SCALE-UP, MANUFACTURE,
FORMULATION AND FILLING REQUIREMENTS FOR SUCH LICENSED PRODUCT AND A DETAILED
STRATEGY, BUDGET AND PROPOSED TIMELINES), AS SUCH PLAN MAY BE AMENDED OR
UPDATED.
EACH PRODUCT COMMERCIALIZATION PLAN, AND EACH AMENDMENT, MODIFICATION
OR UPDATE TO
21
EACH PRODUCT COMMERCIALIZATION PLAN, SHALL BE PREPARED BY, OR AT THE DIRECTION
OF, DS, AND APPROVED BY THE JSC AT SUCH TIME AS THE JSC MAY FROM TIME TO TIME
DIRECT AND IN ANY EVENT, ON OR PRIOR TO THE INITIATION OF COMMERCIALIZATION
ACTIVITIES WITH RESPECT TO THE LICENSED PRODUCT.
1.115
"PRODUCT TECHNOLOGY" MEANS ANY PROGRAM TECHNOLOGY THAT COVERS THE
COMPOSITION OF MATTER, SYNTHESIS, FORMULATION, DELIVERY, MECHANISM OF ACTION,
MECHANISM OF INHIBITION AND/OR USE OF A COLLABORATION COMPOUND AND/OR LICENSED
PRODUCT.
1.116
"PRODUCT TRADEMARK" MEANS ANY TRADEMARK OR TRADE NAME, WHETHER OR
NOT REGISTERED, OR ANY TRADEMARK APPLICATION OR RENEWAL, EXTENSION OR
MODIFICATION THEREOF, IN THE TERRITORY, OR ANY TRADE DRESS AND PACKAGING, IN
EACH CASE THAT ARE USED WITH ANY LICENSED PRODUCT BY DS, TOGETHER WITH ALL
GOODWILL ASSOCIATED THEREWITH AND PROMOTIONAL MATERIALS RELATING THERETO.
1.117
"PROGRAM TECHNOLOGY" MEANS ANY TECHNOLOGY (INCLUDING, WITHOUT
LIMITATION, ANY NEW AND USEFUL PROCESS, METHOD OF MANUFACTURE OR COMPOSITION OF
MATTER) OR PROPRIETARY MATERIAL (A) THAT IS CONCEIVED AND FIRST REDUCED TO
PRACTICE (ACTUALLY OR CONSTRUCTIVELY) BY EITHER PARTY OR JOINTLY BY BOTH PARTIES
IN THE CONDUCT OF THE DEVELOPMENT PROGRAM AND/OR IN THE COMMERCIALIZATION OF
LICENSED PRODUCTS, OR (B) THAT IS CONCEIVED AND FIRST REDUCED TO PRACTICE BY
EMPLOYEES OF, OR CONSULTANTS TO, ONE PARTY AFTER THE EFFECTIVE DATE OTHER THAN
IN THE CONDUCT OF DEVELOPMENT ACTIVITIES WITH THE USE IN ANY MATERIAL RESPECT OF
ANY TECHNOLOGY, PATENT RIGHTS OR PROPRIETARY MATERIALS OF THE OTHER PARTY.
FOR
PURPOSES OF CLARITY, PROGRAM TECHNOLOGY SHALL INCLUDE ANY SUCH TECHNOLOGY THAT
IS A PROCESS FOR MODIFYING, OPTIMIZING, USING, FORMULATING, DELIVERING AND/OR
STABILIZING ANY COLLABORATION COMPOUND OR LICENSED PRODUCT.
1.118
"PROPRIETARY MATERIALS" MEANS ANY TANGIBLE CHEMICAL, BIOLOGICAL OR
PHYSICAL MATERIALS (A) THAT ARE FURNISHED BY OR ON BEHALF OF ONE PARTY TO THE
OTHER PARTY IN CONNECTION WITH THIS AGREEMENT, WHETHER OR NOT SPECIFICALLY
DESIGNATED AS PROPRIETARY BY THE TRANSFERRING PARTY, OR (B) THAT ARE OTHERWISE
CONCEIVED OR REDUCED TO PRACTICE IN THE CONDUCT OF THE DEVELOPMENT PROGRAM
AND/OR IN CONNECTION WITH THE COMMERCIALIZATION OF LICENSED PRODUCTS.
1.119
"REGULATORY ACTIVITIES" MEANS ALL ACTIVITIES RELATING TO THE
OBTAINING AND MAINTAINING OF ANY REGULATORY APPROVAL WITH RESPECT TO A LICENSED
PRODUCT, INCLUDING WITHOUT
22
LIMITATION, THE PREPARATION AND FILING OF REGULATORY FILINGS AND INTERACTING
WITH REGULATORY AUTHORITIES WITH RESPECT TO SUCH REGULATORY FILINGS.
1.120
"REGULATORY APPROVAL" MEANS, WITH RESPECT TO ANY COUNTRY OR REGION
IN THE TERRITORY, ANY APPROVAL, PRODUCT AND ESTABLISHMENT LICENSE, REGISTRATION
OR AUTHORIZATION OF ANY REGULATORY AUTHORITY REQUIRED FOR THE MANUFACTURE, USE,
STORAGE, IMPORTATION, EXPORTATION, TRANSPORT, DISTRIBUTION OR SALE OF A LICENSED
PRODUCT IN SUCH COUNTRY OR REGION.
1.121
"REGULATORY AUTHORITY" MEANS THE FDA, OR ANY COUNTERPART OF THE FDA
OUTSIDE THE UNITED STATES, OR ANY OTHER NATIONAL, SUPRA-NATIONAL, REGIONAL,
STATE OR LOCAL REGULATORY AGENCY, DEPARTMENT,