<PAGE>
[*] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF
THE SECURITIES ACT OF 1933, AS
AMENDED.
Exhibit 10.17
EXCLUSIVE LICENSE AGREEMENT
THIS
AGREEMENT made as of September 5th, 2003.
BETWEEN:
MOLECULAR
INSIGHT PHARMACEUTICALS, INC. F/K/A BIOSTREAM, INC.
a corporation incorporated under the laws of the State of
Massachusetts, and having a place of business at 160 Second
Street,
Cambridge, MA, (the "Licensee")
AND:
THE UNIVERSITY OF WESTERN ONTARIO,
a corporation under the Universities Act (Ontario)
(the "University")
WHEREAS:
A) the University is the
owner of certain Technology (as defined herein)
relating
to the University's Invention Numbers 01-003 and 02-018 known
as:
"Polymer
Precursors of Radiolabeled Compounds and Methods of Making and
Using the
Same" and "Polymer-Supported Propenyl Mesylates as Precursors
for the
Radiolabelling of Amines, Sulfides and Ethers" respectively,
and
has the
authority and capacity to grant licenses to the Technology;
B) the University wishes
to have the Technology developed and commercialized
to benefit
the public and is willing to grant a license to any underlying
Patent Rights
thereto; and
C) the Licensee wishes to
obtain from the University and the University has
agreed to
grant a license to the Licensee to commercially exploit the
Technology
on the terms set out.
NOW THEREFORE in consideration of the
premises and of the mutual covenants set
forth herein, the parties hereto agree as
follows:
ARTICLE 1 - DEFINITIONS
1.1 For purposes of this
Agreement, the following words and phrases shall have
the
following meanings:
(a)
"Business Day"
means every day other than Saturday, Sunday, and
statutory holidays in the Province of Ontario or the Commonwealth
of
Massachusetts;
Page 1 of 27
<PAGE>
(b)
"Confidential
Information" means scientific, technical and/or
business information (including written descriptions, drawings,
samples, compositions, formulae, visual demonstrations,
prototypes
and other data) which is disclosed by one party (the "Discloser")
to
the other party (the "Recipient") and which is in each case
marked
or identified (either in writing or orally) as confidential at
the
time of disclosure.
(c)
"Effective Date"
means the date on which this Agreement shall come
into effect, which shall be the 5th day of September, 2003;
(d)
"Field of Use"
means all uses of the Technology;
(e)
"Net Revenue"
means all revenues and receipts directly or indirectly
receivable by the Licensee and, where sublicensing is permitted
hereunder, its sub-licensees or payable to the Licensee and its
sub-licensees, from third party use, sale, distribution, leasing
or
sublicensing of Licensed Products and/or the use of Licensed
Processes, calculated on the basis of the Licensee's fiscal year,
or
part thereof, less the following amounts relating to such sales:
(i)
discounts allowed in amounts that are reasonable and customary
in
the trade; (ii) actual freight and insurance costs incurred in
transporting Licensed Products to such purchasers; (iii) sales,
use,
value-added and other direct taxes incurred in respect of sale
of
Licensed Products; (iv) customs duties, surcharges and other
governmental charges incurred in connection with the export or
import of Licensed Products; and (v) amounts credited or allowed
on
returns. No deductions shall be made for commissions or fees paid
to
persons whether independent sales agents, or are employed by
the
Licensee or its sub-licensee, or for other similar costs.
Notwithstanding anything in this Agreement to the contrary,
revenues
and receipts shall be considered directly or indirectly
receivable
by Licensee when the Licensee receives such amounts owed to it;
provided, however, that the Licensee has exercised commercially
reasonable efforts to collect all amounts owed to it by its
sub-licensees or other third parties in connection with the
licenses
granted hereunder in a timely manner. Licensed Products shall
be
deemed to have been sold and included in the Net Revenue of the
Licensee and sub-licensee when invoiced, or if not invoiced,
when
delivered or paid for, whichever is the first to occur. Under
no
circumstances
shall Net Revenue include any grant money or other
funding received by the Licensee as re-imbursement of expenses
associated with the research and development of the Technology
by
the Licensee.
(f)
"Licensee" is
the party of the first part and includes any
corporation which controls, is controlled by, or is under
common
control with the Licensee; for this purpose, "control" means
the
direct or indirect ownership of voting shares carrying more than
50%
of the votes for the election of directors;
(g)
"Licensee
Improvement" means any technology, whether patentable or
not, that is developed by or under the direction of the Licensee
and
whose use would infringe one or more claims or rights under the
Patent Rights or whose development has relied upon the
Technology;
Page 2 of 27
<PAGE>
(h)
"Licensed
Process" means any process which relies in whole or in
part upon the Technology or which is covered in whole or in part
by
an issued, unexpired claim or pending claim contained in the
Patent
Rights;
(i)
"Licensed
Product" means any product or part thereof which:
(i) relies in
whole or in part, upon the Technology, or is
utilized to practise a Licensed Process; or
(ii) is produced or
processed by using a Licensed Process; or
(iii) is covered in whole or in part by an issued, unexpired
claim
or a pending claim contained in the Patent Rights in the
country in which any such product or part thereof is made,
used or sold.
(j)
"Materials"
means any substance, product or compound (including all
cell lines, vectors, plasmids, clones, micro organisms,
anti-bodies,
antigens, test plates, reagents, chemicals, compounds, physical
samples, models and specimens) delivered by the University to
the
Licensee, and the Materials specifically described in Schedule
"C",
and all progeny, mutants and derivatives thereof supplied by
the
University;
(k)
"Milestone
Payments" has the meaning set forth in Section 5.2;
(l)
"Patent Rights"
means any of the following intellectual property of
the University:
(i) patents
and/or patent applications listed in Schedule "A";
(ii) patents issued
from the applications listed in Schedule "A",
or from divisions or continuations of such applications, or
any re-issues of such patents; or
(iii) such other statutory or common law protection as may be
available to the University in connection with such patents or
patent applications listed on Schedule A.
(m)
"Royalty Due
Date" means the date 30 days following the last day of
March, June, September and December of each and every year
during
which this Agreement remains in full force and effect, commencing
on
January 30, 2004;
(n)
"Territory"
means worldwide;
(o)
Technology"
means any and all knowledge, know-how, information,
software and/or techniques invented, developed or acquired or
being
invented, developed and/or acquired prior to or after the
Effective
Date by the University, and any Materials related thereto, all
of
which are related to the Patent Rights, University Improvements
or
Licensee Improvements as applicable, provided that for the
purposes
of determining University
Page 3 of 27
<PAGE>
ownership of Technology, Licensee Improvements developed solely
by
the Licensee shall be excluded.
(p)
"University
Improvement" means any technology, whether patentable or
not, that is created by the University under the research program
of
Dr. Duncan Hunter or whose use would infringe one or more claims
or
rights under the Patent Rights; and
(q)
"Trade-marks"
means any mark, trademark, service mark, logo,
insignia, seal, design or other symbol or device used by the
University or Licensee and associated with or referring to either
of
the University or Licensee, as the case may be, or any of its
facilities, property or products.
ARTICLE 2 - GRANT OF RIGHTS AND TERM
2.1 LICENSE. Subject to the
terms and conditions of this Agreement, the
University
hereby grants to the Licensee the right and license, within the
Field of
Use and in the Territory, to use, modify, improve, sublicense
or
otherwise
exploit, for commercial and non-commercial purposes, the
Technology, the Patent Rights, and/or University Improvements
as
applicable, and, to make, have made, use, lease, sell, distribute
and
import
Licensed Products and to use, modify, improve, sublicense and
otherwise
exploit, for commercial and non-commercial purposes, the
Licensed
Processes, until the end of the earlier of 20 years from the
Effective
Date of this Agreement or the term for which a patent or
patents
under the
Patent Rights are granted, and in the latter instance, on a
country by
country basis, unless this Agreement is sooner terminated
according
to the terms hereof. Notwithstanding anything to the contrary,
the
license granted hereunder shall not be construed to confer any
rights
or
benefits upon the Licensee by implication, or otherwise, as to
any
patents,
technology or rights not specifically included in the
Technology.
2.2 PERIOD OF EXCLUSIVITY. In
order to establish a period of exclusivity for
the
Licensee, the University hereby agrees that it shall not grant
any
other
license to make, have made, use, lease, sell and distribute the
Technology, the Patent Rights, the University Improvements or the
Licensed
Products
or to utilize Licensed Processes in the Territory for the Field
of Use
during the period of time commencing the Effective Date and
terminating upon expiration of any patent issued on a country by
country
basis.
2.3 RIGHTS RETAINED BY
UNIVERSITY. Nothing in this Agreement shall affect the
University's right to use the Technology or to use and distribute
the
Materials
to third parties for research, teaching and other
non-commercial
uses and
the Licensee hereby grants back to the University rights to use
the Patent
Rights, whether for the University's own purposes or in
conjunction with other similar research institutions, for
research,
teaching
and other non-commercial applications, including technical
services
and industrially sponsored research. This grant to the
University
expressly
excludes any rights to use the Patent Rights alone or in
conjunction with others, for commercial purposes.
Page 4 of 27
<PAGE>
2.4 OWNERSHIP, IMPROVEMENTS. The
parties acknowledge that the University shall
retain
ownership of the Technology excluding all Licensee
Improvements.
The
Licensee shall own all Licensee Improvements, provided that the
Licensee
hereby grants to the University a perpetual, non-exclusive
royalty-free right to use all Licensee Improvements solely for
research,
teaching
and other non-commercial uses in accordance with the rights
granted
under Section 2.3.
2.5 REPORT OF IMPROVEMENTS. From
time to time and in any event at least
annually:
(a) the Licensee shall disclose
in writing to the University the details
of all Licensee Improvements; and
(b)
the University
shall disclose in writing to the Licensee the details
of all University Improvements, for the purposes of causing same
to
be part of the grant of rights in the Technology hereunder.
2.6 RESTRICTION ON DISCLOSURE;
USE OF TRADE-MARKS. Neither party shall
disclose
any of the financial terms and conditions of this Agreement but
shall be
entitled to reveal the parties and the nature of the license
granted.
Neither Party shall use any of the other's Trade-marks or make
reference
to the other for any advertising or publicity purposes, without
the prior
written consent of that party. Notwithstanding the foregoing,
the
parties (and their representatives) may disclose to any person
or
entity the
tax treatment and tax structure of the transactions
contemplated by this Agreement and any materials (including
opinions and
other tax
analyses) provided to them relating to the tax treatment and
tax
structure
of the transactions contemplated herein.
ARTICLE 3 - SUBLICENSES
3.1 SUBLICENSES. The Licensee
shall have the right to grant sublicenses of the
rights,
privileges and licenses granted hereunder within the Territory
during the
exclusive period of this Agreement in accordance with the
provisions
of Section 3.2. Upon any termination of this Agreement, and at
the
election of the University, any sub-licensees' rights shall
also
terminate.
3.2 COVENANTS OF
SUB-LICENSEES.
(a)
Licensee
covenants and agrees that it shall cause any sublicense
agreement entered into by it to contain, on the part of such
sub-licensee, covenants in favour of the University with respect
to
the obligations set forth in Sections 3.1, 6.1 and Articles 10
and
12 herein, and that to the extent there exists an inconsistency
between the sublicense
agreement and this Agreement, any such
inconsistency or conflict will be resolved in favour of this
Agreement. In granting any sublicense hereunder, the Licensee
undertakes to observe and perform any obligations of the
sub-licensee, to intent that none of the rights, entitlements
or
remedies of the University are impaired by the granting of such
sublicense. The Licensee shall deliver to the University a true
copy
of such sublicense agreement upon execution.
Page 5 of 27
<PAGE>
[*] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF
THE SECURITIES ACT OF 1933, AS
AMENDED.
(b)
In addition, all
sublicenses shall be subject to the following
conditions:
(i) in no event
will a sub-licensee be permitted to further
sublicense or to assign or transfer any rights which have been
granted to it by the Licensee (except to the extent that such
assignment is in connection with the sale of all or
substantially all of the assets or stock of such sub-licensee
or in connection with the merger or similar transaction
between such sub-licensee and a third party and University is
notified of such assignment); and
(ii) the Licensee
shall not be entitled to receive from any
sub-licensee any consideration or matter of value in lieu of
cash payments not otherwise part of Net Revenue, in
consideration for any sublicense under this Agreement, without
the express prior written consent of the University.
ARTICLE 4 - LICENSEE'S PERFORMANCE
OBLIGATIONS
4.1 LICENSEE'S COMMERCIALIZATION
DUE DILIGENCE; MILESTONE OBLIGATIONS. The
Licensee
shall use commercially reasonable efforts to bring one or more
Licensed
Products or Licensed Processes to market through a thorough,
concerted
and diligent program for exploitation of the Technology and to
continue
active, diligent marketing efforts for one or more Licensed
Products
or Licensed Processes during the entire period that this
Agreement
is in effect, in order to meet the milestones set out on
Schedule
"D" from time to time.
4.2 ACKNOWLEDGEMENT OF EXPERTISE
BY LICENSEE. The Licensee covenants and
agrees
that it has the expertise necessary to handle the Technology,
Materials,
the Licensed Products and the Licensed Processes with care and
without danger to the
Licensee, its employees, agents, or the public, and
to observe
and perform the covenants and obligations set out herein.
4.3 COMPLIANCE BY LICENSEE WITH
LAWS. The Licensee covenants and agrees that
it will
comply with all laws, regulations and ordinances, whether
federal,
provincial, state, municipal or otherwise, as appropriate, with
respect to
the
Materials, the Technology, the Licensed Products, the Licensed
Processes
and this Agreement.
4.4 FAILURE TO MEET PERFORMANCE
REQUIREMENTS. In the event the Licensee fails
to meet
any of the milestones or performance criteria set forth in
Schedule
D, or observe and perform the obligations set forth under any
of
Sections
4.1 or 4.3, such shall constitute a default under this
Agreement
pursuant
to Section 13.2 hereof.
4.5 NO PRIOR SECURITY INTERESTS.
The Licensee covenants that it will not grant
a security
interest in or to the Technology.
ARTICLE 5 - FEES, ROYALTIES AND
PAYMENTS
5.1 INITIAL LICENSE FEE. The
Licensee shall pay to the University, an initial
license
fee with respect to the issuance of the license, of Canadian
$[******].
The said sum shall
Page 6 of 27
<PAGE>
[*] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF
THE SECURITIES ACT OF 1933, AS
AMENDED.
be deemed
earned and due immediately upon the Effective Date, and shall
not be
refundable to the Licensee in whole or in part under any
circumstances.
5.2 ROYALTY FOR DISCOVERY,
RESEARCH AND DEVELOPMENT USES.
(a)
The Licensee shall pay to the
University, in advance, an annual fee
of Canadian $[******] ([***************] dollars) per year for
seven
years commencing on the anniversary of the Effective Date
beginning
one year after the Effective Date, and thereafter on each
successive
anniversary of the Effective Date. The parties are agreed that
no
payment shall be required for that period from the Effective Date
to
the first anniversary thereof; and
(b)
As further
consideration for the value of the Technology for
application as a discovery tool and use as a research and
development platform by the Licensee ("Research Uses"):
(i) Licensee
shall pay to the University a royalty of [********]
percent ([***]%) of the Net Revenue receivable by the Licensee
that is attributable to products sold, made, or distributed
directly by Licensee to third parties where such products rely
upon such Research Uses and which no longer are relying upon
the Technology directly;
(ii) Where Licensee
provides Research Uses to third parties on a
fee-for-service basis, Licensee shall pay a royalty to the
University of [**************] percent ([***]%) of the Net
Revenue receivable by the Licensee in connection with such
fee-for-service work which relies upon such Research Uses; and
(iii) Where the Licensee has previously provided to third
parties
Research Uses on a fee-for-service basis and such third party
thereafter sells, makes or distributes a product that relies
on such Research Uses, the Licensee shall pay to the
University a royalty of [********************] ([***]%) of the
Net Revenue receivable by the Licensee as a royalty payment
from such third party in connection with products which rely
upon such Research Uses and which do not require a sublicense
of the Technology.
5.3 MILESTONE PAYMENTS. The
Licensee shall pay to the University milestone
product
development payments with respect to achievement of each of the
enumerated
events arising from the development of each of the Licensed
Products
and/or Licensed Processes, all as set forth in the table below,
with each
payment becoming due and payable on the first date of
completion
for each
element of every Class ("Class" means any of Cardiology,
Oncology,
Central Nervous System, Infection, and Vascular Disease) of
Licensed
Product and/or Licensed Process of such milestone, regardless
of
the
country in which achievement of such milestone first occurs:
<TABLE>
<CAPTION>
Milestone
Payment
---------
-------
<S>
<C>
Initiation of Phase I Clinical Trial
Canadian $[******]
Completion of Phase II Clinical Trial
Canadian $[******]
Completion of Phase III Clinical Trial
Canadian
$[******]
Grant of Regulatory Approval
Canadian $[******]
</TABLE>
Page 7 of 27
<PAGE>
[*] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF
THE SECURITIES ACT OF 1933, AS
AMENDED.
For
certainty with respect to milestone product development
payments,
there are
four (4) milestones anticipated for each of the five (5)
Classes.
5.4 ANNUAL ROYALTIES AND
PAYMENTS. In consideration of the license granted
hereunder,
the Licensee shall pay to the University subject to Section 5.6
below:
(a)
a royalty of
[**************] percent ([***]%) of Net Revenue; For
greater clarification, on sales between Licensee, and/or its
Affiliates, sub-licensees or agents for resale purposes, the
royalty
shall be paid only on the resale value by such Affiliate,
sublicense, or agent. Such royalties shall become due and payable
on
each Royalty Due Date, and shall be calculated with respect to
Net
Revenue for the calendar quarter immediately preceding the month
in
which the applicable Royalty Due Date occurs; and
(b)
in addition to
such annual royalties in subsection (a) hereof, [****
***********] percent ([***]%) of:
(i) initial
up-front fees, or other consideration (including
equity or other participation), or in-kind or non-monetary
contribution, if any, receivable by Licensee upon its
execution of or pursuant to the terms of any sub-license
agreement related to the use of the Technology, Materials,
Licensed Products or Licensed Processes; and
(ii) any payments or
other consideration (including equity or other
participation), or in-kind or non-monetary contribution
receivable by Licensee upon the successful achievement of
milestones set forth in, and pursuant to the terms of, any
sublicense agreement related to the use of the Technology,
Materials, Licensed Products or Licensed Processes. The
Licensee shall be entitled to deduct from any of the foregoing
consideration received that portion which is a reimbursement
of its direct, out-of-pocket costs for research projects
funded on behalf of the sub-licensee relating to the
Licensee's Improvements after the effective date of the
sub-license agreement.
Any
payments under this subsection (b) shall be following receipt by
the
Licensee
of the fees, consideration, or in-kind or non-monetary
contribution, provided Licensee has exercised commercially
reasonable
efforts to
collect such amount or entitlement owing.
Notwithstanding anything herein to the contrary, the University
acknowledges and agrees, that it is not entitled to any
compensation,
royalty or
payment whatsoever in connection with any payments or other
consideration (including equity or other participation), with
respect to
third
party equity investments in the Licensee which are not directly
attributable to the sub-licensing of any of the Technology,
Materials,
Licensed
Products or Licensed Processes.
Page 8 of 27
<PAGE>
5.5 CURRENCY AND PLACE OF
PAYMENTS. All payments to be made by the Licensee to
the
University hereunder shall be made in Canadian dollars at
London,
Ontario
without deduction of taxes or other fees of any other kind
whatsoever, which may be imposed by any government, and which taxes
or
fees shall
be paid by the Licensee. Where any payment or amount is
denominated in a currency other than Canadian dollars, it shall
be
converted
to the equivalent in Canadian dollars at the rate of exchange
set by the
Bank of Montreal in Toronto, Canada for converting the currency
of such
amount into Canadian dollars, on the last Business Day of the
reporting
period to which such payment relates.
5.6 NO DUPLICATION OF PAYMENTS.
For clarification, the royalties owed pursuant
to clauses
(b)(i), or (b)(iii) of Section 5.2 and clause (a) of Section
5.4 are to
be independent of each other.
ARTICLE 6 - RECORDS AND REPORTING
6.1 ACCOUNTING RECORDS. The
Licensee shall maintain at its principal place of
business,
separate accounts and records of transactions arising pursuant
to this
Agreement, such accounts and records to be in sufficient detail
to
enable
proper returns to be made under this Agreement, and the
Licensee
shall
include a similar requirement of its sub-licensees in any
sublicense
agreement.
6.2 REPORTS. The Licensee shall
deliver to the University by no later than
each
Royalty Due Date, together with the royalty payment required, a
report
(the "Accounting") setting out particulars of the sale,
distribution, leasing or sublicensing of the Licensed Products
and/or
Licensed
Processes as shall be requisite for the payment of royalties,
including
the following:
(a)
the number of
Licensed Products sold by Licensee and all
sub-licensees in each country during the applicable royalty
period;
(b)
the gross
revenue for Licensed Products charged by Licensee and all
sub-licensees during the applicable royalty period;
(c)
an accounting
for all Licensed Processes used, sold, leased, or, if
applicable, licensed by the Licensee and all sub-licensees;
(d)
a calculation of Net Revenue in
each country including a listing of
applicable deductions and evidence of the Licensee's payment of
withholding taxes;
(e)
a listing of
additional payments or consideration from sub-licensees
under Section 5.4(b); and
(f)
total royalties
payable on Net Revenue in Canadian dollars, together
with the exchange rates used for any currency conversion in
accordance with Section 5.5.
The
Licensee shall also provide to the University periodic reports at
all
significant stages and milestones in the development, manufacture
and
sale,
distribution,
Page 9 of 27
<PAGE>
leasing or
sublicensing of the Licensed Products and/or Licensed
Processes,
including but not limited to, the milestones described in
Sections
4.1, 4.4 and 5.2, by no later than thirty (30) days following
the
completion
of such stage or milestone; such reports shall be in sufficient
detail to
enable the University to assess the status of all required
regulatory
approvals relating to the Licensed Products, and whether the
Licensee
is meeting its obligations under Sections 4.1, 4.4 and 5.2
during
the term
of this Agreement.
6.3 GENERALLY ACCEPTED
ACCOUNTING PRINCIPLES (GAAP). The calculation of
royalties
shall be made in accordance with generally accepted accounting
principles
from time to time approved by the Federal Bureau of Accounting
Standards
applied on a consistent basis with the Licensee's past
practices.
Licensee certifies that its accounting practices comply with
the
Federal Bureau of Accounting Standards.
6.4 RETENTION OF ACCOUNTS AND
RECORDS. The Licensee shall retain the accounts
and
records referred to in Section 6.1 for at least three (3) years
after
the date
upon which they were made.
6.5 AUDIT RIGHT. During the term
of this Agreement and for one (1) year
thereafter, the University may at its cost and expense audit or
cause to
be
audited, no more than once in any twelve month period, the
applicable
books,
records of other relevant materials of the Licensee referable
hereto, to
verify any report rendered hereunder. The audit must be on
reasonable
advance, written notice, and be conducted during normal
business
hours of the Licensee. The Licensee shall furnish such
reasonable
evidence
as such representative will deem necessary to verify the
Accounting
and may permit such representative to make copies of or
extracts
from such accounts, records and agreements at the University's
expense.
If the audit reveals an underpayment by the Licensee of three
(3)
percent or
more of royalties payable in any fiscal year of the Licensee,
the
Licensee shall pay to the University such deficiency within
fifteen
(15) days
of the determination thereof, together with intere