Exhibit 10.4
EXCLUSIVE LICENSE
AGREEMENT
BETWEEN OHSU AND
D-NOVO THERAPEUTICS,
INC.
This Agreement is made and entered into
between the Oregon Health & Science University
(hereinafter OHSU ) having offices at 3181 S. W. Sam Jackson
Park Road, Portland, Oregon 97201-3098, and D-Novo Therapeutics,
Inc. (hereinafter Licensee ), a California corporation
having offices at 28202 Cabot Road, Suite 200, Laguna Niguel,
California 92677 on this 27th day of June, 2001 (“
Effective Date ”).
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1.01
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In the course
of fundamental research programs at OHSU , inventions were
conceived which relate to Vitamin D and its analogs in oncology and
other disease therapies. The intellectual property rights resulting
from these inventions (and licensed through this Agreement )
are subject to the conditions set forth in 37 CFR Part
401.
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1.02
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By assignment
of the inventions as described in OHSU Disclosure Number
97/413 from the inventors, OHSU is the owner of certain
patent rights and desires to grant licenses under those rights to
Licensee for development of products and processes for
public use and benefit. These patent rights include, but are not
limited to, those rights in PCT Patent Application #WO 99/49870
“Vitamin D and its Analogs in the Treatment of Tumors and
Other Hyperproliferative Disorders” and other patent
applications related to the pulsatile high-dose administration of
Vitamin D and analogs in tumors and other hyperproliferative
disorders.
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1.03
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Licensee desires to develop processes and methods and
marketable products for public use and benefit by using Licensed
Patent Rights .
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2.01
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“
Affiliate ” means any legal entity directly or
indirectly controlling, controlled by or under common control with
Licensee . Any Affiliate or any joint venture or
other entity formed by Licensee that distributes Licensed
Products or Licensed Processes shall execute
(a) this Agreement or (b) a written joinder
agreement in a form satisfactory to OHSU , and will be a
Licensee for the purposes of this Agreement (other
than for the purposes of Section 6.01). Licensee shall
be responsible for such Affiliate ’s or entity’s
performance of its obligations under this Agreement
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2.02
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“
Development Plan ” means a plans) for the development
and/6r marketing of the Licensed Patent Rights that
demonstrates Licensee ’s capability to bring the
Licensed Patent Rights to practical application.
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2.03
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“
First Commercial Sale ” means the initial transfer by
or on behalf of Licensee or its sublicensees of Licensed
Products or the initial practice of a Licensed Process by a on
behalf of Licensee or its sublicensees in exchange for cash
or some equivalent to which value can be assigned for the purpose
of determining Net Sales .
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2.04
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“
Government ” means the government of the United States
of America.
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2.05
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“
Licensed Fields of Use ” means for all uses related to
oncology and other disease therapies.
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2.06
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“
Licensed Patent Rights ” shall mean:
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a)
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U.S. and
foreign patent applications and patents listed in Appendix A or
subsequently added to Appendix A by agreement of the parties, all
divisions and continuations of these applications, all patents
issuing from such applications, divisions, and continuations, and
any reissues, reexaminations, and extensions of all such
patents;
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b)
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and to the
extent that the following contain one or more claims directed to
the invention or inventions claimed in a) above: i)
continuations-in-part of a) above; ii) all divisions and
continuations of these continuations-in-part; iii) all patents
issuing from such continuations-in-part, divisions, and
continuations; and iv) any reissues, reexaminations, and extensions
of all such patents.
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Licensed Patent Rights
shall not include claims in b) above
to the extent that they are directed to new matter which is not the
disclosed in the specifications of a) above.
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2.07
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“
Licensed Product(s) ” means tangible materials which,
in the course of manufacture, use,, or sale would be covered by one
or more claims of the Licensed Patent Rights that have not
been held invalid or unenforceable by an unappealed or unappealable
judgment of a court of competent jurisdiction.
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2.08
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“
Licensed Process(es) ” means processes which, in the
course of being practiced would be covered by one or more claims of
the Licensed Patent Rights that have not been held invalid
or unenforceable by an unappealed or unappealable judgment of a
court of competent jurisdiction.
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2.09
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“
Licensed Territory ” means the world.
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2.10
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“ Net
Sales ” means the total gross receipts for sales of
Licensed Products or practice of Licensed Processes
by or on behalf of Licensee , and from leasing, renting, or
otherwise making Licensed Products or Licensed
Processes available to others without sale or other
dispositions, whether invoiced or not, less returns and allowances
actually granted, packing costs, insurance costs, freight out,
taxes or excise duties imposed on the transaction (if separately
invoiced), and wholesaler and cash discounts in amounts customary
in the trade. No deductions shall be made for commissions paid to
individuals, whether they be with independent sales agencies or
regularly employed by Licensee , or sublicensees, and on its
payroll, or for the cost of collections.
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2.11
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“
Trigger Event ” means any of the following:
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a)
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if Licensee becomes
insolvent, bankrupt or generally fails to pay its debts as such
debts become due; is adjudicated insolvent or bankrupt; admits in
writing its
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inability to pay its debts; or
shall suffer a custodian, receiver or trustee for it or
substantially all of its property to be appointed and, if appointed
without its consent, not be discharged within thirty
(30) days; makes an assignment for the benefit of creditors;
or suffers proceedings under any law related to bankruptcy,
insolvency, liquidation or the reorganization, readjustment or the
release of debtors to be instituted against it and, if contested by
it, not dismissed or stayed within ten (10) days;
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b)
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if proceedings
under any law related to bankruptcy, insolvency, liquidation, or
the reorganization, readjustment or the release of debtors are
instituted or commenced by Licensee ;
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c)
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if any order
for relief is entered relating to any of the proceedings described
in Paragraphs 2.11(a) or (b);
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d)
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if
Licensee shall call a meeting of its creditors with a view
to arranging a composition or adjustment of its debts;
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e)
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if
Licensee shall by any act or failure to act indicate its
consent to, approval of or acquiescence in any of the proceedings
described in Paragraphs 2.11 (a), (b), (c) or (d);
or
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f)
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if
Licensee fails to make commercially reasonable efforts to
cure any breach by a sublicensee of its agreement with
Licensee related to the Licensed Patent Rights , or
if after Licensee makes such commercially reasonable efforts
and sublicensee is still in breach, Licensee fails to
terminate such sublicensee agreement within a reasonable period of
time, but in no event longer than one hundred and twenty
(120) days.
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3.01
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OHSU hereby grants and Licensee accepts,
subject to the terms and conditions of this Agreement , an
exclusive license to Licensee under the Licensed Patent
Rights in the Licensed Territory to make, have made,
use, offer for sale, sell and import any Licensed Products
in the Licensed Fields of Use and to practice and have
practiced any Licensed Processes in the Licensed Fields
of Use .
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3.02
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At no cost to Licensee ,
for two (2) years from the Effective Date: 1) for all
inventions conceived within that two (2) years that are
improvements to the patents and patent applications listed in
Appendix A, Licensee shall have the right to add said
patents and patent applications to Appendix A; and, 2)
Licensee shall have the right to add patents and patent
applications acquired or licensed by or to OHSU that relate
to the pulsatile high-dose administration of Vitamin D and analogs
in tumors and other hyperproliferative disorders. In that event,
the terms and conditions governing said additional patent
applications and patents added to Appendix A shall be the terms and
conditions provided for herein, as modified by any further written
agreement of the parties. After two (2) years from the
Effective Date, the parties agree that Licensee will have
the first right to negotiate in good faith regarding any additional
patent rights that
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relate to pulsatile high-dose
administration of Vitamin D and analogs in tumors and other
hyperproliferative disorders that Licensee desires to
acquire from OHSU .
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3.03
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This
Agreement confers no license or rights by implication,
estoppel, or otherwise under any patent applications or patents of
OHSU other than Licensed Patent Rights regardless of
whether such patents are dominant or subordinate to Licensed
Patent Rights .
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3.04
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The license of
Paragraph 3.01 above is exclusive, except that OHSU may use,
and permit other academic and nonprofit organizations to use, the
Licensed Patent Rights for educational and research
purposes, and further, the U.S. government may use the Licensed
Patent Rights as provided for in Paragraph 5.01.
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3.05
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Licensee hereby agrees that it shall not manufacture,
distribute; market or sell products that directly compete with
Licensed Products or practice processes that directly
compete with Licensed Processes .
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4.01
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Upon written
approval by OHSU , which approval will not be unreasonably
withheld, Licensee may enter into sublicensing agreements
under the Licensed Patent Rights .
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4.02
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Licensee agrees that any sublicenses granted by it shall
provide that the obligations to OHSU of Paragraphs 5.01,
5.02, 8.01, 10.01, 10.02, 12.01-12.05, and 13.01-13.10 of this
Agreement shall be binding upon any sublicensee as if it
were a party to this Agreement . Licensee further
agrees to attach copies of these Paragraphs to all sublicense
agreements.
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4.03
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Licensee agrees to prohibit any sublicensee from further
sublicensing.
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4.04
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Any sublicenses
granted by Licensee shall provide for the termination of the
sublicense, or the conversion to a license directly between such
sublicensees and OHSU , at the option of the sublicensee,
upon termination of this Agreement under Article 13. Such
conversion is subject to OHSU approval and contingent upon
acceptance by the sublicensee of any remaining provisions of this
Agreement required by OHSU .
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4.05
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Licensee agrees to forward to OHSU a copy of each
fully executed sublicense agreement postmarked within thirty
(30) days of the execution of such agreement.
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4.06
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In the event of
a default under Article 13 hereunder, all payments then or
thereafter due to Licensee from each of its sublicensees
shall, upon notice from OHSU to any such sublicensee, become
owed directly to OHSU for the account of Licensee ;
provided that OHSU shall remit to Licensee the amount
by which such payments in the aggregate exceed the total amount
owed by Licensee to OHSU .
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4.07
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Even if
Licensee enters into sublicenses, Licensee remains
primarily liable to OHSU for all of Licensee ’s
duties and obligations contained in this Agreement
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5.
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STATUTORY
AND OHSU REQUIREMENTS AND RESERVED GOVERNMENT
RIGHTS
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5.01
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OHSU reserves on behalf of the Government an
irrevocable, nonexclusive, nontransferable, royalty-free license
for the practice of all inventions licensed under the Licensed
Patent Rights throughout the world by or on behalf of the
Government and on behalf of any foreign government or
international organization pursuant to any existing or future
treaty or agreement to which the Government is a
signatory.
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5.02
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Licensee agrees that products used or sold in the United
States embodying Licensed Patent Rights shall be
manufactured substantially in the United States, unless a written
waiver is obtained in advance from the Government
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6.
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ROYALTIES
AND REIMBURSEMENT
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a)
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Promptly
following the execution of this Agreement , Licensee
shall issue to OHSU as a license issuance royalty [*] shares
of the Common Stock of Licensee , which shares will
represent approximately [*]% of the shares of the Common Stock of
Licensee deemed to be outstanding on a fully-diluted basis
after giving effect to such issuance. A copy of a Term Sheet
relating to Licensee ’s proposed Series A-1 Preferred
Stock and Series A-2 Preferred Stock financing transactions wherein
Licensee will raise an aggregate of $[*] is attached hereto
as Appendix B. It is anticipated that after the closing of the
Series A-1 Preferred Stock financing, wherein it is anticipated
that Licensee will raise $[*], the shares issued to
OHSU will represent approximately [*]% of the Common Stock
of Licensee deemed to be outstanding on a fully diluted
basis and after the closing of the Series A-2 Preferred Stock
financing transaction, wherein it is anticipated that
Licensee will raise an aggregate of $[*], the shares issued
to OHSU will represent approximately [*]% of the Common
Stock of Licensee deemed to be outstanding on a
fully-diluted basis The shares of Common Stock to be issued to
Licensee shall not be subject to forfeiture and shall not be
used as an offset or credit against future royalties. This
Agreement is conditioned upon Licensee raising cash
equity on substantially the terms described in the Series
A-1/Series A-2 Term Sheet attached as Appendix B.
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b)
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Concurrently with the issuance of
the shares of Common Stock to OHSU , OHSU shall
execute an investment representation letter substantially in the
form attached hereto as Appendix C, and OHSU and
Licensee shall execute a Stock Restriction Agreement
substantially in the form attached hereto as Appendix D (the
“Stock Restriction Agreement ”). Licensee
warrants and represents that (i) the Stock Restriction
Agreement is no more restrictive to the stockholder than any
other
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[*] Certain information on this page has been
omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect
to the omitted portions.
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restriction agreement now in use
or contemplated to be entered into between Licensee and
holders of its Common Stock and (ii) all holders of Common
Stock of Licensee who are employees and/or officers of
Licensee have entered into or will enter into a restriction
agreement which includes restrictions substantially the same as
those set forth in the Stock Restriction Agreement
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c)
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Licensee shall grant to OHSU the same
“piggyback” registration rights as are granted to
investors (the “Investors”) participating in
Licensee ’s Series A-1 Preferred Stock and Series A-2
Preferred Stock financing transactions. Licensee will
furnish to OHSU quarterly and annual financial statements
and such other financial information and reports as are furnished
to the Investors, with such statements, information and reports
being furnished to OHSU at the same time they are furnished
to the Investors.
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6.02
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Licensee agrees to pay OHSU earned royalties as
follows:
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a)
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[*] percent
([*]%) royalty on Net Sales by Licensee .
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b)
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In the event
that any Licensed Product or practice of Licensed Process
incorporates other patent rights or rights in other intellectual
property for which royalties are due by Licensee , then
Licensee shall not be required to stack its royalty
payments, and the parties shall negotiate in goad faith among
Licensee , OHSU and the other holders of the
intellectual property rights to determine the division of the
royalties so that Licensee shall not be required to pay an
aggregate royalty of more than [*] percent ([*]%) of Net
Sales . However, in no event shall the share of OHSU
’s royalty be less than [*] percent ([*]%) of Net
Sales of the Licensed Products or Licensed
Processes .
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6.03
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Licensee agrees to pay OHSU milestone royalties
and market launch royalties as follows:
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a)
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$[*] upon
successful completion of [*] for any product covered by Licensed
Patent Rights .
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b)
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$[*] upon
successful completion of [*] for any product, covered by
Licensed Patent Rights .
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c)
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$[*] upon
successful completion of [*] for any product covered by Licensed
Patent Rights .
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[*] Certain information on this page has been
omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect
to the omitted portions.
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d)
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In the event
that any product covered by Licensed Patent Rights fails
after completion of Phase III clinical trials, and a substitute
product (backup compound) covered by the Licensed Patent
Rights must be substituted for the same indication, no
additional Phase I or II milestone royalties shall be due for any
backup compound(s).
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e)
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$[*] upon [*]
for any product covered by Licensed Patent Rights
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f)
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Milestone
royalties set forth in Paragraphs 6.03(a)-(c) are
nonrefundable, and shall have no credit or offset against future
royalties. Market launch royalties set forth in Paragraph 6.03(e)
are refundable and are to be fully credited against future
royalties due.
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6.04
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Licensee shall pay to OHSU a sublicensing royalty
of [*] percent ([*]%) of any monies or other consideration received
by Licensee from any sublicensing of the Licensed Patent
Rights , including without limitation any sublicense initiation
fees, milestone payments, royalties on sales, and any premium on
any equity investment by sublicensees. Any non-cash consideration
received by the Licensee from such sublicensees shall be
valued at its fair market value as of the date of receipt. However,
said payments from any sublicensee shall not include consideration
received for cost reimbursement of R&D services, and no amount
shall be due to OHSU from Licensee for consideration
received as reimbursement for such R&D services.
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6.05
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A claim of a
patent or patent application licensed under this Agreement
shall cease to fall within the Licensed Patent Rights for
the purpose of computing the earned royalty payments in any given
country on the earliest of the dates that a) the claim has been
abandoned but not continued, b) the patent expires, c) the patent
is no longer maintained by OHSU , or d) all claims of the
Licensed Patent Rights have been held to be invalid or
unenforceable by an unappealed or unappealable decision of a court
of competent jurisdiction or administrative agency.
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6.06
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No multiple
royalties shall be payable to OHSU because any Licensed
Products or Licensed Processes are covered by more than
one of the Licensed Patent Rights .
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6.07
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On sales of
Licensed Products and Licensed Processes by
Licensee made in other than an arm’s-length
transaction. The value of the Net
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