By CyDex. CyDex shall defend, indemnify and hold Sage and its Affiliates and Sublicensees, and each of their respective directors, officers, agents and employees, harmless from and against any and all losses, judgments, damages, liabilities, settlements, penalties, fines, costs and expenses (including the reasonable costs and expenses of attorneys and other professionals) (collectively “Losses”) incurred by Sage as a result of any claim, demand, action or other proceeding (each, a “Claim”) by a Third Party, to the extent such Losses arise out of: (a) the manufacture, use, handling, promotion, marketing, distribution, importation, sale or offering for sale of Captisol by CyDex and its Affiliates (including without limitation, the sale of Captisol by CyDex to Sage hereunder); (b) infringement of any person’s intellectual property rights in Captisol per se; (c) CyDex’s breach of this Agreement, including without limitation any of its representations and warranties set forth in Sections 5.1 and 5.2 and (d) CyDex’s negligence or misconduct.
By CyDex. CyDex shall defend, indemnify and hold Spectrum and its Affiliates and Sublicensees, and each of their respective directors, officers and employees, harmless from and against any and all losses, damages, liabilities, costs and expenses (including the reasonable costs and expenses of attorneys and other professionals) (collectively “Losses”) incurred by Spectrum as a result of any claim, demand, action or other proceeding (each, a “Claim”) by a Third Party, to the extent such Losses arise out of: (a) the manufacture, use, handling, promotion, marketing, distribution, importation, sale or offering for sale of Captisol by CyDex and its Affiliates; or (b) an alleged or actual infringement or misappropriation of an intellectual property right by the use, handling, promotion, marketing, distribution, importation, sale or offering for sale of Captisol by Spectrum in connection with the Licensed Products; or (c) CyDex’s breach of this Agreement, to the extent that such Losses are not due to Spectrum’s gross negligence or willful misconduct.
By CyDex. CyDex shall defend, indemnify and hold Company and its Affiliates, and each of their respective directors, managers, officers, agents and employees (collectively, the “Company Indemnitees”), harmless from and against any and all losses, judgments, damages, liabilities, settlements, penalties, fines, costs and expenses (including the reasonable costs and expenses of attorneys and other professionals) (collectively, “Losses”; it being expressly understood, however, that incidental, special, indirect and consequential damages and lost profits, lost savings and interruptions of business are expressly excluded therefrom and from such defined term) incurred by the Company Indemnitees as a result of any claim, demand, action or other proceeding, whether civil, criminal, administrative or otherwise (each, a “Claim”) by a Third Party, to the extent such Losses arise out of (a) CyDex’s breach of this Agreement or the Supply Agreement, including without limitation any of its covenants, representations and warranties set forth herein or therein; (b) any breach or violation of any applicable law by CyDex or its Affiliates, or any of their respective officers, directors, managers, employees, or agents, in connection with the activities contemplated by this Agreement or the Supply Agreement including but not limited to those listed in subsections (c) and (d) below, (c) the research, development, manufacture, use, handling, promotion, marketing, distribution, importation, sale or offering for sale of Captisol by CyDex, its Affiliates, licensees or agents (for clarity, such terms shall not include Company in any event); (d) interactions and communications by CyDex, its Affiliates, manufacturers or agents with governmental authorities, physicians or other Third Parties relating to Captisol, including the Captisol Data Package; (e) the grossly negligent or willful misconduct of CyDex or its Affiliates or any of their respective officers, directors, managers, employees or agents; or (f) a Claim that the development, making, use, selling, marketing, offering for sale, importing or other commercial exploitation of the Licensed Products in and for the Field by any Company Indemnitees infringes the rights of any Third Party to the extent the Claim is based upon or arises out of the Licensed Patents, and for each of subsections (a)-(f), all except to the extent that such Losses are primarily caused by a Company Indemnitee’s breach of applicable law (other than with respect to appl...
By CyDex. CyDex shall defend, indemnify and hold Company and its Affiliates and Sublicensees, and each of their respective directors, officers and employees, harmless from and against any and all losses, damages, liabilities, costs and expenses (including the reasonable costs and expenses of attorneys and other professionals) (collectively “Losses”) incurred by Company as a result of any claim, demand, action or other proceeding (each, a “Claim”) by a third party, to the extent such Losses arise out of ****.
By CyDex. For products being developed by CyDex of its Affiliate (for which CyDex or its Affiliate holds the relevant IND) CyDex shall adhere, and shall require that its Affiliates adhere, to all requirements of applicable law and regulations that relate to the reporting and investigation of any adverse event, including without limitation an unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease attributed to Captisol. CyDex shall provide Company with copies of all reports of any such adverse event which is serious (any such adverse event attributed to Captisol that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in disability, congenital anomaly or is medically important (i.e., may require other medical or surgical intervention to prevent other serious criteria from occurring)) which CyDex has reason to believe are associated with Captisol within two (2) business days following (i) CyDex’s submission of any such report to any regulatory agency, or (ii) receipt from CyDex of any such report. CyDex shall also advise Company regarding any proposed labeling or registration dossier changes affecting Captisol. Reports from CyDex shall be delivered to the attention of Vice President, Chief Scientific Officer, Company, with a copy to Chief Executive Officer, Company, at the address set forth in Section 14.7.
By CyDex. CyDex shall defend, indemnify and hold Company and its Affiliates and Sublicensees, and each of their respective directors, officers and employees, harmless from and against any and all damages, liabilities, costs and expenses (including the reasonable costs and expenses of attorneys and other professionals) (collectively “Losses”) incurred by Company Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. in connection with any claim, demand, action or other proceeding (each, a “Claim”) by a third party, to the extent such Losses arise out of (a) failure of Captisol delivered under this Agreement to conform to the Manufacturing Standards; (b) CyDex’s breach of this Agreement, including without limitation any failure of its representations and warranties set forth in Section 9.1 or 9.2 to have been accurate when made or any breach of the covenants set forth in this Agreement; or (c) the negligence or intentional misconduct of CyDex or any of its Affiliates, or any of their respective directors, officers, employees or Third Party Manufacturers, provided CyDex will not have an indemnification obligation with respect to any Claim to the extent that Company has an indemnification obligation under Section 10.2.
By CyDex. CyDex shall defend, indemnify and hold Company and its Affiliates and Sublicensees, and each of their respective directors, officers and employees, harmless from and against any and all losses, damages, liabilities, costs and expenses (including the reasonable costs and expenses of attorneys and other professionals) (collectively “Losses”) incurred by Company as a result of any claim, demand, action or other proceeding (each, a “Claim”) by a third party, to the extent such Losses arise out of (i) CyDex’s breach of this Agreement, including without limitation any of its representations and warranties set forth in Sections 9.1 and 9.2, (ii) any infringement or alleged infringement of the intellectual property rights of a third party by Captisol alone, but not where the combination of Captisol and any other material is a required element of the alleged or actual infringement, or (iii) CyDex’s or CyDex’s employees’, officers’, directors’ and agents’ negligence or willful misconduct in connection with performance under this Agreement. Notwithstanding the foregoing, CyDex shall have no obligation under this Section 10.1 to the extent that a third party Claim arises from (i) Company’s breach of this Agreement, including without limitation any of its representations and warranties set forth in Section 9.1, or (ii) Company’s or Company’s employees’, officers’, directors’ and agents’ negligence or willful misconduct in connection with performance under this Agreement.
By CyDex. CyDex shall defend, indemnify and hold Prism and its Affiliates and sublicensees, and each of their respective directors, officers and employees, harmless from and against any and all losses, damages, liabilities, costs and expenses (including the reasonable costs and expenses of attorneys and other professionals) (collectively “Losses”) incurred by Prism as a result of any claim, demand, action or other proceeding (each, a “Claim”) by a third party, to the extent such Losses arise out of (a) CyDex’s breach of any of its representations, warranties, covenants or obligations pursuant to this Agreement, (b) the negligence or willful misconduct by CyDex or its Affiliates or Third-Party Manufacturers or their respective officers, directors, employees, agents or consultants in performing any obligations under this Agreement, or (c) failure of CyDex (or its Affiliates or Third-Party Manufacturers) to comply with cGMPs, applicable Specifications or applicable laws, rules or regulations in connection with the manufacture, storage, handling and delivery of CAPTISOL supplied to Prism hereunder; provided, however, that in each of the foregoing subclauses (a) through (c), CyDex shall be relieved of its obligations under this Section 8.1 to the extent such Claims arise out of any of the conditions specified in Section 8.2 below.
By CyDex. CyDex shall defend, indemnify and hold Proteolix and its Affiliates and Sublicensees, and each of their respective directors, officers and employees, harmless from and against any and all losses, damages, liabilities, costs and expenses (including the reasonable costs and expenses of attorneys and other professionals) (collectively “Losses”) incurred by Proteolix as a result of any claim, demand, action or other proceeding (each, a “Claim”) by a third party, to the extent such Losses arise out of: (a) any claim by such third party that the practice of the compositions or methods claimed in the Licensed Patents or the sale of CAPTISOL as included as an excipient within the Product infringe upon such third party’s patent rights; (b) injury or other harm arising from the use of CAPTISOL alone, or (c) CyDex’ breach of any of its representations, warranties and covenants set forth in Section 9 above; provided, however, that the foregoing obligation to indemnify shall not apply to the extent that Proteolix is obligated under Section 10.2 below to indemnify CyDex with respect to a Claim, and CyDex shall be relieved of its obligations under clause (a) of this Section 10.1 for any infringement claim that arises out of: (i) the unauthorized use of the Licensed Patents by Proteolix; or (ii) the manufacture, handling, marketing, sale, distribution or use of Product by Proteolix. If an [ ** ] = 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.
By CyDex. CyDex shall defend, indemnify and hold Sage and its Affiliates and Sublicensees, and each of their respective directors, officers, agents and employees (collectively “Sage Indemnitees”), harmless from and against any and all losses, judgments, damages, liabilities, settlements, penalties, fines, costs and expenses (including the reasonable costs and expenses of attorneys and other professionals) (collectively “Losses”) incurred by any Sage Indemnitees as a result of any claim, demand, action or other proceeding (each, a “Claim”) by a Third Party, to the extent such Losses arise out of: (a) any defect in the supplies or materials provided by CyDex to Sage for use in the CyDex Research Program; (b) infringement of any person’s intellectual property rights relating to Captisol, (c) the negligence or misconduct of CyDex or any CyDex Indemnitees; (d) CyDex’s breach of this Agreement, including without limitation any of its representations and warranties set forth in Section 9.1 or (e) any Claim asserted by a Third Party that is a party to a [***] that is based, in whole or in part, on an alleged breach or impairment of its rights under a [***] (whether such action is styled as a contract claim, tort or other basis).
