Common use of Supplier Representations, Warranties and Covenants Clause in Contracts

Supplier Representations, Warranties and Covenants. Supplier represents, warrants and covenants that: (i) As of the time of Product delivery, the Products (a) conform to the applicable Specifications; (b) are not adulterated; and (c) have been Manufactured, packaged, stored and shipped in accordance with cGMP. (ii) Supplier (a) complies with all Applicable Laws affecting the performance of its duties hereunder and shall maintain any and all permits, certificates or licenses necessary for the conduct of its operations; and (b) has good title to the Products, free and clear of encumbrances of any kind; and (c) is a corporation validly existing under the laws of its state of incorporation, with all requisite power and authority to carry on the business in which Supplier is engaged and proposes to engage pursuant to this Agreement. *** Certain information on this page has been omitted and filed separately with the SEC. Confidential treatment has been requested with respect to the omitted portions. (iii) The Manufacturing Facilities comply with all Applicable Laws. The execution and performance of this Agreement will not result in a violation or breach of any agreement or other instrument under which Supplier is bound or to which any of the assets of Supplier are subject or violate any relevant Applicable Laws. No authorization, consent, approval, permit, or filing of or with any Governmental Authority, any lender or lessor, or any other Person is required to authorize, or is required in connection with, the execution, delivery, and performance of this Agreement. Supplier’s acceptance of any Order shall constitute a continuing representation and warranty that the Products conform to the warranties contained herein. All such warranties shall survive inspection, tests, acceptance and payment until the applicable expiration date of the Products. (iv) As of the time of Product delivery, the Products shall conform to all industry standards governing the Manufacture and supply of the Products. Supplier shall conduct and maintain a stability program to support U.S. and international Products. Supplier will provide Purchaser with all necessary manufacturer documentation necessary for international Product registration, shipping and distribution. (v) Supplier shall: (i) retain the minimum number of samples of Product as are required and specified to comply with the retention requirements set forth in cGMP provisions, regulatory applications in the relevant jurisdiction and under all other Applicable Laws; (ii) report to Purchaser any confirmed out-of-Specification test results with respect to Product delivered to Purchaser within three (3) business days; and (iii) make any such out-of-Specification reports and findings related to those Products available for reasonable inspection by Purchaser or Purchaser’s designees. Supplier shall retain all production records of the Manufacture of Product in accordance with Applicable Laws. (vi) Supplier shall: (i) report to Purchaser and open an investigation of all material out-of-Specification events in Manufacturing and complaints by Purchaser regarding such non-conformance within three (3) business days; (ii) report to Purchaser and open an investigation for all critical Manufacturing deviations within three (3) business days; (iii) keep Purchaser apprised no less frequently than daily upon Purchaser request or otherwise every week of the status of such investigations; and (iv) notify Purchaser about the results of completed investigations within three (3) business days and make copies of all non-privileged investigative reports available to Purchaser for review on premises upon the conclusion of the investigation with Purchaser. Supplier shall also inform Purchaser within three (3) business days of any notification or other information that it receives (directly or indirectly) from any person, which: (A) raises any material concerns regarding the safety of Product manufactured by Supplier, (B) indicates or suggests a potential material liability for either Supplier or Purchaser to third parties arising in connection with Product manufactured by Supplier, or (C) indicates a reasonable potential for a recall or market withdrawal of Products manufactured by Supplier; and shall provide copies of correspondence related thereto within fifteen (15) days of receipt of such notification, provided that all such correspondence shall be considered confidential business information and subject to the terms and conditions in Article XII as Supplier Confidential Information. (vii) Supplier shall inform Purchaser of any Applicable Regulatory Agency inspection of the Manufacturing Facility at least seven (7) calendar days in advance of such inspection, or in the case of an unannounced inspection or notification from an Applicable Regulatory Agency within five (5) days of such inspection, shall inform Purchaser within one (1) business day that such inspection was initiated. Supplier shall, within five (5) business days after receipt by Supplier, provide copies to Purchaser of all inspection observation reports and other regulatory communications that may affect any Product. Supplier shall also provide copies of Supplier’s proposed responses to such inspection observation reports and other regulatory communications within three (3) business days of their preparation (the inspection observation reports, Supplier’s proposed and actual responses and other regulatory communications are referred to collectively as “Regulatory Audit Materials”). Purchaser will be allowed to review and comment on those Regulatory Audit Materials that pertain directly to any Products or the Manufacture thereof, provided that Purchaser is able to provide Supplier with a timely (with “timely” meaning within the period specified in Applicable Law) response to such Regulatory Audit Materials. Supplier will reasonably consider Purchaser’s comments. With regard to the Products, Supplier and Purchaser shall jointly decide as to what corrective measure, if any Supplier should take, and Supplier shall keep Purchaser informed on a regular, ongoing and periodic basis of related developments. With regard to the Manufacturing Facilities, Supplier shall have the sole discretion decide as to what, if any, corrective measure, Supplier should take. (viii) Within ten (10) days of Supplier’s receipt of Purchaser’s written request, Supplier shall provide Purchaser with any and all documentation, records and any and all information (whatever the format) related to the Manufacture of Product by Supplier, excluding any IVC Existing Intellectual Property to allow Purchaser or its Affiliates to prepare and file on a timely basis supplements or amendments to regulatory applications or to provide any information requested by Regulatory Agencies or otherwise required pursuant to Applicable Laws.

Supplier Representations, Warranties and Covenants. Supplier represents, represents and warrants to and covenants with the Province that: (i) As of the time of Product delivery, the Products (a) conform Supplier and Supplier Personnel and all Supplier Subcontractors will have and maintain throughout the Term all skills, qualifications, expertise and experience necessary to perform the Services in an efficient, cost-effective manner with a high degree of quality and responsiveness, at all times consistent with industry standards applicable Specifications; to top tier providers of similar services and otherwise in accordance with the terms of this Agreement; (b) are not adulterated; Supplier will conduct its business in relation to the Services in a professional manner that will reflect favourably on the good name and reputation of the Province; (c) have been Manufactured, packaged, stored and shipped in accordance with cGMP. (ii) Supplier (a) complies will comply with all Applicable Laws affecting in its dealings with the performance of Province and in performing its duties hereunder obligations under this Agreement (including ensuring that all Services comply with Applicable Law) and shall maintain will refrain from engaging in any and unfair or deceptive trade practice, or unethical business practice whatsoever, or any other practice that could unfavourably reflect upon the Province; (d) Supplier has all permits, certificates or licenses necessary for the conduct of its operations; and (b) has good title rights to grant to the Products, free Province and clear of encumbrances of any kind; Other Service Providers the rights and (c) is a corporation validly existing under the laws of its state of incorporation, with all requisite power and authority to carry on the business in which Supplier is engaged and proposes to engage permissions granted pursuant to this Agreement. *** Certain information on ; (e) the performance by Supplier and Supplier Subcontractors of their obligations under this page has been omitted Agreement, and filed the possession and use of any Deliverables and the Services by the Province or Other Service Providers (in each case, whether separately or together in combination) as permitted or required under this Agreement, do not and will not infringe, violate or constitute a misappropriation of any Intellectual Property Right of any Person; (f) subject to Section 4.5, Supplier and Supplier Subcontractors have entered into, and Supplier will and will cause Supplier Subcontractors to enter into, agreements with all Supplier Personnel for the assignment and waiver of Intellectual Property Rights and the treatment of Confidential Information in accordance with the SEC. Confidential treatment has been requested with respect terms hereof; (g) Supplier will not insert or permit any third party to insert any Disabling Code into any Deliverable delivered to the omitted portions.Province; (iiih) The Manufacturing Facilities comply Supplier has obtained all authorizations, approvals or orders by, consents of, notices to, filings with all Applicable Laws. The execution and performance of this Agreement will not result or other acts by or in a violation or breach respect of any agreement or other instrument under which Supplier is bound or to which any of the assets of Supplier are subject or violate any relevant Applicable Laws. No authorization, consent, approval, permit, or filing of or with any Governmental Authority, any lender or lessor, Authority or any other Person is required to authorize, or is required in connection with, for the execution, delivery, and performance operation of this Agreement. Supplier’s acceptance of any Order shall constitute a continuing representation and warranty its business that the Products conform pertains to the warranties contained herein. All such warranties shall survive inspection, tests, acceptance and payment until the applicable expiration date provision of the Products.Services, including all Regulatory Authorizations; (iv) As of the time of Product delivery, the Products shall conform to all industry standards governing the Manufacture and supply of the Products. Supplier shall conduct and maintain a stability program to support U.S. and international Products. Supplier will provide Purchaser with all necessary manufacturer documentation necessary for international Product registration, shipping and distribution. (v) Supplier shall: (i) retain the minimum number Supplier has not given and will not give commissions, payments, kickbacks, gifts, lavish or extensive entertainment, or other inducements of samples of Product as are required and specified more than minimal value to comply with the retention requirements set forth in cGMP provisions, regulatory applications in the relevant jurisdiction and under all other Applicable Laws; (ii) report to Purchaser any confirmed out-of-Specification test results with respect to Product delivered to Purchaser within three (3) business days; and (iii) make any such out-of-Specification reports and findings related to those Products available for reasonable inspection by Purchaser employee or Purchaser’s designees. Supplier shall retain all production records agent of the Manufacture of Product in accordance with Applicable Laws. (vi) Supplier shall: (i) report to Purchaser and open an investigation of all material out-of-Specification events in Manufacturing and complaints by Purchaser regarding such non-conformance within three (3) business days; (ii) report to Purchaser and open an investigation for all critical Manufacturing deviations within three (3) business days; (iii) keep Purchaser apprised no less frequently than daily upon Purchaser request or otherwise every week of the status of such investigations; and (iv) notify Purchaser about the results of completed investigations within three (3) business days and make copies of all non-privileged investigative reports available to Purchaser for review on premises upon the conclusion of the investigation with Purchaser. Supplier shall also inform Purchaser within three (3) business days of any notification or other information that it receives (directly or indirectly) from any person, which: (A) raises any material concerns regarding the safety of Product manufactured by Supplier, (B) indicates or suggests a potential material liability for either Supplier or Purchaser to third parties arising Province in connection with Product manufactured by Supplierthis Agreement and, or (C) indicates a reasonable potential for a recall or market withdrawal of Products manufactured by Supplier; and shall provide copies of correspondence related thereto within fifteen (15) days of receipt of such notification, provided that all such correspondence shall be considered confidential business information and subject to the terms and conditions in Article XII as best of its knowledge, no officer, director, employee, agent or representative of Supplier Confidential Information.has given any such inducements to any employee or agent of the Province; (viij) all information provided by Supplier shall inform Purchaser of any Applicable Regulatory Agency inspection to the Province as part of the Manufacturing Facility at least seven (7) calendar days Services will not be misleading in advance of such inspection, or in the case of an unannounced inspection or notification from an Applicable Regulatory Agency within five (5) days of such inspection, shall inform Purchaser within one (1) business day that such inspection was initiated. Supplier shall, within five (5) business days after receipt by Supplier, provide copies to Purchaser of all inspection observation reports and other regulatory communications that may affect any Product. Supplier shall also provide copies of Supplier’s proposed responses to such inspection observation reports and other regulatory communications within three (3) business days of their preparation (the inspection observation reports, Supplier’s proposed and actual responses and other regulatory communications are referred to collectively as “Regulatory Audit Materials”). Purchaser will be allowed to review and comment on those Regulatory Audit Materials that pertain directly to any Products or the Manufacture thereof, provided that Purchaser is able to provide Supplier with a timely (with “timely” meaning within the period specified in Applicable Law) response to such Regulatory Audit Materials. Supplier will reasonably consider Purchaser’s comments. With regard to the Products, Supplier and Purchaser shall jointly decide as to what corrective measure, if any Supplier should takematerial respect, and Supplier shall keep Purchaser informed on a regular, ongoing and periodic basis will not fail to disclose any further information that would make such information disclosed misleading; and (k) Supplier has no knowledge of related developments. With regard any material fact or matter not disclosed to the Manufacturing Facilities, Province by Supplier shall have the sole discretion decide as to whatthat, if anyknown by the Province, corrective measure, might reasonably be expected to deter the Province from entering into this Agreement or completing the transactions contemplated in this Agreement or that might materially adversely affect the ability of Supplier should taketo perform its obligations under this Agreement. (viii) Within ten (10) days of Supplier’s receipt of Purchaser’s written request, Supplier shall provide Purchaser with any and all documentation, records and any and all information (whatever the format) related to the Manufacture of Product by Supplier, excluding any IVC Existing Intellectual Property to allow Purchaser or its Affiliates to prepare and file on a timely basis supplements or amendments to regulatory applications or to provide any information requested by Regulatory Agencies or otherwise required pursuant to Applicable Laws.