BULK ACTIVE PHARMACEUTICAL INGREDIENT
TADALAFIL AS SET FORTH ON EXHIBIT 1.13.
1.14
"CONFIDENTIAL INFORMATION" OF A PARTY SHALL MEAN ALL INFORMATION
DISCLOSED BY SUCH PARTY TO THE OTHER PARTY DURING THE TERM, INCLUDING ANY AND
ALL INFORMATION EXCHANGED BETWEEN THE PARTIES UNDER THE MANUFACTURING AND SUPPLY
AGREEMENT OR THE CONFIDENTIALITY AGREEMENT.
1.15
"CONFIDENTIALITY AGREEMENT" SHALL MEAN THE CONFIDENTIALITY AGREEMENT
BETWEEN THE PARTIES EFFECTIVE FEBRUARY 25, 2008.
1.16
"CONTROL" SHALL MEAN, WITH RESPECT TO ANY INFORMATION OR
INTELLECTUAL PROPERTY RIGHT, POSSESSION BY A PARTY OF THE ABILITY (WHETHER BY
OWNERSHIP, LICENSE, OR OTHERWISE) TO GRANT ACCESS, A LICENSE, OR A SUBLICENSE TO
SUCH INFORMATION OR INTELLECTUAL PROPERTY RIGHT WITHOUT VIOLATING THE TERMS OF
ANY AGREEMENT OR OTHER ARRANGEMENT WITH ANY THIRD PARTY AS OF THE TIME SUCH
PARTY WOULD FIRST BE REQUIRED HEREUNDER TO GRANT THE OTHER PARTY SUCH ACCESS,
LICENSE OR SUBLICENSE.
1.17
"CORPORATE MARKS" SHALL MEAN, WITH RESPECT TO EACH OF THE PARTIES,
THE CORPORATE NAME OF SUCH PARTY OR THOSE OF AFFILIATES OF SUCH PARTY, AND ITS
AND THEIR TRADE NAMES, TRADEMARKS, SERVICE MARKS, DOMAIN NAMES, AND ASSOCIATED
LOGOS AND DESIGNS; PROVIDED THAT CORPORATE MARKS SHALL NOT INCLUDE THE LILLY
PRODUCT MARKS.
1.18
"DETAIL" OR "DETAILING" SHALL MEAN, WITH RESPECT TO PROMOTION OF THE
PRODUCT IN THE FIELD IN THE TERRITORY UNDER THE COMMERCIALIZATION PLAN, THE
ACTIVITY UNDERTAKEN BY A UNITED THERAPEUTICS SALES REPRESENTATIVE WITH RESPECT
TO A TARGET PHYSICIAN OR OTHER INDIVIDUALS OR ENTITIES WITH PRESCRIBING
AUTHORITY INVOLVED OR POTENTIALLY INVOLVED IN PRESCRIBING THE PRODUCT, TO
PROVIDE INFORMATION ABOUT THE BENEFITS AND FEATURES OF THE PRODUCT IN AN EFFORT
TO INCREASE THE NUMBER OF PHYSICIANS OR OTHER INDIVIDUALS OR ENTITIES WITH
PRESCRIBING AUTHORITY PRESCRIBING THE PRODUCT, AND/OR THE NUMBER OF
PRESCRIPTIONS FOR THE PRODUCT.
1.19
"DEVELOPMENT" (AND, WITH CORRELATIVE MEANINGS, THE TERMS "DEVELOP"
AND "DEVELOPING") SHALL MEAN THE CLINICAL DEVELOPMENT, AND REGULATORY ACTIVITIES
WITH RESPECT TO SEEKING REGULATORY APPROVAL OF THE PRODUCT FOR ANY INDICATION IN
THE FIELD IN THE TERRITORY, AND POST-APPROVAL STUDIES, INCLUDING LABEL
EXTENSIONS IN SUPPORT OF THE PRODUCT IN THE FIELD IN THE
3
TERRITORY AND ANY STUDIES REQUIRED BY A REGULATORY AUTHORITY, AND EXCLUDING ANY
AND ALL MANUFACTURING OF THE PRODUCT.
1.20
"DOLLAR" OR "$" SHALL MEAN THE LEGAL TENDER OF THE
UNITED STATES OF AMERICA.
1.21
"DOMAIN" SHALL MEAN, WITH RESPECT TO UNITED
THERAPEUTICS, THE PRODUCT IN THE FIELD IN THE TERRITORY, AND, WITH RESPECT TO
LILLY, PRODUCTS CONTAINING THE COMPOUND OUTSIDE THE FIELD IN THE TERRITORY, AND
IN ALL FIELDS OUTSIDE THE TERRITORY.
1.22
"EFFECTIVE DATE" SHALL MEAN THE CLOSING DATE AS
DEFINED IN THE STOCK PURCHASE AGREEMENT.
1.23
"EXISTING PATENTS" SHALL HAVE THE MEANING SET FORTH
IN SECTION 8.2(C).
1.24
"FDA" SHALL MEAN THE UNITED STATES FOOD AND DRUG
ADMINISTRATION, OR ANY SUCCESSOR ORGANIZATION.
1.25
"FIELD" SHALL MEAN THE TREATMENT, AMELIORATION, AND
PREVENTION OF ANY AND ALL FORMS OF PULMONARY HYPERTENSION IN HUMANS, INCLUDING
(A) ALL WHO CLASSIFICATIONS OF PULMONARY HYPERTENSION IN THE VENICE 2003 REVISED
CLASSIFICATION SYSTEM AND (B) ALL FORMS OF PULMONARY HYPERTENSION SECONDARY TO
OTHER