OF THE LICENSE AGREEMENT; AND (D) COORDINATE AGREEMENT BETWEEN THE PARTIES ON
THE DEFINITIVE MRD AND DEFINITIVE QUALITY AGREEMENT.
ARTICLE 3
MODIFICATIONS
3.1
PACKAGING AND LABELING. EACH PARTY SHALL HAVE THE RIGHT TO PROPOSE
MODIFICATIONS TO PACKAGING AND LABELING FOR THE PRODUCT IN THE FIELD IN THE
TERRITORY CONSISTENT WITH THE PROCESS SET OUT IN SECTION 2.7.
LILLY'S REVIEW
AND APPROVAL OF ANY LABELING SHALL NOT CAUSE LILLY TO BE LIABLE OR OTHERWISE
RESPONSIBLE FOR THE COMPLIANCE WITH APPLICABLE LAW OF THE FORM AND CONTENTS OF
ANY LABELING AND PACKAGING PROPOSED BY UNITED THERAPEUTICS.
3.2
MANUFACTURING FACILITY. IN RESPECT OF ANY CHANGE IN OR ADDITION TO
A MANUFACTURING FACILITY CONTEMPLATED BY SECTION 2.6(B), LILLY WILL GIVE UNITED
THERAPEUTICS PROMPT ADVANCE WRITTEN NOTICE AND AN OPPORTUNITY TO PROVIDE
COMMENTS TO LILLY IN WRITING FOR LILLY'S GOOD FAITH CONSIDERATION; PROVIDED,
HOWEVER, THAT LILLY, AFTER SUCH GOOD FAITH CONSIDERATION OF UNITED THERAPEUTICS'
COMMENTS, WILL HAVE FINAL DECISION-MAKING AUTHORITY REGARDING THE MANUFACTURING
FACILITY(IES) AT WHICH LILLY WILL MANUFACTURE COMPOUND AND/OR PRODUCT, SO LONG
AS SUCH CHANGE OR MODIFICATION WOULD NOT BE REASONABLY LIKELY TO MATERIALLY
ADVERSELY AFFECT THE PRODUCT IN THE FIELD IN THE TERRITORY.
3.3
COMPOUND AND ITS SPECIFICATIONS AND MANUFACTURING PROCESS.
(A)
LILLY SHALL PROVIDE UNITED THERAPEUTICS WITH WRITTEN NOTICE SOON
AS REASONABLY POSSIBLE AND AT LEAST SIXTY (60) DAYS IN ADVANCE OF THE EFFECTIVE
DATE OF A MODIFICATION TO THE SPECIFICATIONS FOR THE COMPOUND OR PROCESS FOR THE
MANUFACTURE OF THE COMPOUND, UNLESS IMPRACTICAL FOR REGULATORY REASONS, IN WHICH
CASE SUCH NOTICE SHALL BE PROVIDED PROMPTLY AFTER THE NEED FOR SUCH MODIFICATION
ARISES, SUBJECT TO THE TERMS OF THE QUALITY AGREEMENT.
6
(B)
NOTWITHSTANDING ANYTHING TO THE CONTRARY, LILLY, ACTING REASONABLY
AND IN GOOD FAITH, SHALL HAVE THE RIGHT TO MAKE ANY MODIFICATION PROPOSED UNDER
SECTION 3.3(A), WITHOUT THE CONSENT OF UNITED THERAPEUTICS.
3.4
PRODUCT, ITS SPECIFICATIONS AND MANUFACTURING PROCESS.
(A)
EACH PARTY SHALL HAVE THE RIGHT TO PROPOSE MODIFICATIONS TO THE
PRODUCT, ITS SPECIFICATIONS AND THE MANUFACTURING PROCESS. THE MODIFICATIONS
CONTEMPLATED BY THIS SECTION 3.4 INCLUDE CHANGES TO THE NUMBER OF TABLETS IN A
PACKAGE, TYPE OR DESIGN OF THE BOTTLE, BLISTER PACKAGING, THE PRODUCT INSERT,
COUNTERFEITING MEASURES, AND THE LIKE.
(B)
NOTWITHSTANDING ANYTHING TO THE CONTRARY, IN ADDITION TO LILLY'S
RIGHTS UNDER SECTIONS 3.3 AND 3.5, BUT SUBJECT TO LILLY'S OBLIGATIONS UNDER
SECTIONS 2.2(B), 3.1 AND THE REST OF THIS SECTION 3.4, LILLY, ACTING REASONABLY
AND IN GOOD FAITH, SHALL HAVE THE RIGHT TO MAKE MODIFICATIONS TO THE PRODUCT,
ITS SPECIFICATIONS AND MANUFACTURING PROCESS, WITHOUT THE CONSENT OF UNITED
THERAPEUTICS.
(C)
EXCEPT WITH RESPECT TO MODIFICATIONS THAT LILLY BELIEVES IN GOOD
FAITH ARE REASONABLY NECESSARY TO PROMOTE PATIENT SAFETY OR FOR ETHICAL OR
QUALITY REASONS, OR WHICH ARE REQUIRED BY APPLICABLE LAW, LILLY SHALL NOT MAKE
AND SHALL NOT BE OBLIGED TO MAKE, UNLESS MUTUALLY AGREED TO BETWEEN THE PARTIES,
ANY MODIFICATION TO:
(I)
THE SIZE, SHAPE AND THE LILLY IDENTICODE® OF THE PRODUCT,
UNLESS SUCH CHANGE IS REQUIRED TO CONFORM TO CHANGES MADE BY LILLY TO CIALIS®