NO ACCESS TO
ANY AREAS OF THE MANUFACTURING FACILITY WHERE SUCH ACCESS WOULD BE LIKELY TO
RESULT IN THE DISCLOSURE OF ANY OF LILLY'S TRADE SECRETS. NOTWITHSTANDING THE
FOREGOING SENTENCE, IN THE EVENT OF A MATERIAL BREACH OF THIS AGREEMENT, A
REJECTION OF THE PRODUCT BY UNITED THERAPEUTICS PURSUANT TO SECTION 8.6 BECAUSE
OF A FAILURE TO MEET THE SPECIFICATIONS, OR A MATERIAL REGULATORY ISSUE OR
SERIES OF ISSUES AT ANY TIME, UNITED THERAPEUTICS SHALL HAVE AN ADDITIONAL RIGHT
TO CONDUCT AN AUDIT UNDER THE PROVISIONS OF THIS SECTION 8.1(A).
ANY SUCH
UNITED THERAPEUTICS REPRESENTATIVES SHALL BE ADVISED OF THE CONFIDENTIALITY
OBLIGATIONS OF ARTICLE 12, AND SHALL FOLLOW SUCH SECURITY AND FACILITY ACCESS
PROCEDURES AS ARE REASONABLY DESIGNATED BY LILLY.
LILLY MAY REQUIRE THAT THE
UNITED THERAPEUTICS REPRESENTATIVES BE ACCOMPANIED BY A LILLY REPRESENTATIVE AT
ALL TIMES AND THAT THE UNITED THERAPEUTICS REPRESENTATIVES ENTER AREAS OF THE
FACILITY USED IN PRODUCTION OF THE PRODUCT AT TIMES ONLY WHEN THE PRODUCTION OF
THE PRODUCT IS NOT OCCURRING WHERE NECESSARY TO ENSURE PROTECTION OF LILLY
CONFIDENTIAL INFORMATION OR THE CONFIDENTIAL INFORMATION OF A THIRD PARTY.
LILLY SHALL RESPOND TO ANY WRITTEN AUDIT OBSERVATIONS PROVIDED BY UNITED
THERAPEUTICS WITHIN SIXTY (60) DAYS.
(D)
WITHOUT LIMITING THE PARTIES' OBLIGATIONS
UNDER THE LICENSE AGREEMENT, (I) EACH PARTY SHALL CLOSELY CONSULT WITH THE OTHER
PARTY ABOUT ALL REGULATORY ACTIVITIES AFFECTING THE MANUFACTURING FACILITY WITH
RESPECT TO THE PRODUCT AND LILLY'S ABILITY TO MANUFACTURE AND SUPPLY THE PRODUCT
IN THE FIELD IN THE TERRITORY, AND SHALL KEEP THE OTHER PARTY CLOSELY INFORMED
ABOUT ALL REGULATORY ACTIVITIES AND DEVELOPMENTS AFFECTING THE MANUFACTURING
FACILITY WITH RESPECT TO THE PRODUCT AND ITS ABILITY TO MANUFACTURE AND SUPPLY
THE PRODUCT IN THE FIELD IN THE TERRITORY; AND (II) WHERE POSSIBLE, LILLY SHALL
CONSULT WITH UNITED THERAPEUTICS IN ADVANCE OF ANY SUCH REGULATORY ACTIVITIES OR
DEVELOPMENTS, AND IN ANY EVENT REPORT ON SAME TO UNITED THERAPEUTICS AS SOON AS
REASONABLY POSSIBLE AFTER ANY RELEVANT OCCURRENCE.
(E)
LILLY SHALL, WITH
RESPECT TO EACH LOT OF THE PRODUCT PRODUCED BY IT HEREUNDER, FOR THE LONGER OF
(I) ANY PERIOD REQUIRED BY APPLICABLE LAWS, OR (II) A PERIOD OF ONE (1) YEAR
AFTER THE EXPIRY OF THE EXPIRATION DATING OF SUCH LOT, KEEP RETAINED SAMPLES AND
ACCURATE RECORDS OF THE MANUFACTURE AND TESTING OF THE PRODUCT PRODUCED BY IT
HEREUNDER, INCLUDING ALL SUCH RECORDS REQUIRED UNDER APPLICABLE LAWS.
8.2
GMP COMPLIANCE. LILLY SHALL ENSURE THAT THE
MANUFACTURING FACILITY (INCLUDING EQUIPMENT, SYSTEMS, RECORD KEEPING AND
UTILITIES) COMPLIES WITH APPLICABLE LAW AND IS OPERATED IN ACCORDANCE WITH GMPS
AND THE CONDITIONS SET FORTH IN REGULATORY APPROVALS.
LILLY SHALL STORE ALL
COMPONENTS AND RAW MATERIALS (INCLUDING THE COMPOUND) AND THE PRODUCT UNTIL
SHIPMENT IN ACCORDANCE WITH THE SPECIFICATIONS AND APPLICABLE LAWS.
LILLY SHALL
MANUFACTURE THE PRODUCT IN
19
COMPLIANCE WITH APPLICABLE LAW AND THE SPECIFICATIONS.
LILLY SHALL PERFORM
QUALITY CONTROL TESTING AND QUALITY OVERSIGHT ON THE PRODUCT TO BE DELIVERED
HEREUNDER IN ACCORDANCE WITH APPLICABLE LAW, SPECIFICATIONS, CGMPS, THE MRD, AND
THE QUALITY AGREEMENT.
LILLY SHALL SHIP