ROYALTY AGREEMENT
THIS AGREEMENT made and entered into this 25th day of March, 1997 by and
between XXXXXXXXX X. XXXXXXXXX, M.D., Ph.D. ("XXXXXXXXX") who has his principal
place of business at 00000 Xxxxxxxx Xxxxxx, Xxxxx 000, Xxxxxxx, Xxxxx 00000, and
THE XXXXXXXXX RESEARCH INSTITUTE, INC., ("BRI"), a Delaware corporation, with
its principal place of business at 00000 Xxxxxxxx Xxxxxx, Xxxxx 000, Xxxxxxx,
Xxxxx 00000.
WHEREAS, XXXXXXXXX is the owner of certain patents dealing with certain
medical chemical compounds and uses thereof all of which relate to
antineop1aston drugs ("Antineoplastons"); and
WHEREAS, antineoplastons are still investigational new drugs not approved
for interstate marketing by the Federal Food and Drug Administration; and
WHEREAS, in or about Xxxxx 0, 0000 XXXXXXXXX and BRI entered into a Second
Amended License Agreement wherein XXXXXXXXX had assigned or licensed all of
these patents to BRI so that BRI now has the sole right to sell, license,
manufacture, distribute or otherwise exploit antineoplastons in the United
States, Canada and Mexico (with one certain exception discussed infra); and
WHEREAS, pursuant to said Second Amended License Agreement, Xxxxxxxxx has
the right to continue to use antineoplastons in his private medical practice and
has agreed to pay BRI a royalty fee equivalent to seventeen percent of
Xxxxxxxxx'x gross receipts from said medical practice;
WHEREAS, it would be of significant and direct benefit to BRI for
antineoplastons to be approved by the FDA for interstate marketing so that BRI
could either sell, distribute, license or otherwise exploit antineoplastons on a
national scale; and
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WHEREAS, XXXXXXXXX has in the past and is willing to continue to conduct
his medical practice in such a way as to develop the data necessary to support
the FDA approval of the drug for interstate marketing; and
WHEREAS, XXXXXXXXX is willing to continue in his efforts to provide the FDA
the data in order to approve the drug, inter alia, by being the clinical
investigator of FDA-approved clinical trials which trials are necessary for the
approval of any drug; and
WHEREAS, XXXXXXXXX is currently the principal investigator for
approximately 71 FDA-approved clinical trials of antineoplastons, and his
undertaking of such clinical trials may significantly shorten the time in which
antineoplastons can be approved by the FDA.
NOW, THEREFORE, the parties agree as follows:
1. XXXXXXXXX TO CONTINUE AS PRINCIPAL INVESTIGATOR:
XXXXXXXXX agrees to continue in his role as the principal investigator in
all current and such future clinical trials as is necessary to create the data
to support the approval of antineoplastons for interstate marketing.
Furthermore, XXXXXXXXX also agrees to conduct such other and additional clinical
trials as may be required by the FDA to support a new drug application and
approval for interstate marketing. Furthermore, XXXXXXXXX agrees to supervise,
consult, oversee and otherwise deal with any other matters that come up with the
FDA approval process, such as the drafting and oversight of additional clinical
trials by other investigators in general, Xxxxxxxxx agrees to use his best and
continuous efforts to ensure that antineoplastons are approved by the FDA as
soon as possible.
2. COMPENSATION:
In consideration for XXXXXXXXX undertaking and continuing to perform those
responsibilities outlined in Paragraph 1 above, BRI agrees to assign XXXXXXXXX a
royalty
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interest equivalent to l0% (ten percent) of BRI's gross income (excluding
licensing fees generated by XXXXXXXXX licensing payments to BRI), which royalty
interest shall include gross receipts from all future sales, distribution and
manufacture of antineoplastons. The parties acknowledge that there is no such
income at this time and unless antineoplastons are approved for interstate
marketing in the United States, there may never be such income.
3. XXXXXXXXX CONTINUED USE OF ANTINEOPLASTONS AFTER FDA APPROVAL:
As additional consideration, BRI hereby accords XXXXXXXXX the right to
continue to use antineoplastons in his private medical practice, after any and
all formulations of antineoplastons are approved for interstate marketing by the
FDA on the same terms arid conditions, and royalty schedule as is currently in
effect under the Second Amended License Agreement.
4. TERM OF AGREEMENT:
The term of this Agreement shall be indefinite and will continue until such
time as the parties agree that it is in their mutual interest to continue such
agreement.
EXECUTED this 25th day of March, 1997.
/s/ XXXXXXXXX X. XXXXXXXXX
--------------------------------------
XXXXXXXXX X. XXXXXXXXX, M.D., Ph.D.
THE XXXXXXXXX RESEARCH INSTITUTE
BY: /s/ XXXXXXXXX X. XXXXXXXXX
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XXXXXXXXX X. XXXXXXXXX, M.D., Ph.D.
PRESIDENT
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