UNDER THIS
AGREEMENT FOR ONE OR MORE SECONDARY INDICATIONS WITHIN THE TERRITORY.
LILLY
SHALL MANUFACTURE AND SUPPLY THE PRODUCT FOR SUCH DEVELOPMENT AND
COMMERCIALIZATION PURSUANT TO THE MANUFACTURING AND SUPPLY AGREEMENT.
EACH
PARTY SHALL APPOINT A REPRESENTATIVE TO BE SUCH PARTY'S SINGLE POINT OF CONTACT
TO FACILITATE INFORMATION FLOW BETWEEN THE PARTIES RELATING TO EACH PARTY'S
EXPERIENCE AND RELATIONSHIPS IN SUCH PARTY'S DOMAIN TO ASSIST THE OTHER PARTY IN
THE OTHER PARTY'S DOMAIN.
EACH PARTY SHALL FIRST ADDRESS ANY COMMUNICATIONS
RELATING TO COMMERCIALIZATION TO SUCH REPRESENTATIVES UNLESS OTHERWISE AGREED TO
BY THE PARTIES ON A CASE-BY-CASE BASIS.
SUCH REPRESENTATIVES SHALL, WITHOUT
LIMITATION, COORDINATE DIRECT INVOLVEMENT OR MEETINGS WITH SUBJECT MATTER
EXPERTS WITHIN EACH PARTY'S INTERNAL ORGANIZATION AND/OR ITS FIELD ACCOUNT
MANAGEMENT
26
ORGANIZATION.
NOTWITHSTANDING THE FOREGOING, LILLY'S REPRESENTATIVE SHALL NOT
BE REQUIRED TO PROVIDE DETAILS RELATING TO ANY CUSTOMER SPECIFIC TRANSACTION OR
AGREEMENT.
6.2
COMMERCIALIZATION PLAN.
ALL COMMERCIALIZATION OF THE PRODUCT IN
THE FIELD IN THE TERRITORY SHALL BE CONDUCTED PURSUANT TO A COMMERCIALIZATION
PLAN, WHICH SHALL SET FORTH THE PLAN FOR THE DETAILING AND PROMOTION OF THE
PRODUCT IN THE FIELD IN THE TERRITORY IN ACCORDANCE WITH APPLICABLE LAWS AND THE
ACTIVITIES TO BE CARRIED OUT RELATED THERETO (THE "COMMERCIALIZATION PLAN").
THE PARTIES HAVE AGREED UPON A HIGH-LEVEL OUTLINE OF THE COMMERCIALIZATION PLAN,
AS FURTHER DESCRIBED ON EXHIBIT 6.2.
NO LATER THAN NINETY (90) DAYS AFTER THE
EFFECTIVE DATE, AND PRIOR TO JANUARY 1 OF EACH AND EVERY CALENDAR YEAR AFTER THE
FIRST CALENDAR YEAR, UNITED THERAPEUTICS SHALL SUBMIT TO THE JSC FOR REVIEW AN
UPDATED COMMERCIALIZATION PLAN.
FOR PURPOSES OF CLARIFICATION, AFTER SUBMISSION
OF THE FIRST UPDATED COMMERCIALIZATION PLAN AND NOT LATER THAN NINETY (90) DAYS
AFTER THE EFFECTIVE DATE, UNITED THERAPEUTICS SHALL SUBMIT THE FIRST ANNUAL
UPDATED COMMERCIALIZATION PLAN TO THE JSC PRIOR TO THE START OF THE SECOND
CALENDAR YEAR (I.E., PRIOR TO JANUARY 1, 2010).
IF LILLY DETERMINES THAT SUCH
UPDATED COMMERCIALIZATION PLAN DOES NOT COMPLY WITH APPLICABLE LAWS, INCLUDING
LAWS RELATING TO PROMOTIONAL AND ADVERTISING MATERIALS AS WELL AS ACCEPTED
INDUSTRY STANDARDS AND LILLY'S ETHICAL POLICIES, IN EACH CASE WITH RESPECT TO
THE PRODUCT IN THE FIELD IN THE TERRITORY, OR THAT THE ACTIVITIES CONDUCTED
UNDER SUCH UPDATED COMMERCIALIZATION PLAN ARE REASONABLY LIKELY TO MATERIALLY
ADVERSELY AFFECT PRODUCTS IN LILLY'S DOMAIN, LILLY SHALL BE PERMITTED TO
PROPOSE, IN GOOD FAITH, REVISIONS TO SUCH UPDATED COMMERCIALIZATION PLAN, AND
UNITED THERAPEUTICS SHALL REVISE SUCH COMMERCIALIZATION PLAN. IN THE EVENT OF
ANY INCONSISTENCY BETWEEN THE COMMERCIALIZATION PLAN AND THIS AGREEMENT, THE
TERMS OF THIS AGREEMENT SHALL PREVAIL.
6.3
COMMERCIALIZATION ACTIVITIES.
(a)
United Therapeutics Obligations.
Except as otherwise provided
herein, United Therapeutics shall (i) use Commercially Reasonable Efforts to
Commercialize the Product in the Field in the Territory in accordance with the
Commercialization Plan and all Applicable Law, including adapting to market
dynamics and pursuing new opportunities; (ii) utilize Lilly's call center in
coordination with United Therapeutics' medical affairs department for providing
medical information services with respect to the Product in the Field in the
Territory to