Exhibit 10.19
LICENSE AGREEMENT
This License Agreement (the "AGREEMENT") is entered into and made
effective the 31 day of January, 2005 (the "EFFECTIVE DATE") between UNIVERSITY
OF MIAMI and its School of Medicine, whose principal place of business is at
0000 X.X. 00xx Xxxxxx, Xxxxx, Xxxxxxx 00000 (hereinafter referred to as
"LICENSOR") and Somaxon Pharmaceuticals, Inc., whose principal place of business
is at 00000 Xxxx Xxxxx Xxxxx, Xxxxx 000, Xxx Xxxxx, Xxxxxxxxxx 00000
(hereinafter referred to as "LICENSEE").
WITNESSETH
WHEREAS, LICENSOR owns United States Patent Number 5,852,032
entitled "Method of Treating Nicotine Dependence"; and
WHEREAS, LICENSOR warrants that it possesses the right to license
the subject patent and the right to market the Patent Rights; and,
WHEREAS, LICENSEE desires to acquire an exclusive license in the
License Territory (as defined in Section 1.7 below) for the following use: human
treatment of nicotine dependence, with the right to sublicense, under the Patent
Rights (as defined in Section 1.12 below) and Know-How (as defined in Section
1.6 below) for the purposes of making, having made, using, selling, having sold,
offering for sale, importing or otherwise commercializing products and
practicing the invention disclosed and claimed in the Patent Rights;
NOW THEREFORE, for these and other valuable considerations, the
receipt of which is hereby acknowledged, the parties agree as follows:
1. DEFINITIONS:
1.1 "AFFILIATE" shall mean any corporation or other business entity
controlled by, controlling or under common control with LICENSOR or LICENSEE.
For this purpose, "control" shall mean direct or indirect beneficial ownership
of at least a fifty percent (50%) of the voting stock of, or at least a fifty
percent (50%) interest in the income of such corporation or other business
entity, or such other relationship as in fact, constitutes actual control.
CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT
PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1.2 "FIELD OF USE" shall mean human treatment of nicotine
dependence, nicotine addiction and/or tobacco smoking.
1.3 "FORCE MAJEURE EVENT" shall mean events beyond the reasonable
control of either party, including, but not limited to, war, terrorism, riot,
strikes, boycotts, seizure, allocation, requisition, or any further official
action by any department, bureau, board, administration, or other
instrumentality or agency.
1.4 "GENERIC ENTRY DATE" shall mean the date of first regulatory or
marketing approval in the Net Sales Territory of a generic equivalent to any
Product, including, but not limited to, a product covered by an Abbreviated New
Drug Application (ANDA) which references the initial New Drug Application (NDA)
filed by LICENSEE or a sublicensee for such Product.
1.5 "GOVERNMENT" shall mean the United States federal government.
1.6 "KNOW-HOW" shall mean trade secrets, inventions, data,
processes, procedures, devices, methods, formulas, protocols, information and
other know-how, whether or not patentable, which is owned or controlled by
LICENSOR during the License Term and is necessary or useful for the commercial
exploitation of the Patent Rights.
1.7 "LICENSE TERRITORY" shall mean worldwide.
1.8 "METHOD" shall mean any method or process which is covered in
whole or in part by an issued or unexpired claim contained in the Patent Rights
or otherwise incorporating the Know-How.
1.9 "NET SALES" shall mean the sum of all amounts invoiced on
account of sale or use of Products by LICENSEE and its Affiliates and any
Sublicensees to non-affiliated third party purchasers or users of Products, less
(a) wholesale or cash or trade or quantity discounts, refunds, rebates or
retroactive price adjustments to purchasers actually allowed or paid, (b)
amounts for transportation, shipping, freight, and insurance directly related to
the sale and distribution of the Products (excluding amounts reimbursed by third
party customers), (c) credits or allowances for returns or trades (charge
backs), (d) allowances for bad debts and bad debts actually incurred and (e)
taxes and duties levied on the sale of Products or Know How, including, excise
taxes, whether absorbed by Licensee or paid by the purchaser.
1.10 "NET SALES TERRITORY" shall mean the United States of America.
1.11 "PATENT EXPIRATION DATE" shall mean the last to expire of the
Patent Rights.
1.12 "PATENT RIGHTS" shall mean United States Patent Number
5,852,032 of Xxxxx issued December 22, 1998 entitled "Method of Treating
Nicotine Dependence" and all divisions, renewals, continuations,
continuations-in-part, reissues, extensions and substitutions thereof and, to
the extent applicable, all foreign counterparts.
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1.13 "PRODUCT" shall mean any product or part thereof:
(a) the manufacture, use or sale or other commercialization of
which is covered in whole or in part by an issued or unexpired
claim contained in the Patent Rights or otherwise
incorporating the Know-How; or
(b) which is administered by using a Method.
1.14 "SUBLICENSEE" shall mean any third party to whom LICENSEE has
granted a sublicense of LICENSEE's rights hereunder, provided said third party
has agreed in writing with LICENSEE to accept the conditions and restrictions
agreed to by LICENSEE in this Agreement.
2. GRANT:
2.1 In consideration for payment of royalties, LICENSOR hereby
grants to LICENSEE an exclusive (even as to LICENSOR except as specified in
Secantion 2.2 below) license, subject to any rights of the Government, in the
License Territory, for the Field of Use, with the right to sublicense, under the
Patent Rights and Know-How, to make, have made, use, sell, have sold, offer for
sale, import or otherwise commercialize the Product and to practice the Method.
2.2 LICENSOR retains the right to practice such invention for its
own internal non-commercial, educational and research use.
3. TERM:
The license granted in this Agreement shall be Exclusive in the Field of
Use until the later of (i) the Patent Expiration Date or (ii) the date described
in Section 8.1(c)(ii) (the "LICENSE TERM"), unless terminated earlier as
provided herein, and commencing as of the Effective Date of this Agreement.
4. UNITED STATES LAWS:
4.1 LICENSEE understands that the Patent Rights may have been
developed under a funding agreement with the Government and, if so, that the
Government may have certain rights relative thereto. This Agreement is
explicitly made subject to the Government's rights under any
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agreement and any applicable law or regulation. If there is a conflict between
this Agreement and an agreement between LICENSOR and the Government, applicable
law or regulation, the terms of the agreement between LICENSOR and the
Government, applicable law or regulation, respectively, shall prevail.
Specifically, this Agreement is subject to all of the terms and conditions of
Title 35 United States Code sections 200 through 204, including an obligation
that Product sold or produced in the United States be "manufactured
substantially in the United States," and LICENSEE agrees to take all reasonable
action necessary on its part as licensee to enable LICENSOR to satisfy its
obligation thereunder, relating to the Patent Rights.
4.2 It is understood that LICENSOR is subject to United States laws
and regulations controlling the export of technical data, computer software,
laboratory prototypes and other commodities (including the Arms Export Control
Act, as amended and the Export Administration Act of 1979), and that its
obligations hereunder are contingent on compliance by LICENSEE with applicable
United States export laws and regulations. The transfer of certain technical
data and commodities may require a license from the cognizant agency of the
United States Government and/or written assurances by LICENSEE that LICENSEE
shall not export data or commodities to certain foreign countries without prior
approval of such agency. LICENSOR neither represents that a license from an
agency of the Government shall not be required nor that, if required, it shall
be issued.
5. PATENT PROTECTION AND INFRINGEMENT:
5.1 LICENSOR, during the License Term, is responsible for the
maintenance of all Patent Rights. LICENSEE shall reimburse LICENSOR for all
payments made by LICENSOR in respect of the Patent Rights within thirty (30)
days of LICENSEE's receipt of the applicable invoice.
5.2 LICENSEE shall promptly notify LICENSOR in writing of any claim
of Patent Rights infringement which, to LICENSEE's knowledge, is asserted
against LICENSEE or LICENSOR, its Affiliates and any sublicensees because of the
manufacture, use, promotion and sale of Products.
5.3 Upon learning of any infringement of Patent Rights by third
parties in any country, LICENSEE and LICENSOR will promptly inform each other,
as the case may be, in writing
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of that fact and will supply the other with any available evidence pertaining to
the infringement. LICENSEE, at its own expense, shall have the option to take
whatever steps are necessary to stop the infringement at its expense and recover
damages therefore, and will be entitled to retain all damages so recovered. In
the event that LICENSOR and LICENSEE mutually agree to bring suit, costs and
expenses shall be shared equally and any recovery in excess of expenses shall be
shared equally. Each of the parties shall assist and cooperate with the other
party in connection with any such suit or other action relating to infringement.
In any event, no settlement, consent, judgment or other voluntary final
disposition of the suit may be entered into without the consent of LICENSOR,
which shall not be unreasonably withheld. In the event LICENSEE does not take
steps to stop the infringement within ninety days after notice from LICENSOR
specifically requesting such action and referring to this Section 5.3, LICENSOR
shall have the right to terminate the License Agreement. In connection with any
such termination, all Patent Rights and Know-How will revert to LICENSOR.
6. INDEMNIFICATION:
6.1 LICENSEE agrees to release, indemnify, defend and hold harmless
the LICENSOR and its Trustees, officers, faculty, employees and students against
any and all losses, expenses, claims, actions, lawsuits and judgments thereon
(including attorney's fees through the appellate levels) ("DAMAGES") which may
be brought against LICENSOR, its Trustees, officers, faculty, employees or
students as a result of or arising out of (a) any negligent act or omission of
LICENSEE or its agents or employees, (b) the use, production, manufacture, sale,
lease, consumption or advertisement by LICENSEE, its Affiliates or their
sublicensees or any third party with whom LICENSEE has or enters into an
agreement of any Patent Rights, Methods, Know-How, Product, invention or
technology licensed under this Agreement, (c) the use of LICENSEE's own
trademarks and tradenames relating to the Products, or (d) any and all third
party claims of Patent Rights infringement which may be asserted against
LICENSOR, and Affiliates because of the manufacture, use, promotion and sale of
Products; provided, however, that such indemnification right shall not apply to
any judgments and Damages to the extent directly attributable to the negligence,
reckless misconduct, or intentional misconduct of a party seeking
indemnification under this Section 6.1.
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6.2 LICENSOR agrees to release, indemnify, defend and hold harmless
the LICENSEE and its officers, employees and Affiliates against any and all
Damages which may be brought against LICENSEE or its officers, employees or
Affiliates as a result of or arising out of any negligent act or omission of
LICENSOR or its Trustees, officers, faculty, agents, employees or other
Affiliates, provided, however, that such indemnification right shall not apply
to any judgments and Damages to the extent directly attributable to the
negligence, reckless misconduct, or intentional misconduct of a party seeking
indemnification under this Section 6.2.
6.3 Promptly after receipt by a party seeking indemnification under
this Section 6 (an "INDEMNITEE") of notice of any pending or threatened claim
against it (an "ACTION"), such Indemnitee shall give written notice to the party
to whom the Indemnitee is entitled to look for indemnification pursuant to this
Section 6 (the "INDEMNIFYING PARTY") of the commencement thereof, provided that
the failure so to notify the Indemnifying Party shall not relieve it of any
liability that it may have to any Indemnitee hereunder. In case any Action that
is subject to indemnification under this Section 6 shall be brought against an
Indemnitee and it shall give written notice to the Indemnifying Party of the
commencement thereof, the Indemnifying Party shall be entitled to participate
therein and, if it so desires, to assume the defense thereof with counsel
reasonably satisfactory to such Indemnitee and, after notice from the
Indemnifying Party to the Indemnitee of its election to assume the defense
thereof, the Indemnifying Party shall not be liable to such Indemnitee under
this Section 6 for any fees of other counsel or any other expenses, in each case
subsequently incurred by such Indemnitee in connection with the defense thereof,
other than reasonable costs of investigation. Notwithstanding an Indemnifying
Party's election to assume the defense of any such Action that is subject to
indemnification under this Section 6, the Indemnitee shall have the right to
employ separate counsel and to participate in the defense of such Action. If an
Indemnifying Party assumes the defense of such Action, no compromise or
settlement thereof may be effected by the Indemnifying Party without the
Indemnitee's written consent, which consent shall not be unreasonably withheld
or delayed, unless (A) there is no finding or admission of any violation of law
or any violation of the rights of any Person and no effect on any other claims
that may be made against the Indemnitee and (B) the sole relief provided is
monetary damages that are paid in full by the Indemnifying Party.
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6.4 This Agreement to reimburse and indemnify under the
circumstances set forth above shall continue after the termination of this
Agreement.
7. REPRESENTATIONS AND WARRANTIES:
7.1 Mutual Representations and Warranties.
(a) Each party represents and warrants that it is duly authorized
to execute and deliver this Agreement and to perform its
obligations hereunder.
(b) Each party represents and warrants that this Agreement is a
legal and valid obligation binding upon it and enforceable in
accordance with its terms Each party represents that to the
best of its knowledge the execution, delivery and performance
of this Agreement does not conflict with any agreement,
instrument or understanding, oral or written, to which it is a
party or by which it may be bound, nor violate any law or
regulation of any court, governmental body or administrative
or other agency having jurisdiction over it.
7.2 REPRESENTATIONS AND WARRANTIES OF LICENSOR.
(a) LICENSOR represents and warrants that, subject to any interest
of the Government, LICENSOR owns the Patent Rights and
Know-How and has sufficient rights and power to grant the
licenses to LICENSEE which LICENSOR purports to grant herein.
(b) LICENSOR represents that, to the best of its knowledge, except
as set forth in Section 4 above, there are no outstanding
liens, encumbrances, agreements or understandings of any kind,
either written, oral or implied, regarding the Patent Rights
or Know-How which are inconsistent or in conflict with any
provision of this Agreement.
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(c) LICENSOR represents and warrants that it has no knowledge of
any outstanding and unresolved claim or accusation that the
practice of the Patent Rights or Know-How infringes or may
infringe any third-party patent right(s).
(d) LICENSOR represents that, to the best of its knowledge, no
patent application or patent within the Patent Rights or
Know-How is the subject of any interference, opposition,
cancellation or other protest proceeding.
7.3 Disclaimer of Other Warranties. Except as set forth in Sections
7.1 and 7.2 above, LICENSOR MAKES NO WARRANTIES, EXPRESS OR IMPLIED, AND HEREBY
DISCLAIMS ALL SUCH WARRANTIES, AS TO ANY MATTER WHATSOEVER, INCLUDING, WITHOUT
LIMITATION, THE CONDITION OF ANY INVENTION(S) OR PRODUCT, WHETHER TANGIBLE OR
INTANGIBLE, LICENSED UNDER THIS AGREEMENT; OR THE MERCHANTABILITY, OR FITNESS
FOR A PARTICULAR PURPOSE OF THE INVENTION OR PRODUCT; OR THAT THE USE OF THE
LICENSED PRODUCT WILL NOT INFRINGE ANY PATENT, COPYRIGHTS, TRADEMARKS, OR OTHER
RIGHTS. EXCEPT AS SET FORTH IN SECTION 6.2. LICENSOR SHALL NOT BE LIABLE FOR ANY
DIRECT, CONSEQUENTIAL, OR OTHER DAMAGES SUFFERED BY LICENSEE OR ANY THIRD
PARTIES RESULTING FROM THE USE, PRODUCTION, MANUFACTURE, SALE, LEASE,
CONSUMPTION, OR ADVERTISEMENT OF THE PRODUCT.
7.4 The provisions of this Section 7 shall continue beyond the
termination of this Agreement.
8. PAYMENTS:
8.1 In partial consideration of the license herein granted, LICENSEE
shall pay the following amounts to LICENSOR:
(a) "LICENSE ISSUE FEE" of thirty-five thousand dollars ($35,000),
which said License Issue Fee shall be deemed earned and due
immediately upon the execution of this Agreement.
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(b) "LICENSE MAINTENANCE FEES" of [***] dollars ($[***]) per year
payable on the first anniversary of the Effective Date and
each anniversary thereafter until the end of the License Term;
provided, however, that the License Maintenance Fee for any
given year shall be creditable against any Running Royalties
subsequently due during said year under subsection 8.1(c)
below.
(c) "RUNNING ROYALTY" on each Product with the applicable royalty
rate determined on a Product-by-Product basis as follows:
(i) until the Patent Expiration Date for such Product, a
royalty amount equal to [***] percent ([***]%) of the
Net Sales of such Product in the Net Sales Territory;
and
(ii) after the Patent Expiration Date for such Product and
until the earlier of (A) the Generic Entry Date for such
Product or (B) [***] after the date of the first
commercial sale of the first Product developed
hereunder, a royalty amount equal to [***] percent
([***]%) of the Net Sales of such Product in the Net
Sales Territory.
LICENSEE shall be entitled to reduce the royalty rates as set
forth in clause (i) and (ii) above if the LICENSEE licenses
intellectual property rights owned by a third party to
develop, discover, use, make, have made or sell the Product,
excluding LICENSEE's license agreement with BioTie Therapies
Corp. The amount of royalty reduction shall be equal to the
amount of royalty paid to the third party; however, in no case
shall the royalty rate under clause (i) be less than [***]
percent ([***]%) and under clause (ii) be less than [***]
percent ([***]%). For the avoidance of doubt, the parties
agree that no royalty shall be due with respect to the Net
Sales of any Product outside the Net Sales Territory.
8.2 In partial consideration of the license herein granted, LICENSEE
shall pay the following amounts to LICENSOR:
(a) A milestone payment in the amount of [***] dollars ($[***])
shall be payable upon LICENSEE filing the first U.S. IND with
respect to a Product.
(b) A milestone payment in the amount of [***] dollars ($[***])
shall be payable upon successful completion of the first Phase
I/II proof of principle clinical study in human subjects with
respect to a Product.
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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(c) A milestone payment in the amount of [***] dollars ($[***])
shall be payable upon LICENSEE filing the first U.S. NDA with
respect to a Product.
(d) A milestone payment in the amount of [***] dollars ($[***])
shall be payable upon first commercial sale by LICENSEE of
product.
(e) A milestone payment in the amount of [***] dollars ($[***])
shall be payable upon the initial $[***] in cumulative Net
Sales of Products.
8.3 All payments shall be made hereunder in U.S. dollars; provided
however, that if the proceeds of the sales upon which such royalty payments are
based are received by the LICENSEE in a foreign currency or other form that is
not convertible or exportable in dollars, and the LICENSEE does not have ongoing
business operations or bank accounts in the country in which the currency is not
convertible or exportable, the LICENSEE shall pay such royalties in the currency
of the country in which such sales were made by depositing such royalties in
LICENSOR'S name in a bank designated by LICENSOR in such country. Royalties in
dollars shall be computed by converting the royalty in the currency of the
country in which the sales were made at the exchange rate for dollars prevailing
at the close of the business day of the LICENSEE'S quarter for which royalties
are being calculated as published the following day in the Wall Street Journal
(or, if it ceases to be published, a comparable publication to be agreed upon
from time to time by the parties), and with respect to those countries for which
rates are not published in the Wall Street Journal, the exchange rate fixed for
such date by the appropriate United States governmental agency.
8.4 In the event the royalties set forth herein are higher than the
maximum royalties permitted by the law or regulations of a particular country,
the royalty payable for sales in such country shall be equal to the maximum
permitted royalty under such law or regulation.
8.5 In the event that any taxes, withholding or otherwise, are
levied by any taxing authority in connection with accrual or payment of any
royalties payable to LICENSOR under this Agreement, the LICENSEE shall have the
right to pay such taxes to the local tax authorities on behalf of LICENSOR and
the payment to LICENSOR of the net amount due after reduction by the amount of
such taxes shall fully satisfy the LICENSEE'S royalty obligations under this
Agreement.
9. DILIGENCE REQUIREMENTS:
9.1 LICENSEE shall diligently develop, manufacture, market and sell
the Products in the Net Sales Territory and will diligently endeavor to create a
demand for the Products.
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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9.2 LICENSEE agrees to submit reports, upon LICENSOR's request, as
to its efforts to develop markets for the Licensed Products. Such reports shall
include assurance by LICENSEE of its intent to actively develop commercial
embodiments of the inventions of Patents Rights and a summary of its efforts in
this regard.
9.3 Unless LICENSEE has a Product available for commercial sale
prior to January 1, 2012, LICENSEE agrees to pay LICENSOR an annual minimum
royalty of [***] dollars ($[***]) within thirty (30) days of such date and each
January 1 thereafter; provided that the annual minimum royalty shall increase by
[***]% on each January 1 thereafter until a Product is available for commercial
sale or the license subject to this Agreement has expired or been terminated. In
the event that an uncontrollable delay related to the FDA regulatory process and
in the event LICENSEE has exercised diligence consistent with industry standards
which can be demonstrated in writing by LICENSEE, LICENSEE may request a one
year extension from LICENSOR to pay the first annual minimum royalty of [***]
dollars ($[***]) where such extension shall not be unreasonably withheld. In the
event LICENSEE discontinues sales and marketing of the Product for more than
[***], LICENSOR may terminate this Agreement; provided, however, that the
foregoing right to terminate shall not apply in the event that such
discontinuation is primarily the result of (i) any Force Majeure Event, or (ii)
any undue delays caused by the FDA or any other regulatory body.
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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10. REPORTS AND RECORDS:
10.1 Commencing one (1) year after the first commercial sale of a
Product by LICENSEE and/or its Affiliates or sublicensees, the LICENSEE shall
furnish to LICENSOR a report in writing specifying during the preceding calendar
quarter (a) the number or amount of Products sold hereunder by LICENSEE, and/or
its Affiliates or sublicensees, (b) the total xxxxxxxx for all Products sold,
(c) deductions as applicable in Section 1.9, (d) total royalties due, (e) names
and addresses of all sublicensees. Such reports shall be due within forty-five
(45) days following the last day of each calendar quarter in each year during
the License Term of this Agreement. Each such report shall be accompanied by
payment in full of the amount, if any, due LICENSOR in United States dollars
calculated in accordance with Section 8.1 hereof.
10.2 For a period of three (3) years from the date of each report
pursuant to Section 10.1, LICENSEE shall keep records adequate to verify each
such report and accompanying payment made to LICENSOR under this Agreement, and
an independent Certified Public Accountant or Accounting Firm selected by
LICENSOR and acceptable to LICENSEE may have access, on reasonable notice during
regular business hours, not to exceed once per year, to such records to verify
such reports and payments. Such Accountant or Accounting Firm shall not disclose
to LICENSOR any information other than that information relating solely to the
accuracy of, or necessity for, the reports and payments made hereunder. The fees
and expense of the Certified Public Accountant or Accounting Firm performing
such verification shall be borne by LICENSOR unless in the event that the audit
reveals an underpayment of royalty by more than ten (10%) percent, the cost of
the audit shall be paid by LICENSEE.
11. MARKING AND STANDARDS:
11.1 LICENSEE agrees to xxxx and have sublicensees xxxx Products (or
their containers or labels) made, sold, or otherwise disposed of by it under the
license granted in this Agreement with a proper patent notice as specified under
the patent laws of the United States.
11.2 LICENSEE further agrees to maintain standards consistent with
pharmaceutical industry norms in respect to the nature of the Product
manufactured and/or sold by LICENSEE.
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LICENSEE agrees that all Product manufactured and/or sold by it shall be of a
quality which is appropriate to pharmaceutical products. LICENSEE agrees that
similar provisions shall be included by sublicenses of all tiers.
12. ASSIGNMENT:
12.1 This Agreement is not assignable by LICENSEE or by operation of
law without the prior written consent of LICENSOR at its sole discretion.
Notwithstanding the foregoing, LICENSEE shall have the right to assign this
Agreement or its rights or obligations hereunder to any of its Affiliates,
successors in interest or acquirers of all or substantially all of its assets
provided such Affiliate, successor in interest or acquirer assumes all of
LICENSEE's obligations under this Agreement.
12.2 This Agreement shall extend to and be binding upon the
successors and legal representatives and permitted assigns of LICENSOR and
LICENSEE.
13. NOTICE:
Any notice, payment, report or other correspondence (hereinafter
collectively referred to as "correspondence") required or permitted to be given
hereunder shall be mailed by certified mail, overnight delivery (receipt
verified) by recognized courier (e.g., Federal Express, UPS, Airborne Express or
DHL) or delivered by hand to the party to whom such correspondence is required
or permitted to be given hereunder. If mailed, any such notice shall be deemed
to have been given when mailed as evidenced by the postmark at point of mailing.
If delivered by courier by overnight delivery, any such notice shall be deemed
to have been given when delivery is confirmed by the applicable courier. If
delivered by hand, any such correspondence shall be deemed to have been given
when received by the party to whom such correspondence is given, as evidenced by
written and dated receipt of the receiving party.
All correspondence to LICENSEE shall be addressed as follows:
Somaxon Pharmaceuticals, Inc.
00000 Xxxx Xxxxx Xxxxx, Xxxxx 000
Xxx Xxxxx, XX 00000
Attn: Xx. Xxxxx X. Xxxx, Xx. VP
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All correspondence to LICENSOR shall be addressed, in duplicate, as
follows:
FOR OFFICIAL NOTICE ONLY:
University of Miami
School of Medicine
Research and Graduate Studies
P.O. Box 016960
0000 X.X. 00xx Xxxxxx
Xxxxx, XX 00000
Attention: Xx. Xxxxxx Xxxxxx
Vice President
Business Services
327 Xxx Xxxxxxx Building
0000 Xxxxxxx Xxxxxx
Xxxxx Xxxxxx, XX 00000-0000
Attention: Xx. Xxxx X. Xxxx
FOR NOTICE, PAYMENT AND PATENT CORRESPONDENCE:
Assistant Xxxxxxx
Office of Technology Transfer
P.O. Box 016960 (M811)
Xxxxx, XX 00000
Attention: Xx. Xxxx X.Xxxxxxxx
Either party may change the address to which correspondence to it is to be
addressed by notification as provided herein.
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14. TERMINATION:
14.1 LICENSOR shall have the right to terminate this Agreement if
LICENSEE commits a material breach of an obligation under this Agreement or
provides a false report and continues in default for more than two (2) months
after receiving written notice of such default or false report; however, in the
event LICENSEE breaches its obligations under Sections 5.1, 5.3, 8, 9.3 or 15.2,
LICENSEE shall have ten (10) business days after receiving written notice to
cure such breach, after which LICENSOR shall have the right to terminate this
Agreement. Such termination shall be effective upon further written notice to
the breaching party after failure by the breaching party to cure such default.
If LICENSOR commits a material breach or defaults, then LICENSEE has no duty to
continue the payment of royalties, milestones or other amounts set forth in
Section 8 of this Agreement.
14.2 The license and rights granted in this Agreement have been
granted on the basis of the special capability of LICENSEE to perform research
and development work leading to the manufacture and marketing of the Products.
Accordingly, LICENSEE covenants and agrees that in the event any proceedings
under the Bankruptcy Act or any amendment thereto, be commenced by or against
LICENSEE, and, if against LICENSEE, said proceedings shall not be dismissed with
prejudice before either an adjudication in bankruptcy or the confirmation of a
composition, arrangement, or plan of reorganization, or in the event LICENSEE
shall be adjudged insolvent or make an assignment for the benefit of its
creditors, or if a writ of attachment or execution be levied upon the license
hereby created and not be released or satisfied within ten (10) days thereafter,
or if a receiver be appointed in any proceeding or action to which LICENSEE is a
party with authority to exercise any of the rights or privileges granted
hereunder and such receiver be so discharged within a period of forty-five (45)
days after his appointment, any such event shall be deemed to constitute a
breach of this Agreement by LICENSEE and, LICENSOR, at the election of LICENSOR,
but not otherwise, ipso facto, and without notice or other action by LICENSOR,
shall terminate this Agreement and all rights of LICENSEE hereunder and all
rights of any and all persons claiming under LICENSEE.
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14.3 LICENSEE shall have the right to terminate this Agreement upon
sixty (60) days notice to LICENSOR. 14.4 Any termination of this Agreement shall
be without prejudice to LICENSOR's right to recover all amounts accruing to
LICENSOR prior to such termination and cancellation. Except as otherwise
provided, should this Agreement be terminated for any reason, LICENSEE shall
have no rights, express or implied, under any patent property which is the
subject matter of this Agreement, nor have the right to recover any royalties
paid LICENSOR hereunder. Upon termination, LICENSEE shall have the right to
dispose of Products then in its possession and to complete existing contracts
for such Products, so long as contracts are completed within six (6) months from
the date of termination, subject to the payment of royalties to LICENSOR as
provided in Section 8 hereof.
15. CERTIFICATE OF INSURANCE:
15.1 LICENSEE shall maintain liability insurance coverage for the
Product prior to any human subject testing in the amount of five million dollars
($5,000,000) and at no expense to LICENSOR, LICENSEE shall name LICENSOR as an
additional insured. At the time of execution of this Agreement, LICENSEE shall
provide a certificate of insurance to LICENSOR. LICENSEE agrees to carry and
keep in force, at its expense, general liability insurance with limits not less
than $1,000,000 per person and $3,000,000 aggregate to cover liability for
damages on account of bodily or personal injury or death to any person, or
damage to property of any person. Such insurance shall contain an endorsement
naming the LICENSOR as an additional insured with respect to this Agreement.
Insurance Certificates should be sent to LICENSOR upon execution of this
Agreement and on the anniversary of that date every year thereafter as follows:
Office of Technology Transfer, attention Xx. Xxxx Xxxxxxxx, 0000 X.X. 00 Xxxxxx,
Xxxx 0000 (M811), Xxxxx, Xxxxxxx 00000.
15.2 LICENSEE shall not cancel such insurance without thirty (30)
days prior notice to LICENSOR unless it contemporaneously replaces such
insurance with substantially the same or more comprehensive coverage which again
names LICENSOR as an additional insured. Such cancellation shall be cause for
termination subject to the cure provision set forth in Section 14.1.
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15.3 The terms of this provision shall extend beyond the termination
of this Agreement for a period of seven (7) years following the last sale of any
Product.
16. CONFIDENTIALITY; USE OF NAME:
16.1 NON-USE AND NON-DISCLOSURE OBLIGATIONS. Each of LICENSOR and
LICENSEE shall use any information received by it from the other party solely in
connection with performance of their respective obligations under this Agreement
and shall not disclose such information to any third party, without the prior
written consent of the other party. These obligations shall survive the
expiration or termination of this Agreement for a period of seven (7) years.
These obligations shall not apply to information that:
(a) is known by the receiving party, as evidenced by its records, at
the time of receipt and not through a prior disclosure by the disclosing party;
(b) is at the time of disclosure or thereafter becomes published or
otherwise part of the public domain through no breach of this Agreement by the
receiving party;
(c) is subsequently disclosed to the receiving party, as evidenced
by its records, by a third party having the right to make such a disclosure;
(d) is developed by the receiving party, as evidenced by its
records, independently of information received by it from the disclosing party
hereunder;
(e) is disclosed to any governmental authority in order to prosecute
or maintain any Patent Rights or Know-How or any regulatory authority to obtain
approval to market a Product, but such disclosure may be made only to the extent
necessary to pursue such prosecution or maintenance or to obtain such approval;
or
(f) is required by law, regulation, rule, act or order of any
governmental authority or agency to be disclosed by a party, provided that only
such portion of the information which is legally required to be disclosed is so
disclosed and notice is promptly given to the other party in order to provide it
an opportunity to seek a protective order or the like with respect to such
information.
16.2 PERMITTED DISCLOSURE. Information provided under this Agreement
may be disclosed to employees, agents, consultants, or suppliers of the
receiving party, but only to the extent required to accomplish the purposes of
this Agreement; provided that such employees, agents, consultants or suppliers
shall also agree to appropriate and comparable confidentiality and non-use
provisions.
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16.3 PUBLICITY. Except as required by law, regulation or court
order, (a) LICENSEE shall not use the name of the LICENSOR (i.e., University of
Miami), or any of its employees, or any adaptation thereof, in any publication,
including advertising, promotional or sales literature without the prior written
consent of Xx. Xxxx X. Xxxx, Vice President of Business Services (or such
individual's successor), 327 Xxx Xxxxxxx Bldg., 0000 Xxxxxxx Xxxxxx, Xxxxx
Xxxxxx, XX 00000-0000, which consent shall not be unreasonably withheld or
delayed more than 24 hours from the time of LICENSEE's request, and (b) all
publicity, press releases and other announcements relating to the terms of this
Agreement or the transactions contemplated hereby shall be reviewed in advance
by, and shall be subject to the written approval of, both parties.
Notwithstanding the foregoing, (i) if time does not permit a 24 hour prior
review in the reasonable judgment of LICENSEE, LICENSEE may issue a press
release or public announcement concerning any aspect of LICENSEE's development
or commercialization of a Product without the prior written consent of LICENSOR
provided that no reference is made therein to LICENSOR's name (i.e., University
of Miami) and (ii) LICENSEE may disclose the existence of this Agreement and the
terms and conditions hereof, without the prior written consent of LICENSOR, as
reasonably necessary in connection with the due diligence process associated
with future capital investment in LICENSEE or the negotiation or exploration of
a possible strategic transaction.
17. GOVERNING LAW:
This Agreement shall be governed by and interpreted in accordance
with the laws of the State of Florida.
18. CAPTIONS: The captions and section heading of this Agreement are
solely for the convenience of reference and shall not affect its interpretation.
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19. SEVERABILITY:
Should any part or provision of this Agreement be held unenforceable
or in conflict with the applicable laws or regulations of any jurisdiction, the
invalid or unenforceable part or provision shall be replaced with a provision
which accomplishes, to the extent possible, the original business purpose of
such part or provision in valid and enforceable manner, and the remainder of the
Agreement shall remain binding upon the parties hereto.
20. SURVIVAL:
20.1 The provisions of Sections 1.8, 1.13, 5, 6, 7, 15, 16, 19, 20,
21, 22, 23, and 24 shall survive the termination or expiration of this Agreement
and shall remain in full force and effect. In addition, for clarity, absent an
uncured breach of this Agreement by LICENSEE, nothing herein shall be deemed to
prevent LICENSEE from making, having made, using, selling, having sold, offering
for sale, importing or otherwise commercializing the Product and to practice the
Method following the expiration of the License Term.
20.2 The provisions of this Agreement which do not survive
termination or expiration hereof (as the case may be) shall, nonetheless, be
controlling on, and shall be used in construing and interpreting, the rights and
obligations of the parties hereto with regard to any dispute, controversy or
claim which may arise under, out of, in connection with, or relating to this
Agreement.
21. AMENDMENT:
No amendment or modification of the terms of this Agreement shall be
binding on either party unless reduced to writing and signed by an authorized
officer of the party to be bound.
22. WAIVER:
No failure or delay on the part of a party in exercising any right
hereunder will operate as a waiver of, or impair, any such right. No single or
partial exercise of any such right will preclude any other or further exercise
thereof or the exercise of any other right. No waiver of any such right will be
deemed a waiver of any other right hereunder.
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23. ENTIRE AGREEMENT:
This Agreement constitutes the entire agreement between the parties
hereto respecting the subject matter hereof, and supersedes and terminates all
prior agreements respecting the subject matter hereof, whether written or oral,
and may be amended only by an instrument in writing executed by both parties
hereto.
24. COUNTERPARTS:
This Agreement may be executed in counterparts and each such
counterpart shall be deemed an original hereof.
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to
be executed by their respective officers thereunto duly authorized to be
effective as of the Effective Date.
SOMAXON PHARMACEUTICALS, INC.
Date: 1-26-05 By: /s/ Xxxxxxx Xxxxx
--------------------------------------------
Name: Xxxxxxx Xxxxx
Title: President and Chief Executive Officer
UNIVERSITY OF MIAMI
Date: 1-31-05 By: /s/ Xxxx X. Xxxx
--------------------------------------
Name: Xxxx X. Xxxx
Title: VP, Business Services
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