Common use of PRODUCT WARRANTY; QUALITY CONTROL Clause in Contracts

PRODUCT WARRANTY; QUALITY CONTROL. Hologic warrants to Ostex that all NTx Meter Strips and NTx Meters sold by Hologic to Ostex hereunder shall (i) comply with the product specifications attached hereto as ATTACHMENT 7.2.4 when used in accord with applicable Hologic instructions, as modified by mutual agreement of the parties, (ii) be free from defects in material, workmanship and design, and (iii) comply with all applicable laws, rules and regulations related to the manufacture and distribution of such product (to the extent applicable to a manufacturer). Without limiting the generality of the foregoing, Hologic warrants that all NTx Meter Strips and NTx Meters manufactured and supplied for the United States market under this Agreement shall be manufactured, tested, documented, packaged, and transported in compliance with GMP requirements of the FDA including, without limitation, 21 CFR Part 820 and any amendments or successors thereto; and that all NTx Meter Strips and NTx Meters manufactured and supplied under this Agreement, regardless of intended market, shall be manufactured, tested, documented, packaged and transported in compliance with appropriate quality assurance requirements agreed to by the parties. Ostex shall have the right to audit and inspect Hologic facilities, books, and records to confirm such compliance. Hologic further represents that is working toward compliance with the quality standards established by ISO 9000 and warrants that it will comply with such standards when legally required to do so. In the event that Ostex demonstrates within one year of receipt that any product supplied pursuant to this Agreement fails to meet these specifications and warranties, Hologic shall, as Ostex's sole remedy for such failure, replace said product (returned by Ostex to the factory pursuant to Hologic's reasonable standard return procedures) with product which conforms to the above specifications and warranties, provided that Hologic shall not be obligated to replace NTx Meter Strips distributed as "Promotional Samples" which pass Hologic quality assurance tests and comply with all FDA and other governmental regulations relating to such Promotional Samples. These warranties shall not apply to any item that is subjected to abuse, stress, or misuse; or used in any manner inconsistent with applicable Hologic instructions; or insofar as any such warranty violation is caused by Ostex's violation of its warranties set out in SECTION 3.4 hereof.

PRODUCT WARRANTY; QUALITY CONTROL. Hologic Ostex warrants to Ostex Hologic and its designated manufacturer(s) that all NTx Meter Strips and NTx Meters Critical Reagents sold by Hologic to Ostex hereunder shall (i) comply with the product specifications attached hereto as set out in ATTACHMENT 7.2.4 3.4 hereof when used in accord with applicable Hologic instructionsOstex instructions for use, and amendments thereto as modified mutually agreed upon by mutual agreement of the parties, (ii) be free from defects in material, workmanship and design, and (iii) comply with all applicable laws, rules and regulations related to the manufacture and distribution of such product (to the extent applicable to a manufacturer). Without limiting the generality of the foregoing, Hologic Ostex warrants that all NTx Meter Strips and NTx Meters Critical Reagents manufactured and supplied for the United States market under this Agreement shall be manufactured, tested, documented, packaged, and transported in compliance with GMP requirements of the FDA including, without limitation, 21 CFR Part 820 and any amendments or successors thereto; and that all NTx Meter Strips and NTx Meters Critical Reagents manufactured and supplied under this Agreement, regardless of intended market, shall be manufactured, tested, documented, packaged and transported in compliance with appropriate Hologic's reasonable quality assurance requirements agreed to by the partiesrequirements. Ostex Hologic shall have the right to audit and inspect Hologic Ostex facilities, books, and records to confirm such compliance. Hologic Ostex further represents that it is working toward compliance with the quality standards established by ISO 9000 and warrants that it will comply with such standards when legally required to do so. In the event that Ostex Hologic or its designated manufacturer(s) demonstrates within one year of receipt that any product Critical Reagent supplied pursuant to this Agreement fails to meet these specifications and warranties, Hologic Ostex shall, as OstexHologic's sole remedy for such failure, immediately replace said product (returned demonstrated by Ostex to the factory pursuant to HologicHologic or its designated manufacturer(s) as non-conforming in accord with Ostex's reasonable standard return procedures) with product which conforms to the above specifications and warranties, provided that Hologic shall not be obligated to replace NTx Meter Strips distributed as "Promotional Samples" which pass Hologic quality assurance tests and comply with all FDA and other governmental regulations relating to such Promotional Samples. These warranties shall not apply to any item that is subjected to abuse, stress, or misuse; or used in any manner inconsistent with applicable Hologic Ostex instructions; or insofar as any such warranty violation is caused by Ostex's violation of its warranties set out in SECTION 3.4 hereof.

PRODUCT WARRANTY; QUALITY CONTROL. Hologic Ostex warrants to Ostex Metrika and its designated manufacturer(s) that all NTx Meter Strips and NTx Meters Critical Reagents sold by Hologic to Ostex or its contract manufacturer hereunder shall (i) comply with the product specifications therefor attached hereto as ATTACHMENT 7.2.4 when used in accord with applicable Hologic instructions, EXHIBIT C and amendments thereto as modified mutually agreed upon by mutual agreement of the parties, (ii) be free from defects in material, workmanship material and designworkmanship, and (iii) comply with all applicable laws, rules and regulations related to the manufacture and distribution of such product (to the extent applicable to a manufacturer). Without limiting the generality of the foregoing, Hologic Ostex warrants that all NTx Meter Strips and NTx Meters Critical Reagents manufactured and supplied for the United States market to Metrika and its designated manufacturer under this Agreement shall be manufactured, tested, documented, packaged, and transported in compliance with GMP requirements of QSR by the FDA including, without limitation, 21 CFR Part 820 and any amendments or successors thereto510(k) clearance date; and that all NTx Meter Strips and NTx Meters Critical Reagents manufactured and supplied under this Agreement, regardless of intended market, shall be manufactured, tested, documented, packaged and transported in compliance with appropriate Metrika's reasonable quality assurance requirements agreed to by the partiesrequirements. Ostex Metrika shall have the right to audit and inspect Hologic Ostex facilities, books, and records to confirm such compliance. Hologic Ostex further represents that it is working toward compliance with the quality standards established by ISO 9000 and warrants that it will comply with such standards when legally required to do so. In the event that Ostex Metrika or its designated manufacturer(s) demonstrates within one year of receipt that any product Critical Reagent supplied pursuant to this Agreement fails to meet these specifications and warranties, Hologic Ostex shall, as OstexMetrika's sole remedy for such failure, immediately replace said product (returned demonstrated by Ostex to the factory pursuant to Hologic's Metrika or its designated manufacturer(s) as non-conforming, in accordance with reasonable standard return procedures) ), with product which conforms to the above specifications and warranties, provided that Hologic shall not be obligated to replace NTx Meter Strips distributed as "Promotional Samples" which pass Hologic quality assurance tests and comply with all FDA and other governmental regulations relating to such Promotional Samples. These warranties shall not apply to any item that is subjected to abuse, stress, or misuse; , or used in any manner inconsistent with applicable Hologic Ostex instructions; or insofar as any such warranty violation is caused by Ostex's violation of its warranties set out in SECTION 3.4 hereof.

PRODUCT WARRANTY; QUALITY CONTROL. Hologic Metrika warrants to Ostex that all NTx Meter Strips and NTx Meters sold NTx/DRx Devices manufactured by Hologic to Metrika for Ostex hereunder shall (i) comply with the product specifications attached hereto as ATTACHMENT 7.2.4 Specifications when used in accord accordance with applicable Hologic Metrika instructions, as may be modified by mutual agreement of the parties, (ii) be free from defects in material, workmanship material and designworkmanship, and (iii) comply with all applicable laws, rules and regulations related to the manufacture and distribution of such product (to the extent applicable to a manufacturer). Without limiting the generality of the foregoing, Hologic Metrika warrants that all NTx Meter Strips and NTx Meters NTx/DRx Devices manufactured and supplied for the United States market under this Agreement shall be manufactured, tested, documented, packaged, and transported in compliance with GMP requirements of the FDA including, without limitation, 21 CFR Part 820 and any amendments or successors thereto; QSR and that all NTx Meter Strips and NTx Meters NTx/DRx Devices manufactured and supplied under this Agreement, regardless of intended market, shall be manufactured, tested, documented, packaged and transported in compliance with appropriate quality assurance requirements agreed to by the parties. Ostex or its designee shall have the right to audit and inspect Hologic Metrika facilities, books, and records records, during normal business hours and upon reasonable notice to Metrika, but only to the extent reasonably necessary to confirm such compliance, and only in good faith. Hologic Metrika further represents that it is working toward compliance with the quality standards established by ISO 9000 9001 and warrants that it will comply with such standards when legally required to do so. In the event that Ostex demonstrates within one year of receipt that any product NTx/DRx Device supplied pursuant to this Agreement fails to meet these specifications and warrantieswarranties during the Shelf-Life of such NTx/DRx Device, Hologic Metrika shall, as Ostex's sole remedy for such failure, immediately replace said product (returned demonstrated by Ostex to the factory pursuant to Hologic's as non-conforming, in accordance with reasonable standard return procedures) ), with product which conforms to the above specifications and warranties, provided that Hologic shall not be obligated to replace NTx Meter Strips distributed as "Promotional Samples" which pass Hologic quality assurance tests and comply with all FDA and other governmental regulations relating to such Promotional Samples. These warranties shall not apply to any item that is subjected to abuse, stress, or misuse; , or used in any manner inconsistent with applicable Hologic Metrika instructions; or insofar as any such warranty violation is caused by Ostex's violation of its warranties set out in SECTION 3.4 hereof.

PRODUCT WARRANTY; QUALITY CONTROL. Hologic Ostex warrants to Ostex Metrika and its designated manufacturer(s) that all NTx Meter Strips and NTx Meters Critical Reagents sold by Hologic to Ostex or its contract manufacturer hereunder shall (i) comply with the product specifications attached hereto as set out in ATTACHMENT 7.2.4 3.4 hereof when used in accord accordance with applicable Hologic instructionsOstex instructions for use as set forth in such attachment or of a similar nature thereto, and amendments thereto as modified mutually agreed upon by mutual agreement of the parties, (ii) be free from defects in material, workmanship material and designworkmanship, and (iii) comply with all applicable laws, rules and regulations related to the manufacture and distribution of such product (to the extent applicable to a manufacturer). Without limiting the generality of the foregoing, Hologic Ostex warrants that all NTx Meter Strips and NTx Meters Critical Reagents manufactured and supplied for the United States market under this Agreement shall be manufactured, tested, documented, packaged, and transported in compliance with GMP requirements of the FDA including, without limitation, 21 CFR Part 820 and any amendments or successors thereto; and that all NTx Meter Strips and NTx Meters Critical Reagents manufactured and supplied under this Agreement, regardless of intended market, shall be manufactured, tested, documented, packaged and transported in compliance with appropriate Metrika's reasonable quality assurance requirements agreed to by the partiesrequirements. Ostex Metrika shall have the right to audit and inspect Hologic Ostex facilities, books, and records to confirm such compliance. Hologic Ostex further represents that it is working toward compliance with the quality standards established by ISO 9000 and warrants that it will comply with such standards when legally required to do so. In the event that Ostex Metrika or its designated manufacturer(s) demonstrates within one year of receipt that any product Critical Reagent supplied pursuant to this Agreement fails to meet these specifications and warranties, Hologic Ostex shall, as OstexMetrika's sole remedy for such failure, immediately replace said product (returned demonstrated by Ostex to the factory pursuant to Hologic's Metrika or its designated manufacturer(s) as non-conforming, in accordance with reasonable standard return procedures) , with product which conforms to the above specifications and warranties, provided that Hologic shall not be obligated to replace NTx Meter Strips distributed as "Promotional Samples" which pass Hologic quality assurance tests and comply with all FDA and other governmental regulations relating to such Promotional Samples. These warranties shall not apply to any item that is subjected to abuse, stress, or misuse; or used in any manner inconsistent with applicable Hologic Ostex instructions; or insofar as any such warranty violation is caused by Ostex's violation of its warranties set out in SECTION 3.4 hereof.