AS
ENFORCEMENT MAY BE AFFECTED BY BANKRUPTCY, INSOLVENCY, OR OTHER SIMILAR LAWS.
9.4
GOVERNMENTAL APPROVAL.
EXCEPT AS CONTEMPLATED
BY THIS AGREEMENT, NO CONSENT, APPROVAL, WAIVER, ORDER OR AUTHORIZATION OF, OR
REGISTRATION, DECLARATION OR FILING WITH, ANY REGULATORY AUTHORITY OR ANY OTHER
THIRD PERSON IS REQUIRED IN CONNECTION WITH THE EXECUTION, DELIVERY AND
PERFORMANCE OF THIS AGREEMENT, OR ANY AGREEMENT OR INSTRUMENT CONTEMPLATED BY
THIS AGREEMENT, BY LILLY OR THE PERFORMANCE BY LILLY OF ITS OBLIGATIONS
CONTEMPLATED HEREBY AND THEREBY.
9.5
BROKERAGE.
NO BROKER, FINDER OR SIMILAR AGENT
HAS BEEN EMPLOYED BY OR ON BEHALF OF LILLY, AND NO PERSON WITH WHICH LILLY HAS
HAD ANY DEALINGS OR COMMUNICATIONS OF ANY KIND IS ENTITLED TO ANY BROKERAGE
COMMISSION, FINDER'S FEE OR ANY SIMILAR COMPENSATION, IN CONNECTION WITH THIS
AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.
22
9.6
LITIGATION.
THERE ARE NO PENDING OR, TO
LILLY'S KNOWLEDGE, THREATENED JUDICIAL, ADMINISTRATIVE OR ARBITRAL ACTIONS,
CLAIMS, SUITS OR PROCEEDINGS PENDING AS OF THE DATE HEREOF AGAINST LILLY
RELATING TO THE SUBJECT MATER OF THIS AGREEMENT, WHICH, EITHER INDIVIDUALLY OR
TOGETHER WITH ANY OTHER, WILL HAVE A MATERIAL ADVERSE EFFECT ON THE ABILITY OF
LILLY TO PERFORM ITS OBLIGATIONS UNDER THIS AGREEMENT OR ANY AGREEMENT OR
INSTRUMENT CONTEMPLATED HEREBY.
9.7
DEVICES SPECIFICATIONS.
LILLY WILL USE
COMMERCIALLY REASONABLE EFFORTS TO ENSURE THAT AS OF THE DATE OF DELIVERY, ALL
DEVICES DELIVERED BY LILLY TO AMYLIN HEREUNDER:
(I) WILL CONFORM, IN ALL
MATERIAL RESPECTS, TO THE SPECIFICATIONS IN EFFECT AT THE TIME OF MANUFACTURE,
(II) WILL HAVE BEEN MANUFACTURED IN ACCORDANCE WITH CGMP AND CQSR IN EFFECT AT
THE TIME OF MANUFACTURE, (III) WILL NOT BE ADULTERATED OR MISBRANDED BY LILLY
WITHIN THE MEANING OF THE FD&C ACT, AND (IV) WILL NOT HAVE BEEN KNOWINGLY
MANUFACTURED OR SOLD IN VIOLATION OF ANY APPLICABLE LAWS OF THE U.S. IN ANY
MATERIAL RESPECT (COLLECTIVELY, THE "PRODUCT WARRANTY").
UPON DELIVERY TO
AMYLIN, FCA LILLY'S MANUFACTURING FACILITY INCOTERMS 2000, LILLY WILL CONVEY
GOOD TITLE TO SUCH DEVICES TO AMYLIN AS OF THE DATE OF SHIPMENT, FREE AND CLEAR
OF ANY LIEN OR ENCUMBRANCE.
9.8
NOT DEBARRED.
LILLY IS NOT DEBARRED AND HAS
NOT AND WILL NOT USE IN ANY CAPACITY THE SERVICES OF ANY PERSON DEBARRED UNDER
SUBSECTIONS 306(A) OR (B) OF THE GENERIC DRUG ENFORCEMENT ACT OF 1992.
IF AT
ANY TIME THIS REPRESENTATION AND WARRANTY IS NO LONGER ACCURATE, LILLY WILL
NOTIFY AMYLIN OF SUCH FACT.
9.9
APPLICABLE LAWS.
LILLY WILL COMPLY WITH ALL
APPLICABLE LAWS RELATING TO ITS MANUFACTURE OF THE DEVICES.
9.10
INTELLECTUAL PROPERTY.
TO THE BEST OF LILLY'S
KNOWLEDGE, AS OF THE EFFECTIVE DATE, THE USE OF LILLY'S EXISTING PEN PLATFORM IN
PERFORMANCE OF DEVICE DEVELOPMENT AS CONTEMPLATED HEREUNDER DOES NOT INFRINGE OR
MISAPPROPRIATE ANY VALID AND ENFORCEABLE INTELLECTUAL PROPERTY RIGHTS OWNED BY
ANY THIRD PARTY.
9.11
IMPLIED WARRANTIES.
EXCEPT AS EXPRESSLY PROVIDED IN
THIS ARTICLE 9, LILLY MAKES NO REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED,
EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND LILLY
SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED