with all applicable rules and regulations relating to facility security, health and safety, and shall execute a written confidentiality agreement with terms at least as restrictive as those set forth in Section 8 hereof. In no event shall any such manufacturing audit exceed two (2) days in duration. Company shall ensure that its authorized representatives conduct each manufacturing audit in such a manner as to not interfere with the normal and ordinary operations of CyDex or its Third-Party Manufacturer. CyDex shall inform Company of any regulatory inspection that may impact Captisol or the Licensed Product and shall provide Company with a summary of the outcome of such inspection and a copy of any Form 483 or other letter of deficiency received from a regulatory agency inspection, subject to confidentiality obligations of CyDex to Third Parties related to matters other than Captisol alone. Except as expressly set forth in this Section 3.6, neither Company nor its Affiliates, Sublicensees or their respective employees or representatives shall have access to CyDex’s facilities or the facilities of any Third-Party Manufacturer. [***] 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.

Facilities and Inspections. Without limiting CyDex’s 's responsibility under this Agreement, CyDex shall have the right at any time to satisfy its supply obligations to Company hereunder either in whole or in part through arrangements with third parties engaged to perform services or supply facilities or goods in connection with the manufacture or testing of Captisol CAPTISOL (each, a “Third"THIRD-Party Manufacturer”PARTY MANUFACTURER"). CyDex shall give Company at least sixty (60) days prior written notice of any such arrangement. The , provided, the parties hereby acknowledge and agree that [***] that, as of the Effective Date, The Hovione Group is a Third-Party Manufacturer as of the Effective Date of this AgreementManufacturer. CyDex shall permit no more than two (2) [**] of Company’s 's authorized representatives, during normal working hours and upon reasonable prior notice to CyDex but in no event less than sixty (60) days’ [**] days prior notice, to inspect that portion of all CyDex facilities utilized for the manufacture, preparation, processing, storage or quality control of Captisol CAPTISOL or such facilities of any Third-Party Manufacturer, once no more frequently than [**] per calendar year per facility for existing facilities (unless the inspection reveals material deficiencies or concerns which require additional follow-up inspections, including without limitation, noncompliance with GMP, Specifications or any applicable law). In addition, CyDex shall permit any such inspection of a new facility (one time per new facility) upon not less than sixty (60) days’ prior notice and such initial inspection shall not count as a yearly inspection under the preceding sentence. If any such inspection is of a facility the facilities of a Third Third-Party Manufacturer, Company shall paypay CyDex's cost of inspection (as of the Effective Date, on a pass through basis, the amount charged to CyDex by its Third Party Manufacturer specifically by reason of Company’s participation in such inspection[**] Dollars ($[**]) per person per day). Company’s 's authorized representatives shall be accompanied by CyDex personnel at all times, shall be qualified to conduct such manufacturing audits, and shall comply with all applicable rules and regulations relating to facility security, health and safety. The results of such inspection shall be deemed Confidential Information of CyDex, and which shall execute a written confidentiality agreement with be governed by the terms at least as restrictive as those set forth in Section of SECTION 8 (Confidentiality) hereof. In no event shall any such manufacturing audit exceed two (2) [**] days in duration. Company shall ensure that its authorized representatives conduct each manufacturing audit in such a manner as to not interfere with the normal and ordinary operations operation of CyDex or its Third-Party Manufacturer. CyDex shall inform Company of any regulatory inspection that may impact Captisol or the Licensed Product and shall provide Company with a summary of the outcome of such inspection and a copy of any Form 483 or other letter of deficiency received from a regulatory agency inspection, subject to confidentiality obligations of CyDex to Third Parties related to matters other than Captisol alone. Except as expressly set forth in this Section SECTION 3.6, neither Company nor its Affiliates, Sublicensees or their respective employees or representatives shall have access to CyDex’s 's facilities or the facilities of any Third-Party Manufacturer. CyDex shall inform Company of any regulatory inspection that may impact CAPTISOL or the Licensed Product and shall provide Company with a summary of the outcome of such inspection or a copy of any Form 483 or other letter of deficiency received from a regulatory agency inspection.

Facilities and Inspections. Without limiting CyDex’s responsibility under this Agreement, CyDex shall have the right at any time to satisfy its supply obligations to Company hereunder either in whole or in part through arrangements with third parties engaged to perform services or supply facilities or goods in connection with the manufacture or testing of Captisol (each, a “Third-Party Manufacturer”). CyDex shall give Company at least sixty (60) days prior written notice of any such arrangement. The parties hereby agree that [***] is a Third-Party Manufacturer as of the Effective Date of this Agreement. CyDex shall permit no more than two (2) of a reasonable and limited number Company’s authorized representatives, during normal working hours and upon reasonable prior notice to CyDex but in no event less than sixty [***] prior notice (60) days’ prior noticesubject to Third Party Manufacturer’s consent to be reasonably sought by CyDex), to confidentially inspect for a reasonable and limited number of days that portion of all CyDex facilities utilized for the manufacture, preparation, processing, storage or quality control of Captisol or such facilities of any Third-Party Manufacturer, once per calendar year per facility for existing facilities (unless the inspection reveals material deficiencies or concerns which require additional follow-up inspections, including without limitation, noncompliance with GMP, Specifications or any applicable law). In addition, CyDex shall permit any such inspection of a new facility (one time per new facility) upon not less no more frequently than sixty (60) days’ prior notice and such initial inspection shall not count as a yearly inspection under the preceding sentence[***]. If any a defect in Licensed Product is attributed to Captisol, there are pending Licensed Product recall decisions, or significant regulatory actions, such inspection is of as warning letters, then a facility of a Third Party Manufacturer, Company shall pay, on a pass through basis, the amount charged to CyDex for-cause audit upon short notice may be performed by its Third Party Manufacturer specifically by reason of Company’s participation in such inspection. Company’s authorized representatives shall be accompanied by CyDex personnel at all times, shall be qualified to conduct such manufacturing audits, shall comply with *** 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. all applicable rules and regulations relating to facility security, health and safety, and shall execute a written confidentiality agreement with terms at least as restrictive as those set forth in Section 8 hereof. In no event shall any such manufacturing audit exceed two (2) days in duration. safety Company shall ensure that its authorized representatives conduct each manufacturing audit in such a manner as to not interfere with the normal and ordinary operations of CyDex or its Third-Party Manufacturer. CyDex shall inform Company of any regulatory inspection that may impact Captisol or the Licensed Product and shall provide Company with a summary of the outcome of such inspection and a copy of any Form 483 or other letter of deficiency received from a regulatory agency inspection, subject to confidentiality obligations of CyDex to Third Parties related to matters other than Captisol alone. Except as expressly set forth in this Section 3.63.7, neither Company nor its AffiliatesCompany, Sublicensees or Permitted Purchasers and their respective employees or representatives shall not have access to CyDex’s facilities or the facilities of any Third-Party Manufacturer.

Facilities and Inspections. Without limiting CyDex’s 's responsibility under this Agreement, CyDex shall have the right at any time to satisfy its supply obligations to Company hereunder either in whole or in part through arrangements with third parties engaged to perform services or supply facilities or goods in connection with the manufacture or testing of Captisol (each, a “Third-Party Manufacturer”). CyDex shall give Company at least sixty (60) days prior written notice of any such arrangement. The parties hereby agree that [***] is a Third-Party Manufacturer as of the Effective Date of this Agreement. CyDex shall permit no more than two (2) [***] of Company’s authorized representatives, during normal working hours and upon reasonable prior notice to CyDex but in no event less than sixty (60) days’ [***] prior notice, to inspect that portion of all CyDex facilities utilized for the manufacture, preparation, processing, storage or quality control of Captisol or such facilities of any Third-Party Manufacturer, once no more frequently than [***] per calendar year per facility for existing facilities (unless the inspection reveals material deficiencies or concerns which require additional follow-up inspections, including without limitation, noncompliance with GMP, Specifications or any applicable law). In addition, CyDex shall permit any such inspection of a new facility (one time per new facility) upon not less than sixty (60) days’ prior notice and such initial inspection shall not count as a yearly inspection under the preceding sentenceyear. If any such inspection is of a facility the facilities of a Third Third-Party Manufacturer, Company shall pay, on a pass through basis, the amount charged to CyDex by its Third Party Manufacturer specifically by reason of Company’s participation in such inspectionpay [***]. Company’s authorized representatives shall be accompanied by CyDex personnel at all times, shall be qualified to conduct such manufacturing audits, shall comply with all applicable rules and regulations relating to facility security, health and safety, and shall execute a written confidentiality agreement with terms at least as restrictive as those set forth in Section 8 hereof. In no event shall any such manufacturing audit exceed two (2) days [***] in duration. Company shall ensure that its authorized representatives conduct each manufacturing audit in such a manner as to not interfere with the normal and ordinary operations of CyDex or its Third-Party Manufacturer. CyDex shall inform Company of any regulatory inspection that may impact Captisol or the Licensed Product and shall provide Company with a summary of the outcome of such inspection and a copy of any Form 483 or other letter of deficiency received from a regulatory agency inspection, subject to confidentiality obligations of CyDex to Third Parties related to matters other than Captisol alone. Except as expressly set forth in this Section 3.6, neither Company nor its Affiliates, Sublicensees or their respective employees or representatives shall have access to CyDex’s facilities or the facilities of any Third-Party Manufacturer.

Facilities and Inspections. Without limiting CyDex’s ’ responsibility under this Agreement, CyDex shall have the right at any time to satisfy its supply obligations to Company Proteolix hereunder either in whole or in part through arrangements with third parties engaged to perform services or supply facilities or goods in connection with the manufacture or testing of Captisol CAPTISOL (each, a “Third-Party Manufacturer”). CyDex shall give Company at least sixty (60) days Proteolix prior written notice of any such arrangement. The parties hereby agree that [***] is a Third-Party Manufacturer as of the Effective Date of this Agreement. CyDex shall permit no more than two (2) [ ** ] of Company’s Proteolix’ authorized representatives, during normal working hours and upon reasonable prior notice to CyDex but in no event less than sixty (60) days’ [ ** ] days prior notice, to inspect that portion of all CyDex facilities utilized for the manufacture, preparation, processing, storage or quality control of Captisol CAPTISOL or such facilities of any Third-Party Manufacturer, once no more frequently than [ ** ] per calendar year per facility for existing facilities (unless year. Notwithstanding the inspection reveals material deficiencies or concerns which require additional follow-up inspections, including without limitation, noncompliance with GMP, Specifications or any applicable law). In additionforegoing, CyDex agrees to reasonably cooperate, and shall permit require any Third-Party Manufacturer to reasonably cooperate, with all regulatory authorities and shall submit to reasonable CAPTISOL-related inspections by such authorities. With respect to inspection of a new facility (one time per new facility) upon not less than sixty (60) days’ prior notice and such initial inspection shall not count as a yearly inspection under the preceding sentence. If any such inspection is of a facility facilities of a Third Party ManufacturerManufacturer by Proteolix, Company its Affiliates or Sublicensees, Proteolix shall pay, on a pass through basis, the amount be responsible for any reasonable fees charged to CyDex by its CyDex’ Third Party Manufacturer specifically by reason in connection with such inspections (as of Company’s participation in such inspectionthe Effective Date, [ ** ] Dollars [ ** ] per person per day). Company’s Proteolix’ authorized representatives shall be accompanied by CyDex personnel at all times, shall be qualified to conduct such manufacturing audits, shall comply with all applicable rules and regulations relating to facility security, health and safety, and shall execute a written confidentiality agreement with terms at least as restrictive as those set forth in Section 8 (Confidentiality) hereof. In no event shall any such manufacturing audit exceed two (2) [ ** ] days in duration. Company Proteolix shall ensure that its authorized representatives conduct each manufacturing audit in such a manner as to not interfere with the normal and ordinary operations operation of CyDex or its Third-Party Manufacturer. CyDex shall inform Company of any regulatory inspection that may impact Captisol or the Licensed Product and shall provide Company with a summary of the outcome of such inspection and a copy of any Form 483 or other letter of deficiency received from a regulatory agency inspection, subject to confidentiality obligations of CyDex to Third Parties related to matters other than Captisol alone. Except as expressly set forth in this Section 3.6, neither Company Proteolix nor its Affiliates, Sublicensees sublicensees or their respective employees or representatives shall have access to CyDex’s ’ facilities or the facilities of any Third-Party Manufacturer. [ ** ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.