“Products” shall mean, collectively, the Branded VPM Product, Branded V Product and/or Generic VPM Pro duct manufactured and supplied to KU by Alkermes under this Agreement.
“Promotional Materials” shall mean any tangible advertising and promotional labeling bearing a name (trade name or generic name) used in the promotion of the Products, including, without limitation, promotional materials produced by KU (examples include, but are not limited to, journal ads, brochures, service items, managed care pull through sheets, formulary presentations, price lists, monographs, Internet pages and telephone or television advertisements) and materials produced by outside sources (examples include, but are not limited to, medical reprints, textbooks and CME materials) to the extent funded by, created in cooperation with, reviewed, or distributed by KU. The definition of Promotional Materials shall also include press releases and other releases of information to the media regarding the Products.
“Quarter” shall mean, as the case may be, the three months ending on March 31, June 30, September 30 or December 31 in any Year.
“Specifications” shall mean, at any time and as to either Product, the specifications for such Products that are then approved by the FDA and contained in the NDA applicable to such Product, as in effect at that time.
“Technology” includes all of the intellectual property owned or controlled by Alkermes that is used in, claims or covers the manufacturing process used by Alkermes and its Affiliates to manufacture the Products supplied to KU hereunder, or any aspect of such manufacturing process.
“Territory” shall mean the fifty (50) states, the District of Columbia and the territories and possessions comprising the United States of America, including Puerto Rico.
“Trademarks” shall mean all of Alkermes’s right, title and interest in and to:
(a)those United States trademarks and trademark applications set forth on Schedule 6.4 hereto and any trademark application or trademark which constitutes an extension, registration, contribution, reissue, renewal, reexamination or continuation in part of any such trademark or trademark application; and
(b)all registrations thereof, all variations thereof and logos used in connection therewith, and all goodwill associated therewith.
“UCB Agreement” shall mean that that certain License and Supply Agreement dated 30 September 1998, as amended, relating to Products that currently exists between UCB and Alkermes (the “Agreement”) which is due to expire on December 31, 2013.
“UCB” shall mean KU’s affiliate company, UCB, Inc.
“U.S. GAAP” shall mean generally accepted accounting practices in the United States, as in effect from time to time.