Common use of Catalent Clause in Contracts

Catalent. Catalent represents, warrants and undertakes to Client that: A. this Agreement has been duly executed and delivered by Catalent’s authorized representative and, assuming the due authorization, execution and delivery hereof by Client, constitutes and will at all times constitute the legal, valid and binding obligation of Catalent enforceable against Catalent in accordance with its terms, subject to the effects of bankruptcy, insolvency, reorganization, moratorium and other similar laws relating to or affecting creditor’s rights generally and to general principles of equity; B. Catalent has no obligations, contractual or otherwise, that would conflict with Catalent entering into and performing its obligations set forth in this Agreement; C. at the time of delivery by Catalent to the designated carrier hereunder, the Supplies shall have been manufactured in accordance with Applicable Laws and shall not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws; provided, that Catalent shall not be liable for defects attributable to Drug or other Client-supplied Materials (including artwork, advertising, packaging and labeling) provided to Catalent by Client or its Affiliates; (i) to Catalent’s knowledge, it has all necessary authority to use and to permit Client to use pursuant to the terms of this Agreement and the performance of services contemplated hereunder, all Catalent IP related to the Drug and the Zydis Technology, including any copyrights, trademarks, trade secrets, patents, inventions and developments; (ii) to Catalent’s knowledge and except pursuant to which Catalent has a valid license, there are no patents, trade secrets or other proprietary rights owned by others that would be infringed or misused by Catalent’s performance of the Agreement; and (iii) to Catalent’s knowledge and except pursuant to which Catalent has a valid license, no trade secrets or other proprietary rights of others related to the Catalent IP utilized with the Drug or Zydis Technology that would be infringed or misused by Catalent’s performance of this Agreement; E. no transactions or dealings under this Agreement shall be conducted with or for an individual or entity that is designated as the target of any sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom or the United States of America; and F. Catalent will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b).

Catalent. Catalent represents, represents and warrants and undertakes to Client that: A. this Agreement has been duly executed and delivered by Catalent’s authorized representative and, assuming the due authorization, execution and delivery hereof by Client, constitutes and will at all times constitute the legal, valid and binding obligation of Catalent enforceable against Catalent in accordance with its terms, subject to the effects of bankruptcy, insolvency, reorganization, moratorium and other similar laws relating to or affecting creditor’s rights generally and to general principles of equity; B. Catalent has no obligations, contractual or otherwise, that would conflict with Catalent entering into and performing its obligations set forth in this Agreement; C. at the time of delivery by Catalent of the Product as provided in Section 6.1, such Product will conform to the designated carrier hereunder, the Supplies shall and will have been manufactured Processed and/or Packaged in accordance conformance with Applicable Laws the Product Specifications and shall not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws; provided, provided that Catalent shall not be liable for defects attributable to Drug API or other Client-Client supplied Materials materials (including artwork, advertisingpackaging, packaging and labeling) provided to Catalent by Client or its Affiliates); (i) B. it has, and shall have, good, complete and valid rights to Catalent’s utilize the Catalent Technology utilized in connection with the Product and as contemplated by this Agreement. To its knowledge, it has all necessary authority to use and to permit Client to use pursuant to the terms of this Agreement and the performance of services contemplated hereunder, all Catalent IP related to the Drug and the Zydis Technology, including any copyrights, trademarks, trade secrets, patents, inventions and developments; (ii) to Catalent’s knowledge and except pursuant to which Catalent has a valid license, there are no patents, trade secrets or other proprietary rights patents owned by others that related to the Catalent Technology used with 14 ***Confidential Treatment Requested the Product which would be infringed or misused by Catalent’s performance of the Agreement; and (iii) Agreement and, to Catalent’s knowledge and except pursuant to which Catalent has a valid licenseits knowledge, there are no trade secrets or other proprietary rights of others related to the Catalent IP utilized Technology used with the Drug or Zydis Technology that Product which would be infringed or misused by Catalent’s performance of this Agreement; E. no transactions or dealings under this Agreement shall C. All Products will be conducted with or for an individual or entity that is designated as Processed and Packaged at the target of any sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom or the United States of AmericaFacilities; and F. D. Catalent will not in the comply with all Applicable Laws relative to Catalent’s performance of its obligations under this Agreement use the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b)Agreement. E. THE LIMITED WARRANTY SET FORTH IN THIS SECTION 12.1 IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY AND ANY WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE. EXCEPT FOR THE WARRANTY EXPRESSED IN THIS SECTION 12.1, CATALENT MAKES NO OTHER WARRANTY, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE PROCESSING OR THE PRODUCT. IN ADDITION, CATALENT HEREBY DISCLAIMS LIABILITY FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES FOR BREACH OF ANY EXPRESS OR IMPLIED WARRANTY, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY AND ANY IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO PRODUCT.

Catalent. Catalent represents, warrants and undertakes to Client Vaccinex that, unless otherwise agreed to by the parties in the SOW: A. this Agreement has been duly executed and delivered by Catalent’s authorized representative and, assuming the due authorization, execution and delivery hereof by Client, constitutes and will at Catalent shall perform all times constitute the legal, valid and binding obligation of Catalent enforceable against Catalent Services in accordance with its terms, subject to the effects of bankruptcy, insolvency, reorganization, moratorium SOW and other similar laws relating to or affecting creditor’s rights generally and to general principles of equityall Applicable Laws; B. Catalent has no obligationswhen Manufacturing and/or Fill Finishing Drug Substance or Drug Product, contractual or otherwise, that would conflict with Catalent entering into and performing its obligations set forth in this Agreement; C. at the time of tender of delivery by Catalent to the designated carrier hereunderas provided in Section 2.10, the Supplies Drug Substance and/or Drug Product shall have been manufactured Manufactured and/or Fill Finished (as applicable) in accordance with Applicable Laws and in conformance with Specifications, and shall not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws; , provided, that Catalent shall not be liable for defects to the extent directly attributable to Drug or other ClientVaccinex-supplied Materials (including artwork, advertising, packaging and labeling) provided to Catalent ), which were properly used by Client or its AffiliatesCatalent; (i) C. Catalent is free to supply to Vaccinex the Catalent Confidential Information and all other information to be supplied by Catalent to Vaccinex under this Agreement, and, Catalent has the legal right to grant Vaccinex the rights set forth in Section 7 of this Agreement; D. without having made any investigation or search solely for the purposes of this representation, to the best of Catalent’s knowledge, it the use by Catalent of Catalent Intellectual Property in accordance with the terms of this Agreement and in performance of the Services hereunder (including its use in the Manufacture of the Drug Substance and/or Drug Product, but excluding the Drug Substance and/or Drug Product itself), do not and will not infringe any intellectual property rights or industrial property rights of any third party and do not involve the wrongful use of any trade secret or confidential information; E. Catalent owns or lawfully controls the Facility, and has sufficient facilities and equipment, as well as a sufficient number of employees with such expertise and experience, as is necessary or appropriate to perform the Services in accordance with the terms hereof; F. the Facility, and all the processes used in producing Expression Product, Drug Substance and/or Drug Product and performing the Services, shall be in accordance with cGMP, if applicable; G. Catalent has the corporate power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder; and H. Catalent has taken all necessary authority corporate action on its part to use authorize the execution and to permit Client to use pursuant to the terms delivery of this Agreement and the performance of services contemplated hereunder, all Catalent IP related to the Drug and the Zydis Technology, including any copyrights, trademarks, trade secrets, patents, inventions and developments; (ii) to Catalent’s knowledge and except pursuant to which Catalent has a valid license, there are no patents, trade secrets or other proprietary rights owned by others that would be infringed or misused by Catalent’s performance of the Agreement; and (iii) to Catalent’s knowledge and except pursuant to which Catalent has a valid license, no trade secrets or other proprietary rights of others related to the Catalent IP utilized with the Drug or Zydis Technology that would be infringed or misused by Catalent’s performance of this Agreement; E. no transactions or dealings under this Agreement shall be conducted with or for an individual or entity that is designated as the target of any sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom or the United States of America; and F. Catalent will not in the performance of its obligations under this hereunder. This Agreement use the services has been duly executed and delivered on behalf of any person debarred or suspended under 21 U.S.C. §335(a) or (b)Catalent, and constitutes a legal, valid, binding obligation, enforceable against Catalent in accordance with its terms.

Catalent. Catalent represents, represents and warrants and undertakes to Client that: A. this Agreement has been duly executed and delivered by Catalent’s authorized representative and, assuming the due authorization, execution and delivery hereof by Client, constitutes and will at all times constitute the legal, valid and binding obligation of Catalent enforceable against Catalent in accordance with its terms, subject to the effects of bankruptcy, insolvency, reorganization, moratorium and other similar laws relating to or affecting creditor’s rights generally and to general principles of equity; B. Catalent has no obligations, contractual or otherwise, that would conflict with Catalent entering into and performing its obligations set forth in this Agreement; C. at the time of delivery by Catalent of the Product as provided in Section 6.1, such Product will conform to the designated carrier hereunder, the Supplies shall and will have been manufactured Processed and/or Packaged in accordance conformance with Applicable Laws the Product Specifications and shall not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws; provided, provided that Catalent shall not be liable for defects attributable to Drug API or other Client-Client supplied Materials materials (including artwork, advertisingpackaging, packaging and labeling) provided to Catalent by Client or its Affiliates); (i) B. it has, and shall have, good, complete and valid rights to Catalent’s utilize the Catalent Technology utilized in connection with the Product and as contemplated by this Agreement. To its knowledge, it has all necessary authority to use and to permit Client to use pursuant to the terms of this Agreement and the performance of services contemplated hereunder, all Catalent IP related to the Drug and the Zydis Technology, including any copyrights, trademarks, trade secrets, patents, inventions and developments; (ii) to Catalent’s knowledge and except pursuant to which Catalent has a valid license, there are no patents, trade secrets or other proprietary rights patents owned by others that related to the Catalent Technology used with the Product which would be infringed or misused by Catalent’s performance of the Agreement; and (iii) Agreement and, to Catalent’s knowledge and except pursuant to which Catalent has a valid licenseits knowledge, there are no trade secrets or other proprietary rights of others related to the Catalent IP utilized Technology used with the Drug or Zydis Technology that Product which would be infringed or misused by Catalent’s performance of this Agreement; E. no transactions or dealings under this Agreement shall C. All Products will be conducted with or for an individual or entity that is designated as Processed and Packaged at the target of any sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom or the United States of AmericaFacilities; and F. D. Catalent will not in the comply with all Applicable Laws relative to Catalent’s performance of its obligations under this Agreement use the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b)Agreement. E. THE LIMITED WARRANTY SET FORTH IN THIS SECTION 12.1 IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY AND ANY WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE. EXCEPT FOR THE WARRANTY EXPRESSED IN THIS SECTION 12.1, CATALENT MAKES NO OTHER WARRANTY, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE PROCESSING OR THE PRODUCT. IN ADDITION, CATALENT HEREBY DISCLAIMS LIABILITY FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES FOR BREACH OF ANY EXPRESS OR IMPLIED WARRANTY, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY AND ANY IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO PRODUCT.

Catalent. Catalent represents, warrants and undertakes to Client that: A. this Agreement has been duly executed and delivered by Catalent’s authorized representative and, assuming the due authorization, execution and delivery hereof by Client, constitutes and will at all times constitute the legal, valid and binding obligation of Catalent enforceable against Catalent in accordance with its terms, subject to the effects of bankruptcy, insolvency, reorganization, moratorium and other similar laws relating to or affecting creditor’s rights generally and to general principles of equity; B. Catalent has no obligations, contractual or otherwise, that would conflict with Catalent entering into and performing its obligations set forth in this Agreement; C. at the time of delivery by Catalent to the designated carrier hereunderas provided in Section 6.1, the Supplies Product shall have been manufactured Processed in accordance with this Agreement and with Applicable Laws and in conformance with the Specifications and shall not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws; provided, that Catalent shall not be liable for defects attributable to Drug or other Client-supplied Materials (including artwork, advertising, packaging advertising and labeling); B. all personnel, employees, and agents of Catalent and its Affiliates and their respective subcontractors who perform services, are and will continue to be qualified and to have sufficient technical expertise to perform Catalent’s obligations under this Agreement; C. Catalent has the full power and authority to execute and deliver this Agreement and perform its covenants, duties, and obligations described in this Agreement, and once executed, this Agreement will be a valid, legal, and binding obligation upon Catalent; D. Catalent is not now, nor will it be, a party to any agreement which would prevent Catalent from fulfilling its obligations under this Agreement, and that during the Term of this Agreement will not enter into any agreement with any other party that would in any way prevent Catalent from performing its obligations under this Agreement; E. Catalent will maintain all records and reports as required under this Agreement, and as required to comply with Applicable Laws. F. Catalent will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended (or subject to debarment or suspension) provided to Catalent under 21 U.S.C. §335(a) or (b) or otherwise disqualified by Client or its AffiliatesApplicable Law; (i) Catalent is not nor has it ever been, and (ii) Catalent has not used, and will not use, the services of any person excluded, debarred, suspended, or otherwise ineligible to participate in the Federal health care programs or in Federal procurement or non-procurement programs, and has not used, and will not use, the services of any person listed on the HHS/OIG List of Excluded Individuals/Entities (hxxx://xxx.xxx.xxx.xxx), the GSA’s List of Parties Excluded from Federal Programs (hxxx://xxx.xxxx.xxx), or the FDA Debarment List (hxxx://xxx.xxx.xxx/xxx/compliance_ref/debar/default.htm), as amended or replaced from time to time, in connection with any of the services performed under this Agreement. Catalent further certifies that it, and any other person or entity used by Catalent in performing any of the services under this Agreement, has not been convicted of a criminal offense that falls within the ambit of 42 U.S.C. §1320a-7(a). Catalent agrees to notify Client promptly in the event Catalent’s knowledge, it or any person used by Catalent in connection with this Agreement, ever becomes excluded, debarred, suspended, or otherwise ineligible to participate in Federal health care programs or in Federal procurement or non-procurement programs. This certification applies to Catalent and its respective officers, agents, and employees as well as subcontractors performing on behalf of Catalent under this Agreement; H. Catalent has all necessary authority to use the Catalent technology utilized with the Product and to permit Client to use pursuant to the terms of as contemplated by this Agreement and the performance of services contemplated hereunder, all Catalent IP Agreement; there are no patents owned by others related to the Drug and Catalent IP utilized with the Zydis Technology, including any copyrights, trademarks, trade secrets, patents, inventions and developments; (ii) to Catalent’s knowledge and except pursuant to which Catalent has a valid license, there are no patents, trade secrets or other proprietary rights owned by others Product that would be infringed or misused by Catalent’s performance of the Agreement; and (iii) and, to Catalent’s knowledge and except pursuant to which Catalent has a valid licenseits knowledge, no trade secrets or other proprietary rights of others related to the Catalent IP utilized with the Drug or Zydis Technology Product that would be infringed or misused by Catalent’s performance of this Agreement; E. I. Catalent will not release any Batch of Product if the required certificates of conformance indicate that Product does not comply with the Specifications; and J. no transactions or dealings under this Agreement shall be conducted with or for an individual or entity that is designated as the target of any sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom Kingdom, or the United States of America; and F. Catalent will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b)States.

Catalent. Catalent represents, warrants and undertakes to Client that: A. this Agreement has been duly executed and delivered by Catalent’s authorized representative and, assuming the due authorization, execution and delivery hereof by Client, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ***Text Omitted and Filed Separately Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(B)(4) and 230.406 constitutes and will at all times constitute the legal, valid and binding obligation of Catalent enforceable against Catalent in accordance with its terms, subject to the effects of bankruptcy, insolvency, reorganization, moratorium and other similar laws relating to or affecting creditor’s rights generally and to general principles of equity; B. Catalent has no obligations, contractual or otherwise, that would conflict with Catalent entering into and performing its obligations set forth in this Agreement; C. at the time of delivery by Catalent to the designated carrier hereunder, the Supplies shall have been manufactured in accordance with Applicable Laws and shall not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws; provided, that Catalent shall not be liable for defects attributable to Drug or other Client-supplied Materials (including artwork, advertising, packaging and labeling) provided to Catalent by Client or its Affiliates; (i) to Catalent’s knowledge, it has all necessary authority to use and to permit Client to use pursuant to the terms of this Agreement and the performance of services contemplated hereunder, all Catalent IP related to the Drug and the Zydis Technology, including any copyrights, trademarks, trade secrets, patents, inventions and developments; (ii) to Catalent’s knowledge and except pursuant to which Catalent has a valid license, there are no patents, trade secrets or other proprietary rights owned by others that would be infringed or misused by Catalent’s performance of the Agreement; and (iii) to Catalent’s knowledge and except pursuant to which Catalent has a valid license, no trade secrets or other proprietary rights of others related to the Catalent IP utilized with the Drug or Zydis Technology that would be infringed or misused by Catalent’s performance of this Agreement; E. no transactions or dealings under this Agreement shall be conducted with or for an individual or entity that is designated as the target of any sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom or the United States of America; and F. Catalent will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b).

Catalent. Catalent represents, warrants and undertakes to Client that: A. this Agreement has been duly executed and delivered by Catalent’s authorized representative and, assuming the due authorization, execution and delivery hereof by Client, constitutes and will at all times constitute the legal, valid and binding obligation of Catalent enforceable against Catalent in accordance with its terms, subject to the effects of bankruptcy, insolvency, reorganization, moratorium and other similar laws relating to or affecting creditor’s rights generally and to general principles of equity; B. Catalent has no obligations, contractual or otherwise, that would conflict with Catalent entering into and performing its obligations set forth in this Agreement; C. at the time of delivery by Catalent to the designated carrier hereunderas provided in Section 6.1, the Supplies Product shall have been manufactured Processed in accordance with this Agreement and with Applicable Laws and in conformance with the Specifications and shall not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws; provided, that Catalent shall not be liable for defects attributable to Drug or other Client-supplied Materials (including artwork, advertising, packaging advertising and labeling); B. all personnel, employees, and agents of Catalent and its Affiliates and their respective subcontractors who perform services, are and will continue to be qualified and to have sufficient technical expertise to perform Catalent’s obligations under this Agreement; C. Catalent has the full power and authority to execute and deliver this Agreement and perform its covenants, duties, and obligations described in this Agreement, and once executed, this Agreement will be a valid, legal, and binding obligation upon Catalent; D. Catalent is not now, nor will it be, a party to any agreement which would prevent Catalent from fulfilling its obligations under this Agreement, and that during the Term of this Agreement will not enter into any agreement with any other party that would in any way prevent Catalent from performing its obligations under this Agreement; E. Catalent will maintain all records and reports as required under this Agreement, and as required to comply with Applicable Laws; F. Catalent will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended (or subject to debarment or suspension) provided to Catalent under 21 U.S.C. §335(a) or (b) or otherwise disqualified by Client or its AffiliatesApplicable Law; (i) Catalent is not nor has it ever been, and (ii) Catalent has not used, and will not use, the services of any person excluded, debarred, suspended, or otherwise ineligible to participate in the Federal health care programs or in Federal procurement or non-procurement programs, and has not used, and will not use, the services of any person listed on the HHS/OIG List of Excluded Individuals/Entities (xxxx://xxx.xxx.xxx.xxx), the GSA’s List of Parties Excluded from Federal Programs (xxxx://xxx.xxxx.xxx), or the FDA Debarment List (xxxx://xxx.xxx.xxx/ora/compliance_ref/debar/default.htm), as amended or replaced from time to time, in connection with any of the services performed under this Agreement. Catalent further certifies that it, and any other person or entity used by Catalent in performing any of the services under this Agreement, has not been convicted of a criminal offense that falls within the ambit of 42 U.S.C. §1320a-7(a). Catalent agrees to notify Client promptly in the event Catalent’s knowledge, it or any person used by Catalent in connection with this Agreement, ever becomes excluded, debarred, suspended, or otherwise ineligible to participate in Federal health care programs or in Federal procurement or non-procurement programs. This certification applies to Catalent and its respective officers, agents, and employees as well as subcontractors performing on behalf of Catalent under this Agreement; H. Catalent has all necessary authority to use the Catalent technology utilized with the Product and to permit Client to use pursuant to the terms of as contemplated by this Agreement and the performance of services contemplated hereunder, all Catalent IP Agreement; there are no patents owned by others related to the Drug and Catalent IP utilized with the Zydis Technology, including any copyrights, trademarks, trade secrets, patents, inventions and developments; (ii) to Catalent’s knowledge and except pursuant to which Catalent has a valid license, there are no patents, trade secrets or other proprietary rights owned by others Product that would be infringed or misused by Catalent’s performance of the Agreement; and (iii) and, to Catalent’s knowledge and except pursuant to which Catalent has a valid licenseits knowledge, no trade secrets or other proprietary rights of others related to the Catalent IP utilized with the Drug or Zydis Technology Product that would be infringed or misused by Catalent’s performance of this Agreement; E. I. Catalent will not release any Batch of Product if the required certificates of conformance indicate that Product does not comply with the Specifications; and J. no transactions or dealings under this Agreement shall be conducted with or for an individual or entity that is designated as the target of any sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom Kingdom, or the United States of America; and F. Catalent will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b)States.

Catalent. Catalent represents, warrants and undertakes to Client that: A. this Agreement has been duly executed and delivered by Catalent’s authorized representative and, assuming the due authorization, execution and delivery hereof by Client, constitutes and will at all times constitute the legal, valid and binding obligation of Catalent enforceable against Catalent in accordance with its terms, subject to the effects of bankruptcy, insolvency, reorganization, moratorium and other similar laws relating to or affecting creditor’s rights generally and to general principles of equity; B. Catalent has no obligations, contractual or otherwise, that would conflict with Catalent entering into and performing its obligations set forth in this Agreement; C. at the time of delivery by Catalent to the designated carrier hereunderas provided in Section 6.1, the Supplies Product shall meet all Specifications therefor and shall have been manufactured Processed and Packaged in accordance with Applicable Laws and in conformance with the Specifications and shall not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws; provided, that Catalent shall not be liable for defects attributable to Drug API or other Client-supplied Materials existing at the time of delivery to Catalent; B. during the term of this Agreement, each Facility, all equipment used for the Processing and/or Packaging of Product (including artworkand the Validation Services or Product Maintenance Services) within each Facility, advertisingand the Processing, packaging Packaging, Validation Services, and labeling) Product Maintenance Services activities contemplated herein will conform to all Applicable Laws; C. title to all Product supplied under this Agreement will pass as provided in this Agreement, free and clear of any security interest, lien, or other encumbrance; D. each employee and subcontractor of Catalent who will receive or have access to Catalent by Confidential Information of Client or its Affiliates; perform activities hereunder will have signed Catalent’s confidentiality agreement (which such agreement contains normal and customary provisions for confidentiality and assignment of inventions), prior to the earlier to occur of: (i) to Catalent’s knowledge, it has all necessary authority to use and to permit any disclosure of Confidential Information of Client to use pursuant to the terms of this Agreement and the performance of services contemplated hereunder, all Catalent IP related to the Drug and the Zydis Technology, including any copyrights, trademarks, trade secrets, patents, inventions and developmentssuch employee or subcontractor; or (ii) to Catalent’s knowledge and except pursuant to which Catalent has a valid license, there are no patents, trade secrets the commencement of any such performance by such employee or other proprietary rights owned by others that would be infringed or misused by Catalent’s performance of the Agreement; and (iii) to Catalent’s knowledge and except pursuant to which Catalent has a valid license, no trade secrets or other proprietary rights of others related to the Catalent IP utilized with the Drug or Zydis Technology that would be infringed or misused by Catalent’s performance of this Agreementsubcontractor; E. no transactions neither Catalent nor any of its employees or dealings subcontractors performing or involved with its performance under this Agreement shall be conducted with or for an individual or entity that is designated as the target of any sanctions, restrictions or embargoes administered have been “debarred” by the United Nations, European Union, United Kingdom FDA or a Regulatory Authority in any jurisdiction outside the United States States, nor have debarment proceedings against Catalent or any of Americaits employees or subcontractors been commenced. Catalent will promptly notify Client in writing if any such proceedings have commenced or if Catalent or any of its employees or subcontractors are debarred by the FDA or a Regulatory Authority in any jurisdiction outside the United States; and F. Catalent will not all Validation Services and Product Maintenance Services shall be carried out in a diligent, professional manner in accordance with Catalent’s standard operating procedures and the prevailing standards in the performance of its obligations under this Agreement use the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b)pharmaceutical industry that are applicable to such services, including cGMP and cGLP, if applicable.

Catalent. Catalent represents, warrants and undertakes to Client that: A. this Agreement has been duly executed and delivered by Catalent’s authorized representative and, assuming the due authorization, execution and delivery hereof by Client, constitutes and will at all times constitute the legal, valid and binding obligation of Catalent enforceable against Catalent in accordance with its terms, subject to the effects of bankruptcy, insolvency, reorganization, moratorium and other similar laws relating to or affecting creditor’s rights generally and to general principles of equity; B. Catalent has no obligations, contractual or otherwise, that would conflict with Catalent entering into and performing its obligations set forth in this Agreement; C. at At the time of delivery by Catalent to the designated carrier hereunderas provided in Section 6.1, the Supplies Product shall have been manufactured Processed in accordance with Applicable Laws and cGMP and the Product shall be in conformity with the applicable Specifications and the Quality Agreement and shall not be have been adulterated, misbranded or mislabeled within the meaning of Applicable LawsLaws and cGMP; provided, that Catalent shall not be liable for defects attributable to Drug or other Client-supplied Materials (including artwork, advertising, packaging advertising and labeling) provided to Catalent by Client or its Affiliates); (i) to Catalent’s B. To its knowledge, it has all necessary authority to use and to permit Client to use pursuant to the terms of this Agreement and the performance of services contemplated hereunder, all Catalent IP related to the Drug and the Zydis Technology, including any copyrights, trademarks, trade secrets, patents, inventions and developments; (ii) to Catalent’s knowledge and except pursuant to which Catalent has a valid license, there are no patents, trade secrets or other proprietary rights patents owned by others any Third Parties related to the Zydis Technology that are not owned by, or licensed to, Catalent or its Affiliates, that would be infringed or misused by Catalent’s performance of the under this Agreement; and (iii) and, to Catalent’s knowledge and except pursuant to which Catalent has a valid licenseits knowledge, no trade secrets secret, trademark, trade name, copyright or other proprietary rights of others related to the Catalent IP utilized with the Drug or Zydis Technology that any Third Party would be infringed or misused by Catalent’s performance of this Agreement; E. no transactions or dealings ; provided, however, that Catalent’s representation under this Agreement Section 12.1 (B) shall be not extend to activities conducted with or for an individual or entity that is designated as by Catalent due to Client’s exercise of control over the target of any sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom or the United States of AmericaProcessing; and F. Catalent C it will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b); D Catalent will deliver Product to Client with unencumbered title; E The Facility and its operation in Processing shall be in compliance with Applicable Laws, including health, safety and environmental permits and Regulatory Approvals, necessary for the operation of the Facility or conduct of the Processing; F Catalent has not employed and does not employ, and will promptly take appropriate disciplinary actions against and immediately remove from any service, any individual who is or becomes debarred under 21 U.S.C. § 335(a) or (b) or any comparable provision of any other Applicable Laws, and will provide, upon request by Client, a certification that it has not employed and does not employ, and will promptly take appropriate disciplinary actions against and immediately cease using any such individual in the provision of any services under this Agreement; and G Catalent has the right to use the Zydis Technology in the activities conducted by it in the performance of this Agreement.

Catalent. Catalent represents, warrants and undertakes to Client that: A. this Agreement has been duly executed and delivered by Catalent’s authorized representative and, assuming the due authorization, execution and delivery hereof by Client, constitutes and will at all times constitute the legal, valid and binding obligation of Catalent enforceable against Catalent in accordance with its terms, subject to the effects of bankruptcy, insolvency, reorganization, moratorium and other similar laws relating to or affecting creditor’s rights generally and to general principles of equity; B. Catalent has no obligations, contractual or otherwise, that would conflict with Catalent entering into and performing its obligations set forth in this Agreement; C. at the time of delivery by Catalent to the designated carrier hereunderas provided in Section 6.1, the Supplies Product shall have been manufactured Processed in accordance with this Agreement and with Applicable Laws and in conformance with the Specifications and shall not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws; provided, that Catalent shall not be liable for defects attributable to Drug or other Client-supplied Materials (including artwork, advertising, packaging advertising and labeling); B. all personnel, employees, and agents of Catalent and its Affiliates and their respective subcontractors who perform services, are and will continue to be qualified and to have sufficient technical expertise to perform Catalent’s obligations under this Agreement; C. Catalent has the full power and authority to execute and deliver this Agreement and perform its covenants, duties, and obligations described in this Agreement, and once executed, this Agreement will be a valid, legal, and binding obligation upon Catalent; D. Catalent is not now, nor will it be, a party to any agreement which would prevent Catalent from fulfilling its obligations under this Agreement, and that during the Term of this Agreement will not enter into any agreement with any other party that would in any way prevent Catalent from performing its obligations under this Agreement; E. Catalent will maintain all records and reports as required under this Agreement, and as required to comply with Applicable Laws; F. Catalent will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended (or subject to debarment or suspension) provided to Catalent under 21 U.S.C. §335(a) or (b) or otherwise disqualified by Client or its AffiliatesApplicable Law; (i) Catalent is not nor has it ever been, and (ii) Catalent has not used, and will not use, the services of any person excluded, debarred, suspended, or otherwise ineligible to participate in the Federal health care programs or in Federal procurement or non-procurement programs, and has not used, and will not use, the services of any person listed on the HHS/OIG List of Excluded Individuals/Entities (hxxx://xxx.xxx.xxx.xxx), the GSA’s List of Parties Excluded from Federal Programs (hxxx://xxx.xxxx.xxx), or the FDA Debarment List (hxxx://xxx.xxx.xxx/xxx/compliance_ref/debar/default.htm), as amended or replaced from time to time, in connection with any of the services performed under this Agreement. Catalent further certifies that it, and any other person or entity used by Catalent in performing any of the services under this Agreement, has not been convicted of a criminal offense that falls within the ambit of 42 U.S.C. §1320a-7(a). Catalent agrees to notify Client promptly in the event Catalent’s knowledge, it or any person used by Catalent in connection with this Agreement, ever becomes excluded, debarred, suspended, or otherwise ineligible to participate in Federal health care programs or in Federal procurement or non-procurement programs. This certification applies to Catalent and its respective officers, agents, and employees as well as subcontractors performing on behalf of Catalent under this Agreement; H. Catalent has all necessary authority to use the Catalent technology utilized with the Product and to permit Client to use pursuant to the terms of as contemplated by this Agreement and the performance of services contemplated hereunder, all Catalent IP Agreement; there are no patents owned by others related to the Drug and Catalent IP utilized with the Zydis Technology, including any copyrights, trademarks, trade secrets, patents, inventions and developments; (ii) to Catalent’s knowledge and except pursuant to which Catalent has a valid license, there are no patents, trade secrets or other proprietary rights owned by others Product that would be infringed or misused by Catalent’s performance of the Agreement; and (iii) and, to Catalent’s knowledge and except pursuant to which Catalent has a valid licenseits knowledge, no trade secrets or other proprietary rights of others related to the Catalent IP utilized with the Drug or Zydis Technology Product that would be infringed or misused by Catalent’s performance of this Agreement; E. I. Catalent will not release any Batch of Product if the required certificates of conformance indicate that Product does not comply with the Specifications; and J. no transactions or dealings under this Agreement shall be conducted with or for an individual or entity that is designated as the target of any sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom Kingdom, or the United States of America; and F. Catalent will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b)States.

Catalent. Catalent represents, warrants and undertakes to Client Supernus that: A. this Agreement has been duly executed and delivered by Catalent’s authorized representative and, assuming the due authorization, execution and delivery hereof by Client, constitutes and will at all times constitute the legal, valid and binding obligation of Catalent enforceable against Catalent in accordance with its terms, subject to the effects of bankruptcy, insolvency, reorganization, moratorium and other similar laws relating to or affecting creditor’s rights generally and to general principles of equity; B. Catalent has no obligations, contractual or otherwise, that would conflict with Catalent entering into and performing its obligations set forth in this Agreement; C. at At the time of delivery by Catalent to the designated carrier hereunderas provided in Section 6.1, the Supplies Product shall have been manufactured Processed in accordance with Applicable Laws and in conformity with the Specifications and shall not be adulterated, misbranded or mislabeled within the meaning of Applicable Laws; provided, that Catalent shall not be liable for defects attributable to Drug or other ClientSupernus-supplied Materials (including artwork, advertising, packaging advertising and labeling) provided to Catalent by Client or its Affiliates); (i) to Catalent’s knowledge, it has all necessary authority to use and to permit Client to use pursuant to the terms of this Agreement and the performance of services contemplated hereunder, all Catalent IP related to the Drug and the Zydis Technology, including any copyrights, trademarks, trade secrets, patents, inventions and developments; (ii) to Catalent’s knowledge and except pursuant to which Catalent has a valid license, there are no patents, trade secrets or other proprietary rights owned by others that would be infringed or misused by Catalent’s performance of the Agreement; and (iii) to Catalent’s knowledge and except pursuant to which Catalent has a valid license, no trade secrets or other proprietary rights of others related to the Catalent IP utilized with the Drug or Zydis Technology that would be infringed or misused by Catalent’s performance of this Agreement; E. no transactions or dealings under this Agreement shall be conducted with or for an individual or entity that is designated as the target of any sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom or the United States of America; and F. Catalent B. It will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b).; C. To the best of its knowledge, Catalent has all necessary authority to use the Catalent IP as contemplated by this Agreement; D. No transaction or dealing under this Agreement shall be conducted with or for an individual or entity that is designated as the target of any sanction, restriction or embargo administered by the United Nations, European Union, United Kingdom, or United States; E. Catalent is in compliance with all Applicable Laws with respect to general Facility operations at the site to be used for the Processing of API and, to Catalent’s knowledge, there are no circumstances or conditions which would reasonably be expected to alter this during the Term of this Agreement; F. At all times during the Term of this Agreement, it will have, comply with and maintain in force all licenses, consents, permits and authorization which may be required with respect to the Facility and its performance of its obligations hereunder, including without limitation licenses and permits issued or required by a Regulatory Authority and those required in relation to the generation, storage, treatment, transport, possession, handling and disposal of any waste and Catalent will perform its obligations in strict with all such licenses, consents, permits and authorization; G. Catalent shall not, during the Term, modify, alter or otherwise change any manufacturing, processing or other component of the Process, including without limitation, the installation of new or upgraded equipment used in the Process, from that utilized on the Effective Date without first receiving Supernus’ prior written consent to such modification, alteration or change. Supernus shall deliver written notice of such modification, alteration or change to Supernus at least [**] prior to Supernus’ intended implementation of such modification, alteration or change. Supernus shall have the right to reject and direct Catalent not to undertake any such proposed modification, alteration or [**] = CERTAIN CONFIDENTIAL INFORMATION OMITTED change if, in Supernus’ sole and reasonable opinion, such modification, alteration or change will conflict with the Specifications related to this Agreement or with any Applicable Laws; and