rights to
Develop, Manufacture, and Commercialize Products (as such capitalized terms are
defined below); and
WHEREAS, Ikaria desires to obtain such exclusive rights in accordance with the
terms and conditions of this Agreement.
NOW, THEREFORE, BioLineRx and Ikaria agree as follows:
ARTICLE I
DEFINITIONS; INTERPRETATION
When used in this Agreement, each of the following capitalized terms has the
meaning set forth in this Article I:
SECTION 1.1
"AFFILIATE" SHALL MEAN, WITH RESPECT TO A PARTY, ANY
PERSON THAT CONTROLS, IS CONTROLLED BY, OR IS UNDER COMMON CONTROL WITH SUCH
PARTY.
FOR PURPOSES OF THIS SECTION 1.1, "CONTROL" SHALL REFER TO (A) IN THE
CASE OF A PERSON THAT IS A CORPORATE ENTITY, DIRECT OR INDIRECT OWNERSHIP OF
MORE THAN FIFTY PERCENT (50%) OF THE STOCK, SHARES OR MEMBERSHIP UNITS HAVING
THE RIGHT TO VOTE FOR THE ELECTION OF A MAJORITY OF THE DIRECTORS OF SUCH
PERSON, AND (B) IN THE CASE OF A PERSON THAT IS AN ENTITY, BUT IS NOT A
CORPORATE ENTITY, THE POSSESSION, DIRECTLY OR INDIRECTLY, OF THE
1
POWER TO DIRECT, OR CAUSE THE DIRECTION OF, THE MANAGEMENT OR POLICIES OF SUCH
PERSON, WHETHER THROUGH THE OWNERSHIP OF VOTING SECURITIES, BY CONTRACT OR
OTHERWISE.
SECTION 1.2
"BGN LICENSE AGREEMENT" SHALL MEAN THAT CERTAIN LICENSE
AGREEMENT, DATED JANUARY 10, 2005, AS AMENDED, BY AND AMONG BIOLINE JERUSALEM
L.P. AND B.G. NEGEV TECHNOLOGIES AND APPLICATIONS LTD. ("BGN") ON BEHALF OF BEN
GURION UNIVERSITY.
SECTION 1.3
"BIOLINERX KNOW-HOW" SHALL MEAN ALL KNOW-HOW THAT IS
(A) NECESSARY OR USEFUL FOR THE DEVELOPMENT, MANUFACTURE, OR COMMERCIALIZATION
OF ANY PRODUCT AND (B) EITHER (I) IS CONTROLLED BY BIOLINERX AS OF THE EFFECTIVE
DATE OR (II) BIOLINERX COMES TO CONTROL DURING THE TERM OF THIS AGREEMENT.
SECTION 1.4
"BIOLINERX PATENT RIGHTS" SHALL MEAN PATENT RIGHTS THAT
CLAIM OR DISCLOSE BIOLINERX KNOW-HOW, INCLUDING THE PATENT RIGHTS LISTED IN
EXHIBIT B.
SECTION 1.5
"BIOLINERX INTELLECTUAL PROPERTY" SHALL MEAN BIOLINERX
PATENT RIGHTS (INCLUDING PATENT RIGHTS IN THE SUBLICENSED IP), AND BIOLINERX
KNOW-HOW (INCLUDING KNOW-HOW IN THE SUBLICENSED IP).
SECTION 1.6
"BUSINESS DAY" SHALL MEAN A DAY THAT IS NOT A SATURDAY, A
SUNDAY OR A DAY ON WHICH BANKING INSTITUTIONS IN NEW YORK, NEW YORK, USA ARE
AUTHORIZED BY LAW TO REMAIN CLOSED.
SECTION 1.7
"COMMERCIALIZATION" OR "COMMERCIALIZE" SHALL MEAN ANY
ACTIVITIES DIRECTED TO MARKETING, PROMOTING, DISTRIBUTING, IMPORTING, EXPORTING,
OR SELLING A PRODUCT.
SECTION 1.8
"COMMERCIALLY REASONABLE EFFORTS" SHALL MEAN THE EFFORTS,
EXPERTISE AND RESOURCES NORMALLY USED BY A PARTY TO DEVELOP, MANUFACTURE AND
COMMERCIALIZE A PRODUCT OWNED BY IT OR TO WHICH IT HAS RIGHTS, WHICH IS OF
SIMILAR MARKET POTENTIAL AT A SIMILAR STAGE IN ITS DEVELOPMENT OR PRODUCT LIFE,
TAKING INTO ACCOUNT ISSUES OF SAFETY AND EFFICACY, PRODUCT PROFILE, DIFFICULTY
IN DEVELOPING THE PRODUCT, COMPETITIVENESS OF THE MARKETPLACE FOR THE PRODUCT,
THE PROPRIETARY POSITION OF THE PRODUCT, THE REGULATORY STRUCTURE INVOLVED, THE
AVAILABILITY AND LEVEL OF REIMBURSEMENT FOR SUCH TREATMENT BY THIRD PARTY PAYORS
OR HEALTH INSURANCE PLANS, THE POTENTIAL TOTAL PROFITABILITY OF THE APPLICABLE
PRODUCT(S) MARKETED OR TO BE MARKETED AND