Common use of Warranties; Indemnities Clause in Contracts

Warranties; Indemnities. 8.1. Elan represents and warrants to Newco and Celtrix that, as of the Effective Date, to Elan's best knowledge (a) Elan has the right to grant the Elan License and any other rights granted herein, (b) Schedule 1 contains the Elan Patent Rights existing as of the Effective Date, and (c) [*****] 8.2. Newco represents and warrants to Elan that the execution of this Agreement by Newco and the full performance and enjoyment of the rights of Newco under this Agreement will not breach the terms and conditions of any license, contract, understanding or agreement, whether express, implied, written or oral between Newco and any third party. 8.3. Newco represents and warrants to Elan that the Products shall be developed, transported, stored, handled, packaged, marketed, promoted, distributed, offered for sale and sold in accordance with all regulations and requirements of the FDA and Regulatory Authorities including, without limitation, cGCP, cGLP, cGMP regulations. The Products shall not be adulterated or misbranded as defined by the United States Federal Food, Drug and Cosmetic Act (or applicable foreign law) and shall not violate any section of such Act if introduced in interstate commerce. 8.4. In addition to any other indemnifications provided for herein, Elan shall indemnify and hold harmless Newco and its Affiliates and their respective employees, agents, partners, officers and directors from and against any claims, losses, liabilities or damages (including reasonable attorney's fees and expenses) incurred or sustained by Newco arising out of any (a) breach of any representation, covenant, warranty or obligation by Elan hereunder, or (b) any act or omission on the part of Elan or any of its agents or employees in the performance of this Agreement. 8.5. In addition to any other indemnifications provided for herein, Newco shall indemnify and hold harmless Elan and its Affiliates and their respective employees, agents, partners, officers and directors from and against any claims, losses, liabilities or damages [*****] INDICATES THAT CONFIDENTIAL MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND EXCHANGE COMMISSION. (including reasonable attorney's fees and expenses) incurred or sustained by Elan arising out of or in connection with any (a) breach of any representation, covenant, warranty or obligation by Newco hereunder, or (b) any act or omission on the part of Newco or any of its agents or employees in the performance of this Agreement . 8.6. The Party seeking an indemnity shall: 8.6.1 fully notify the other Party of any claim or proceeding, or threatened claim or proceeding within thirty (30) days of becoming aware of such claim or threatened claim; 8.6.2 permit the indemnifying Party to take sole control of the defense and/or settlement of such claim or proceeding; 8.6.3 cooperate in the investigation, defense and/or settlement of such claim or proceeding; 8.6.4 not compromise or otherwise settle any such claim or proceeding without the prior written consent of the other Party, which consent shall not be unreasonably withheld, conditioned or delayed; and 8.6.5 take all reasonable steps to mitigate any loss or liability in respect of any such claim or proceeding. 8.7. NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, IN NO EVENT SHALL ELAN OR NEWCO BE LIABLE TO THE OTHER BY REASON OF ANY REPRESENTATION OR WARRANTY, CONDITION OR OTHER TERM OR ANY DUTY OF COMMON LAW, OR UNDER THE EXPRESS TERMS OF THIS AGREEMENT, FOR ANY CONSEQUENTIAL, INCIDENTAL, SPECIAL, PUNITIVE OR INDIRECT LOSS OR DAMAGE (WHETHER FOR LOSS OF PROFIT OR OTHERWISE) AND WHETHER OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR EMPLOYEES OR AGENTS OR OTHERWISE. 8.8. [*****] ELAN IS GRANTING THE LICENSES HEREUNDER ON AN "AS IS" BASIS WITHOUT RECOURSE, REPRESENTATION OR WARRANTY WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR INFRINGEMENT OF THIRD PARTY RIGHTS, AND ALL SUCH WARRANTIES ARE EXPRESSLY DISCLAIMED.

Warranties; Indemnities. 8.112.1. Elan represents and warrants to Newco and Celtrix that, as of the Effective Date, Company that to Elan's best knowledge knowledge, after reasonable investigations, (a) Elan has the right to grant the Elan License licenses and any other rights granted herein, (b) Schedule 1 contains a summary of the Elan Patent Rights Technology existing as of the Effective Date, and (c) [*****]other than the Maynooth Agreement there are no agreements with any third parties that relate to Elan Technology existing as of Effective Date, (d) that to the best of its knowledge and belief, Elan is not in breach or threatened breach of the Maynooth Agreement and will in the future not procure a breach and (e) there are no agreements with any Independent Third Parties that conflict with the rights granted by Elan pursuant to this Agreement. 8.212.2. Newco Elan represents and warrants to the Company that it has the sole, exclusive and unencumbered right to grant the licenses and rights herein granted to the Company, and that it has not granted any option, license, right or interest in or to the Elan Technology to any Independent Third Party which would conflict with the rights granted by this Agreement. 12.3. The Company represents and warrants to Elan that it has the sole, exclusive and unencumbered right to grant the licenses and rights herein granted to Elan and that it has not granted any option, license, right or interest in or to the Elan Program Technology, the Orasomal Program Technology or the Company Program Technology to any Independent Third Party which would conflict with the rights granted by this Agreement. 12.4. Elan represents and warrants to the Company that to the best of its knowledge, the true inventors of the subject matter claimed are named in the Elan Patents and all such inventors have irrevocably assigned all their rights and interests therein to Elan. 12.5. Elan and the Company each represent and warrant to and for the benefit for each other that the execution of this Agreement by Newco them and the full performance and enjoyment of the rights of Newco them under this Agreement will not breach the terms and conditions of any license, contract, understanding or agreement, whether express, implied, written or oral between Newco them and any third partyIndependent Third Party. 8.3. Newco represents and warrants to Elan that the Products shall be developed, transported, stored, handled, packaged, marketed, promoted, distributed, offered for sale and sold in accordance with all regulations and requirements of the FDA and Regulatory Authorities including, without limitation, cGCP, cGLP, cGMP regulations. The Products shall not be adulterated or misbranded as defined by the United States Federal Food, Drug and Cosmetic Act (or applicable foreign law) and shall not violate any section of such Act if introduced in interstate commerce. 8.412.6. In addition to any other indemnifications provided for herein, Elan shall indemnify and hold harmless Newco the Company and its Affiliates and their respective employees, agents, partners, officers and directors from and against any claims, losses, liabilities or damages (including reasonable attorney's fees and expenses) incurred or sustained by Newco the Company arising out of or in connection with any (a) breach of any representation, covenant, warranty or obligation by Elan hereunder, or (b) any act or omission on the part of Elan or any of its agents or employees in the performance of this Agreement. 8.512.7. In addition to any other indemnifications provided for herein, Newco the Company shall indemnify and hold harmless Elan and its Affiliates and their respective employees, agents, partners, officers and directors from and against any claims, losses, liabilities or damages [*****] INDICATES THAT CONFIDENTIAL MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND EXCHANGE COMMISSION. (including reasonable attorney's fees and expenses) incurred or sustained by Elan arising out of or in connection with any (a) breach of any representation, covenant, warranty or obligation by Newco the Company hereunder. 12.8. The Company shall assume the sole and entire responsibility and shall indemnify and save harmless Elan from any and all claims, liabilities, expenses, including reasonable attorney's fees, responsibilities and damages by reason of any claim, proceedings, action, liability or (b) injury arising out of any act faults of the Product resulting from the transport, packaging, storage, handling, distribution, marketing or omission sale of the Product by the Company, to the extent that it was caused by the negligence or wrongful acts or omissions on the part of Newco or any the Company. 12.9. As a condition of its agents or employees obtaining an indemnity in the performance of this Agreement . 8.6. The circumstances set out above, the Party seeking an indemnity shall: 8.6.1 12.9.1. fully and promptly notify the other Party of any claim or proceeding, or threatened claim or proceeding within thirty (30) days of becoming aware of such claim or threatened claimproceeding; 8.6.2 12.9.2. permit the indemnifying Party to take sole full care and control of the defense and/or settlement of such claim or proceeding; 8.6.3 cooperate 12.9.3. co-operate in the investigation, defense and/or settlement investigation and defence of such claim or proceeding; 8.6.4 12.9.4. not compromise or otherwise settle any such claim or proceeding without the prior written consent of the other Party, which consent shall not be unreasonably withheld, withheld conditioned or delayed; and 8.6.5 12.9.5. take all reasonable steps to mitigate any loss or liability in respect of any such claim or proceeding. 8.712.10. NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, IN NO EVENT ELAN AND NEWCO SHALL ELAN OR NEWCO NOT BE LIABLE TO THE OTHER BY REASON OF ANY REPRESENTATION OR WARRANTY, CONDITION OR OTHER TERM OR ANY DUTY OF COMMON LAW, OR UNDER THE EXPRESS TERMS OF THIS AGREEMENT, FOR ANY CONSEQUENTIAL, INCIDENTAL, SPECIAL, PUNITIVE INDIRECT OR INDIRECT INCIDENTAL LOSS OR DAMAGE (WHETHER FOR LOSS OF PROFIT OR OTHERWISE) AND WHETHER OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR EMPLOYEES OR AGENTS OR OTHERWISE. 8.8. [*****] ELAN IS GRANTING THE LICENSES HEREUNDER ON AN "AS IS" BASIS WITHOUT RECOURSE, REPRESENTATION OR WARRANTY WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR INFRINGEMENT OF THIRD PARTY RIGHTS, AND ALL SUCH WARRANTIES ARE EXPRESSLY DISCLAIMED.

Warranties; Indemnities. 8.113.1. Elan and EMT represents and warrants to the Company that to their respective best knowledge, after reasonable investigations:- 13.1.1. Elan and EMT have the right to grant the licenses and rights granted herein; 13.1.2. Schedule 1 contains a summary of the primary pending patent applications and issued patents comprising the Elan Patents existing as of the Effective Date; 13.1.3. there are no agreements between Elan, EMT, NanoSystems or Sano and any Independent Third Parties that conflict with the rights granted by Elan in or pursuant to this Agreement, 13.2. Elan represents and warrants to Newco and Celtrix that, as of the Effective Date, to Elan's best knowledge (a) Elan has the right to grant Company that the Elan License and any other rights granted herein, (b) Patents listed in Schedule 1 contains the are solely owned by Elan Patent Rights existing as or EMT and are free and clear of the Effective Date, encumbrances and (c) [*****]liens. 8.213.3. Newco The Company represents and warrants to Elan that it has the execution of this Agreement by Newco sole, exclusive and unencumbered right to grant the full performance licenses and enjoyment of rights herein granted to Elan and that it has not granted any option, license, right or interest in or to the Company Technology to any Independent Third Party which would conflict with the rights of Newco under granted by this Agreement will not breach the terms and conditions of any license, contract, understanding or agreement, whether express, implied, written or oral between Newco and any third partyAgreement. 8.313.4. Newco Elan represents and warrants to Elan that the Products shall be developed, transported, stored, handled, packaged, marketed, promoted, distributed, offered for sale and sold in accordance with all regulations and requirements Company as of the FDA and Regulatory Authorities including, without limitation, cGCP, cGLP, cGMP regulationsdate of the Effective Date:- 13.4.1. The Products shall not be adulterated or misbranded as defined by the United States Federal Food, Drug and Cosmetic Act (or applicable foreign law) and shall not violate any section of such Act if introduced in interstate commerce[****]; 13.4.2. [****]; and 13.4.3. [****]. 8.413.5. In addition to any other indemnifications provided for herein, Elan shall indemnify and hold harmless Newco the Company and its Affiliates and their respective employees, agents, partners, officers and directors from and against any claims, losses, liabilities or damages (including reasonable attorney's fees and expenses) incurred or sustained by Newco the Company arising out of or in connection with any (a) breach of any representation, covenant, warranty or obligation by Elan or EMT hereunder, or (b) any act or omission on the part of Elan or any of its agents or employees in the performance of this Agreement. 8.513.6. In addition to any other indemnifications provided for herein, Newco the Company shall indemnify and hold harmless Elan and its Affiliates and their respective employees, agents, partners, officers and directors from and against any claims, losses, liabilities or damages [*****] INDICATES THAT CONFIDENTIAL MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND EXCHANGE COMMISSION. (including reasonable attorney's fees and expenses) incurred or sustained by Elan arising out of or in connection with any (a) breach of any representation, covenant, warranty or obligation by Newco the Company hereunder. 13.7. The Company shall assume the sole and entire responsibility and shall indemnify and save harmless Elan from any and all claims, liabilities, expenses, including reasonable attorney's fees, responsibilities and damages by reason of any claim, proceedings, action, liability or (b) injury arising out of any act faults of the Elan Royalty Products resulting from the transport, packaging, storage, handling, distribution, marketing or omission sale of the Elan Royalty Products by the Company, to the extent that it was caused by the negligence or wrongful acts or omissions on the part of Newco or any the Company. 13.8. As a condition of its agents or employees obtaining an indemnity in the performance of this Agreement . 8.6. The circumstances set out above, the Party seeking an indemnity shall: 8.6.1 13.8.1. fully and promptly notify the other Party of any claim or proceeding, or threatened claim or proceeding within thirty (30) days of becoming aware of such claim or threatened claimproceeding; 8.6.2 13.8.2. permit the indemnifying Party to take sole full care and control of the defense and/or settlement of such claim or proceeding; 8.6.3 cooperate 13.8.3. co-operate in the investigation, defense and/or settlement investigation and defence of such claim or proceeding;; _____________ [****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 8.6.4 13.8.4. not compromise or otherwise settle any such claim or proceeding or make any formal written admission in the course of proceedings without the prior written consent of the other Party, which consent shall not be unreasonably withheld, withheld conditioned or delayed; and 8.6.5 13.8.5. take all reasonable steps to mitigate any loss or liability in respect of any such claim or proceeding. 8.713.9. [****] NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, IN NO EVENT NONE OF THE PARTIES SHALL ELAN OR NEWCO BE LIABLE TO THE OTHER OTHERS BY REASON OF ANY REPRESENTATION OR WARRANTY, CONDITION OR OTHER TERM OR ANY DUTY OF COMMON LAW, OR UNDER THE EXPRESS TERMS OF THIS AGREEMENT, FOR ANY CONSEQUENTIAL, INCIDENTAL, SPECIAL, PUNITIVE INDIRECT OR INDIRECT INCIDENTAL LOSS OR DAMAGE (WHETHER FOR LOSS OF PROFIT OR OTHERWISE) AND WHETHER OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR EMPLOYEES OR AGENTS OR OTHERWISE. 8.8. [*****] ELAN IS GRANTING THE LICENSES HEREUNDER ON AN "AS IS" BASIS WITHOUT RECOURSE, REPRESENTATION OR WARRANTY WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR INFRINGEMENT OF THIRD PARTY RIGHTS, AND ALL SUCH WARRANTIES ARE EXPRESSLY DISCLAIMED.

Warranties; Indemnities. 8.112.1. Elan represents and warrants to Newco and Celtrix that, as of the Effective Date, Company that to Elan's best knowledge knowledge, after reasonable investigations, (a) Elan has the right to grant the Elan License licenses and any other rights granted herein, (b) Schedule 1 contains a summary of the Elan Patent Rights Technology existing as of the Effective Date, and (c) other than [****] there are no agreements with any third parties that relate to Elan Technology existing as of Effective Date, (d) that to the best of its knowledge and belief, Elan is not in breach or threatened breach of the [*]***] and will in the future not procure a breach and (e) there are no agreements with any Independent Third Parties that conflict with the rights granted by Elan pursuant to this Agreement. 8.212.2. Newco Elan represents and warrants to the Company that it has the sole, exclusive and unencumbered right to grant the licenses and rights herein granted to the Company, and that it has not granted any option, license, right or interest in or to the Elan Technology to any Independent Third Party which would conflict with the rights granted by this Agreement. 12.3. The Company represents and warrants to Elan that it has the sole, exclusive and unencumbered right to grant the licenses and rights herein granted to Elan and that it has not granted any option, license, right or interest in or to the Elan Program Technology, the Orasomal Program Technology or the Company Program Technology to any Independent Third Party which would conflict with the rights granted by this Agreement. 12.4. Elan represents and warrants to the Company that to the best of its knowledge, the true inventors of the subject matter claimed are named in the Elan Patents and all such inventors have irrevocably assigned all their rights and interests therein to Elan. 12.5. Elan and the Company each represent and warrant to and for the benefit for each other that the execution of this Agreement by Newco them and the full performance and enjoyment of the rights of Newco them under this Agreement will not breach the terms and conditions of any license, contract, understanding or agreement, whether express, implied, written or oral between Newco them and any third partyIndependent Third Party. **** REPRESENTS MATERIAL REACTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 8.3. Newco represents and warrants to Elan that the Products shall be developed, transported, stored, handled, packaged, marketed, promoted, distributed, offered for sale and sold in accordance with all regulations and requirements of the FDA and Regulatory Authorities including, without limitation, cGCP, cGLP, cGMP regulations. The Products shall not be adulterated or misbranded as defined by the United States Federal Food, Drug and Cosmetic Act (or applicable foreign law) and shall not violate any section of such Act if introduced in interstate commerce. 8.412.6. In addition to any other indemnifications provided for herein, Elan shall indemnify and hold harmless Newco the Company and its Affiliates and their respective employees, agents, partners, officers and directors from and against any claims, losses, liabilities or damages (including reasonable attorney's fees and expenses) incurred or sustained by Newco the Company arising out of or in connection with any (a) breach of any representation, covenant, warranty or obligation by Elan hereunder, or (b) any act or omission on the part of Elan or any of its agents or employees in the performance of this Agreement. 8.512.7. In addition to any other indemnifications provided for herein, Newco the Company shall indemnify and hold harmless Elan and its Affiliates and their respective employees, agents, partners, officers and directors from and against any claims, losses, liabilities or damages [*****] INDICATES THAT CONFIDENTIAL MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND EXCHANGE COMMISSION. (including reasonable attorney's fees and expenses) incurred or sustained by Elan arising out of or in connection with any (a) breach of any representation, covenant, warranty or obligation by Newco the Company hereunder. 12.8. The Company shall assume the sole and entire responsibility and shall indemnify and save harmless Elan from any and all claims, liabilities, expenses, including reasonable attorney's fees, responsibilities and damages by reason of any claim, proceedings, action, liability or (b) injury arising out of any act faults of the Product resulting from the transport, packaging, storage, handling, distribution, marketing or omission sale of the Product by the Company, to the extent that it was caused by the negligence or wrongful acts or omissions on the part of Newco or any the Company. 12.9. As a condition of its agents or employees obtaining an indemnity in the performance of this Agreement . 8.6. The circumstances set out above, the Party seeking an indemnity shall: 8.6.1 12.9.1. fully and promptly notify the other Party of any claim or proceeding, or threatened claim or proceeding within thirty (30) days of becoming aware of such claim or threatened claimproceeding; 8.6.2 12.9.2. permit the indemnifying Party to take sole full care and control of the defense and/or settlement of such claim or proceeding; 8.6.3 cooperate 12.9.3. co-operate in the investigation, defense and/or settlement investigation and defence of such claim or proceeding; 8.6.4 12.9.4. not compromise or otherwise settle any such claim or proceeding without the prior written consent of the other Party, which consent shall not be unreasonably withheld, withheld conditioned or delayed; and 8.6.5 12.9.5. take all reasonable steps to mitigate any loss or liability in respect of any such claim or proceeding. 8.712.10. NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, IN NO EVENT ELAN AND NEWCO SHALL ELAN OR NEWCO NOT BE LIABLE TO THE OTHER BY REASON OF ANY REPRESENTATION OR WARRANTY, CONDITION OR OTHER TERM OR ANY DUTY OF COMMON LAW, OR UNDER THE EXPRESS TERMS OF THIS AGREEMENT, FOR ANY CONSEQUENTIAL, INCIDENTAL, SPECIAL, PUNITIVE INDIRECT OR INDIRECT INCIDENTAL LOSS OR DAMAGE (WHETHER FOR LOSS OF PROFIT OR OTHERWISE) AND WHETHER OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR EMPLOYEES OR AGENTS OR OTHERWISE. 8.8. [*****] ELAN IS GRANTING THE LICENSES HEREUNDER ON AN "AS IS" BASIS WITHOUT RECOURSE, REPRESENTATION OR WARRANTY WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR INFRINGEMENT OF THIRD PARTY RIGHTS, AND ALL SUCH WARRANTIES ARE EXPRESSLY DISCLAIMED.

Warranties; Indemnities. 8.1. 8.1 Elan represents and warrants to Newco and Celtrix TGEN, as a third party beneficiary, that: (a) Elan is a corporation duly organized under the laws of its jurisdiction of organization and has all the requisite corporate power and authority to own and lease its respective properties, to carry on its respective business as presently conducted and as proposed to be conducted and to carry out the transactions contemplated hereby; (b) Elan has full corporate power and authority to enter into this Agreement and to perform its obligations hereunder, which have been duly authorized by all requisite corporate action of Elan. This Agreement is the valid and binding obligation of Elan, enforceable against it in accordance with its terms, except as limited by applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting the enforcement of creditors' rights generally, and by general equity principles and limitations on the availability of equitable relief, including specific performance; (c) The execution, delivery and performance by Elan of this Agreement will not: (i) violate any provision of applicable law, statute, rule or regulation known by and applicable to Elan or any ruling, writ, injunction, order, judgment or decree of any court, arbitrator, administrative agency or other governmental body applicable to Elan or any of its properties or assets; or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of the charter or organizational documents of Elan; (d) To Elan's best knowledge, except as set forth on Schedule 2 hereto, as of the Effective Date, to Elan's best knowledge : (ai) Elan has the right to grant the Elan License and any other rights granted herein, (bii) Schedule 1 contains primary examples of the Elan Patent Rights Intellectual Property existing as of the Effective Date, which listing is not necessarily exhaustive, (iii) there are no agreements between Elan and any third parties that conflict with the Elan License which would have a material adverse effect on the ability of Newco to conduct the Project, and (civ) [*****]Elan is the owner or licensee of all rights, title and interest in the Elan Intellectual Property. 8.2. 8.2 Newco represents and warrants to Elan that that: (a) Newco is duly and validly existing in good standing in the jurisdiction of its incorporation and each other jurisdiction in which the conduct of its business requires such qualification (except where such failure to so qualify shall not have a material adverse affect on the business and assets of Newco), and Newco is in compliance with all applicable laws, rules, regulations or orders relating to its business and assets; (b) Newco has full corporate authority to execute and deliver this Agreement and to consummate the transactions contemplated hereby; this Agreement has been duly executed and delivered and constitutes the legal and valid obligations of Newco and is enforceable against Newco in accordance with its terms; and the execution, delivery and performance of this Agreement and the transactions contemplated hereby will not violate or result in a default under or creation of lien or encumbrance under Newco's certificate of incorporation, by-laws or other organic documents, any material agreement or instrument binding upon or affecting Newco, or its properties or assets or any applicable laws, rules, regulations or orders affecting Newco or its properties or assets; (c) Newco is not in default of its charter or by-laws, any applicable laws or regulations or any material contract or agreement binding upon or affecting it or its properties or assets and the execution, delivery and performance of this Agreement and the transactions contemplated hereby will not result in any such violation; (d) The execution of this Agreement by Newco and the full performance and enjoyment of the rights of Newco under this Agreement will not breach the terms and conditions of any license, contract, understanding or agreement, whether express, implied, written or oral between Newco and any third party.; 8.3. (e) Newco represents has the sole, exclusive and warrants unencumbered right to grant the licenses and rights herein granted to Elan and that it has not granted and will not grant any option, license, right or interest in or to the Elan Intellectual Property, the Newco Technology, or other property to any third party which would conflict with the rights granted by this Agreement and the Definitive Documents; (f) The Products shall be developed, manufactured, transported, stored, handled, packaged, marketed, promoted, distributed, offered for sale and sold in accordance with all regulations and requirements of the FDA and Regulatory Authorities foreign regulatory authorities including, without limitation, cGCP, cGLP, cGMP regulations. The Products shall not be adulterated or misbranded as defined by the United States Federal Food, Drug and Cosmetic Act (or applicable foreign law) and shall not be a product which would violate any section of such Act if introduced in interstate commerce; and (g) It is fully cognizant of all applicable statutes, ordinances and regulations of the United States of America and countries in the Territory with respect to the manufacture of the Products including, but not limited to, the U.S. Federal Food, Drug and Cosmetic Act and regulations thereunder and similar statutes in countries outside of the United States. Newco shall manufacture or procure the manufacture of the Products in conformity with the Marketing Authorizations and in a manner which fully complies with all United States of America and foreign statutes, ordinances, regulations and practices. 8.4. 8.3 In addition to any other indemnifications provided for herein, Elan shall indemnify and hold harmless Newco Newco, TGEN and its their Affiliates and their respective employees, agents, partners, officers and directors from and against any claims, losses, liabilities or damages (including reasonable attorney's fees and expenses) incurred or sustained by Newco arising out of or in connection with any (a) breach of any representation, covenant, warranty or obligation by Elan hereunder, or (b) any act or omission on the part of Elan or any of its agents or employees in the performance of this Agreement. 8.5. 8.4 In addition to any other indemnifications provided for herein, Newco shall indemnify and hold harmless Elan and its Affiliates and their respective employees, agents, partners, officers and directors from and against any claims, losses, liabilities or damages [*****] INDICATES THAT CONFIDENTIAL MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES AND EXCHANGE COMMISSION. (including reasonable attorney's fees and expenses) incurred or sustained by Elan arising out of or in connection with any (a) breach of any representation, covenant, warranty or obligation by Newco hereunder, or (b) any act or omission on the part of Newco or any of its agents or employees in the performance of this Agreement Agreement. 8.6. 8.5 The Party Person seeking an indemnity shall: 8.6.1 8.5.1 fully and promptly notify the other indemnifying Party of any claim or proceeding, or threatened claim or proceeding within thirty (30) days of becoming aware of such claim or threatened claimproceeding; 8.6.2 8.5.2 permit the indemnifying Party to take sole full care and control of the defense and/or settlement of such claim or proceeding; 8.6.3 8.5.3 cooperate in the investigation, investigation and defense and/or settlement of such claim or proceeding; 8.6.4 8.5.4 not compromise or otherwise settle any such claim or proceeding without the prior written consent of the other indemnifying Party, which consent shall not be unreasonably withheld, conditioned or delayed; and 8.6.5 8.5.5 take all reasonable steps to mitigate any loss or liability in respect of any such claim or proceeding. 8.7. 8.6 NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, IN NO EVENT NEITHER ELAN NOR NEWCO SHALL ELAN OR NEWCO BE LIABLE TO THE OTHER PARTY, BY REASON OF ANY REPRESENTATION OR WARRANTY, CONDITION OR OTHER TERM OR ANY DUTY OF COMMON LAW, OR UNDER THE EXPRESS TERMS OF THIS AGREEMENT, FOR ANY CONSEQUENTIAL, INCIDENTAL, SPECIAL, PUNITIVE CONSEQUENTIAL OR INDIRECT INCIDENTAL LOSS OR DAMAGE (WHETHER FOR LOSS OF PROFIT OR OTHERWISE) AND WHETHER OCCASIONED BY THE APPLICABLE PARTY'S NEGLIGENCE OR THAT OF THE RESPECTIVE PARTIES, THEIR ITS EMPLOYEES OR AGENTS OR OTHERWISE. 8.8. [*****] 8.7 EXCEPT AS SET FORTH IN THIS SECTION 8, ELAN IS GRANTING THE LICENSES ELAN LICENSE HEREUNDER ON AN "AS IS" BASIS WITHOUT RECOURSE, REPRESENTATION OR WARRANTY WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR INFRINGEMENT OF THIRD PARTY RIGHTS, AND ALL SUCH WARRANTIES ARE EXPRESSLY DISCLAIMED.