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Exhibit
10.5
NOTE: C ERTAIN C
ONFIDENTIAL I NFORMATION
HAS BEEN OMITTED
FROM THIS DOCUMENT
AND REPLACED BY
“[*]”. A COMPLETE COPY
OF THIS DOCUMENT
INCLUDING THE C
ONFIDENTIAL I NFORMATION
HAS BEEN FILED
SEPARATELY WITH THE S
ECURITIES AND E
XCHANGE C OMMISSION .
LICENSE
AGREEMENT
THIS AGREEMENT, effective
September 28, 1995, is entered into
- BY -
1149336 ONTARIO
INC.,
a corporation incorporated
under the laws of the
Province of Ontario, having
its registered office at
19 Fernwood Road, Toronto,
Ontario M6B 3G3
(herein called “DRUCKER
LTD.” )
- AND -
DANIEL J. DRUCKER,
M.D.
an individual residing
at
19 Fernwood Road, Toronto,
Ontario M6B 3G3
(herein called “DR.
DRUCKER”)
- AND -
ALLELIX BIOPHARMACEUTICALS
INC.,
a corporation incorporated
under the laws of Canada,
having its principal place of
business at
6850 Goreway Drive,
Mississauga, Ontario L4V IV7
(herein called
“ALLELIX”).
| I. |
Background of Agreement |
1.0 DR. DRUCKER is a clinician and
medical researcher operating out of the Toronto Hospital and the
University of Toronto and has been, and continues to be, engaged in
research aimed at the elucidation of a gastrointestinal growth
factor.
1.1 ALLELIX is a biopharmaceuticals
research and development company, and has sponsored DR.
DRUCKER’s research in the gastrointestinal growth factor
field, through cash payments; through in kind provisions of
reagents and services; and by the supporting of DR. DRUCKER’s
research under the Industrially Oriented Research (IOR) Grant
Program. During the course of the research program, ALLELIX has
provided advice and suggestions as to the conduct of the research
and the potential utility of the gastrointestinal growth
factor.
1.2 Under this research program, DR.
DRUCKER has invented (1) a peptide to treat various medical
conditions including conditions resulting from the impaired growth
or loss of tissue, (2) a pharmaceutical composition including
such a peptide, (3) a salt of such peptide, and (4) a
method of medical treatment including the use of such
pharmaceutical composition, and ALLELIX has arranged at its expense
for the filing of a priority patent application therefor in the
name of DR. DRUCKER.
1.3 DR. DRUCKER has assigned the results
of his research and the aforementioned patent application to
DRUCKER LTD.
1.4 ALLELIX, DRUCKER LTD. and DR.
DRUCKER now wish to set forth the terms and conditions of a license
under which ALLELIX shall be entitled to commercialize certain
rights to the results of DR. DRUCKER’s research as assigned
to DRUCKER LTD.
NOW THEREFORE, in
consideration of the foregoing premises, the mutual covenants and
obligations hereinafter contained, and other good and valuable
consideration, DRUCKER LTD., DR. DRUCKER and ALLELIX agree as
follows:
As used herein, the following terms
shall have the meanings set forth below:
2.1 AFFILIATE means any COMPANY that is
controlled directly or indirectly by a party hereto, or any COMPANY
that directly or indirectly controls a party hereto, or any COMPANY
that is directly or indirectly controlled by a COMPANY which also
directly or indirectly controls a party hereto, so that AFFILIATE
shall include any parent or subsidiary of a party hereto, or any
directly or indirectly held subsidiary of a party
hereto.
2.2 BASIC PATENTS means (1) the
United States patent application filed April 14, 1995 entitled
“Glucagon-Like Peptide-2 and Its Therapeutic Use” and
includes (2) patents to be issued pursuant to (1) and all
divisions, continuations in whole and in part, reissues,
re-examinations, substitutes, extensions and foreign counterparts
thereof.
2.3 COMPANY includes a corporation,
firm, partnership or other entity.
2.4 CONFIDENTIAL INFORMATION shall mean
all disclosures of know-how, inventions and other intellectual
property under this Agreement, and any other information about the
businesses or affairs of the other, but excluding information
which:
(a) was already known to the
receiving party at the time of its disclosure by the disclosing
party;
(b) has been published or is
otherwise within the public knowledge or is generally known to the
public;
- 2 -
(c) has come into the public
domain without any breach of this Agreement;
(d) became known or available
to the receiving party from a source having the right to make such
disclosure to the receiving party and without restriction on such
disclosure to the receiving party;
(e) is disclosed to the
public and is generally available to the public as a result of
compliance with any applicable law or regulation; or
(f) is disclosed as the
result of any applications for, or publication of, the PATENT
RIGHTS.
2.5 CONTROL means the ownership,
directly or indirectly, of more than 50% of voting rights attached
to the issued voting shares or comparable interests in a
COMPANY.
2.6 EFFECTIVE DATE shall be
September 28, 1995.
2.7 EXPENDITURES means expenditures in
cash and equivalent-to-cash value of expenditures in kind that
ALLELIX has made on (1) research, development and exploitation
of the PRODUCT, including expenditures made pursuant to the product
development obligations specified in Article V hereof and
expenditures under the SPONSORED RESEARCH AGREEMENT; and
(2) expenditures on patent preparation, patent prosecution and
patent maintenance pursuant to Article VIII hereof.
2.8 FIELD means, and is limited to,
veterinary and human therapeutic and diagnostic products and the
manufacture, use and sale thereof.
2.9 GROSS SALES shall mean the total
sales price of PRODUCT sold by ALLELIX, its AFFILIATES and
permitted assigns in final dosage form. Sales by ALLELIX to its
SUB-LICENSEES shall not be included in GROSS SALES, but shall be
included in any calculation of SUPPLY PROFIT.
2.10 IMPROVEMENT PATENTS means
(1) patent applications for those inventions that
(a) arise from research that is sponsored by ALLELIX and
performed by or on behalf of DR. DRUCKER or DRUCKER LTD. and
(b) relates to PRODUCT or to a method of making, using or
selling PRODUCT, and all divisions, continuations in whole and in
part, reissues, re-examinations, substitutes, extensions and
foreign counterparts thereof.
2.11 NET SALES shall mean the total NET
SALES PRICE of PRODUCT sold by ALLELIX, its AFFILIATES and
permitted assigns in final dosage form. Sales by ALLELIX to its
SUB-LICENSEES shall not be included in NET SALES, but shall be
included in any calculation of SUPPLY PROFTT.
- 3 -
2.12 NET SALES PRICE shall mean the
total of net invoice prices for all PRODUCT sold in arm’s
length sales by ALLELIX, its AFFILIATES and permitted assigns, for
any given period of time during the term of this Agreement, less
wholesaler’s or distributor’s commissions, discounts
rebates, samples and freight charges, and taxes separately listed
on such invoices, and less the amount of any credits or refunds
actually given by ALLELIX for defective or returned
PRODUCT.
2.13 PATENT RIGHTS includes BASIC
PATENTS and IMPROVEMENT PATENTS.
2.14 PRODUCT means all products which
are Glucagon-Like Peptide-2 (GLP-2), and all analogues, fragments,
derivatives, receptors and compositions thereof whether developed
by ALLELIX and/or DR. DRUCKER pursuant to the SPONSORED RESEARCH
AGREEMENT or otherwise.
2.15 SPONSORED RESEARCH AGREEMENT has
the meaning attributed thereto in Section 4.6.
2.16 SUB-LICENSEE means a person to whom
ALLELIX has sub-licensed or assigned all or part of the rights
granted to ALLELIX by DRUCKER LTD. by this Agreement.
2.17 SUBLICENSEE REVENUE shall mean
(1) SUPPLY PROFIT and (2) payments in cash and
equivalent-to-cash value in-kind payments whether in the form of up
front payments, royalties or in any other form actually received by
ALLELIX from the sublicensing and assignment of the rights granted
to ALLELIX under this Agreement, but shall exclude payments
received by ALLELIX in consideration for the issuance of any debt
or equity interest in ALLELIX within the definition of
“security” in the Securities Act (Ontario)
required for bona fide financing of ALLELIX.
2.18 SUPPLY PROFIT means the invoiced
price of PRODUCT sold by ALLELIX to a SUB-LICENSEE, less 120% of
the direct cost of manufacturing the supplied PRODUCT and less the
amount of any credits or refunds actually given by ALLELIX for
defective or returned PRODUCT.
2.19 TERRITORY means all countries of
the world.
2.20 TOXICOLOGY REPORT has the meaning
attributed thereto in Section 5.0(a).
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2.21 TRADE SECRETS means all
information, expertise, technical assistance and other trade
secrets developed by or for DR. DRUCKER or DRUCKER LTD. relating to
the manufacture, use or sale of PRODUCT and which constitute
CONFIDENTIAL INFORMATION and which he discloses in writing to
ALLELIX.
3.0 DRUCKER LTD. hereby grants to
ALLELIX in the FIELD and TERRITORY, a license under PATENT RIGHTS
and TRADE SECRETS to develop and to make, have made, use, sell,
have sold and otherwise dispose of PRODUCT.
3.1 The license granted pursuant to
Section 3.0 hereof shall be exclusive. Subject only to DRUCKER
LTD.’s consent which shall not be unreasonably withheld or
delayed having regard to the rights and obligations of ALLELIX
under this Agreement, ALLELIX shall have the right to grant
sublicenses of its rights set out in Section 3.0 which may, in
ALLELIX’S discretion, convey to SUBLICENSEES the right to
grant further sublicenses.
3.2 Section 3.1 notwithstanding,
DRUCKER LTD. reserves a royalty-free license for the University of
Toronto, the Toronto Hospital or any other like institution
employing DR. DRUCKER under PATENT RIGHTS and TRADE SECRETS for
purposes of research and teaching at the University of Toronto, the
Toronto Hospital or like institution.
| IV. |
Licensing Consideration |
4.0 In consideration of the rights
granted by DRUCKER LTD. to ALLELIX under this Agreement, ALLELIX
shall pay DRUCKER LTD. the consideration set out in this
Article.
4.1 On the execution of this agreement
by DRUCKER LTD., DR. DRUCKER and ALLELIX, ALLELIX shall pay DRUCKER
LTD. the non-refundable sum of [*] Cdn.
4.2 On April 1, l996 and annually
thereafter, ALLELIX shall pay DRUCKER LTD. an annual non-refundable
license maintenance fee of [*] Cdn.
4.3 On sales by ALLELIX, its AFFILIATES
and permitted assigns of PRODUCT, ALLELIX shall pay DRUCKER LTD. a
royalty which is equal to the greater of [*] of NET SALES and [*]
of GROSS SALES. These royalty payments shall be made in accordance
with Article VII of this Agreement. There shall be no minimum
annual royalty payments payable by ALLELIX to DRUCKER LTD. for the
rights set out in this Agreement.
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4.4 To maintain its exclusive rights
under this Agreement, ALLELIX shall make the following guaranteed
non-refundable payments to DRUCKER LTD. At the following
milestones. SUBLICENSING REVENUE paid under Section 4.5 shall
apply to reduce guaranteed payments due under this Section 4.4
and guaranteed payments made under this Section 4.4 shall
apply to reduce the SUBLICENSING REVENUE due under
Section 4.5. For greater certainty, ALLELIX shall pay DRUCKER
LTD. the greater of the payments set out in Section 4.5 or in
this Section 4.4, but shall not make payments under both
Sections.
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[*] Cdn. upon
grant of the first BASIC PATENT by the United States Patent
Office.
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[*] Cdn. upon
grant of approval to proceed with the first clinical trial of the
PRODUCT in any country in the TERRITORY.
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[*] Cdn. upon
the initiation of the first phase III clinical trial of the PRODUCT
in one of the United States, Japan, the United Kingdom, France or
Germany.
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[*] Cdn. upon
the acceptance of the first new drug application (NDA) to market a
PRODUCT in one of the United States, Japan, the United Kingdom,
France or Germany.
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4.5 ALLELIX shall provide DUCKER LTD.
with a percentage of SUBLICENSING REVENUE actually received by
ALLELIX, determined having regard to the EXPENDITURES made before
the date ALLELIX receives the SUBLICENSING REVENUE as
follows:
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EXPENDITURE
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Percentage of Sublicensing Revenue |
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less than [*] Cdn.
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[*] |
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between [*] and less than [*]
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[*] |
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between [*] and less than [*]
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[*] |
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[*] or more
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[*] |
4.6 DR. DRUCKER and ALLELIX shall
execute on the date of execution of this Agreement, a sponsored
research agreement the “SPONSORED RESEARCH AGREEMENT”)
effective September 1, 1995 regarding further research and
development by DR. DRUCKER.
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| V. |
Commercialization and Further Research |
5.0 Upon execution of this Agreement
ALLELIX, on its own or through a SUB-LICENSEE, shall ensure that
reasonable commercial efforts are used, in relation to PRODUCT,
to:
(a) perform in a timely
fashion pre-clinical testing and evaluation, which shall include an
assessment of toxicology based on results from both acute and
chronic studies in two different mammalian species, the results of
all of which shall be reported to DRUCKER LTD. as a toxicology
report (the “TOXICOLOGY REPORT”) promptly after results
of the final toxicology study are obtained; and
(b) seek governmental
approvals required to produce, manufacture, distribute and market
PRODUCT in the TERRITORY, including
1) commencing Phase II
clinical trials in a first country in the TERRITORY within [*] from
the date of the TOXICOLOGY REPORT; and
2) commencing Phase III
clinical trials in a first country in the TERRITORY within [*] from
the date of the TOXICOLOGY REPORT; and
3) filing a new drug
application within [*] of the date on which the Phase III clinical
trial is completed; and
(c) market PRODUCT in those
countries within the TERRITORY where governmental approvals are
obtained.
5.1 DRUCKER LTD. shall disclose to
ALLELIX, and ALLELIX shall be entitled to use all information
relating to the PRODUCT, including PATENT RIGHTS and all TRADE
SECRETS, to enable ALLELIX or its SUB-LICENSEES to perform its
obligations and enjoy the rights granted under this Agreement. DR.
DRUCKER shall continue to conduct research in accordance with the
SPONSORED RESEARCH AGREEMENT.
5.2 All know-how, inventions and all
other intellectual property, whether or not protectable, generated
solely by ALLELIX or its employees during the term of this
Agreement and relating to the PRODUCT shall belong solely to
ALLELIX but any PRODUCT derived therefrom shall be subject to the
Licensing Consideration set out in Sections 4.3, 4.4 and 4.5.
Determination of inventorship, for this Section 5.2 and for
Sections 5.3 and 5.4, shall be made in accordance with United
States patent law. Allelix shall disclose this intellectual
property to DRUCKER LTD.
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5.3 All know-how, inventions and all
other intellectual property, whether or not protectable, generated
solely by DR. DRUCKER and/or DRUCKER LTD. or by persons working
with DR. DRUCKER in his laboratory, and relating to the PRODUCT
shall belong solely to DR. DRUCKER. DR. DRUCKER shall disclose this
intellectual property to ALLELIX. To the extent that such
intellectual property relates to PRODUCT, such intellectual
property shall be within the grant of rights from DRUCKER LTD. to
ALLELIX as set out in Article III of this Agreement, subject to the
agreement assigning rights of original property effected
betwee
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