- MUTUAL REPRESENTATIONS, WARRANTIES AND COVENANTS
Each Party represents, warrants and covenants to the other as follows:
13.1
GOOD STANDING.
THE PARTY IS A CORPORATION VALIDLY
EXISTING AND IN GOOD STANDING WITH THE POWER TO OWN ALL OF ITS PROPERTIES AND
ASSETS AND TO CARRY ON ITS BUSINESS AS IT IS CURRENTLY BEING CONDUCTED.
13.2
POWER AND AUTHORIZATION.
THE PARTY HAS ALL
REQUISITE POWER AND AUTHORITY (CORPORATE AND OTHERWISE) TO ENTER INTO THIS
AGREEMENT AND TO PERFORM ITS OBLIGATIONS UNDER THIS AGREEMENT.
THE PARTY IS NOT
REQUIRED TO OBTAIN THE CONSENT OF ANY PERSON, INCLUDING, WITHOUT LIMITATION, THE
CONSENT OF ANY PARTY TO ANY CONTRACT TO WHICH IT IS A PARTY, IN CONNECTION WITH
EXECUTION AND DELIVERY OF THIS AGREEMENT AND PERFORMANCE OF ITS OBLIGATIONS
UNDER THIS AGREEMENT.
13.3
NO CONFLICT.
THE PARTY'S EXECUTION AND DELIVERY OF
THIS AGREEMENT AND THE PERFORMANCE OF ITS OBLIGATIONS HEREUNDER DO NOT AND WILL
NOT CONFLICT WITH OR RESULT IN A BREACH OF OR A DEFAULT UNDER ITS ORGANIZATIONAL
INSTRUMENTS OR ANY OTHER AGREEMENT, INSTRUMENT, ORDER, LAW OR REGULATION
APPLICABLE TO IT OR BY WHICH IT MAY BE BOUND.
13.4
ENFORCEABILITY.
THE PARTY'S EXECUTION AND DELIVERY
OF THIS AGREEMENT AND PERFORMANCE OF ITS OBLIGATIONS UNDER THIS AGREEMENT DO NOT
AND SHALL NOT (A) CONFLICT WITH, RESULT IN A BREACH OF, CONSTITUTE A DEFAULT
UNDER (OR AN EVENT WHICH, WITH NOTICE OR LAPSE OF TIME OR BOTH, WOULD CONSTITUTE
A DEFAULT UNDER), ACCELERATE THE PERFORMANCE REQUIRED BY, RESULT IN THE CREATION
OF ANY LIEN UPON ANY OF ITS PROPERTIES OR ASSETS UNDER, OR CREATE IN ANY PARTY
THE RIGHT TO ACCELERATE, TERMINATE, MODIFY OR CANCEL, OR REQUIRE ANY NOTICE
UNDER, ANY CONTRACT TO WHICH IT IS A PARTY OR BY WHICH ANY OF ITS PROPERTIES OR
ASSETS ARE BOUND, OR (B) TO THE BEST OF ITS KNOWLEDGE, VIOLATE ANY APPLICABLE
LAW OR JUDGMENT CURRENTLY IN EFFECT TO WHICH IT IS SUBJECT.
13.5
COMPLIANCE WITH APPLICABLE LAWS.
THE PARTY WILL
COMPLY WITH APPLICABLE FEDERAL, STATE AND LOCAL LAWS IN CONNECTION WITH THE
PERFORMANCE OF THIS AGREEMENT.
13.6
NO VIOLATIONS.
NEITHER IT NOR ANY OF ITS AGENTS,
SUBCONTRACTORS OR OTHER REPRESENTATIVES, NOR ANY OF THEIR RESPECTIVE AFFILIATES,
NOR ANY MEMBERS OF THEIR RESPECTIVE STAFFS, ARE, NOR WILL THEY BE, AT THE TIME
OF PERFORMANCE OF ANY MATERIAL OBLIGATION UNDER THIS AGREEMENT,
17
(A)
DISQUALIFIED OR DEBARRED BY THE FDA OR ANY
OTHER REGULATORY AUTHORITY FOR ANY PURPOSE PURSUANT TO 21 U.S.C. § 355A OR ANY
FOREIGN COUNTERPARTS THEREOF; OR
(B)
CHARGED WITH OR CONVICTED UNDER UNITED STATES
FEDERAL LAW, OR FOREIGN COUNTERPARTS THEREOF, FOR CONDUCT RELATING TO THE
DEVELOPMENT OR APPROVAL OF, OR OTHERWISE RELATING TO THE REGULATION OF, ANY DRUG
PRODUCT UNDER THE GENERIC DRUG ENFORCEMENT ACT OF 1992 OR ANY OTHER RELEVANT
STATUTE, LAW OR REGULATION.
13.7
FULL RIGHTS.
IT OWNS OR POSSESSES ADEQUATE LICENSES
OR OTHER RIGHTS NECESSARY TO ENTER INTO THIS AGREEMENT, AND ITS FULFILLMENT OF
ITS OBLIGATIONS HEREUNDER WILL NOT VIOLATE THE RIGHTS OF ANY THIRD PARTY.
13.8
SAFETY CLAIMS.
EACH