EFFECTIVE DATE, THE PROTOCOL FOR WHICH IS ATTACHED HERETO AS
SCHEDULE 1.30.
SECTION 1.31
"OTHER ON-GOING TRIALS" SHALL MEAN THOSE PRE-CLINICAL AND
CMC TRIALS (OTHER THAN THE ON-GOING PHASE I/II TRIAL) THAT WERE INITIATED BY
BIOLINERX PRIOR TO, AND THAT ARE ONGOING AS OF, THE EFFECTIVE DATE, DESCRIPTIONS
OF WHICH ARE ATTACHED HERETO AS SCHEDULE 1.31.
SECTION 1.32
"PARTY" SHALL MEAN BIOLINERX OR IKARIA; "PARTIES" SHALL
MEAN BIOLINERX AND IKARIA.
SECTION 1.33
"PATENT RIGHTS" SHALL MEAN UNITED STATES AND FOREIGN
PATENTS AND PATENT APPLICATIONS (INCLUDING PROVISIONAL APPLICATIONS) AND ALL
SUBSTITUTIONS, DIVISIONALS, CONTINUATIONS, CONTINUATIONS-IN-PART, REISSUANCES,
REEXAMINATIONS, REGISTRATIONS, RENEWALS, CONFIRMATIONS, SUPPLEMENTARY PROTECTION
CERTIFICATES AND EXTENSIONS THEREOF.
SECTION 1.34
"PERSON" SHALL MEAN ANY NATURAL PERSON OR ANY CORPORATION,
COMPANY, PARTNERSHIP, JOINT VENTURE, FIRM, UNIVERSITY, OTHER ENTITY,
GOVERNMENTAL AUTHORITY, OR SUBDIVISION THEREOF.
SECTION 1.35
"PIVOTAL CLINICAL TRIAL" SHALL MEAN A RANDOMIZED,
CONTROLLED CLINICAL TRIAL OF A PRODUCT DESIGNED TO DEMONSTRATE STATISTICALLY
SIGNIFICANT CLINICAL EFFICACY AND SAFETY IN HUMAN PATIENTS (IN CONJUNCTION WITH
PERFORMANCE OF A THERAPEUTIC PROCEDURE) PURSUANT TO A CLINICAL STUDY AGREED WITH
THE FDA, WHICH TRIAL THE FDA ACCEPTS AS A PIVOTAL CLINICAL TRIAL NECESSARY FOR
REGULATORY APPROVAL OF SUCH PRODUCT.
AN OUTLINE OF THE STRUCTURE OF THE INITIAL
PIVOTAL CLINICAL TRIAL IS ATTACHED AS SCHEDULE 1.35.
SECTION 1.36
"PRIMARY INDICATION" SHALL MEAN THE DIAGNOSIS, PREVENTION,
MITIGATION, OR TREATMENT OF INJURY TO MYOCARDIAL TISSUE VIA THE ADMINISTRATION
OF A PRODUCT TO A HUMAN PATIENT.
SECTION 1.37
"PRODUCT" SHALL MEAN A LIQUID POLYMER COMPOSED OF SODIUM
ALGINATE AND CA-D-GLUCONATE (DESIGNATED BY BIOLINERX AS "BL-1040"), OR ANY
BACK-UPS OR SECOND-GENERATION POLYMERS OR POLYMER COMBINATIONS THEREOF THAT IS
DEVELOPED UNDER THE DEVELOPMENT PROGRAM.
SECTION 1.38
"REGULATORY APPROVAL" SHALL MEAN, WITH RESPECT TO A
JURISDICTION, THE APPROVAL OF THE APPLICABLE REGULATORY AUTHORITY REQUIRED TO
MARKET AND SELL A PRODUCT IN SUCH JURISDICTION.
FOR CLARITY, REGULATORY
APPROVAL FOR A PRODUCT SHALL OCCUR:
(A)
IN THE UNITED STATES, ON THE DATE WHEN THE FDA APPROVES A PREMARKET
APPROVAL (PMA) APPLICATION;
(B)
IN EUROPE, ON THE DATE WHEN SUCH PRODUCT MAY FIRST BE PLACED ON THE MARKET
AS A MEDICAL DEVICE (AS SUCH TERMS ARE DEFINED IN ART. 1 PARAGRAPHS 2(A) AND
(H) OF DIRECTIVE 93/42/EEC, AS AMENDED) BEARING THE CE MARKING ACCORDING TO ART.
17 OF DIRECTIVE 93/42/EEC, AS AMENDED, IN ANY MEMBER STATE OF THE EU; AND
6
(C)
IN JAPAN, ON THE DATE WHEN THE MINISTRY OF HEALTH APPROVES A MARKETING
AUTHORIZATION.
SECTION 1.39
"REGULATORY AUTHORITY" SHALL MEAN ANY NATIONAL (E.G., THE
FDA), SUPRA-NATIONAL OR OTHER REGULATORY AGENCY OR GOVERNMENTAL ENTITY INVOLVED
IN THE GRANTING OF REGULATORY APPROVAL FOR, OR IN THE REGULATION OF HUMAN
CLINICAL STUDIES OF, THERAPEUTIC MEDICAL DEVICES.
SECTION 1.40
"ROYALTY TERM" SHALL MEAN, WITH RESPECT TO A PRODUCT IN A
COUNTRY OF THE TERRITORY, THE PERIOD OF TIME COMMENCING ON THE FIRST COMMERCIAL
SALE OF SUCH PRODUCT IN SUCH COUNTRY AND ENDING UPON THE EARLIER OF (A) THE
EXPIRATION OF THE LAST-TO-EXPIRE VALID CLAIM IN THE BIOLINERX PATENT RIGHTS THAT
COVERS THE SALE OR USE OF SUCH PRODUCT IN THE FIELD