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 under the Supply Agreement); (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 Section 9.1, 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. 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. 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 herein; (ii) the research, development, manufacture, use, handling, promotion, marketing, distribution, importation, sale or offering for sale of Captisol by CyDex, its Affiliates, distributors or agents (for clarity, such terms shall not include Company in any event); or (iii) interactions and communications by CyDex, its Affiliates, distributors or agents (for clarity, such terms shall not include Company in any event) with governmental authorities, physicians or other third parties relating to Captisol, including the Captisol Data Package.
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).
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: (a) 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 Licensed Product infringe upon such third party's patent rights provided that such claim does not arise out of Company's or its Affiliates' or Sublicensees' unauthorized use of the Licensed Patents; or (b) CyDex's breach of any of its representations and warranties set forth in SECTION 9.1 or SECTION 9.2 above; provided, however, that CyDex shall be relieved of its obligations under this SECTION 10.1 to the extent that Company is responsible under SECTION 10.2
