ALL PROTOCOLS FOR CONDUCTING PRECLINICAL AND
CLINICAL STUDIES AND DATA AND RESULTS OBTAINED FROM SUCH PRECLINICAL AND
CLINICAL STUDIES, INCLUDING DATA RELATING TO PRODUCT SAFETY, THAT (A) IS WITHIN
THE CONTROL OF UNITED THERAPEUTICS AT ANY TIME DURING THE TERM, AND (B) IS
NECESSARY OR USEFUL IN THE RESEARCH, NON-CLINICAL DEVELOPMENT, DEVELOPMENT,
MANUFACTURE, USE, OR COMMERCIALIZATION OF THE PRODUCT.
1.59
"UNITED THERAPEUTICS PROMOTIONAL MATERIALS" SHALL
HAVE THE MEANING SET FORTH IN SECTION 6.5(A).
1.60
"UNITED THERAPEUTICS SALES REPRESENTATIVE" SHALL
MEAN AN EMPLOYEE OF UNITED THERAPEUTICS OR ITS PERMITTED CONTRACTORS AND A
MEMBER OF UNITED THERAPEUTICS' SALES FORCE ENGAGED IN THE CONDUCT OF DETAILS OF
THE PRODUCT AND TRAINED AS PROVIDED UNDER THIS AGREEMENT AND THE
COMMERCIALIZATION PLAN.
1.61
"USEFUL" SHALL MEAN, WITH RESPECT TO UNITED
THERAPEUTICS, REASONABLY LIKELY TO BE NECESSARY OR MATERIALLY USEFUL IN THE
DEVELOPMENT OR COMMERCIALIZATION OF THE PRODUCT IN UNITED THERAPEUTICS' DOMAIN,
AND, WITH RESPECT TO LILLY, REASONABLY LIKELY TO BE NECESSARY OR MATERIALLY
USEFUL IN THE DEVELOPMENT, MANUFACTURE OR COMMERCIALIZATION OF PRODUCTS
CONTAINING THE COMPOUND IN LILLY'S DOMAIN.
1.62
"VALID CLAIM" SHALL MEAN A CLAIM WITHIN A LILLY
PATENT THAT HAS NOT EXPIRED, LAPSED, OR BEEN CANCELLED OR ABANDONED, AND THAT
HAS NOT BEEN DEDICATED TO THE PUBLIC, DISCLAIMED, OR HELD UNENFORCEABLE,
INVALID, OR BEEN CANCELLED BY A COURT OR ADMINISTRATIVE AGENCY OF COMPETENT
JURISDICTION IN AN ORDER OR DECISION FROM WHICH NO APPEAL HAS BEEN OR CAN BE
TAKEN, INCLUDING THROUGH OPPOSITION, RE-EXAMINATION, REISSUE, OR DISCLAIMER.
ARTICLE 2
GRANT OF RIGHTS
2.1
LICENSE GRANT TO UNITED THERAPEUTICS.
SUBJECT
TO THE TERMS AND CONDITIONS OF THIS AGREEMENT, LILLY HEREBY GRANTS TO UNITED
THERAPEUTICS AN EXCLUSIVE (EVEN AS TO LILLY), NON-TRANSFERABLE (SUBJECT TO
SECTIONS 2.3 AND 15.2), SUBLICENSEABLE (SUBJECT TO SECTION 2.3) LICENSE, UNDER
THE LILLY KNOW-HOW AND THE LILLY PATENTS, TO DEVELOP AND COMMERCIALIZE THE
PRODUCT IN THE FIELD IN THE TERRITORY DURING THE TERM.
NOTWITHSTANDING THE
FOREGOING, LILLY MAY CONDUCT RESEARCH AND OTHER DEVELOPMENT ACTIVITIES WITH THE
COMPOUND INCLUDING, IN CONNECTION WITH LILLY'S DEVELOPMENT, MANUFACTURE AND
COMMERCIALIZATION OF THE PRODUCT IN LILLY'S DOMAIN; PROVIDED THAT LILLY SHALL
NOT HAVE THE RIGHT TO CONDUCT ANY CLINICAL STUDY OF THE PRODUCT IN THE FIELD IN
THE TERRITORY, OTHER THAN THE ONGOING LILLY TRIALS, WITHOUT THE PRIOR WRITTEN
CONSENT OF UNITED THERAPEUTICS.
2.2
LICENSE GRANT TO LILLY.
SUBJECT TO THE TERMS
AND CONDITIONS OF THIS AGREEMENT, UNITED THERAPEUTICS HEREBY GRANTS TO LILLY,
UNDER ANY AND ALL UNITED THERAPEUTICS KNOW-HOW, A ROYALTY-FREE, NON-EXCLUSIVE,
SUBLICENSEABLE LICENSE TO:
(a)
make and have made the Compound and the
Product for use in the Field in the Territory;
8
(b)
in connection with Lilly's research,
non-clinical development, Development, manufacture, and Commercialization of the
Product in the Field outside the Territory, conduct Development with respect to
the Compound and the Product in the Field in the Territory;
(c)
Develop, make and have made, use and
Commercialize the Compound and the Product outside the Field in the Territory;
and
(d)
Develop, make and have made, use and
Commercialize the Compound and the Product