NGSX » Topics » 12. REPRESENTATIONS AND WARRANTIES .

This excerpt taken from the NGSX 8-K filed Jul 1, 2009.

12. REPRESENTATIONS AND WARRANTIES.

12.1 Mutual Warranties. Each Party warrants and represents to the other that the Supply Agreement is a legal and valid obligation binding upon such Party and enforceable in accordance with its terms. The execution, delivery and performance of the Agreement by such Party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor to such Party’s knowledge, violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it.

 

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

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12.2 Product Warranties.

12.2.1 Patch Warranties. NGX represents and warrants that the Patches supplied hereunder:

(a) shall be in conformity with the Patch Specifications;

(b) shall be manufactured in accordance with cGMP and the Quality Agreement;

(c) shall comply with all Regulatory Requirements;

(d) shall have a remaining shelf-life of no less than (i) in the case of Patch Inventory, the Inventory Shelf-Life and (ii) in all other cases, the Shelf-Life; and

(e) shall be manufactured by LTS pursuant to the LTS Agreement ((a) to (e) inclusive being the “Patch Warranties”).

12.2.2 Gel Warranties. NGX represents and warrants that:

(a) the Gel supplied hereunder shall be in conformity with the Gel Specifications and shall conform with the information shown on the Certificate of Analysis provided for the particular shipment;

(b) the Gel supplied hereunder shall be manufactured in accordance with cGMP and the Quality Agreement;

(c) all raw materials used in the manufacture of the Gel shall comply with the applicable specifications, cGMP and the Quality Agreement; and

(d) none of the product supplied shall be adulterated or misbranded within the meaning of the United States Federal Food, Drug and Cosmetic Act (21 USC 301 et seq) and the regulations promulgated thereunder, as may be amended from time to time;

(e) the Gel supplied hereunder shall comply with all Regulatory Requirements;

(f) title to all Gel shall pass as provided in the CPL Agreement, free and clear of any security interest, lien or other encumbrance; and

(g) as of 22 December 2005, [***].

12.2.3 API Warranties. NGX represents and warrants that:

(a) all API supplied by Formosa for use by LTS in the manufacture of Patches for NGX shall comply with the API Specifications shown on the API CoA provided for the particular shipment of API;

 

***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

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(b) the API supplied by Formosa for use by LTS in the manufacture of Patches for NGX shall comply with the API Regulatory Requirements and the API Quality Agreement, and all API Raw Materials used by Formosa in the manufacture of API for use by LTS in the manufacture of Patches for NGX shall comply with the applicable specifications, API Regulatory Requirements, and the API Quality Agreement;

(c) none of the API supplied by Formosa for use by LTS in the manufacture of Patches for NGX shall be adulterated or misbranded within the meaning of the Act;

(d) title to all API supplied by Formosa shall pass as provided in the Formosa Agreement, free and clear of any security interest, lien, or other encumbrance; and

(e) as of 19 August 2008, to [***].

12.3 DISCLAIMER. EXCEPT AS EXPRESSLY SET FORTH IN THIS SUPPLY AGREEMENT AND THE AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY KIND EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT, OR VALIDITY OF ANY PATENTS ISSUED OR PENDING.

12.4 LIMITATION OF LIABILITY. NOTWITHSTANDING ANYTHING IN THIS SUPPLY AGREEMENT OR OTHERWISE, NEITHER PARTY SHALL BE LIABLE TO THE OTHER WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT, WHETHER UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY, FOR ANY INCIDENTAL, INDIRECT, SPECIAL, EXEMPLARY, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES (INCLUDING, WITHOUT LIMITATION, LOST PROFITS, LOSS OF ROYALTIES AND MILESTONE PAYMENTS, LOSS OF USE, DAMAGE TO GOODWILL, OR LOSS OF BUSINESS).

This excerpt taken from the NGSX 8-K filed Aug 22, 2008.

REPRESENTATIONS AND WARRANTIES

11.1 Supplier. Supplier represents and warrants that: (a) it has full power to enter into this Agreement; (b) it has the corporate authority to enter into and execute the Agreement; (c) Supplier shall fully comply with the requirements of any and all applicable federal, state, local and foreign laws, regulations, rules, and orders of any governmental body having jurisdiction over the activities contemplated by this Agreement or having jurisdiction over the Territory and to the extent applicable to Supplier, including all Regulatory Requirements; (d) it shall perform all Services in a professional manner in accordance with industry standards; (e) the manufacture and supply of API hereunder will not infringe or misappropriate any intellectual property right of any third party and (f) it has not been debarred under the Generic Drug Enforcement Act of 1992 and that it will not employ any person or entity that has been so debarred to perform any activities under this Agreement.

11.2 NeurogesX. NeurogesX represents and warrants that: (a) it has full power to enter into the Agreement; (b) it has obtained all necessary corporate approvals to enter and execute into this Agreement; and (c) NeurogesX shall fully comply with the requirements of any and all applicable federal, state, local and foreign laws, regulations, rules and orders of any governmental body having jurisdiction over the activities contemplated by this Agreement and to the extent applicable to NeurogesX.

11.3 Disclaimer. EXCEPT AS PROVIDED IN THIS ARTICLE 11, SECTION 8.1 AND 8.2 ABOVE, NEITHER PARTY MAKES ANY REPRESENTATIONS, WARRANTIES OR CONDITIONS (EXPRESS, IMPLIED, STATUTORY OR OTHERWISE) WITH RESPECT TO THE SUBJECT MATTER HEREOF AND EACH PARTY EXPRESSLY DISCLAIMS ANY SUCH ADDITIONAL REPRESENTATIONS, WARRANTIES OR CONDITIONS.

EXCERPTS ON THIS PAGE:

8-K
Jul 1, 2009
8-K
Aug 22, 2008
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