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Exhibit
10.2
AMENDED AND RESTATED
EXCLUSIVE LICENSE AGREEMENT
BETWEEN OHSU
AND
NOVACEA,
INC.
This Amended and Restated
Agreement (hereinafter this “ Agreement ”)
is made and entered into as of May 25, 2007 (“
Effective Date ”) between the Oregon Health &
Science University (hereinafter OHSU ) having offices at
2525 S.W. First Avenue, Suite 120, Portland, Oregon 97201, and
Novacea, Inc. (formerly known as D-Novo Therapeutics, Inc.)
(hereinafter Licensee ), a Delaware corporation having
offices at 601 Gateway Blvd., Suite 800, South San Francisco,
California 94080; and hereby amends and restates the Exclusive
License Agreement between OHSU and Licensee effective June 27,
2001 (the “ Original License Agreement
”).
| 1.01 |
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. |
| 1.02 |
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, including, but not limited to those
listed in Appendix A to this Agreement . |
| 1.03 |
Licensee desires to develop processes and methods and
marketable products for public use and benefit by using Licensed
Patent Rights. |
| 1.04 |
OHSU and Licensee entered into an agreement dated
June 27th, 2001, the Original License Agreement, which was
subsequently amended on November 21, 2005. |
| 1.05 |
OHSU and Licensee hereby seek to further amend and restate the
Original License Agreement as indicated herein. |
| 2.01 |
“ 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
. |
| 2.02 |
“ Development Plan ” means a plan(s) for the
development and/or marketing of the Licensed Patent Rights
that demonstrates Licensee ’s capability to bring the
Licensed Patent Rights to practical application as such term
is defined in 35 U.S.C. §201(f). |
| 2.03 |
“ 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 or 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 . For the
avoidance of doubt, (1) sales for test marketing, sampling and
promotional uses, clinical trial purposes or compassionate or
similar use and (2) transfers of Licensed Products ,
whether by sale or otherwise, or practice of the Licensed
Process , as between Affiliates of Licensee , or
Affiliates of its sublicensees, will not constitute a
First Commercial Sale or a sale for the purpose of
determining Net Sales , provided that (i) the
Affiliate to whom the transfer is made is not an end-user
for the purpose of patient administration, and (ii) if
Licensee , or a sublicense, sells a Licensed Product
or Licensed Process to an Affiliate for resale,
Net Sales will include any amounts received by such
Affiliate from third parties on the resale of such
Licensed Product or Licensed Process . |
| 2.04 |
“ Government ” means the government of the
United States of America. |
| 2.05 |
“ Licensed Fields of Use ” means all
prophylactic, therapeutic, and diagnostic uses in humans and/or
animals. |
| 2.06 |
“Licensed Know-How” means all proprietary
information, methods, processes, techniques, data and biologic
materials (including, without limitation, pre-clinical and clinical
data) which are in the possession of or controlled by OHSU
during the term of this Agreement , which OHSU is
free to license or sublicense, and which is necessary or useful for
the manufacture, use or sale of a Licensed Product in the
Licensed Fields of Use or to practice any Licensed
Process in the Licensed Fields of Use in the Licensed
Territory . Except as otherwise expressly agreed by the
parties, the license to Licensee of Licensed Know-How
set forth above shall not obligate OHSU to conduct
additional research or otherwise initiate any action with respect
to creation of new Licensed Know-How . |
| 2.07 |
“ Licensed Patent Rights ” shall
mean: |
| |
a) |
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) |
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.
| 2.08 |
“ 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. |
| 2.09 |
“ 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. |
| 2.10 |
“ Licensed Territory ” means the
world. |
| 2.11 |
“ Net Sales ” means the aggregate gross
amount invoiced by Licensee or its Affiliates on all
sales or transfers for consideration of Licensed
Product or Licensed Process in the Licensed
Territory to a third party, less the following deductions to
the extent such deductions are documented and (i) listed in
the invoice as a credit or charge added to the unit price of a
Licensed Product or Licensed Process or
(ii) directly paid or actually incurred and not reimbursed to
or recovered by Licensee or its Affiliates with
respect to the sale of such Licensed Product or Licensed
Process : |
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a) |
bad debts actually written off which are attributable to sales
of Licensed Product or Licensed Process ; |
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b) |
trade, quantity and cash discounts and any other adjustments,
including, without limitation, those granted on account of price
adjustments, billing errors, rejected goods, damaged goods,
returns, recalls, rebates, chargeback rebates, fees, reimbursements
or similar payments granted or given to wholesalers or other
distributors, buying groups, health care insurance carriers or
other institutions: |
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c) |
freight, packing, handling, shipping, postage and insurance
charges to the extent that they are included in the price or
otherwise paid by the purchaser; |
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d) |
customs or excise taxes, including, without limitation, import
duties, sales tax and other taxes (except income taxes) or duties
relating to sales, |
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e) |
distribution, packing, handling and transportation charges for
Licensed Product to the extent that they are included in the
price or otherwise paid by the customer; |
The foregoing adjustments
shall be consistent with customary accounting practices within the
selling party and its Affiliates (or their respective
sublicensees) and in accordance with United States Generally
Accepted Accounting Principles (“ GAAP ”),
consistently applied.
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It is understood, however,
that in certain countries, Licensee or its Affiliates
may commercialize Licensed Products through a third party
distributor or agent under an arrangement in which Licensee
or its Affiliates , (x) transfer the Licensed
Product to such distributor or agent at a fixed price that is
not necessarily related to the final selling price of the
distributor or agent, and (y) are not responsible for
marketing and promoting such Licensed Product in such
countries and receive no compensation from the sale of such
Licensed Products by the distributor or agent. To the extent
that such third party distributors or agents would be considered
“sublicensees”, the OHSU and Licensee
agree that the gross invoiced sales prices for the sale of the
Licensed Product by Licensee or its Affiliates
to such third parties shall be the price to be used for purposes of
computing Net Sales in such countries provided, however,
that (i) such gross invoiced sales prices are determined prior
to any deductions by the selling party, (ii) the selling party
receives no form of consideration other than such gross invoiced
sales prices from such third party distributors or
agents.
| 2.12 |
“Reasonable Commercial Efforts” means
efforts and resources commonly used in the pharmaceutical industry
for a drug of similar commercial potential at a similar stage in
its lifecycle, taking into consideration its safety and efficacy,
the cost to develop and commercialize the product, its
competitiveness compared to alternative products, the proprietary
position of the product, the scope, timing and likelihood of
regulatory approvals, the profitability of the product and other
relevant factors. |
| 2.13 |
“ Trigger Event ” means any of the
following: |
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a) |
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 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) |
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) |
if any order for relief is entered relating to any of the
proceedings described in Paragraphs 2.13(a) or (b); |
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d) |
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) |
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 2.13 (a), (b), (c) or (d);
or |
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f) |
if Licensee fails to make commercially reasonable
efforts to cure any material breach by a sublicensee of any
provision of its agreement with Licensee that is directly related
to the Licensed Patent Rights and would have a material
adverse impact on OHSU ’s rights under this
Agreement , or if after Licensee makes such
commercially reasonable efforts and sublicensee is still in
material breach for which there is no other adequate remedy other
than termination, Licensee fails to terminate such
sublicense agreement within a reasonable period of time, but in no
event longer than one hundred eighty (180) days. |
| 3.01 |
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
and Licensed Know-How in the Licensed Territory to
make, have made, use, offer for sale, sell, export, 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 . |
| 3.02 |
At no cost to Licensee , for two (2) years from the
effective date of the Original License Agreement : 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 of the Original License Agreement , the
parties agree that Licensee will have the first right to
negotiate in good faith regarding any additional patent rights that
relate to pulsatile high-dose administration of Vitamin D and
analogs in tumors and other hyperproliferative disorders that
Licensee desires to acquire from OHSU . |
| 3.03 |
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 . |
| 3.04 |
The license of Paragraph 3.01 above is exclusive, except that
(i) OHSU may practice and use the Licensed Patent
Rights and Licensed Know-How for educational and
non-commercial research purposes, (ii) OHSU may grant
non-exclusive licenses to other universities, academic
institutions, and nonprofit research organizations, with whom it
has a contractual non-commercial research collaboration, to
practice the Licensed Patent Rights and Licensed
Know-How for educational and non-commercial research purposes,
and (iii) the U.S. government may use the Licensed Patent
Rights as provided for in Paragraph 5.01. |
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| 4.01 |
Upon written approval by OHSU , which approval will not
be unreasonably withheld, Licensee may enter into
sublicensing agreements under the Licensed Patent Rights
. |
| 4.02 |
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. |
| 4.03 |
Licensee shall have the right to enter into
sub-licensing arrangements for the rights, privileges and licenses
granted hereunder. Any sublicensee shall have the right to grant
further sublicenses as necessary to meet its obligations under any
sublicense agreement with Licensee , provided that there be
no dilution of the royalties due to OHSU under Paragraph
6.02, 6.03, and 6.04. Any further sublicensee will have no right to
grant further sublicenses. |
| 4.04 |
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, provided that, at the time of the election of such
conversion, such sublicensee is not in material breach of its
sublicense agreement with License e. Such conversion is
contingent upon acceptance by the sublicensee of the provisions of
this Agreement . |
| 4.05 |
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, provided that
Licensee may, in its sole discretion, redact from such copy
technical information that does not relate to Licensed Patent
Rights , and economic or competitive terms that do not relate
to consideration paid for, or other financial obligations relating
to, the grant of the sublicense under the Licensed Patent
Rights . |
| 4.06 |
In the event of a default under Article 13 hereunder, all
portions relating to this Agreement of any payments then or
thereafter due to Licensee from each of its sublicensees
shall, to the extent not yet paid to Licensee as of the
effective date of any termination by OHSU due to such
uncured default, 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 owed by Licensee to OHSU . |
| 4.07 |
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. |
STATUTORY AND OHSU REQUIREMENTS AND RESERVED GOVERNMENT
RIGHTS |
| 5.01 |
If and only to the extent required and applicable under 35.
U.S.C. §202(c)(4), OHSU reserves on behalf of the
Government an irrevocable, nonexclusive, nontransferable,
royalty-free license for the practice of all subject inventions, as
such term is defined in 35 U.S.C §201(e), licensed under the
Licensed Patent Rights . |
| 5.02 |
If and only to the extent required and applicable under 35
U.S.C §204, Licensee agrees that products used or sold
in the United States embodying Licensed Patent Rights that
are subject inventions as defined in 35 U.S.C. §201(e) shall
be manufactured substantially in the United States, unless a
written waiver is obtained in advance from the Government
. |
| 6. |
ROYALTIES AND REIMBURSEMENT |
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a) |
Promptly following the execution of the Original License
Agreement , Licensee shall issue to OHSU as a
license issuance royalty 800,000 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) |
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 restriction agreement
now in use or contemplated to be entered into between |
| [*] |
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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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) |
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. |
| 6.02 |
Licensee agrees to pay OHSU earned royalties as
follows: |
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a) |
[*] percent ([*]%) royalty on Net Sales by
Licensee . |
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b) |
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 good
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 . |
| 6.03 |
Licensee agrees to pay OHSU milestone royalties
and market launch royalties as follows: |
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a) |
$[*] upon successful completion of [*] for any product covered
by Licensed Patent Rights . |
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b) |
$[*] upon successful completion of [*] for any product, covered
by Licensed Patent Rights . |
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