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= Portions of
this exhibit are subject to a request for confidential treatment
and have been redacted and filed separately with the Securities and
Exchange Commission.
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Exhibit 10.13
AMENDED AND RESTATED LICENSE
AGREEMENT
T HIS A GREEMENT is effective as of the 1
st
day of July, 2005 (the
“ Effective Date ”), between I
NSERT
T
HERAPEUTICS
, I
NC
.
, 2585 Nina Street,
Pasadena, CA 91107 (“ Licensor ”) and Calando
Pharmaceuticals (“ Licensee ”), a corporation
having a place of business at 1710 Flower Avenue, Suite 100,
Duarte, Ca 91010.
RECITALS
A . Licensee and Licensor
have entered into a License Agreement, dated as of March 14,
2005 (the “Original License”);
B. The Original License
[**].
C. Licensor is desirous of modifying
the Original License to provide for [**].
N OW ,
T HEREFORE
, in consideration of the transfer
by Licensor to Licensee of 480,000 shares of Licensee common stock,
the receipt of which is hereby acknowledged, the parties agree to
amend and restate the Original License in its entirety to read as
follows:
ARTICLE 1
DEFINITIONS
1.1 “Affiliate”
means any corporation, limited liability company or other legal
entity which directly or indirectly controls, is controlled by, or
is under common control with Licensee as of the Effective Date of
this Agreement. For the purpose of this Agreement,
“control” shall mean the direct or indirect ownership
of greater than 50 percent (>50%) of the outstanding shares on a
fully diluted basis or other voting rights of the subject entity to
elect directors, or if not meeting the preceding, any entity owned
or controlled by or owning or controlling at the maximum control or
ownership right permitted in the country where such entity exists.
In addition, a party’s status as an Affiliate of License
shall terminate if and when such control ceases to
exist.
1.2 “Exclusively Licensed
Patent Rights” means Licensor’s rights under:
(a) all patents and patent applications listed in Exhibit A
attached hereto; (b) any patents issuing
therefrom; and (c) any patents or patent
applications claiming a right of priority thereto (including
reissues, reexaminations, renewals, extensions, divisionals,
continuations, continued prosecution applications,
continuations-in-part and foreign counterparts of any of the
foregoing).
1.3 “Technology”
means all inventions, proprietary information, know-how,
procedures, methods, prototypes, and designs owned or controlled by
Licensor that exist as of the Effective Date or are developed
thereafter during the term of this Agreement and which in each case
are invented or created in the course of performing activities
specifically directed to the research, discovery, analysis,
characterization, optimization, development, manufacture, use or
sale of compounds covered by, or made by a process covered by, any
Valid Claim, that are necessary or convenient for the Licensee to
develop, make, have made, use, import, offer to sell and sell
Licensed Products.
1.4 “Licensor
Technology” means the Exclusively Licensed Patent Rights,
Improvement Patent Rights and the Technology.
1.5 “Deductible
Expenses” means the following expenses incurred in
connection with sales or licensing of Licensed Products to the
extent actually paid by Licensee or an Affiliate in accordance with
generally recognized principles of accounting: (a) sales, use
or turnover taxes; (b) excise, value added or other, taxes or
custom duties; (c) transportation, freight, and handling
charges, and insurance on shipments to customers; (d) trade,
cash or quantity discounts or rebates to the extent actually
granted; (e) agent fees or commissions; and (f) rebates,
refunds, and credits for any rejected or returned Licensed Products
or because of retroactive price reductions, or rebates.
1.6 “Effective
Date” has the meaning set forth in the
preamble.
1.7 “Field” means
the discovery, development, and commercialization of RNAi
Therapeutics. The term “RNAi Therapeutic” refers to
small interfering RNAs (siRNAs), hairpin RNAs or other nucleic
acids or analogs thereof that are substrates of the enzyme Dicer
and/or associates with intracellular proteins to form an assembly
known as a RNA-induced silencing complex (“RISC”), and
which causes sequence dependent gene silencing. RNAi Therapeutic
also includes expression vectors capable of giving rise to
transcripts which form siRNA, hairpin
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RNAs or other RNA species that are substrates of
the enzyme Dicer, and which can cause sequence dependent gene
silencing.
1.7 “Improvement Patent
Rights” means either Licensor’s or License’s
rights, as the case may be, under: (a) all patents and patent
applications with claims directed to Improvements; (b) any
patents issuing therefrom; and (c) any patents or patent
applications claiming a right of priority thereto (including
reissues, reexaminations, renewals, extensions, divisionals,
continuations, continued prosecution applications,
continuations-in-part and foreign counterparts of any of the
foregoing).
1.8
“Improvements” means any future invention that
is (a) conceived and reduced to practice or otherwise
developed by either Licensor or Licensee, as the case may be, and
its employees or third parties working on its behalf, to the extent
such inventions are owned and controlled by either Licensor or
Licensee, as the case may be, and (b) dominated by a Valid
Claim under Exclusively Licensed Patent Rights.
1.9 “Licensed
Product” means any product, device, system, article of
manufacture, composition of matter, or process or service that is
covered by, or is made by a process covered by, any Valid Claim or
that utilizes Technology in material part.
1.10 “Net
Revenues” means all amounts, less Deductible Expenses,
received by Licensee and/or its Affiliates from the sale or other
distribution (whether commercial or not) of Licensed Products or
the licensing of Exclusively Licensed Patent Rights. Any non-cash
consideration received by Licensee for the sale or other
distribution of Licensed Products or the licensing of Exclusively
Licensed Patent Rights will be converted to a cash value based on
the fair market value or a value mutually agreed upon.
1.11 “Valid
Claim” means:
(a) a claim of an issued patent
within the Exclusively Licensed Patent Rights or Improvement Patent
Rights that has not:
(i) expired or been
canceled,
-3-
(ii) been finally adjudicated to be
invalid or unenforceable by a decision of a court or other
appropriate body of competent jurisdiction (and from which no
appeal is or can be taken),
(iii) been admitted to be invalid or
unenforceable through reissue, disclaimer or otherwise,
or
(iv) been abandoned in accordance
with or as permitted by the terms of this Agreement or by mutual
written agreement; or
(b) a claim included in a pending
patent application within the Exclusively Licensed Patent Rights or
Improvement Patent Rights, which claim is being actively prosecuted
in accordance with this Agreement and which has not
been:
(i) canceled,
(ii) withdrawn from
consideration,
(iii) finally determined to be
unallowable by the applicable governmental authority (and from
which no appeal is or can be taken), or
(iv) abandoned in accordance with or
as permitted by the terms of this Agreement or by mutual written
agreement.
ARTICLE 2
LICENSE GRANT
2.1 Grant of Rights by
Licensor . Licensor hereby grants to Licensee the following
licenses:
(a) an exclusive, royalty bearing
license under the Exclusively Licensed Patent Rights and the
Improvement Patent Rights owned or controlled by Licensor to make,
have made, import, use, sell, and offer for sale Licensed Products
in the Field throughout the world; and
-4-
(b) a nonexclusive, royalty bearing
license under the Technology to make, have made, import, use, sell,
offer for sale, reproduce, distribute, display, perform, create
derivative works of, and otherwise exploit Licensed Products in the
Field throughout the world.
These licenses are personal to and
nontransferable by Licensee, except as provided in
Section 14.9.
Rights not explicitly granted herein
are reserved by Licensor.
2.2 Grant of Rights by
Licensee to Certain Improvements . Licensee hereby grants
to Licensor the following licenses:
(a) an exclusive, fully paid,
non-royalty bearing license under the Improvement Patent Rights
owned or controlled by Licensee to make, have made, import, use,
sell, and offer for sale Licensed Products outside of the Field
throughout the world; and
(b) a nonexclusive, fully paid,
non-royalty bearing license under the Technology to make, have
made, import, use, sell, offer for sale, reproduce, distribute,
display, perform, create derivative works of, and otherwise exploit
Licensed Products outside of the Field throughout the
world.
Rights not explicitly granted herein
are reserved by Licensee. The license granted under this
Section 2.2 will be governed by the provisions of Sections 1,
2, 5, 8, 9, 12, 13 and 14 of this Agreement, as if Calando
Pharmaceuticals Inc. were the Licensor and Insert Therapeutics,
Inc. were the Licensee.
2.3 Sublicensing .
Licensee has the right hereunder to grant sublicenses to third
parties, but sublicensees shall not have the right to grant further
sublicenses, and the sublicenses may be of no greater scope than
the licenses under Sections 2.1.
Licensee shall not receive, or agree
to receive, anything of value in lieu of cash or equity from a
third party under a sublicense granted pursuant to this
Section 2.3, without Licensor’s express prior written
permission which shall not be unreasonably withheld. Licensee shall
furnish Licensor within thirty (30) days of the execution
thereof a true and complete copy of
-5-
each sublicense and any changes or additions
thereto.
Any sublicenses granted by Licensee
shall survive termination of the licenses granted in
Section 2.1, or of this Agreement, provided that the following
conditions are met as of the date of such termination: (a) the
written agreement between Licensee and sublicensee pursuant to
which the sublicense was granted (i) obligates the sublicensee
to thereafter render to Licensor all sublicense royalties or other
sublicense-related consideration that the sublicensee would have
owed to Licensee under the sublicense, (ii) names Licensor as
a third party beneficiary, and (iii) affirms that Licensee
shall remain responsible for all obligations to sublicensee (other
than those requiring Licensee to hold a license under the
Exclusively Licensed Patent Rights or Technology, unless Licensor
(at its discretion) elects to assume such obligations; and
(b) Licensee informs the sublicensee in writing (with a copy
to Licensor) that the sublicensee’s obligations pursuant to
(a) are in effect as a result of the termination.
2.4 No Other Rights
Granted . The parties agree that neither this Agreement,
nor any action of the parties related hereto, may be interpreted as
conferring by implication, estoppel or otherwise, any license or
rights under any intellectual property rights of Licensor other
than as expressly and specifically set forth in this Agreement,
regardless of whether such other intellectual property rights are
dominant or subordinate to the Exclusively Licensed Patent
Rights.
2.5 Preferential Purchaser
Status . Licensor shall be entitled to purchase Licensed
Products from Licensee for educational, research or other
noncommercial purposes on pricing terms that are at least as
favorable as any commercial pricing made available by Licensee to
any third party.
ARTICLE 3
DISCLOSURE AND
DELIVERY
Exclusively Licensed Patent
Rights . Within one
month of the Effective Date, Licensor shall disclose and deliver to
Licensee copies of all patent applications and issued patents
within the Exclusively Licensed Patent Rights.
ARTICLE 4
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PROSECUTION OF PATENT
APPLICATIONS AND
PAYMENT OF PATENT
COSTS
4.1 Prosecution by
Licensor . Licensor shall use reasonable efforts,
consistent with its normal practices, to: (a) prosecute any
and all patent application(s) in connection with the Exclusively
Licensed Patent Rights; and (b) file and prosecute Improvement
Patent Rights licensed hereunder for which Licensor or Licensee
deems it beneficial to obtain additional coverage. Licensee may
recommend patent counsel for this purpose. Licensor shall permit
Licensee to review all patent applications and claims made therein,
and Licensor shall make reasonable efforts to implement
modifications thereto as may be requested by Licensee prior to
filing. With respect to filings pursuant to Paragraph
(b) herein above, Licensor shall promptly disclose such
Improvements to Licensee and Licensee shall elect within thirty
(30) days whether such Improvements shall be included within
the Improvement Patent Rights, at its expense. Licensor will have
no obligation to prosecute patent applications that may constitute
Improvements that are not elected by Licensee. Upon written
election by Licensee, the parties will amend Exhibit A hereto to
include inventions within the Exclusively Licensed Patent Rights,
in a timely manner.
4.2 Prosecution by
Licensee . If Licensor declines to file, prosecute or
maintain Exclusively Licensed Patent Rights or Improvement Patent
Rights, then Licensee may elect to assume responsibility for such
filing, prosecution or maintenance at its expense in
Licensor’s name. Licensor agrees to fully cooperate with
Licensee in filing, prosecuting, and maintaining any such patent
applications and patents, and Licensor agrees to execute any
documents as shall be necessary for such purpose, and not to impair
in any way the patentability of any of the foregoing.
4.3 Patent Costs .
Except as specified in the next paragraph, Licensee shall reimburse
Licensor for all reasonable expenses (including attorneys’
fees) incurred by Licensor from and after the Effective Date for
the filing, prosecution and maintenance, interference or
reexamination proceedings, of Exclusively Licensed Patent Rights
and Improvement Patent Rights that relate to or arise from [**].
All amounts owed by Licensee for the reimbursement of patent
expenses shall be due within thirty (30) days following
receipt by Licensee from Licensor of an invoice covering such
fees.
-7-
Licensee may elect not to pay the
foregoing patent costs and fees with respect to a particular patent
application or patent. In the event that Licensee elects not to pay
any of the forgoing costs and fees with respect to a particular
application or patent, Licensor, may, at its option, continue such
prosecution or maintenance, although any patent or patent
application resulting from such prosecution or maintenance will
thereafter no longer be subject to the licenses granted in
Section 2.1 hereunder.
ARTICLE 5
ROYALTIES
5.1 Timing and
Computation . All royalties hereunder shall be computed on
a quarterly basis for the quarters ending March 31
st
, June 30
th
, September 30
th
, and
December 31 st of each calendar year. Royalties for
each such quarter shall be due and payable within thirty
(30) days after the end of such quarter.
5.2 Valid Claims . For
any country in which the Exclusively Licensed Patent Rights or
Improvement Patent Rights includes a Valid Claim, Licensee shall
pay Licensor a royalty [**].
5.3 Technology . For
any country in which the Exclusively Licensed Patent Rights or
Improvement Patent Rights do not include a Valid Claim, Licensee
shall pay Licensor a royalty of [**].
5.4 Bundled Products and
Services . In the event that Licensed Products are sold,
licensed, distributed or used in combination with one or more other
products or services which are not Licensed Products, the Net
Revenues for such combination products will be calculated
[**].
5.5 Sublicensing
Royalties . Licensee shall pay Licensor [**].
5.6 Minimum Annual
Royalties . A minimum annual royalty of [**]. Any royalties
paid under Sections 5.2, 5.3, 5.4 and 5.5 for the one-year period
preceding the date of payment of the minimum annual royalty shall
be creditable against the annual minimum. Licensor shall have the
right to terminate this Agreement pursuant to Section 10.2 for
failure to pay such minimum annual royalty.
-8-
5.7 Third Party Royalty
Offset . If Licensee or an Affiliate is required to make
any payment (including, but not limited to, royalties or other
license fees) to one or more third parties to obtain a patent
license in the absence of which it could not legally make, import,
use, sell, or offer for sale Licensed Products in any country, and
Licensee provides Licensor with reasonably satisfactory evidence of
such third-party payments, such third-party payments shall be
[**].
5.8 Currency
Conversion . For the purpose of determining royalties
payable under this Agreement, any royalties or other revenues
Licensee receives from sublicensees in currencies other than U.S.
dollars and any Net Revenues denominated in currencies other than
U.S. dollars shall be converted into U.S. dollars according to the
noon buying rate of the Federal Reserve Bank of New York on the
last business day of the quarterly period for which such royalties
are calculated.
5.9 Recordkeeping and
Audits . Licensee shall keep complete and accurate
production and accounting records relating to commercialization
(including via sublicensing) of Licensed Products. Licensor shall
be entitled to have an independent CPA periodically audit such
records, during Licensee’s normal business hours, to
determine Licensee’s compliance with the provisions of this
Article 5. Licensee shall reimburse Licensor [**]% of any unpaid
royalties resulting from any noncompliance discovered as a result
of any such audit; and Licensee shall also pay Licensor an
additional [**]% of the entire amount of any underpayment exceeding
[**]% of the corresponding amount previously paid. Such audits
shall be at Licensor’s expense, and shall occur no more than
once annually, except that in the case of any underpayment
exceeding [**]% of the amount actually paid: (a) Licensee
shall reimburse Licensor for the cost of such audit; and
(b) Licensor shall be entitled to conduct additional quarterly
audits, at Licensee’s expense, until any such audit
demonstrates that Licensee is in compliance with its
obligations.
5.10 For so long as royalties are
payable under this Agreement, Licensee shall report in writing to
Licensor on or before April 30 th , July 31
st
, October 31
st
, and
January 31 st , Net Revenues and the number of
units of Licensed Products sold during the preceding calendar
quarter by Licensee and Related Companies, and the royalties or
other revenues Licensee received from sublicensees other than
Related Companies during the preceding calendar quarter
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for the sale of Licensed Products. Each such
report shall also set forth an explanation of the calculation of
the royalties payable hereunder and be accompanied by payment of
the royalties shown by said report to be due Licensor.
ARTICLE 6
LICENSEE EQUITY
INTEREST
6.1 Common Stock Grant
. Licensee agrees to irrevocably issue to Licensor, in partial
consideration of Licensee’s receipt of the licenses
granted