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Exhibit
10.3
AMENDED AND RESTATED
LICENSE AGREEMENT
This Amended and Restated
License Agreement (the “Agreement”) is made and entered
into as of the 24 th day
of May, 2007 (the “Effective Date”), by and between the
UNIVERSITY OF PITTSBURGH OF THE COMMONWEALTH SYSTEM OF HIGHER
EDUCATION, a non-profit corporation, organized and existing under
the laws of the Commonwealth of Pennsylvania, having its principal
office at 4200 Fifth Avenue, Pittsburgh, Pennsylvania 15260
(“UNIVERSITY”) and NOVACEA, INC., a Delaware
corporation having its primary place of business at 601 Gateway
Boulevard, Suite 800, South San Francisco, California 94080
(“LICENSEE”).
WHEREAS, UNIVERSITY and
LICENSEE entered into a License Agreement with an effective date of
July 1, 2002, (the “Original License
Agreement”),
WHEREAS, UNIVERSITY and
LICENSEE now wish to amend and restate the Original License
Agreement herein,
WHEREAS, UNIVERSITY is the
owner of certain PATENT RIGHTS and KNOW-HOW (as hereinafter
defined) and has the right to grant licenses under such PATENT
RIGHTS and KNOW-HOW,
WHEREAS, UNIVERSITY desires
to have the PATENT RIGHTS and KNOW-HOW utilized in the public
interest;
WHEREAS, LICENSEE has
represented to UNIVERSITY, to induce UNIVERSITY to enter into this
Agreement, that LICENSEE, shall commit itself to a thorough,
vigorous and diligent program of exploiting the PATENT RIGHTS and
KNOW-HOW so that public utilization results therefrom;
and
WHEREAS, LICENSEE desires to
obtain a license under the PATENT RIGHTS and KNOW-HOW upon the
terms and conditions hereinafter set forth.
NOW, THEREFORE, in
consideration of the premises and the mutual covenants contained
herein, the parties hereto, intending to be legally bound, agree as
follows:
ARTICLE 1 -
DEFINITIONS
For purposes of this
Agreement, the following words and phrases shall have the following
meanings:
1.1 “ AFFILIATE
” shall mean, with respect to UNIVERSITY, any clinical or
research entity that is operated or managed as a facility under the
UPMC Health System, whether or not owned by UNIVERSITY.
1.2 “ KNOW-HOW
” shall mean any and all non-patented, proprietary technology
and information (including, without limitation, research data,
designs, formulas, process information, clinical data, and other
information pertaining or relating to any technology or invention
claimed in the Patent Rights) existing as of the effective date of
the Original License
Agreement as a result of activities
conducted in the laboratories of Drs. Donald Trump and/or Candace
Johnson, which is necessary or useful for the practice of the
Patent Rights, or for the manufacture, use, offer for sale or sale
of a Licensed Product.
1.3 “ LICENSED
PRODUCT ” shall mean VITAMIN D and one or more cytotoxic
agents administered or otherwise used or offered for use in a
manner which would, but for the license granted herein, infringe
one or more of the PATENT RIGHTS.
1.4 “ LICENSEE
” shall mean NOVACEA, INC. and all entities directly or
indirectly controlling, controlled by or under common control with
NOVACEA, INC.
1.5 “ NET SALES
” shall mean LICENSEE’s and any sublicensee’s
invoiced price for LICENSED PRODUCTS, less the sum of the
following:
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(a) |
actual cost of freight charges or freight absorption and
insurance, separately stated in such invoice; |
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(b) |
actual trade, quantity or cash discounts allowed, if
any; |
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(c) |
taxes such as sales taxes, tariff duties and/or use taxes
separately stated on each invoice and borne by the seller;
and |
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(d) |
credit allowances given or made for rejection or return of
previously sold goods. |
1.6 “ PATENT
RIGHTS ” shall mean the interest of UNIVERSITY
in:
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(a) |
the United States and foreign patents and/or patent
applications listed in Exhibit “A” attached
hereto; |
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(b) |
United States and foreign patents issued from the applications
listed in Exhibit “A” and from divisionals,
continuations and continuations-in-part of these
applications; |
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(c) |
claims of U.S. and foreign continuation-in-part applications,
and of the resulting patents, which are directed to subject matter
specifically described in the U.S. and foreign applications listed
in Exhibit “A”; and |
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(d) |
claims of all foreign patent applications, and of the resulting
patents, which are directed to subject matter specifically
described in the United States patents and/or patent applications
described in (a), (b) or (c) above. |
1.7 “REASONABLE
COMMERCIAL EFFORTS” shall mean 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.
1.8 “ SUB-LICENSE
REVENUES ” shall mean all consideration paid to LICENSEE
in return for the grant of a sub-license under the PATENT RIGHTS,
including license fees and
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milestone payments but excluding:
(i) the purchase of equity in LICENSEE, (ii) payments or
reimbursement for consulting, research, development, or other
services. (iii) reimbursement for patent expenses or other
actual disbursements of LICENSEE, and (iv) running royalties
payable as a function of the manufacture, sale or use of a LICENSED
PRODUCT.
1.9 “ VITAMIN D
” shall mean cholecalciferol, as well as all derivatives and
analogs thereof or thereto.
ARTICLE 2 -
GRANT
2.1 To the extent it may
lawfully do so, UNIVERSITY hereby grants to LICENSEE a worldwide
sole and exclusive license under the PATENT RIGHTS and KNOW-HOW to
make, have made, use, import, export, offer for sale and sell the
LICENSED PRODUCTS. The license granted hereby is subject to the
rights of the United States government, if any, as set forth in 35
U.S.C. Section 200, et seq .
2.2 UNIVERSITY reserves a
royalty-free, non-exclusive right to practice under the PATENT
RIGHTS for its own noncommercial research and educational
purposes.
2.3 LICENSEE shall have the
right to enter into sub-licensing arrangements for the rights,
privileges and licenses granted hereunder upon notice to and prior
written approval of UNIVERSITY, which approval shall not be
unreasonably withheld or delayed. Any sublicensee shall have the
right to grant further sublicenses as necessary to meet its
obligations under any sublicense agreement with LICENSEE. Any
further sublicensee will have no right to grant further
sublicenses. Upon termination of this Agreement, any exclusive
first level sublicensee shall have the right, but not the
obligation, to replace LICENSEE and become a direct licensee with
UNIVERSITY to the extent of such exclusivity under the same terms
and conditions as this Agreement, provided that (i) such
exclusive first level sublicensee provides written notice to
University of its election to become a direct licensee within
thirty (30) days of receipt of notice of termination of this
Agreement, and (ii) to the extent LICENSEE has breached this
Agreement due to a failure to make any payment when due after any
cure period, such first level exclusive sublicensee first cures
such breach.
2.4 Any sub-license granted
by LICENSEE hereunder shall provide that the obligations to
UNIVERSITY of Sections 2, 7, 8, 9, 10 and 13 of this Agreement
shall be binding upon the sub-licensee as if it were party to this
Agreement.
2.5 LICENSEE shall forward to
UNIVERSITY a copy of any and all sub-license agreements promptly
upon execution thereof, provided that LICENSEE may redact from such
copies technical information that does not relate to consideration
paid for, or other financial obligations relating to, the grant of
the sublicense under the PATENT RIGHTS. LICENSEE shall not redact
any information from such sublicense agreements material to
determination of royalties under this Agreement or verification of
sublicensee’s obligations to UNIVERSITY. Such copies and the
non-public information reflected therein shall be kept confidential
by UNIVERSITY.
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2.6 The license granted
hereunder shall not be construed to confer any rights upon LICENSEE
by implication, estoppel or otherwise as to any intellectual
property other than PATENT RIGHTS and KNOW-HOW.
ARTICLE 3 - DUE
DILIGENCE
3.1 LICENSEE shall use
REASONABLE COMMERCIAL EFFORTS to bring one or more LICENSED
PRODUCTS to market and to continue active marketing efforts for
such LICENSED PRODUCTS throughout the term of this
Agreement.
3.2 Without limiting
Section 3.1, above, LICENSEE shall adhere to each of the
following milestones:
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(a) |
begin a Phase II trial of a LICENSED PRODUCT by January 1,
2004; |
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(b) |
begin a Phase II trial of a LICENSED PRODUCT for a second
clinical indication by July 1, 2004; and |
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(c) |
begin a pivotal Phase III trial of a LICENSED PRODUCT by
July 1, 2006. |
3.3 LICENSEE’s failure
to perform in accordance with Section 3.1 or Section 3.2
shall constitute a material breach of this Agreement. Such breach
shall entitle UNIVERSITY to terminate as provided in
Section 10.1(a), below.
ARTICLE 4 - ROYALTIES AND
OTHER CONSIDERATION
4.1 In consideration of the
rights, privileges and license granted by UNIVERSITY hereunder,
LICENSEE shall pay royalties and other consideration as
follows:
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(a) |
as an initial license fee, within ten (10) days execution
of the Original License Agreement, One Hundred Thousand Dollars
($100,000) and Fifty Thousand (50,000) fully-paid shares of
Common Stock of LICENSEE, upon the terms set forth in the Stock
Issuance Agreement attached hereto as Exhibit “B”,
(plus the reimbursement of reasonable patent expenses incurred as
of the effective date of the Original License
Agreement); |
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(b) |
within ten (10) days following the issuance of a United
States patent [*] and which includes, inter alia, claims
substantially identical to those identified as pending claims [*]
in UNIVERSITY’s “Response to Office Action” dated
October 3, 2001, a milestone payment of Fifty Thousand
(50,000) Shares of fully-paid Common Stock of LICENSEE upon
the terms set forth in Exhibit “B”; and |
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(c) |
royalties in an amount equal to [*] percent ([*]%) of NET SALES
determined in a manner consistent with Section 4.7,
below. |
| [*] |
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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4.2 Royalty payments pursuant
to Section 4.1(c), above, shall be paid to UNIVERSITY in
United States dollars and directed to the address set forth in
Section 12 hereof within sixty (60) days after
March 31, June 30, September 30 and
December 31 of each calendar year during the term of this
Agreement. LICENSEE shall have the right to reduce the royalty rate
payable under Section 4.1(c) in any calendar quarter by [*]
([*]) of the royalty rate paid to any third party, by judgment,
contract or otherwise, for the right to manufacture, use or sell
any LICENSED PRODUCT in such calendar quarter; provided, however,
that the royalty rate due UNIVERSITY hereunder shall in no event be
reduced to less than [*] percent ([*]%) of NET SALES.
4.3 Commencing on the first
anniversary of the effective date of the Original License
Agreement, LICENSEE shall pay to UNIVERSITY a minimum annual
royalty, which amount shall be creditable against royalties
actually due to the UNIVERSITY with respect to NET SALES in such
calendar year. The first such payment shall be One Hundred Thousand
Dollars ($100,000). The amount of such annual payment shall
increase each year by Twenty-Five Thousand Dollars ($25,000), up to
a maximum of Two Hundred Fifty Thousand Dollars ($250,000) per
year.
4.4 UNIVERSITY shall also
receive: (i) [*] percent ([*]%) of all SUB-LICENSE REVENUES
received by LICENSEE within the first twelve (12) months after
the effective date of the Original License Agreement; (ii) [*]
percent ([*]%) of all SUB-LICENSE REVENUES received more than
twelve (12) months but fewer than twenty-four (24) months
after the EFFECTIVE DATE OF THE Original License Agreement, and of
such payments; and (iii) five percent (5%) of all
SUB-LICENSE REVENUES received more than twenty-four
(24) months after the Effective date of the Original License
Agreement.
4.5 Payments pursuant to this
Agreement which are overdue shall bear interest calculated from the
due date until payment is received at the rate of eight percent
(8%) per annum.
4.6 LICENSEE shall sell
LICENSED PRODUCTS in the ordinary course to the UPMC Health System
upon request solely for patient use and not for resale, at such
price(s) and on such terms and conditions as such products of
similar quantities are made available to similar health systems.
For purposes of clarity , section 2.2 does not impose a restriction
on University’s right to use the LICENSED PRODUCTS purchased
from LICENSE
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