Exhibit 10.1
LICENSE AGREEMENT
This License Agreement ("Agreement") is effective and entered into as of _____,
2006 (the "Effective Date"), by and between GE Healthcare AS., ("GEHC"), a
Norwegian corporation with offices at
Nycoveien 1-2 Postboks 4220 Nydalen, Oslo
Norway and Acusphere Inc. ("ACUS") a Delaware corporation
with offices at 500
Arsenal St., Watertown, MA 02472.
(GEHC and ACUS collectively "the Parties").
WHEREAS, GEHC owns certain patents relating to the compositions, methods of
preparing, and methods of use of ultrasound contrast agents;
WHEREAS, ACUS is developing that certain ultrasound contrast agent, AI-700,
which is the subject of
Investigational New Drug Application ("INDA") with the
U.S. Food and Drug Administration;
WHEREAS, ACUS desires to obtain a non-exclusive license to certain of GEHC's
patents.
NOW, THEREFORE, in consideration of the foregoing and the covenants,
acknowledgements and representations contained in this Agreement, the Parties
hereby agree as follows:
ARTICLE I.
DEFINITIONS
1.1.
DEFINITIONS.
FOR PURPOSES OF THIS AGREEMENT, THE TERMS DEFINED
HERE SHALL HAVE THE MEANINGS SPECIFIED BELOW.
THESE TERMS ARE INTENDED TO
ENCOMPASS BOTH SINGULAR AND PLURAL FORMS.
1.1.1.
"AFFILIATE" SHALL MEAN AN ENTITY THAT DIRECTLY, OR
INDIRECTLY THROUGH ONE OR MORE INTERMEDIARIES, CONTROLS, OR IS CONTROLLED BY, OR
IS UNDER COMMON CONTROL WITH A PARTY.
WITHOUT LIMITING THE GENERALITY OF THE
FOREGOING, "CONTROL" SHALL MEAN THE OWNERSHIP, DIRECTLY OR INDIRECTLY, OF FIFTY
PERCENT (50%) OR MORE OF THE ISSUED SHARE CAPITAL OR SHARES OF STOCK ENTITLED TO
VOTE FOR THE ELECTION OF DIRECTORS, IN THE CASE OF A CORPORATION, OR FIFTY
PERCENT (50%) OR MORE OF THE EQUITY INTERESTS IN THE CASE OF ANY OTHER ENTITY OR
THE LEGAL POWER TO DIRECT OR CAUSE THE DIRECTION OF THE GENERAL MANAGEMENT AND
POLICIES OF THE ENTITY IN QUESTION.
1.1.2.
"AI-700" SHALL MEAN THE ULTRASOUND CONTRAST PRODUCT
CURRENTLY UNDER DEVELOPMENT BY ACUS AND FOR WHICH ACUS HAS FILED AN INDA.
THE
TERM "AI-700" INCLUDES POSTAPPROVAL CHANGES MADE TO THE PRODUCT
IN ACCORDANCE
WITH SECTION 506A OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AND SECTION 314.70
(21 CFR 314.70) AS RECOMMENDED IN THE DOCUMENT: GUIDANCE FOR INDUSTRY, CHANGES
TO AN APPROVED NDA OR ANDA, APRIL 2004, U.S. DEPARTMENT OF HEALTH
1
AND HUMAN SERVICES, FOOD AND
DRUG ADMINISTRATION, CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), APRIL 2004,
CMC, REVISION 1.
1.1.3.
"FIELD" SHALL MEAN ULTRASOUND DIAGNOSTIC IMAGING IN
HUMANS AND ANIMALS.
1.1.4.
"GEHC LICENSED PATENTS" SHALL MEAN (I) ALL PRESENT
PATENTS AND PATENT APPLICATIONS WORLDWIDE THAT CLAIM THE COMPOSITION OF,
MANUFACTURE OF, OR METHODS OF USE OF ULTRASOUND CONTRAST AGENTS, WHICH ARE
ISSUED OR PENDING AS OF THE EFFECTIVE DATE, TOGETHER WITH ALL FUTURE PATENTS AND
PATENT APPLICATIONS THAT CLAIM PRIORITY (DIRECTLY OR INDIRECTLY THROUGH OTHER
APPLICATIONS) TO ANY PATENT OR PATENT APPLICATION PENDING AS OF OR BEFORE THE
EFFECTIVE DATE THAT ARE OWNED BY OR LICENSED TO GEHC OR AN AFFILIATE WITH A
RIGHT TO SUBLICENSE, INCLUDING WITHOUT LIMITATION, THOSE LISTED ON EXHIBIT A
HERETO AND (II) ALL PATENTS AND PATENT APPLICATIONS WORLDWIDE THAT CLAIM THE
COMPOSITION OF, MANUFACTURE OF, OR