Common use of Patheon Warranties Clause in Contracts

Patheon Warranties. Patheon covenants, represents, and warrants that: (a) it will perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws; (b) any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate's unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not infringe and will not infringe any Third Party Rights; (c) it will not in the performance of its obligations under this Agreement use the services of any person it knows is debarred or suspended under 21 U.S.C. §335(a) or (b); (d) it does not currently have, and it will not hire, as an officer or an employee any person whom it knows has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the United States Federal Food, Drug, and Cosmetic Act; (e) it has and will maintain throughout the term of this Agreement, the expertise, with respect to personnel and equipment, to fulfill the obligations established hereunder, and has obtained all requisite material licenses, authorizations and approvals required by all Authorities to manufacture the Products (excluding the Regulatory Approval); (f) the Manufacturing Site, all other facilities, all equipment and all personnel to be employed by Patheon in rendering the Manufacturing Services are currently, and will be at the time each batch of Products is produced, qualified in accordance with all Applicable Laws, including, but not limited to, cGMPs; (g) there are no pending or uncorrected citations or adverse conditions noted in any inspection of the Manufacturing Site or any other facilities to be employed by Patheon in rendering the Manufacturing Services which would cause the Products to be misbranded or adulterated within the meaning of the Act, including, but not limited to, all cGMPs; (h) to the knowledge of Patheon, the Patheon Intellectual Property used by Patheon to manufacture the finished Product in accordance with this Agreement does not and will not infringe any Third Party Rights, except to the extent caused or contributed to by any breach of Client’s warranties under Section 9.2(a); (i) to the knowledge of Patheon, there are no claims against Patheon asserting that any Patheon Intellectual Property to be used for the Manufacturing Services infringes, misappropriates, or violates any Third Party Rights; (j) all employees, consultants, subcontractors and agents performing services for Patheon hereunder have assigned, or will assign, in writing to Patheon all of their right, title and interest in, to and under any and all Inventions directly relating to the Product; and (k) all Product manufactured and supplied to the Client under this Agreement will not be, as a result of any failure by Patheon to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act or other Applicable Laws as of the time that the finished Product is transferred to the carrier at Patheon’s shipping point.

Patheon Warranties. Patheon covenants, represents, and warrants that: (a) it will perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable LawsLaws and in a professional manner, in accordance with the standard of care and diligence practiced by recognized organizations in performing the services of a similar nature; (b) any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate's unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not knowingly infringe and will not knowingly infringe any Third Party Rights;. (c) it will not in the performance of its obligations under this Agreement use the services of any person it knows is debarred or suspended under 21 U.S.C. §335(a) or (b);; an (d) it does not currently have, and it will not hire, as an officer or an employee any person whom it knows has been convicted of a felony under the laws Laws of the United States for conduct relating to the regulation of any drug product under the United States Federal Food, Drug, and Cosmetic Act (the “Act; (e”) it has and will maintain throughout or debarred pursuant to the term of this AgreementAct or excluded from any United States federal health care program, the expertise, with respect to personnel and equipment, to fulfill the obligations established hereunder, and has obtained all requisite material licenses, authorizations and approvals required by all Authorities to manufacture the Products (excluding the Regulatory Approval); (f) the Manufacturing Site, all other facilities, all equipment and all personnel to be employed by Patheon in rendering the Manufacturing Services are currently, and will be at the time each batch of Products is produced, qualified in accordance with all Applicable Laws, including, including but not limited toto Medicare or Medicaid (“Federal Health Care Program”). In addition, cGMPs; (g) there are no pending or uncorrected citations or adverse conditions noted in any inspection of the Manufacturing Site Patheon agrees to notify Indivior promptly if Patheon or any other facilities to be employed by Patheon in rendering officer, director, employee, or subcontractor is debarred under the Manufacturing Services which would cause Act or excluded under a Federal Health Care Program during the Products to be misbranded or adulterated within the meaning Term of the Act, including, but not limited to, all cGMPs; (h) to the knowledge of Patheon, the Patheon Intellectual Property used by Patheon to manufacture the finished Product in accordance with this Agreement does not and will not infringe or upon becoming aware that either Patheon or any Third Party Rightsofficer, except to the extent caused or contributed to by any breach of Client’s warranties under Section 9.2(a); (i) to the knowledge of Patheondirector, there are no claims against Patheon asserting that any Patheon Intellectual Property to be used for the Manufacturing Services infringes, misappropriatesemployee, or violates subcontractor is the subject of any Third Party Rights; (j) all employees, consultants, subcontractors and agents performing services for Patheon hereunder have assigned, or will assign, in writing to Patheon all of their right, title and interest in, to and under any and all Inventions directly federal investigation into criminal conduct relating to the Product; and (k) all Product manufactured and supplied to the Client under this Agreement will development or approval of new drugs, provided such notification does not be, as a result of any failure by Patheon to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or contravene Applicable Laws, adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act or other Applicable Laws as of the time that the finished Product is transferred to the carrier at Patheon’s shipping pointLaw.

Patheon Warranties. Patheon covenants, represents, and warrants that: (a) it will perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws; (b) it has or shall have and shall maintain all necessary licences, permits, and approvals required by any Regulatory Authority for the manufacture of the Product; (c) it has disclosed and will disclose to Client all warnings or other notices from any applicable Regulatory Authority it has received relating to its Manufacturing Site to the extent that such notice or warning would affect Patheon’s ability to perform the Manufacturing Services in accordance with this Agreement; (d) it shall not at any time without Client's prior written consent: (i) make any changes to the manufacturing, packaging, testing, or storage of the Product; or (ii) knowingly take any actions which would likely affect the validation status or quantity of the Product (e) any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate's unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not knowingly infringe and will not knowingly infringe any Third Party Rights; (c) it will not in the performance of its obligations under this Agreement use the services of any person it knows is debarred or suspended under 21 U.S.C. §335(a) or (b); (d) it does not currently have, and it will not hire, as an officer or an employee any person whom it knows has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the United States Federal Food, Drug, and Cosmetic Act; (e) it has and will maintain throughout the term of this Agreement, the expertise, with respect to personnel and equipment, to fulfill the obligations established hereunder, and has obtained all requisite material licenses, authorizations and approvals required by all Authorities to manufacture the Products (excluding the Regulatory Approval); (f) the Manufacturing Site, all other facilities, all equipment and all personnel to Product when delivered will be employed in compliance with the certificate of analysis provided by Patheon in rendering the Manufacturing Services are currently, and will be at the time each batch of Products is produced, qualified in accordance to Client with all Applicable Laws, including, but not limited to, cGMPsrespect thereto; (g) there are no pending or uncorrected citations or adverse conditions noted in any inspection of the Manufacturing Site or any other facilities to be employed by Patheon in rendering the Manufacturing Services which would cause the Products to be misbranded or adulterated within the meaning of the Act, including, but not limited to, all cGMPs; (h) to the knowledge of Patheon, the Patheon Intellectual Property used by Patheon to manufacture the finished Product in accordance with this Agreement does not and will not infringe any Third Party Rights, except to the extent caused or contributed to by any breach of Client’s warranties under Section 9.2(a); (i) to the knowledge of Patheon, there are no claims against Patheon asserting that any Patheon Intellectual Property to be used for the Manufacturing Services infringes, misappropriates, or violates any Third Party Rights; (j) all employees, consultants, subcontractors and agents performing services for Patheon hereunder have assigned, or will assign, in writing to Patheon all of their right, title and interest in, in the Product will be transferred to and under Client free of any and all Inventions directly relating liens, security interests or other encumbrances (provided however, Client has provided all API and Client Supplied Components to the ProductPatheon free of any and all liens, security interests or other encumbrances; and (kh) all Product manufactured and supplied to the Client under this Agreement will not be, as a result of any failure by Patheon to provide the Manufacturing Services and other work performed hereunder will be performed in accordance a professional, expeditious and workmanlike manner, consistent with the Specifications, cGMPs, or Applicable Laws, adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act or other Applicable Laws as of the time that the finished Product is transferred to the carrier at Patheon’s shipping pointindustry standards.

Patheon Warranties. Patheon covenants, represents, and warrants that: (a) the Products upon delivery to Client or its designee will: (i) have been manufactured in accordance with this Agreement, and all cGMPs and Applicable Laws, (ii) meet the Specifications, and (iii) have not been adulterated, misbranded or mislabelled within the meaning of the FFDCA or equivalent laws in Canada, Japan or China (except to the extent as attributable to the API or any Client-Supplied Components where the deficiencies could not reasonably have been detected by Patheon when properly performing the Processing Instructions); (b) it will perform the Manufacturing Services in accordance with this Agreement, the SpecificationsProcessing Instructions, cGMPs, and Applicable Laws; (bc) it will at all times use commercially reasonable measures to protect API, Product and Components in its possession or control from theft, damage, loss or misuse; (d) any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate's unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not infringe and will not infringe any Third Party Rights; (ce) it will not in the performance of its obligations under this Agreement use the services of any person it knows who is debarred or suspended under 21 U.S.C. §335(a) or (b); (df) it does not currently have, and it will not hire, as an officer or an employee any person whom it knows who has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the United States Federal Food, Drug, and Cosmetic Act; (e) it has and will maintain throughout the term of this Agreement, the expertise, with respect to personnel and equipment, to fulfill the obligations established hereunder, and has obtained all requisite material licenses, authorizations and approvals required by all Authorities to manufacture the Products (excluding the Regulatory Approval); (f) the Manufacturing Site, all other facilities, all equipment and all personnel to be employed by Patheon in rendering the Manufacturing Services are currently, and will be at the time each batch of Products is produced, qualified in accordance with all Applicable Laws, including, but not limited to, cGMPs;; and (g) there are no pending or uncorrected citations or adverse conditions noted in it will promptly notify Client if at any inspection time during the Term if it becomes aware that any of the Manufacturing Site or any other facilities to be employed by Patheon representations and warranties in rendering the Manufacturing Services which would cause the Products to be misbranded or adulterated within the meaning of the Act, including, but not limited to, all cGMPs; subsections (ha) to the knowledge of Patheon, the Patheon Intellectual Property used by Patheon to manufacture the finished Product in accordance with this Agreement does not and will not infringe any Third Party Rights, except to the extent caused or contributed to by any breach of Client’s warranties under Section 9.2(a); through (ie) to the knowledge of Patheon, there are no claims against Patheon asserting that any Patheon Intellectual Property to be used for the Manufacturing Services infringes, misappropriates, or violates any Third Party Rights; (j) all employees, consultants, subcontractors and agents performing services for Patheon hereunder have assigned, or will assign, in writing to Patheon all of their right, title and interest in, to and under any and all Inventions directly relating to the Product; and (k) all Product manufactured and supplied to the Client under this Agreement will not be, as a result of any failure by Patheon to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act or other Applicable Laws as of the time that the finished Product is transferred to the carrier at Patheon’s shipping pointuntrue.

Patheon Warranties. Patheon covenants, represents, and warrants that: (a) it will perform the Manufacturing Services in accordance with the Specifications, cGMPs, the Quality Agreement and Applicable Laws; (b) any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s 's or its Affiliate's Affiliates’ unencumbered property, (iiproperty,(ii) may be lawfully used by Patheon, and (iii) does not infringe and will not infringe any Third Party Rights; (c) it will not in Patheon is a corporation duly incorporated, validly existing and ln good standing under the laws of the jurisdiction of its incorporation and has all requisite corporate power to execute and deliver this Agreement and to perform its obligations hereunder. The execution and delivery by Patheon of this Agreement and its performance of Its obligations hereunder have been duly and validly authorized. This Agreement constitutes a legal, valid and binding obligation on Patheon, enforceable in accordance with Its terms, subject to applicable bankruptcy, insolvency, reorganization, and other laws of general application limiting the enforcement of creditor's rights. (d) As of the Effective Date hereof, Patheon holds, and shall continue during the term to hold, all licenses and permits necessary for Patheon to perform the Manufacturing Services as contemplated herein. (e) As of the Effective Date hereof and during the term of this Agreement the Manufacturing Services, Manufacturing Site, Materials and all equipment utilized, in performing its obligations under this Agreement use the services of any person shall be In full compliance and In accordance with Specifications, cGMP and all Applicable Laws in which it knows is debarred or suspended under 21 U.S.C. §335(a) or (b); (d) it does not currently have, and it will not hire, as an officer or an employee any person whom it knows has been convicted of a felony under the laws of the United States for conduct relating contemplated to the regulation of any drug product under the United States Federal Food, Drug, and Cosmetic Act; (e) it has and will maintain throughout the term of this Agreement, the expertise, with respect to personnel and equipment, to fulfill the obligations established hereunder, and has obtained all requisite material licenses, authorizations and approvals required by all Authorities to manufacture the Products (excluding the Regulatory Approval);be performed and/or provided. (f) Patheon is not aware of any safety, efficacy, or regulatory Issues relating to its manufacturing processes other than the Manufacturing Siteinformation that has previously been made available to the Client, all other facilities, all equipment and all personnel to be employed by that would preclude Patheon from manufacturing the Product in rendering the Manufacturing Services are currently, and will be at the time each batch of Products is produced, qualified in accordance compliance with all Applicable Laws, including, but not limited to, cGMPs; (g) there are no pending or uncorrected citations or adverse conditions noted in any inspection of the Manufacturing Site or any other facilities to be employed by Patheon in rendering the Manufacturing Services which would cause the Products to be misbranded or adulterated within the meaning of the Act, including, but not limited to, all cGMPs; (h) to the knowledge of Patheon, the Patheon Intellectual Property used by Patheon to manufacture the finished Product in accordance with this Agreement does not and will not infringe any Third Party Rights, except to the extent caused or contributed to by any breach of Client’s warranties under Section 9.2(a); (i) to the knowledge of Patheon, there are no claims against Patheon asserting that any Patheon Intellectual Property to be used for the Manufacturing Services infringes, misappropriates, or violates any Third Party Rights; (j) all employees, consultants, subcontractors and agents performing services for Patheon hereunder have assigned, or will assign, in writing to Patheon all of their right, title and interest in, to and under any and all Inventions directly relating to the Product; and (k) all Product manufactured and supplied to the Client under this Agreement will not be, as a result of any failure by Patheon to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act or other Applicable Laws as of the time that the finished Product is transferred to the carrier at Patheon’s shipping point.

Patheon Warranties. Patheon covenants, represents, represents and warrants thatthat to Patheon’s knowledge as of the Effective Date: (a) it will perform any Intellectual Property owned by Patheon and utilized by Patheon in connection with the provision of the Manufacturing Services in accordance with which has not been provided by Client or used at the Specificationsdirection of Client, cGMPs, and Applicable Laws; (b) any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate's ’s unencumbered property, (ii) may be lawfully used by Patheon, Patheon and (iii) does not infringe and will not infringe any Third Party Rights; (cb) it will not and its Manufacturing Site are in the performance of its obligations under this Agreement use the services of any person it knows is debarred or suspended under 21 U.S.C. §335(a) or (b)compliance with all laws and regulations applicable to their operations, including, without limitation, cGMPs and Applicable Laws; (dc) it does not currently haveall Patheon personnel are fully qualified (by education, training and it will not hire, as an officer or an employee any person whom it knows has been convicted of a felony experience) to properly perform their tasks under the laws of the United States for conduct relating to the regulation of any drug product under the United States Federal Food, Drug, and Cosmetic Act; (e) it has and will maintain throughout the term of this Agreement. In addition, the expertisePatheon covenants, with respect to personnel represents and equipment, to fulfill the obligations established hereunder, and has obtained all requisite material licenses, authorizations and approvals required by all Authorities to manufacture the Products (excluding the Regulatory Approval); (f) the Manufacturing Site, all other facilities, all equipment and all personnel to be employed by Patheon in rendering the Manufacturing Services are currently, and will be at the time each batch of Products is produced, qualified in accordance with all Applicable Laws, including, but not limited to, cGMPs; (g) there are no pending or uncorrected citations or adverse conditions noted in any inspection of the Manufacturing Site or any other facilities to be employed by Patheon in rendering the Manufacturing Services which would cause the Products to be misbranded or adulterated within the meaning of the Act, including, but not limited to, all cGMPs; (h) to the knowledge of Patheon, the Patheon Intellectual Property used by Patheon to manufacture the finished Product in accordance with this Agreement does not and will not infringe any Third Party Rights, except to the extent caused or contributed to by any breach of Client’s warranties under Section 9.2(a);warrants that: (i) to the knowledge of Patheon, there are no claims against Patheon asserting that any Patheon Intellectual Property to be used for it shall perform the Manufacturing Services infringes, misappropriates, or violates any Third Party Rights; (j) all employees, consultants, subcontractors and agents performing services for Patheon hereunder have assigned, or will assign, in writing to Patheon all of their right, title and interest in, to and under any and all Inventions directly relating to the Product; and (k) all Product manufactured and supplied to the Client under this Agreement will not be, as a result of any failure by Patheon to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, adulterated the Quality Agreement and this Agreement; (ii) it will convey good title to the Product, free of all liens of any kind whatsoever; and (iii) the Products, when delivered to Client, will be Manufactured according to the Specifications. For the sake of clarity, if Patheon performs any additional steps not specified in the Specifications in Manufacturing Products (e.g., by adding one or misbranded within more additional components to the meaning Products that are not specified in the Specifications), then Patheon will be deemed to have failed to Manufacture such Products in accordance with the Specifications. The warranties provided in (i), (ii) and (iii) above shall survive inspection, test, acceptance and use of the Federal Food, Drug, and Cosmetic Act or other Applicable Laws as of the time that the finished Product is transferred to the carrier at Patheon’s shipping pointProduct. ****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

Patheon Warranties. Patheon covenants, represents, and warrants that: (a) it will perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws;; and (b) any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate's ’s unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not infringe and will not infringe any Third Party Rights;. (c) it will not in the performance of its obligations under this Agreement use the services of any person it knows is debarred or suspended under 21 U.S.C. §335(a) or (b); (d) it does not currently have, and it will not hire, as an officer or an employee any person whom it knows has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the United States Federal Food, Drug, and Cosmetic Act; (e) it has and will maintain throughout the term of this Agreement, the expertise, with respect to personnel and equipment, to fulfill the obligations established hereunder, and has obtained all requisite material licenses, authorizations and approvals required by all Authorities to manufacture the Products (excluding the Regulatory Approval)Products; (fd) the Manufacturing Site, all other facilities, all equipment and all personnel to be employed by Patheon in rendering the Manufacturing Services are currently, and will be at the time each batch of Products is produced, qualified in accordance with all Applicable Laws, including, but not limited to, cGMPs; (ge) there are no pending or uncorrected citations or adverse conditions noted in any inspection of the Manufacturing Site or any other facilities to be employed by Patheon in rendering the Manufacturing Services which would cause the Products to be misbranded or adulterated within the meaning of the Act, including, but not limited to, all cGMPs; (hf) the Manufacturing Services and the contributions of Patheon to the knowledge manufacture of Patheon, the Patheon Intellectual Property used by Patheon to manufacture the finished Product in accordance with this Agreement does do not and will not infringe any Third Party Rights, except to the extent caused or contributed to by any breach of Client’s warranties under Section 9.2(a); (ig) to the knowledge of Patheon, there are no pending or threatened claims against Patheon asserting that any of the activities of Patheon Intellectual Property relating to be used for the Manufacturing Services infringesconduct of the activities contemplated herein by Client, misappropriatesinfringe, misappropriate, or violates violate any Third Party Rights; (jh) all employees, consultants, subcontractors and agents performing services for Patheon hereunder have assigned, or will assign, in writing to Patheon all of their right, title and interest in, to and under any and all Inventions directly relating to the Product; and; (ki) all Product manufactured and supplied to the Client under this Agreement will not be, as a result of any failure by Patheon to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, be adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act or other Applicable Laws as of the time that the finished Product is transferred to the carrier at Patheon’s shipping point; and (j) all Product manufactured and supplied to the Client under this Agreement will have the minimum Shelf Life specified for such Product in the Specifications and, in any event, will be shipped to the Client promptly (and in any event not more than three months) after the date of its manufacture.

Patheon Warranties. Patheon covenants, represents, and warrants that: (a) Patheon is a corporation duly organized, validly existing and in good standing under the laws of its jurisdiction of organization. (b) The execution and delivery of this Agreement by Patheon has been authorized by all requisite corporate or company action. This Agreement is and will remain a valid and binding obligation of Patheon, enforceable in accordance with its terms, subject to Applicable Laws. (c) it will perform the Manufacturing Services in accordance with the SpecificationsProcessing Instructions, cGMPs, the Quality Agreement, this Agreement, and Applicable Laws; (bd) any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate's unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not infringe and will not infringe any Third Party Rights; (ce) it Patheon has engaged, will engage and will cause its Affiliates involved in rendering Services to engage, employees and permitted subcontractors including consultants with the proper skill, training and experience to provide Manufacturing Services detailed in this Agreement. The foregoing is provided that the involvement of Affiliates of Patheon in providing the Manufacturing Services hereunder shall require Client’s prior approval. Before providing Manufacturing Services hereunder, all Patheon personnel must be subject to binding commitments with Patheon under which they have confidentiality obligations with regard to Client’s Confidential Information (as defined below) that are consistent with the terms of this Agreement. Patheon will not in the performance of its obligations under this Agreement use the services of any person it knows is debarred or suspended under 21 U.S.C. §335(a) or (b);; and (df) it does not currently have, and it will not hire, as an officer or an employee any person whom it knows has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the United States Federal Food, Drug, and Cosmetic Act; (e) it has and will maintain throughout the term of this Agreement, the expertise, with respect to personnel and equipment, to fulfill the obligations established hereunder, and has obtained all requisite material licenses, authorizations and approvals required by all Authorities to manufacture the Products (excluding the Regulatory Approval); (f) the Manufacturing Site, all other facilities, all equipment and all personnel to be employed by Patheon in rendering the Manufacturing Services are currently, and will be at the time each batch of Products is produced, qualified in accordance with all Applicable Laws, including, but not limited to, cGMPs; (g) there are no pending or uncorrected citations or adverse conditions noted in any inspection of the Manufacturing Site or any other facilities to be employed by Patheon in rendering the Manufacturing Services which would cause the Products to be misbranded or adulterated within the meaning of the Act, including, but not limited to, all cGMPs; (h) to the knowledge of Patheon, the Patheon Intellectual Property used by Patheon to manufacture the finished Product in accordance with this Agreement does not and will not infringe any Third Party Rights, except to the extent caused or contributed to by any breach of Client’s warranties under Section 9.2(a); (i) to the knowledge of Patheon, there are no claims against Patheon asserting that any Patheon Intellectual Property to be used for the Manufacturing Services infringes, misappropriates, or violates any Third Party Rights; (j) all employees, consultants, subcontractors and agents performing services for Patheon hereunder have assigned, or will assign, in writing to Patheon all of their right, title and interest in, to and under any and all Inventions directly relating to the Product; and (k) all Product manufactured and supplied to the Client under this Agreement will not be, as a result of any failure by Patheon to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act or other Applicable Laws as of the time that the finished Product is transferred to the carrier at Patheon’s shipping point.

Patheon Warranties. Patheon covenants, represents, represents and warrants that: (a) it Patheon will perform the Manufacturing Services in accordance with the Specifications, cGMPsthe Quality Agreement, cGMPs and Applicable Laws; (b) any Patheon Intellectual Property used XenoPort will be entitled to rely upon the Certificates provided by Patheon in distributing the Products to perform the Manufacturing Services (i) is Patheon’s or its Affiliate's unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not infringe and will not infringe any Third Party RightsMarket; (c) it will not Patheon is a validly existing corporation in good standing under the performance laws of the jurisdiction of its obligations under this Agreement use the services of any person it knows is debarred or suspended under 21 U.S.C. §335(a) or (b)incorporation; (d) it does not currently havethe execution, delivery and it will not hire, as an officer or an employee any person whom it knows performance of this Agreement by Patheon (where applicable) has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the United States Federal Food, Drug, and Cosmetic Actduly authorized by all requisite corporate action; (e) it has and will maintain throughout the term provision of this Agreement, the expertise, with respect to personnel and equipment, to fulfill the obligations established hereunder, and has obtained all requisite material licenses, authorizations and approvals required by all Authorities to manufacture the Products (excluding the Regulatory Approval); (f) the Manufacturing Site, all other facilities, all equipment and all personnel to be employed by Patheon in rendering the Manufacturing Services are currently, and will be at the time each batch of Products is produced, qualified in accordance with all Applicable Laws, including, but not limited to, cGMPs; (g) there are no pending or uncorrected citations or adverse conditions noted in any inspection of the Manufacturing Site or any other facilities to be employed by Patheon in rendering the Manufacturing Services which would cause the Products for any Product pursuant to be misbranded this Agreement or adulterated within the meaning use of the Actany Intellectual Property, including, but not limited to, all cGMPs; (h) to the knowledge of Patheon, the including Patheon Intellectual Property used Property, by Patheon as may be required to manufacture the finished Product in accordance with perform its obligations under this Agreement does not and will not infringe any Third Party Rights; (f) Patheon has and will maintain all Consents necessary or desirable in performance of its obligations hereunder and the manufacture of the Products; (g) Patheon will not market the Products produced under this Agreement and will not sell the Products produced under this Agreement except for sales to XenoPort or XenoPort’s designees permitted by this Agreement; [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, except MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. (h) Except for Products manufactured and sold to XenoPort or XenoPort’s designee under this Agreement, or sold to an authorized licensee of XenoPort, Patheon will not [ * ] manufacture[ * ] gabapentin enacarbil or any product containing gabapentin enacarbil[ * ] on behalf of any Person, nor assist any Person other than XenoPort or its designee to do any of the extent caused or contributed to by any breach of Client’s warranties under Section 9.2(a)foregoing; (i) the manufacture, generation, processing, packaging, distribution, transport, treatment, storage, disposal and other handling of any Materials or Products by Patheon will (i) be in accordance with and conform to the knowledge Specifications, the Quality Agreement, cGMPs and (ii) otherwise conform to any provisions of Patheon, there are no claims against Patheon asserting that any Patheon Intellectual Property to be used for the Manufacturing Services infringes, misappropriates, or violates any Third Party Rights; Law. The Products will: (jA) all employees, consultants, subcontractors and agents performing services for Patheon hereunder have assigned, or will assign, in writing to Patheon all of their right, title and interest in, to and under any and all Inventions directly relating to the Product; and (k) all Product manufactured and supplied to the Client under this Agreement will not be, as a result of any failure by Patheon to provide the Manufacturing Services in accordance strictly comply with the Specifications, cGMPs(B) be free from defects in materials and workmanship, or Applicable Laws, (C) not be adulterated or misbranded within the meaning of Laws of the Federal Food, DrugUnited States and the Act, and Cosmetic (D) not be articles that may not, under the Act or any other Applicable Laws as applicable Law, be introduced into interstate commerce. THE REPRESENTATIONS AND WARRANTIES PROVIDED IN THIS AGREEMENT DO NOT APPLY TO THE FAILURE OF ANY PRODUCTS TO CONFORM TO SPECIFICATIONS WHERE THE FAILURE TO CONFORM TO SPECIFICATIONS IS DUE TO OCCURRENCES AFTER THE PRODUCTS ARE DELIVERED TO THE CARRIER OR FREIGHT FORWARDER THAT AFFECT OR ALTER THE PRODUCTS, OR ACTIONS TAKEN OR FAILED TO BE TAKEN THAT ARE NOT OTHERWISE CAUSED BY OR THE RESPONSIBILITY OF PATHEON; (j) during the Term, Patheon will maintain a temperature-controlled, humidity-controlled manufacturing suite at the Facility for manufacture of the time Product in accordance with the applicable Specifications, master batch records and procedures for the Product, and will maintain the Facility, all personal property, equipment, machinery, systems, intangibles, Intellectual Property and contract rights in use at the Facility during the Term in the ordinary course of business, and free of material defects, except for defects attributable to wear and tear consistent with the age and usage of these assets, and except for defects that do not and will not, in the aggregate, materially impair the ability to use the assets to manufacture, process, store, dispose or otherwise handle any Materials or Products; (k) Patheon will not pledge or otherwise transfer, without XenoPort’s prior written consent, Materials or any work-in-process or finished goods inventory of Products, other than to XenoPort or XenoPort’s designee as expressly provided in this Agreement; (l) Patheon will maintain reasonable security policies at the Facility to protect the integrity of the Products and all other XenoPort assets, tangible and intangible, at the Facility; [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. (m) to the extent that Patheon imports goods into the customs territory of the United States or into any United States Foreign Trade Zone in order to meet its obligations under this Agreement or any Product Addendum, Patheon represents and warrants that Patheon is a participant in the Customs Trade Partnership Against Terrorism (“C-TPAT”) initiative sponsored by the United States Customs Service (“Customs”), and that Customs has certified Patheon as a C-TPAT member; or Patheon has completed and submitted all necessary C-TPAT application materials to Customs, and is currently awaiting notification from Customs that Patheon qualifies for inclusion in C-TPAT. If Customs suspends Patheon’s certification or participation in C-TPAT or determines that Patheon’s C-TPAT application is deficient, Patheon will take all reasonable measures and provide Customs with all necessary documentation in order to obtain certification as a C-TPAT member; (n) to the extent Patheon is designated as the source of the Material under any Product Addendum, the manufacture, generation, processing, packaging, distribution, transport, treatment, storage, disposal and other handling of this Material by Patheon will (i) be in accordance with and conform to the Material specifications and cGMPs; and (ii) be in accordance with and conform to any standards specified by the United States Pharmacopeia and Pharmacopeia Forum and the European Pharmacopeia and Pharmacopeial Forum applicable to the Material. The Material will be free from defects in materials and workmanship and will not be adulterated or misbranded within the meaning of applicable Regulatory Acts or the Act; (o) Patheon will ensure that XenoPort-supplied Materials are not lost (except for permitted XenoPort-supplied Material yield loss under Section 4.2), damaged or destroyed while in Patheon’s custody or control and that the finished Product is transferred processing, distribution, transport, treatment, storage, disposal and other handling of such Materials by Patheon are performed in a competent, professional and workmanlike manner by qualified personnel in accordance with the standard of care usually and reasonably expected in the performance of such services in the pharmaceutical manufacturing industry; (p) ethical Standards and Human Rights; (i) Unless otherwise required or prohibited by law, Patheon warrants, to the carrier best of its knowledge, that in relation to the supply of goods or services under the terms of this Agreement: (A) it does not employ, engage or otherwise use any child labor in circumstances under which the tasks performed by the child labor could reasonably be foreseen to cause either physical or emotional impairment to the development of the child; [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. (B) it does not use forced labor in any form (prison, indentured, bonded or otherwise) and its employees are not required to lodge papers or deposits on starting work; (C) it provides a safe and healthy workplace, presenting no immediate hazards to its employees. Any housing provided by Patheon to its employees is safe for habitation. Patheon provides access to clean water, food and emergency healthcare to its employees if accidents or incidents occur at Patheon’s shipping pointworkplace; (D) it does not discriminate against any employees on any grounds (including race, religion, disability or gender); (E) it does not engage in or support the use of corporal punishment, mental, physical, sexual or verbal abuse and does not use cruel or abusive disciplinary practices in the workplace; (F) it pays each employee at least the minimum wage or a fair representation of the prevailing industry wage and provides each employee with all legally mandated benefits; (G) it complies with the Laws on working hours and employment rights in the countries in which it operates; and (H) it is respectful of its employees’ right to join and form independent trade unions and freedom of association; (ii) Patheon agrees that it is responsible for controlling its own supply chain and that it will encourage compliance with ethical standards and human rights by any supplier of goods and services that are used by Patheon when performing its obligations under this Agreement; (iii) Patheon will ensure that it has ethical and human rights policies and an appropriate complaints procedure to deal with any breaches of such policies; and (q) this Agreement constitutes the legal, valid and binding obligation of Patheon, enforceable against Patheon in accordance with the terms hereof, subject to the effect of bankruptcy, insolvency, reorganization, receivership, moratorium and other similar Laws affecting the rights and remedies of creditors generally and the effect of general principles of equity, whether applied by a court of law or equity; and the execution, delivery and performance of this Agreement by Patheon will not violate or conflict with any other agreement or instrument to which Patheon is a party. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

Patheon Warranties. Patheon covenants, represents, and warrants that: (a) it has engaged and will engage Patheon Personnel with the proper skill, training and experience to provide the Manufacturing Services. Patheon will be solely responsible for paying Patheon Personnel and providing any employee or other benefits that they are owed. Before providing Manufacturing Services, all Patheon Personnel must have agreed in writing to (a) confidentiality obligations consistent with the terms of this Agreement, and (b) assign and otherwise effectively vest in Patheon any and all rights that the Patheon Personnel might otherwise have in the results of their work. (b) it will perform the Manufacturing Services in accordance with the SpecificationsProcessing Instructions, cGMPs, and Applicable Laws;. Without limiting the generality of the foregoing: (bi) During the term of this Agreement, if Patheon (or any Patheon Personnel) is a member of a committee that sets formularies or develops clinical guidelines affiliated with any healthcare institute, medical committee, or other medical or scientific organization (collectively, the “Committee”), Patheon agrees to disclose to the Committee the existence of its relationship with Client without breaching any obligations of confidentiality to Client as provided under this Agreement for up to [***] following the expiration or termination of this Agreement. (ii) Patheon will comply with all applicable anti-bribery laws and regulations, including, without limitation, the U.S. Foreign Corrupt Practices Act of 1977, as amended, and the U.K. Bribery Act of 2010, as amended, and will not cause Client to be in breach of any of the anti-bribery laws and regulations in the countries where Client operates. Without limiting the generality of the foregoing, in performing the Services, neither Patheon nor any of its officers, directors, Patheon Personnel or other representatives will pay, offer or promise to pay, or authorize the payment of, any money, or give or promise to give, or authorize the giving of, any services or anything else of value, either directly or through a third party, to any official or employee of any governmental authority or instrumentality, or of a public international organization, or of any agency or subdivision thereof, or to any political party or official thereof or to any candidate for political office, or to any other company, person or entity, corruptly for the purpose of (i) influencing any act or decision of that person in his/her official capacity, including a decision to fail to perform his/her official functions with the governmental agency or instrumentality or the public international organization, or the political party, or any other company, person or entity, or to perform its functions improperly; (ii) inducing the person to use his/her influence with the governmental agency or instrumentality or the public international organization or the political party, or any other company, person or entity to affect or influence any act or decision thereof; or (iii) securing any improper advantage. (c) any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate's unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not infringe and will not infringe any Third Party Rights; (cd) Absence of Debarment. August 13, 2021 Master Manufacturing Services Agreement (i) it has not been and will not in be debarred under Section 306 of the performance of its obligations under this Agreement use the services of any person it knows is debarred or suspended under Federal Food, Drug and Cosmetic Act, 21 U.S.C. X.X.X §335(a000x(x) or (b);, or similar local law. If Patheon becomes debarred, Patheon agrees to notify Client immediately. (dii) it has not and will not use in any capacity the services of any individual, corporation, partnership, or association (including without limitation any Patheon Personnel) which has been debarred under Section 306 of the Federal Food, Drug and Cosmetic Act, 21 X.X.X §000x(x) or (b), or similar local law. If Patheon becomes aware of or receives notice of the debarment of any individual, corporation, partnership, or association (including without limitation Patheon Personnel) providing services to Patheon, which relate to the Manufacturing Services being provided under this Agreement, Patheon agrees to notify Client immediately. (e) it does not currently have, and it will not hire, as an officer or an employee any person whom it knows has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the United States Federal Food, Drug, and Cosmetic Act; (e) it has and will maintain throughout the term of this Agreement, the expertise, with respect to personnel and equipment, to fulfill the obligations established hereunder, and has obtained all requisite material licenses, authorizations and approvals required by all Authorities to manufacture the Products (excluding the Regulatory Approval);. (f) the Manufacturing SiteNone of Patheon and its Affiliates have received any written notice of or have any knowledge of, all other facilities, all equipment any event or circumstance that would reasonably be expected to result in any Security Breach. Patheon and all personnel to be employed by Patheon its Affiliates are in rendering the Manufacturing Services are currently, compliance with and will be at the time each batch of Products is produced, qualified in accordance all times continue to comply with all Applicable Laws, includingas well as internal policies and contractual obligations relating to the protection from and against a Security Breach. Patheon and its Affiliates have implemented commercially reasonable policies and procedures to protect against and from a Security Breach, but not limited along with commercially reasonable back-up and disaster recovery plans. Patheon will be responsible for, and remain liable to, cGMPs; (g) Client for the actions and omissions of all Patheon Personnel if there are no pending is any Security Breach. If Patheon becomes aware of or uncorrected citations receives notice of any Security Breach that may affect Client, its business, or adverse conditions noted in any inspection its Confidential Information, Patheon agrees to notify Client immediately. Patheon agrees to fully cooperate with Client’s handling of the Manufacturing Site matter as it pertains to Client, its business or any other facilities to be employed by Patheon its Confidential Information in rendering the Manufacturing Services which would cause the Products to be misbranded or adulterated within the meaning of the Actsuch manner as Client may determine, including, but not limited to, all cGMPs; without limitation: (hi) assisting with any investigation; (ii) providing Client with physical access to the knowledge facilities and operations affected; (iii) facilitating interviews with Patheon’s employees and others involved in the matter; and (iv) making available all relevant records, logs, files, data reporting and other materials required to comply with Applicable Laws, industry standards or as otherwise reasonably required by Client. Patheon agrees that Client will have the sole right to determine: (x) whether notice of Patheonthe Security Breach that may affect Client, its business or its Confidential Information is to be provided to any individuals, regulators, law enforcement agencies, consumer reporting agencies or others as required by law or regulation, or otherwise in Client’s discretion; and (y) the contents of the notice, whether any type of remediation may be offered to affected persons, and the nature and extent of any remediation. Patheon Intellectual Property used by Patheon to manufacture the finished Product in accordance with this Agreement does agrees that money damages may not and will not infringe any Third Party Rights, except to the extent caused or contributed to by be a sufficient remedy for any breach of Client’s warranties under Section 9.2(a); (i) to the knowledge of Patheon, there are no claims against Patheon asserting that any Patheon Intellectual Property to be used for the Manufacturing Services infringes, misappropriates, or violates any Third Party Rights; (j) all employees, consultants, subcontractors confidentiality obligations hereunder and agents performing services for Patheon hereunder have assigned, or will assignthat, in writing addition to Patheon all of their rightother remedies, title and interest in, Client will be entitled to and under any and all Inventions directly relating to the Product; and (k) all Product manufactured and supplied to the Client under this Agreement will not be, seek injunctive or other equitable relief as a result of remedy for any failure breach by Patheon without having to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act or other Applicable Laws as of the time that the finished Product is transferred to the carrier at Patheon’s shipping pointpost a bond.

Patheon Warranties. Patheon covenants, represents, and warrants that: (a) it will perform the Manufacturing Services with experienced, trained employees and qualified subcontractors and in accordance with this Agreement, a Quality Agreement, a Product Agreement, the SpecificationsProcessing Instructions, cGMPs, and Applicable Laws; (b) any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services Services: (i) is Patheon’s or its Affiliate's ’s unencumbered property, (ii) may be lawfully used by Patheon, and (iii) to Patheon’s knowledge, does not infringe and will not infringe any Third Party Rights; (c) it will not in the performance of its obligations under this Agreement use the services of any person it knows is debarred or suspended under 21 U.S.C. §335(a) or (b);; and (d) it does not currently have, and it will not hire, as an officer or an employee any person whom it knows has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the United States Federal Food, Drug, and Cosmetic Act;. (e) it has and will maintain throughout Patheon shall perform all of its obligations under this Agreement in full compliance with all Applicable Laws in the term Territory. Patheon shall hold during the Term of this Agreement, the expertise, with respect to personnel and equipment, to fulfill the obligations established hereunder, and has obtained Agreement all requisite material licenses, permits and similar authorizations and approvals required by all Authorities any Regulatory Authority in the Territory for Patheon to manufacture the Products (excluding the Regulatory Approval);perform its obligations under this Agreement. (f) the Manufacturing Site, all other facilities, all equipment and all personnel to be employed by Patheon in rendering the Manufacturing Services are currently, and will be at the time each batch of Products is produced, qualified in accordance with all Applicable Laws, including, but not limited to, cGMPs; (g) there are no pending or uncorrected citations or adverse conditions noted in any inspection of the Manufacturing Site or any other facilities to be employed by Patheon in rendering the Manufacturing Services which would cause the Products to be misbranded or adulterated within the meaning of the Act, including, but not limited to, all cGMPs; (h) to the knowledge of Patheon, the Patheon Intellectual Property used The Product furnished by Patheon to manufacture the finished Product in accordance with Client under this Agreement does not and will not infringe any Third Party Rights, except to the extent caused or contributed to by any breach of Client’s warranties under Section 9.2(a);Agreement: (i) to the knowledge of Patheon, there are no claims against Patheon asserting that any Patheon Intellectual Property to be used for the Manufacturing Services infringes, misappropriates, or violates any Third Party Rights; (j) all employees, consultants, subcontractors and agents performing services for Patheon hereunder have assigned, or will assign, in writing to Patheon all of their right, title and interest in, to and under any and all Inventions directly relating to the Product; and (k) all Product manufactured and supplied to the Client under this Agreement will not be, as a result of any failure by Patheon to provide perform the Manufacturing Services in accordance with the Specificationsagreed Processing Instructions, cGMPs, or Applicable LawsLaws and shall be manufactured, adulterated or misbranded within packaged, labelled, handled, stored and shipped in compliance with all applicable Laws including the meaning of the Federal Foodagreed Processing Instructions, DrugcGMPs, and Cosmetic Act in accordance with the Quality Agreement; and (ii) shall only contain Product material that has been used, handled, or other Applicable stored in accordance with the specifications, all applicable Laws as of and the time that the finished Product is transferred to the carrier at Patheon’s shipping point.Quality Agreements;

Patheon Warranties. Patheon covenants, represents, represents and warrants that: (a) it will shall perform the Manufacturing Services in accordance with the Specifications, cGMPs, cGMPs and Applicable Laws, and the terms and conditions of this Agreement and the Quality Agreement; (b) title to all Products sold pursuant to this Agreement, upon payment thereof by Avanir as provided in this Agreement, will pass to Avanir free and clear of any security interest, lien or other encumbrance; (c) any Patheon Intellectual Property used utilized by Patheon to perform in connection with the provision of the Manufacturing Services (i) is Patheon’s or its Affiliate's ’s unencumbered property, (ii) may may, to the best of Patheon’s knowledge, be lawfully used as permitted and directed by Patheon, and (iii) to the best of Patheon’s knowledge, such use does not infringe and will not infringe any Third Party Rights; (cd) as of the time that the Product is transferred to the carrier at Patheon’s shipping point it will not in be adulterated, or misbranded within the performance of its obligations under this Agreement use the services of any person it knows is debarred or suspended under 21 U.S.C. §335(a) or (b); (d) it does not currently have, and it will not hire, as an officer or an employee any person whom it knows has been convicted of a felony under the laws meaning of the United States for conduct relating to the regulation of any drug product under the United States Federal Food, Drug, and Cosmetic ActFFDCA or other Applicable Laws; (e) it has and will maintain throughout At all times during the term of this Agreement, all parts of the expertiseManufacturing Site that are directly associated with the testing and storage of the Active Materials and Components and the manufacturing, with respect to personnel packaging, testing and equipment, to fulfill the obligations established hereunder, and has obtained all requisite material licenses, authorizations and approvals required by all Authorities to manufacture storage of the Products (excluding the Regulatory Approval)will remain in compliance with all Applicable Laws; (f) Patheon will obtain and maintain all necessary licenses, permits or approvals required by Applicable Laws to perform the Manufacturing Services at the Manufacturing Site, all other facilities, all equipment and all personnel to be employed by Patheon in rendering the Manufacturing Services are currently, and will be at the time each batch of Products is produced, qualified in accordance with all Applicable Laws, including, but not limited to, cGMPs; (g) there are no pending or uncorrected citations or adverse conditions noted in any inspection Throughout the term of this Agreement, Patheon has, and will maintain, sufficient facilities, resources, and a work force suitably qualified and trained to meet its obligations to supply the Manufacturing Site or any other facilities Product to be employed by Patheon in rendering the Manufacturing Services which would cause the Products Avanir pursuant to be misbranded or adulterated within the meaning of the Act, including, but not limited to, all cGMPsthis Agreement; (h) to the knowledge Patheon is not aware of Patheon, the Patheon Intellectual Property used by Patheon to manufacture the finished Product in accordance with this Agreement does not and will not infringe any Third Party Rights, except to the extent caused pending or contributed to by any breach of Client’s warranties under Section 9.2(a); (i) to the knowledge of Patheon, there are no threatened claims against Patheon asserting that any of the activities of Patheon Intellectual Property relating to be used for the Manufacturing Services infringes, misappropriatesmanufacture of pharmaceutical products, or violates the conduct of the activities contemplated in this Agreement by Avanir, infringe, misappropriate, or violate the rights of any Third Party RightsParty; (ji) Patheon will ensure all employees, consultants, subcontractors and agents performing services for Patheon hereunder have assigned, or will assign, pursuant to this Agreement assign in writing to Patheon all of their right, title and interest in, to and under any and all Inventions directly relating to the Product; and (k) all Product manufactured and supplied to the Client under this Agreement will not be, as a result of any failure by Patheon to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act or other Applicable Laws as of the time that the finished Product is transferred to the carrier at Patheon’s shipping point.Inventions;

Patheon Warranties. Patheon covenants, represents, and warrants that: (a) it will perform the Manufacturing Services, Validation Services and Stability Services in accordance with the Specifications, cGMPs, and Applicable Laws;; and (b) any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate's unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not infringe and will not infringe any Third Party Rights;. (c) it will not the Manufacturing Site and any other facility of Patheon or any other Person where, in accordance with the performance of its obligations under this Agreement use the services of any person it knows is debarred or suspended under 21 U.S.C. §335(a) or (b); (d) it does not currently have, and it will not hire, as an officer or an employee any person whom it knows has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the United States Federal Food, Drug, and Cosmetic Act; (e) it has and will maintain throughout the term provisions of this Agreement, the expertiseany Product will be manufactured, tested, packaged, distributed or stored, are in compliance with respect to personnel cGMP and equipment, to fulfill the obligations established hereunderall applicable Law, and has obtained all requisite material licenses, authorizations and approvals required by all Authorities to manufacture the Products (excluding the Regulatory Approval); (f) the Manufacturing Site, all other facilities, all equipment and all personnel to be employed by Patheon in rendering the Manufacturing Services are currently, and will be at the time each batch of Products is produced, qualified in accordance with all Applicable Laws, including, but not limited to, cGMPs; (g) there are no pending or uncorrected citations citation or adverse conditions condition has been noted in any recent inspection by any Authority of the Manufacturing Site or any other facilities to be employed by Patheon in rendering that would cause any Product developed, tested, manufactured, packaged, stored or shipped at or from the Manufacturing Services which would cause the Products Site or any other facilities to be misbranded or adulterated within the meaning of the ActFD&C Act or any other Law. Patheon will maintain the Manufacturing Site, and maintain or cause to be maintained the other facilities, in compliance with cGMP and all applicable Law. Patheon has not received any FDA 483 incident report that would adversely affect its ability to develop, manufacture, package, test, store or ship any Product. Except as otherwise expressly provided in this Agreement, Patheon will obtain and maintain all necessary licenses, permits or approvals required by the FDA or other relevant Authority in connection with the manufacture, filling, packaging, storage, and shipment of the Product, including, but not limited towithout limitation, all cGMPsmaterial permits and Authorizations related to the Manufacturing Site; (hd) to During the knowledge of PatheonTerm, the Patheon Intellectual Property used by Patheon to manufacture the finished Product in accordance with this Agreement does it will not and will cause its Affiliates not infringe to manufacture any Third Party Rights, except to the extent caused or contributed to by any breach pharmaceutical product containing all of Client’s warranties under Section 9.2(a); (i) to the knowledge of Patheonpseudoephedrine HCI, there are no claims against Patheon asserting that (ii) polyethylene oxide, (iii) ethyl cellulose, and (iv) hydroxy-propyl cellulose, along with any Patheon Intellectual Property to be used other pharmaceutical active or inactive ingredients, for the Manufacturing Services infringessame indication as Client’s Product, misappropriates, or violates any Third Party Rights; (j) all employees, consultants, subcontractors and agents performing services for Patheon hereunder have assigned, or will assign, commercialization in writing to Patheon all of their right, title and interest in, to and under any and all Inventions directly relating to the Product; and (k) all Product manufactured and supplied to the Client under this Agreement will not be, as a result of any failure by Patheon to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act or other Applicable Laws as of the time that the finished Product is transferred to the carrier at Patheon’s shipping pointTerritory.

Patheon Warranties. Patheon covenants, represents, represents and warrants thatthat to Patheon’s knowledge as of the Effective Date: (a) it will perform any Intellectual Property owned by Patheon and utilized by Patheon in connection with the provision of the Manufacturing Services in accordance with which has not been **** CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. provided by Client or used at the Specificationsdirection of Client, cGMPs, and Applicable Laws; (b) any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate's ’s unencumbered property, (ii) may be lawfully used by Patheon, Patheon and (iii) does not infringe and will not infringe any Third Party Rights; (cb) it will not and its Manufacturing Site are in the performance of its obligations under this Agreement use the services of any person it knows is debarred or suspended under 21 U.S.C. §335(a) or (b)compliance with all laws and regulations applicable to their operations, including, without limitation, cGMPs and Applicable Laws; (dc) it does not currently haveall Patheon personnel are fully qualified (by education, training and it will not hire, as an officer or an employee any person whom it knows has been convicted of a felony experience) to properly perform their tasks under the laws of the United States for conduct relating to the regulation of any drug product under the United States Federal Food, Drug, and Cosmetic Act; (e) it has and will maintain throughout the term of this Agreement. In addition, the expertisePatheon covenants, with respect to personnel represents and equipment, to fulfill the obligations established hereunder, and has obtained all requisite material licenses, authorizations and approvals required by all Authorities to manufacture the Products (excluding the Regulatory Approval); (f) the Manufacturing Site, all other facilities, all equipment and all personnel to be employed by Patheon in rendering the Manufacturing Services are currently, and will be at the time each batch of Products is produced, qualified in accordance with all Applicable Laws, including, but not limited to, cGMPs; (g) there are no pending or uncorrected citations or adverse conditions noted in any inspection of the Manufacturing Site or any other facilities to be employed by Patheon in rendering the Manufacturing Services which would cause the Products to be misbranded or adulterated within the meaning of the Act, including, but not limited to, all cGMPs; (h) to the knowledge of Patheon, the Patheon Intellectual Property used by Patheon to manufacture the finished Product in accordance with this Agreement does not and will not infringe any Third Party Rights, except to the extent caused or contributed to by any breach of Client’s warranties under Section 9.2(a);warrants that: (i) to the knowledge of Patheon, there are no claims against Patheon asserting that any Patheon Intellectual Property to be used for it shall perform the Manufacturing Services infringes, misappropriates, or violates any Third Party Rights; (j) all employees, consultants, subcontractors and agents performing services for Patheon hereunder have assigned, or will assign, in writing to Patheon all of their right, title and interest in, to and under any and all Inventions directly relating to the Product; and (k) all Product manufactured and supplied to the Client under this Agreement will not be, as a result of any failure by Patheon to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, adulterated the Quality Agreement and other Technical Information and this Agreement; (ii) it will convey good title to the Product, free of all liens of any kind whatsoever; and (iii) the Products, when delivered to Client, will be Manufactured according to the Specifications. For the sake of clarity, if Patheon performs any additional steps not specified in the Specifications in Manufacturing Products (e.g., by adding one or misbranded within more additional components to the meaning Products that are not specified in the Specifications), then Patheon will be deemed to have failed to Manufacture such Products in accordance with the Specifications. The warranties provided in (i), (ii) and (iii) above shall survive inspection, test, acceptance and use of the Federal Food, Drug, and Cosmetic Act or other Applicable Laws as of the time that the finished Product is transferred to the carrier at Patheon’s shipping pointProduct.

Patheon Warranties. Patheon covenants, represents, and warrants that: (a) it will perform the Manufacturing Services in accordance with the Specifications, cGMPs, the Quality Agreement and Applicable Laws; (b) each Product at the time of delivery to Client shall (i) conform with Specifications, cGMPs and Applicable Laws, (ii) not be adulterated or misbranded within the meaning of the FD&C Act; (c) it will allocate reasonably adequate resources to execute its obligations under this Agreement or any Product Agreement on the basis of Client’s reasonable forecasts; (d) any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate's unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not infringe and will not infringe any Third Party Rights; (ce) [* * *]; (f) it will not in the performance of its obligations under this Agreement use the services of any person it knows is debarred or suspended under 21 U.S.C. §335(a) or (b); (dg) it does not currently have, and it will not hire, as an officer or an employee any person whom it knows has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the United States Federal Food, Drug, and Cosmetic Act; (e) it has and will maintain throughout the term of this Agreement, the expertise, with respect to personnel and equipment, to fulfill the obligations established hereunder, and has obtained all requisite material licenses, authorizations and approvals required by all Authorities to manufacture the Products (excluding the Regulatory Approval); (f) the Manufacturing Site, all other facilities, all equipment and all personnel to be employed by Patheon in rendering the Manufacturing Services are currently, and will be at the time each batch of Products is produced, qualified in accordance with all Applicable Laws, including, but not limited to, cGMPs; (g) there are no pending or uncorrected citations or adverse conditions noted in any inspection of the Manufacturing Site or any other facilities to be employed by Patheon in rendering the Manufacturing Services which would cause the Products to be misbranded or adulterated within the meaning of the Act, including, but not limited to, all cGMPs;; and (h) to the knowledge of Patheon, the Patheon Intellectual Property used by Patheon to manufacture the finished Product in accordance with this Agreement does not and will not infringe any Third Party Rights, except to the extent caused or contributed to by any breach of Client’s warranties under Section 9.2(a);[* * *] 9.4 Permits. (ia) to the knowledge of PatheonExcept as set forth in Section 9.4(b), there are no claims against Patheon asserting that Client will be solely responsible for obtaining or maintaining, on a timely basis, any Patheon Intellectual Property to be used permits or other Regulatory Approvals for the Manufacturing Services infringes, misappropriates, Products or violates any Third Party Rights; (j) all employees, consultants, subcontractors and agents performing services for Patheon hereunder have assigned, or will assign, in writing to Patheon all of their right, title and interest in, to and under any and all Inventions directly relating to the Product; and (k) all Product manufactured and supplied to the Client under this Agreement will not be, as a result of any failure by Patheon to provide the Manufacturing Services in accordance with the Specifications, cGMPsincluding, or Applicable Lawswithout limitation, adulterated or misbranded within the meaning of the Federal Foodall marketing and post-marketing approvals. (b) Patheon will maintain at all relevant times all governmental permits, Druglicenses, approval, and Cosmetic Act authorities required to enable it to lawfully and properly perform the Manufacturing Services, including any permits or other Applicable Laws as of approvals required to conduct such Manufacturing Services at the time that the finished Product is transferred to the carrier at Patheon’s shipping pointManufacturing Site.

Patheon Warranties. Patheon covenants, represents, represents and warrants that: (a) it will shall perform the Manufacturing Services in accordance with the Specifications, Specifications and cGMPs, and Applicable Laws; (b) any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate's unencumbered property, (ii) may be lawfully used by Patheon, and (iii) does not infringe and will not infringe any Third Party Rights; (c) it will not in the performance of its obligations under this Agreement use the services of any person it knows is debarred or suspended under 21 U.S.C. §335(a) or (b); (d) it does not currently have, and it will not hire, as an officer or an employee any person whom it knows has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the United States Federal Food, Drug, and Cosmetic Act; (e) it has and will maintain throughout the term of this Agreement, the expertise, with respect to personnel and equipment, to fulfill the obligations established hereunder, and has obtained all requisite material licenses, authorizations and approvals required by all Authorities to manufacture the Products (excluding the Regulatory Approval)Products; (fc) the Manufacturing Site, all other facilities, all equipment and all personnel to be employed by Patheon in rendering the Manufacturing Services are currently, and will be at the time each batch of Products is produced, qualified in accordance with all Applicable Laws, including, but not limited to, cGMPs; (gd) there are no pending or uncorrected citations or adverse conditions noted in any inspection of the Manufacturing Site or any other facilities to be employed by Patheon in rendering the Manufacturing Services which would cause the Products to be misbranded or adulterated within the meaning of the Act, including, but not limited to, all cGMPs; (he) to the knowledge of Patheon, the Patheon Intellectual Property used by Manufacturing Services and the contributions of Patheon to the manufacture of the finished Product in accordance with this Agreement does do not and will not infringe any Third Party RightsRights provided, except however, that Patheon does not warrant against infringement attributable to the extent caused or contributed to by any breach of Clientfinished Product which, when used together with Patheon’s warranties under Section 9.2(a)manufacturing processes, results in a claim for infringement; (if) to the knowledge Patheon is not aware of Patheon, there are no any pending or threatened claims against Patheon asserting that any of the activities of Patheon Intellectual Property relating to be used for the Manufacturing Services infringesmanufacture, misappropriatesimport, use, or violates sale of pharmaceutical products, or the conduct of the activities contemplated herein by the Client, infringe, misappropriate, or violate the rights of any Third Party Rights;; and (jg) all employees, consultants, subcontractors and agents performing services for Patheon hereunder have assigned, or will assign, in writing to Patheon all of their right, title and interest in, to and under any and all Inventions directly relating to the Product; and. (kh) all Product manufactured and supplied to the Client under this Agreement will shall not be, as a result of any failure by Patheon to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, be adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act or other Applicable Laws as of the time that the finished Product is transferred to the carrier at Patheon’s shipping point. (i) all Product manufactured and supplied to the Client under this Agreement shall have the minimum shelf life specified for such Product in the Specifications and, in any event, shall be shipped to the Client promptly (and in any event not more than three (3) months) after the date of its manufacture.

Patheon Warranties. Patheon covenants, represents, and warrants that: (a) it will perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws; (b) any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or its Affiliate's ’s unencumbered property, (ii) may be lawfully used by Patheon, and (iii) to its knowledge, does not infringe and will not infringe any Third Party Rights; (c) it will not in the performance of its obligations under this Agreement use the services of any person it knows is debarred or suspended under 21 U.S.C. §335(a) or (b); (d) it does not currently have, and it will not hire, as an officer or an employee any person whom it knows has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the United States Federal Food, Drug, and Cosmetic Act; (e) it has and will maintain throughout the term of this Agreement, the expertise, with respect to personnel and equipment, to fulfill the obligations established hereunder, and has obtained all requisite material licenses, authorizations and approvals required by all Authorities to manufacture the Products (excluding the Regulatory Approval)Products; (fd) the Manufacturing Site, all other facilities, all equipment and all personnel to be employed by Patheon in rendering the Manufacturing Services are currently, and will be at the time each batch of Products is produced, qualified in accordance with all Applicable Laws, including, but not limited to, cGMPs; (ge) there are no pending or uncorrected citations or adverse conditions noted in any inspection of the Manufacturing Site or any other facilities to be employed by Patheon in rendering the Manufacturing Services which would cause the Products to be misbranded or adulterated within the meaning of the Act, including, but not limited to, all cGMPs; (hf) to the knowledge of Patheon, the Patheon Intellectual Property used by Manufacturing Services and the contributions of Patheon to the manufacture of the finished Product in accordance with this Agreement does do not and will not infringe any Third Party Rights, except to the extent caused or contributed to by any breach of Client’s warranties under Section 9.2(a); (ig) to the knowledge of Patheon, there are no pending or threatened claims against Patheon asserting that any of the activities of Patheon Intellectual Property relating to be used for the Manufacturing Services infringesmanufacture, misappropriatesimport, use, or violates sale of pharmaceutical products, or the conduct of the activities contemplated herein by Client, infringe, misappropriate, or violate any Third Party Rights; (jh) all employees, consultants, subcontractors and agents performing services for Patheon hereunder have assigned, or will assign, in writing to Patheon all of their right, title and interest in, to and under any and all Inventions directly relating to the Product; and; (ki) all Product manufactured and supplied to the Client under this Agreement will not be, as a result of any failure by Patheon to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, be adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act or other Applicable Laws as of the time that the finished Product is transferred to the carrier at Patheon’s shipping point; and (j) all Product manufactured and supplied to the Client under this Agreement will have the minimum Shelf Life specified for such Product in the Specifications and, in any event, will be shipped to the Client promptly (and in any event not more than three months) after the date of its manufacture.