AGAINST IT IN
ACCORDANCE WITH ITS TERMS, SUBJECT TO BANKRUPTCY, INSOLVENCY, REORGANIZATION,
FRAUDULENT CONVEYANCE, MORATORIUM, OR SIMILAR LAWS RELATING TO OR AFFECTING THE
RIGHTS AND REMEDIES OF CREDITORS GENERALLY.
THIS AGREEMENT HAS BEEN DULY
EXECUTED AND DELIVERED BY SUCH PARTY.
(C)
THE EXECUTION, DELIVERY, AND PERFORMANCE BY IT OF THIS AGREEMENT
DOES NOT AND WILL NOT VIOLATE ANY APPLICABLE LAW OR REGULATION, NOR ANY
AGREEMENT TO WHICH IT IS A PARTY OR BY WHICH IT IS BOUND.
(D)
THE EXECUTION, DELIVERY, AND PERFORMANCE BY IT OF THIS AGREEMENT
DOES NOT REQUIRE THE APPROVAL OF ANY GOVERNMENTAL AUTHORITY NOR THE APPLICATION
FOR OR FILING OF OR FOR ANY LICENSE, PERMIT, APPROVAL, WAIVER, NO-ACTION, OR
SIMILAR PERMISSION FROM ANY GOVERNMENTAL AUTHORITY (EXCLUDING THE REGULATORY
APPROVALS EXPRESSLY DESCRIBED IN THIS AGREEMENT).
4.2.
Warranties Regarding Reloads.
(A)
WARRANTY STATEMENT.
PMII WARRANTS THAT ALL RELOADS SHALL (I) BE
MANUFACTURED IN ACCORDANCE WITH, AND CONFORM TO, THE APPLICABLE RELOAD
DOCUMENTATION AND ALL APPLICABLE DEVICE REGULATION, (II) BE FREE OF DEFECTS IN
MATERIALS AND WORKMANSHIP UNDER NORMAL USE AND SERVICE, AND (III) NOT BE
ADULTERATED OR MISBRANDED WITHIN THE MEANING OF THE FDA ACT, NOR BE AN ARTICLE
WHICH MAY NOT BE INTRODUCED INTO INTERSTATE COMMERCE PURSUANT TO REQUIREMENTS OF
THE FDA ACT (IT BEING AGREED THAT ANY RELOADS THAT DO NOT COMPLY WITH THIS
SECTION 4.2(A) SHALL BE DEEMED TO BE NON-CONFORMING AND DEFECTIVE).
PMII SHALL
HAVE NO LIABILITY FOR BREACH OF THE FOREGOING WARRANTIES TO THE EXTENT ARISING
FROM: (I) ANY ALTERATION OR MODIFICATION TO THE RELOAD NOT MADE BY OR WITH THE
APPROVAL OF PMII; OR (II) STORAGE, HANDLING, OR USE OF THE RELOADS OTHERWISE
THAN IN ACCORDANCE WITH THE RELOAD DOCUMENTATION OR PMII'S PUBLISHED
INSTRUCTIONS.
(B)
INSPECTION; RIGHT TO REJECT.
WITHIN THIRTY (30) DAYS AFTER
RECEIPT OF ANY RELOAD, ISRG SHALL INSPECT THE RELOAD AND, IN ITS DISCRETION,
TEST THE RELOAD TO DETERMINE WHETHER THE RELOAD CONFORMS IN ALL MATERIAL
RESPECTS TO THE REQUIREMENTS OF THIS AGREEMENT.
NOTWITHSTANDING THE FOREGOING,
EACH RELOAD SHALL BE DEEMED ACCEPTED BY ISRG ON THE THIRTY-FIRST (31ST) DAY
AFTER RECEIPT OF THE RESPECTIVE RELOAD, UNLESS PMII HAS RECEIVED NOTIFICATION
FROM ISRG WITHIN SUCH TIME OF THE RESPECTIVE RELOAD'S FAILURE TO CONFORM IN ALL
MATERIAL RESPECTS TO THE REQUIREMENTS OF THIS AGREEMENT.
(C)
REMEDY FOR NON-CONFORMING AND DEFECTIVE RELOADS.
ISRG'S SOLE AND
EXCLUSIVE REMEDY, AND PMII'S SOLE AND EXCLUSIVE LIABILITY, WITH RESPECT TO
BREACH OF THE WARRANTIES SET FORTH IN THIS SECTION 4.2 SHALL BE THAT ISRG SHALL
BE ENTITLED TO REPLACEMENT RELOADS, OR CREDIT, OR REIMBURSEMENT, AT ITS OPTION,
IF RELOADS ARE NON-CONFORMING AND DEFECTIVE.
11
PMII SHALL MAKE ANY SUCH REPLACEMENT, CREDIT, OR REIMBURSEMENT WITHIN THIRTY
(30) DAYS AFTER NOTICE BY ISRG THAT SUCH RELOADS ARE NON-CONFORMING AND
DEFECTIVE.
(d)
THE EXPRESS WARRANTIES CONTAINED IN THIS SECTION 4.2 ARE IN LIEU
OF, AND PMII HEREBY EXPRESSLY DISCLAIMS, ALL OTHER WARRANTIES OF ANY KIND,
EXPRESS OR IMPLIED, WRITTEN OR ORAL, INCLUDING ANY WARRANTY OF NON-INFRINGEMENT,
MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE, AND ANY WARRANTY ARISING
FROM