Exhibit No. 10.27
Confidential Materials omitted
and filed separately with the
Securities and Exchange
Commission. Asterisks denote omissions.
AGREEMENT
This License Agreement (this
“Agreement”), effective as of December 4, 2002
(“Effective Date”), is made by and between Curis Inc.,
a Delaware corporation (“Curis”), having a place of
business at 601 Moulton Street, Cambridge, Massachusetts
02138-1118, and Amylin Pharmaceuticals, Inc., a Delaware
corporation (“Amylin”), having a place of business at
9373 Towne Centre Drive, Suite 250, San Diego, California
92121.
R E C I T A L S
Whereas, Curis owns certain
intellectual property relating to peptide YY
(“PYY”);
Whereas, Amylin desires to secure
the exclusive right and license to use, develop, manufacture,
market and exploit such intellectual property;
Whereas, Curis has determined that
the exploitation of such intellectual property by Amylin is in the
best interest of Curis; and
Now, Therefore, in consideration of
the premises and of the promises and covenants contained herein and
intending to be legally bound hereby, the parties agree as
follows:
A. “Amylin” shall mean
Amylin Pharmaceuticals, Inc. and its Affiliates.
B. “Affiliate” means,
when used with reference to a party, any Entity directly or
indirectly controlling, controlled by or under common control with
such party. For purposes of this Agreement, “control”
means the direct or indirect ownership of over fifty percent (50%)
of the outstanding voting securities of an Entity, or the right to
receive over fifty percent (50%) of the profits or earnings of an
Entity, or the right to control the policy decisions of an
Entity.
C. “Bankruptcy Event”
means voluntary or involuntary proceedings by or against an Entity
are instituted in bankruptcy or under any insolvency law, or a
receiver or custodian is appointed for such Entity, or proceedings
are instituted by or against such Entity for corporate
reorganization or the dissolution of such Entity, which
proceedings, if involuntary, shall not have been dismissed within
60 days after the date of filing, or such Entity makes an
assignment for the benefit or creditors, or substantially all of
the assets of such Entity are seized or attached and not released
within 60 days thereafter.
D. “Confidential
Information” means and includes all technical information,
inventions, trade secrets, developments, discoveries, software,
know-how, methods, techniques, formulae, data, processes and other
proprietary ideas, whether or not patentable or copyrightable, that
the disclosing party identifies as confidential or proprietary at
the time it is delivered or communicated to the receiving
party.
E. “Curis” means Curis,
Inc.
F. “Curis Patents” means
those (i) patents and patent applications (including provisional
applications and applications for certificates of invention) listed
in Exhibit A attached hereto and made a part hereof; (ii) any
patents issuing from such patent applications (including
certificates of invention); (iii) all patents and patent
applications based on, corresponding to, or claiming the priority
date(s) of any of the foregoing; (iv) any reissues, substitutions,
confirmations, registrations, validations, re-examinations,
additions, continuations, continued prosecution applications,
continuations-in-part, or divisions of or to any of the foregoing;
and (v) term extensions, supplementary protection certificates and
other governmental action which provide exclusive rights beyond the
original patent expiration date, which are owned or controlled by
Curis as of the Effective Date or during the Term.
G. “Entity” means a
corporation, an association, a joint venture, a partnership, a
trust, a business, an individual, a government or political
subdivision thereof, including an agency, or any other organization
which can exercise independent legal standing.
H. “FDA” means the Food
and Drug Administration of the United States.
I. “Field” means in
vivo use of Products for treating metabolic disorders in humans
and conducting research in humans and animals.
J. “IND” means an
Investigational New Drug Application (together with all additions,
deletions, and supplements thereto) filed with the FDA, or its
foreign equivalent.
K. “License” means the
license or licenses granted pursuant to Section 2(A).
L. “Marketing Approval”
means the act of a Regulatory Authority necessary for the
manufacture, marketing and sale of Products in a country or
regulatory jurisdiction, including, without limitation, the
approval of the new drug application by the FDA, and approval of
Products for marketing in the European Union by the European
Commission, and satisfaction of all applicable regulatory and
notification requirements.
M. “Net Sales” means,
with respect to a Product:
The gross amount invoiced for sales
of Products by Amylin or its sublicensees to third persons
(excluding Amylin’s sublicensees), less:
(i) trade, quantity and cash
discounts and rebates and retroactive price reductions or
allowances actually granted from the billed amount;
(ii) credits or allowances actually
granted upon claims, rejections or returns of such sales of
Products, including recalls;
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(iii) prepaid transportation
insurance premiums and prepaid outbound transportation
expenses;
(iv) taxes imposed on the
production, sale, delivery or use of Products (including, without
limitation, sales, use, excise or value added taxes but excluding
income taxes), duties or other governmental charges levied on or
measured by the billing amount when included in billing, as
adjusted for rebates and refunds; and
(v) a provision for uncollectible
accounts determined in accordance with Amylin or its
sublicensees’ normal accounting procedures consistently
applied within and across its/their pharmaceutical operating
units.
N. “Phase 3 Clinical
Trial” means large scale human clinical trials conducted in
patients anywhere in the world in accordance with good clinical
practice to generate data concerning the efficacy and a level of
safety in the particular indication tested sufficient to obtain
Marketing Approval.
O. “Product” means any
pharmaceutical product containing or incorporating a PYY receptor
ligand or a PYY peptide, fragment, analogue or derivative, the
making, using or selling of which, in the absence of this
Agreement, would infringe at least one claim in the Field of any
Curis Patent.
P. “Regulatory
Authority” means, in a particular country or jurisdiction,
any applicable government regulatory authority involved in granting
Marketing Approval and/or, to the extent required in such country
or jurisdiction, Pricing Approval of a Product in such country or
jurisdiction, including without limitation, (a) in the U.S., the
FDA, and any other applicable governmental or regulatory authority
in the U.S. having jurisdiction over a Product, and any successor
government authority having substantially the same function, and
(b) any foreign equivalent thereof.
Q. “Sale” means any bona
fide third party commercial sale of a Product after Marketing
Approval.
R. “Term” means the term
of this Agreement as defined in Section 7(A).
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2.
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Licenses
Granted and Development Reports .
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A. Curis hereby grants to Amylin
during the Term, an exclusive (even as to Curis), worldwide right
and license, under the Curis Patents, to make, have made, use and
sell Products for use in the Field, with the right to grant
sublicenses. Curis hereby grants a non-exclusive license on any
future patents in the Field which come under its ownership or
control to make, have made, use and sell Products for use in the
Field.
B. Amylin shall use commercially
reasonable efforts to develop and market Products. On or before the
first anniversary of this Agreement and annually thereafter until
Amylin markets a Product, Amylin will submit a report on the
progress Amylin has made in the preceding year toward commercial
use of Products.
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3.
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License
Fees, Royalties and Milestones .
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A. In partial consideration of the
License and any assignment of Divided Patents granted herein,
Amylin shall pay to Curis an amount equal to [**] Dollars ($[**])
(“License Fee”). The License Fee shall be paid within
thirty (30) days of the parties’ signing of this
Agreement.
B. In further consideration of the
License and any assignment of Divided Patents granted herein,
beginning upon the first Sale of each Product in a country, Amylin
shall pay Curis a royalty equal to [**]% of Net Sales of such
Product, provided that (i) a Curis Patent or Divided Patent with
claims covering the Product has issued in such country and is in
force, or (ii) if Curis or its licensee is prosecuting an undivided
application in such country for a Curis Patent or Divided Patent,
such application has been pending for no more than seven (7) years
from its earliest filing date and Curis or its licensee has
diligently pursued prosecution and issuance of claims in the Field
during such time, or (iii) if Amylin is prosecuting an application
in such country for a Divided Patent, such application is pending.
In the event that seven years transpires according to (ii) above,
and a Curis Patent or Divided Patent with claims in the Field
subsequently issues in a country where Product is sold, any
obligation of Amylin to pay royalties shall cease in the
intervening time, and Amylin’s royalty obligations shall
begin again upon issuance of the Curis Patent or Divided Patent for
the remainder of the Term.
(a) In applying the royalty terms of
Section 3(B), the royalty terms shall be applied on a
country-by-country basis, it being the intention of the parties
that the royalty in this Section 3(B) shall only apply if a Curis
Patent or Divided Patent either has issued or is being prosecuted
in accordance with the first paragraph of this Section 3(B) in any
one country in which a Product is made, used or sold, having claims
that cover the particular making, using, or selling that occurred
in such country.
(b) The payment of royalties to
Curis on any particular Product shall terminate in each country on
the expiration date of the last-to-expire issued Curis Patent or
Divided Patent covering such Product in such country.
(c) Amylin may at any time,
effective upon providing 30 days prior written notice to Curis,
cease to develop, market or sell any Product in a country and
delete such Product from the License in such country. Effective as
of the date of such notice, all royalties and other fees on such
Product in such country shall thereafter cease to
accrue.
C. Exhibit B attached hereto
and made a part hereof, lists mutually agreed upon performance
milestones (“Milestones”) along with the corresponding
milestone payments due for completion of each such milestone.
Amylin will notify Curis when any Milestone is achieved and pay
Curis the milestone payment due within thirty (30) days after
achievement of such Milestone. For Milestone Numbers 6 through 8,
their respective milestone payments shall only be paid one time for
the first Product to achieve such Milestone.
A. After Amylin commences the Sale
of Products, Amylin shall, within sixty (60) days of the end of
each calendar quarter, deliver to Curis a report, certified by the
chief financial officer of Amylin, that sets forth in reasonable
detail the calculation of the royalties due to Curis for such
calendar quarter.
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B. Royalties payable under Section
3(B) hereof shall be paid within 60 days following the last day of
the calendar quarter in which the royalties accrue.
C. Amylin will maintain and cause
its sublicensees to maintain, complete and accurate books and
records which enable the royalties payable hereunder to be
verified. The records for each calendar quarter shall be maintained
for three years after the submission of each report under Section
4(A) hereof. Upon reasonable prior notice to Amylin (but in no
event less than ten business days), Curis and its accountants shall
have access to all books and records relating to the Net Sales of
Products by Amylin and its sublicensees to conduct a review or
audit thereof. Such access shall be available not more than once
each calendar year, during normal business hours, and for each of
three years after the expiration or termination of this Agreement;
provided that once a calendar year has been audited, it may not
thereafter be audited again in that calendar year. If the audit
reveals 5% or more under reporting of royalties due Curis, Amylin
will pay the audit costs, as well as any additional sum that would
have been payable to Curis had Amylin reported correctly, plus 5%
interest.
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5.
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Currency,
Place Of Payment .
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A. All dollar amounts referred to in
this Agreement are expressed in United States dollars. All payments
to Curis under this Agreement shall be made in United States
dollars.
B. If Amylin receives revenues from
Sales of Products in currency other than United States dollars,
revenues shall be converted into United States dollars at the
conversion rate used by sublicensees in any agreement with Amylin,
or if there is no such agreement, such conversion shall be at the
conversion rate for the foreign currency as published in the
eastern edition of The Wall Street Journal as of the last
business day of the applicable calendar quarter.
A. Each pa