Representations and Warranties of IMPAX Sample Clauses

Representations and Warranties of IMPAX. 7.2.1 IMPAX hereby represents and warrants to WCH with respect to each delivery of Products that: (i) the Products (a) have been Manufactured in the United States; (b) have been Manufactured, stored and shipped in accordance with GMPs and all applicable laws, rules, regulations or requirements in effect at the time of Manufacture; (c) conform to the Specifications, are free from defects and are merchantable; (d) at the point of shipment to WCH or WCH’s designee are not adulterated or misbranded; and (e) have been shipped and stored in accordance with approved procedures agreed between WCH and IMPAX; (ii) the D-12 Products and D-24 Products are pharmaceutically equivalent and bioequivalent to CLARITIN-D® 12-hour Extended Release Tablets and CLARITIN-D® 24-hour Extended Release Tablets, respectively; (iii) IMPAX has good and marketable title to all Products and Products are free from all liens, charges, encumbrances and security interests; (iv) to the knowledge of IMPAX, (A) as of the Effective Date and (B) thereafter, except as disclosed in writing by IMPAX to WCH, the Manufacture, use, importation, offer for sale and sale of Products do not infringe any intellectual property rights of any Third Party, including but not limited to U.S. Patents 4,659,716; 4,863,931; 6,335,347; and 5,314,697 and any foreign counterparts thereof; (v) the Facilities conform in all respects to applicable law governing such Facilities; and (vi) neither IMPAX nor its Affiliates used in any capacity the services of any person debarred under the U.S. Generic Drug Enforcement Act, 21 USA §335a(k)(l) and further it did not use any person who has been convicted of a crime as defined under the Generic Drug Enforcement Act in connection with the Manufacture of Products or any service rendered to WCH. 7.2.2 IMPAX hereby represents and warrants with respect to the IMPAX Patents and Technical Information: (i) IMPAX has no knowledge that the IMPAX Patents (a) are not valid and enforceable; or (b) are dominated or the practice of then claimed subject matter infringes the intellectual property rights of any Third Party in the Territory as of the Effective Date; (ii) IMPAX has the full right, power and authority to grant the licenses set forth in Sections 2.1 and 2.2; (iii) IMPAX has not previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in the Products, the IMPAX Patents or the Technical Information in the OTC Field in the Exclusive Territory; and ...
AutoNDA by SimpleDocs
Representations and Warranties of IMPAX. Except (a) as disclosed in the Impax SEC Documents (as defined herein) filed prior to the date hereof and publicly available on the SEC’s Electronic Data Gathering Analysis and Retrieval system (but (i) without giving effect to any amendment thereof filed with, or furnished to the SEC (as defined herein) on or after the date of this Agreement, (ii) excluding any disclosure contained in such Impax SEC Documents under the heading “Risk Factors” or “Cautionary Statement About Forward-Looking Statements” or similar heading and any other disclosures contained or referenced therein of factors or risks that are predictive, cautionary or forward-looking in nature and (iii) not with respect to Sections 3.01, 3.02, 3.03, 3.04, 3.05, 3.23, 3.24, 3.25, 3.26, 3.27, 3.28, and 3.29), or (b) as set forth in the disclosure letter delivered by Impax to Amneal prior to the execution of this Agreement (the “Impax Disclosure Letter”), Impax represents and warrants to Amneal as follows:
Representations and Warranties of IMPAX. Impax hereby represents and/or warrants and/or undertakes to Andrx and Teva that: (a) it has the corporate power and authority to enter into this Agreement and to perform its obligations hereunder; (b) neither the execution and delivery of this Agreement by Impax nor its performance hereunder conflicts with or results in any violation or breach of, or constitute (with or without due notice or lapse of time or both) a default under any of the terms or conditions of any note, bond, mortgage, indenture, license, agreement or other instrument or obligation to which it is a party or by which it or any of its properties or assets may be bound, or to its best knowledge, violate any statute, law, rule, regulation, writ, injunction, judgment, order or decree of any court, administrative agency or governmental authority binding on it or any of its properties or assets, excluding any such breaches or defaults that, individually and in the aggregate, would not have a material adverse effect on its business or financial condition; (c) this Agreement is a legal, valid and binding agreement of Impax, enforceable in accordance with its terms; (d) it has not and will not, directly or indirectly, enter into any contract or any other transaction with any third party or Affiliate that conflicts or derogates from its undertakings hereunder; (e) in the event and to the extent that Impax and/or its Affiliates shall manufacture the Products, all such Products shall: (a) meet the applicable Specifications at the time of shipment; (b) meet regulatory requirements of any relevant Regulatory Authority in the Territory; (c) be manufactured, packaged, tested, stored and shipped in accordance with applicable cGMPs, the Approvals and Applicable Law; (d) not be adulterated or misbranded under the United States Food, Drug and Cosmetic Act, as amended from time to time; and (e) be produced, packaged, tested and stored in facilities that have been approved by the applicable Regulatory Authority, to the extent required by Applicable Law; (f) in the event and to the extent that Impax and/or its Affiliates shall manufacture the Products, Impax's and/or its Affiliates' manufacturing facilities for such Products shall conform in all respects to Applicable Law governing such facilities; and (g) neither it nor any of its Affiliates have been debarred or is subject to debarment and will not use in any capacity, in connection with the services to be performed under this Agreement, any Person who has ...

Related to Representations and Warranties of IMPAX

  • Representations and Warranties of XXXX XXXX hereby represents and warrants to the Seller and the Servicer as of the Initial Closing Date and each Subsequent Closing Date:

  • Representations and Warranties of ALPS ALPS represents and warrants to the Trust that: (a) It is duly organized and existing as a corporation and in good standing under the laws of the State of Colorado. (b) It is empowered under applicable laws and by its Articles of Incorporation and By-laws to enter into and perform this Agreement. (c) All requisite corporate proceedings have been taken to authorize it to enter into and perform this Agreement. (d) It has and will continue to have access to the necessary facilities, equipment and personnel to perform its duties and obligations under this Agreement in accordance with industry standards.

  • Representations and Warranties of Xxxxx Xxxxx represents and warrants to Spruce that, as of the Effective Date: (a) it has the full right, power and authority to enter into this Agreement, to grant the rights and licenses granted under Articles 2 and 3, and its execution of this Agreement, the fulfillment of its obligations and performance of its activities hereunder do not conflict with, violate, or breach or constitute a default under any material contractual obligation or court or administrative order by which Lilly is bound; (b) to the knowledge of Lilly, there are no legal claims, judgments or settlements against or owed by Lilly or any of its Affiliates, threatened or pending legal claims or litigation, in each case relating to the Licensed Patents; (c) all necessary consents, approvals and authorizations of all government authorities and other persons required to be obtained by Lilly as of the Effective Date in connection with the execution, delivery and performance of this Agreement have been obtained; (d) it is the owner or exclusive licensee of or otherwise Controls the right, title and interest in and to the Licensed Patents and related Licensed Know-How, and has the right to grant to Spruce the licenses that it purports to grant hereunder and has not granted any Third Party rights that would interfere or be inconsistent with Spruce’s rights hereunder; (e) the Licensed Patents and Licensed Know-How are not subject to any existing royalty or other payment obligations to any Third Party; (f) it has disclosed to Spruce a complete and accurate record of all material information and data relating to the results of all pre-clinical and clinical studies on Licensed Products or the Licensed Compound, conducted by or on behalf of Lilly or any of its Affiliates or otherwise known to Lilly, including, without limitation, the status and interim results of all ongoing clinical and preclinical studies, and the clinical development and Regulatory Application and Regulatory Approval activities undertaken to date, and all such information and data is complete and accurate in all material respects; (g) neither it nor any of its Affiliates has been debarred or is subject to debarment; (h) it has the authority to bind its Affiliates to the terms of this Agreement, as applicable, and to grant the rights and licenses granted on behalf of its Affiliates as set forth herein; (i) all documents required to be filed and all payments required to be made in order to prosecute and maintain each Patent in the Licensed Patents have been filed or made, as the case may be, in a timely manner, and no action has been taken that would constitute waiver, abandonment or any similar relinquishment of such rights; (j) the Licensed Patents constitute all Patents owned by or licensed to Lilly or any of its Affiliates that contain one or more claims covering any Licensed Product or Licensed Compound, or the composition of matter, method of use or manufacture thereof; (k) neither Lilly nor any of its Affiliates is or has been a party to any agreement with any U.S. Governmental Authority pursuant to which any U.S. Governmental Authority provided funding for the Development of any Licensed Compound or any Licensed Product, and the inventions claimed or covered by the Existing Patents are not a “subject invention” as that term is described in 35 U.S.C. Section 201(f); and (l) neither Lilly nor any of its Affiliates, nor any of its or their respective officers, employees, or agents has made an untrue statement of material fact or fraudulent statement to the FDA or any other Regulatory Authority with respect to the Development of any Licensed Compound or Licensed Product, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority with respect to the Development of any Licensed Compound or any Licensed Product, or committed an act, made a statement, or failed to make a statement with respect to the Development of any Licensed Compound or Licensed Product that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto or any analogous laws or policies in any other country.

  • REPRESENTATIONS AND WARRANTIES OF BUYER Buyer hereby represents and warrants to Seller as follows:

  • Representations and Warranties of Both Parties On the Execution Date, each Party represents and warrants to the other Party that: It is duly organized, validly existing and in good standing under the laws of the jurisdiction of its formation; Except for CPUC Approval in the case of Buyer, it has or will timely acquire all regulatory authorizations necessary for it to legally perform its obligations under this Agreement; The execution, delivery and performance of this Agreement are within its powers, have been duly authorized by all necessary action and do not violate any of the terms and conditions in its governing documents, any contracts to which it is a party or any law, rule, regulation, order or the like applicable to it; This Agreement constitutes its legally valid and binding obligation, enforceable against it in accordance with its terms; It is not Bankrupt and there are no proceedings pending or being contemplated by it or, to its knowledge, threatened against it which would result in it being or become Bankrupt; There is not pending or, to its knowledge, threatened against it, any legal proceedings that could materially adversely affect its ability to perform its obligations under this Agreement; It (i) is acting for its own account, (ii) has made its own independent decision to enter into this Agreement and as to whether this Agreement is appropriate or proper for it based upon its own judgment, (iii) is not relying upon the advice or recommendations of the other Party in so doing, and (iv) is capable of assessing the merits of and understanding, and understands and accepts, the terms, conditions, and risks of this Agreement; and It has entered into this Agreement in connection with the conduct of its business and it has the capability or ability to make available or take delivery of, as applicable, the Product under this Agreement in accordance with the terms of this Agreement.

  • REPRESENTATIONS AND WARRANTIES OF XXXXXX Xxxxxx hereby represents and warrants to the Xxxxxx Group that (a) Xxxxxx has the power and authority to enter into this Agreement and the Xxxxxx Assignment and to carry out his obligations hereunder and thereunder, (b) the execution and delivery of this Agreement and the Xxxxxx Assignment by Xxxxxx has been duly authorized by all necessary action on the part of Xxxxxx and no other proceedings on the part of Xxxxxx are necessary to authorize this Agreement or the Xxxxxx Assignment, (c) this Agreement has been duly executed and delivered by Xxxxxx and constitutes a valid and binding obligation of Xxxxxx, and, assuming this Agreement constitutes a valid and binding obligation of the Xxxxxx Group, is enforceable against Xxxxxx in accordance with its terms (subject to applicable bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and other laws affecting creditors’ rights generally and general principles of equity), (d) the Xxxxxx Assignment has been duly executed and delivered by Xxxxxx and constitutes a valid and binding obligation of Xxxxxx, and, assuming the Xxxxxx Assignment constitutes a valid and binding obligation of Splitco, is enforceable against Xxxxxx in accordance with its terms (subject to applicable bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and other laws affecting creditors’ rights generally and general principles of equity), (e) neither the execution, delivery or performance of this Agreement or the Xxxxxx Assignment by Xxxxxx constitutes a breach or violation of, or conflicts with any provision of any material agreement to which Xxxxxx is a party, and (f) none of such material agreements would impair in any material respect the ability of Xxxxxx to perform his obligations hereunder or thereunder.

  • Representations and Warranties of Vendor Vendor represents and warrants that the following shall be true and correct as of the effective date of this Agreement and shall continue to be true and correct during the Term of this Agreement:

  • Representations and Warranties; Etc Each Obligor hereby affirms: (a) that as of the date of execution and delivery of this First Amendment, all of the representations and warranties contained in each Loan Document to which such Obligor is a party are true and correct in all material respects as though made on and as of the First Amendment Effective Date (unless made as of a specific earlier date, in which case, was true as of such date); and (b) that after giving effect to this First Amendment and to the transactions contemplated hereby, no Defaults exist under the Loan Documents or will exist under the Loan Documents.

  • Representations and Warranties of Parties A. Redeveloper represents and warrants to City as follows:

  • Representations and Warranties of Party B Party B hereby represents and warrants on his own behalf to Party A that as of the date of this Agreement: 4.1.1 he has the power and right to sign, deliver, and perform his obligations under this Agreement, and that the said documents shall constitute his legal, valid, and binding obligations enforceable in accordance with their terms; 4.1.2 the execution and delivery of this Agreement or any other contracts, and the performance of his obligations thereunder, will not violate PRC law, breach or result in a default of any contract or instrument to which he is subject, or result in a breach, suspension, or revocation of any grant, license, or approval or result in the imposition of any additional conditions being imposed thereon; and 4.1.3 he is the lawful owner of the Equity Interest held by himself and has not created any Security Interest over such Equity Interest other than the Equity Pledge Agreement.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!