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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:
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(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:
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(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
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(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
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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.
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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.
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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 under this
Agreement, [**] .
6.2 Transfer Restrictions . Licensor agrees that,
in the event of any underwritten or public offering of securities
of Licensee or an Affiliate, Licensor shall comply with and agree
to any legally require
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