EXCLUSIVE LICENSE AGREEMENT
This
Exclusive License Agreement (the “Agreement”), dated as of 15th
day of
February 2007 (the “Effective Date”), is entered into by and between Pfizer
Inc., a Delaware corporation and Pfizer Products, Inc., a Connecticut
corporation (hereinafter collectively defined as “Licensor”), and InSite Vision
Incorporated, a Delaware corporation (“Licensee”).
WHEREAS,
Licensee desires to obtain from Licensor, and Licensor wishes to grant to
Licensee, an exclusive, royalty bearing license under certain patents as more
particularly set forth below.
THEREFORE,
Licensor and Licensee agree as follows:
1. Definitions.
a. “Affiliate”
shall mean any person, corporation, or business entity that directly or
indirectly controls, is controlled by, or is under common control with a Party.
As used herein, “control” means ownership or other beneficial interest in 50% or
more of the voting stock or other voting interest of a corporation or other
business entity, or the ability to direct an entity’s affairs or actions.
b. “Business
Day” means a day that is not a Saturday, Sunday or a day on which banking
institutions in New York, New York, United States of America are authorized
or
obligated by law or executive order to close.
c. “Confidential
Information” means all trade secrets or other proprietary information, including
without limitation any proprietary data and materials (whether or not patentable
or protectable as a trade secret), regarding a party’s technology, products,
business or objectives or regarding the Licensed Product, including without
limitation the terms of this Agreement. Notwithstanding the foregoing, there
shall be excluded from the foregoing definition of Confidential Information
any
of the foregoing that:
(i) was
known
by the receiving party or its Affiliates prior to its date of disclosure to
the
receiving party as shown by the receiving party’s written records;
or
(ii) either
before or after the date of the disclosure to the receiving party is lawfully
disclosed to the receiving party or its Affiliates by a Third Party not in
violation of any obligation to the disclosing party; or
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(iii) either
before or after the date of the disclosure to the receiving party becomes
published or generally known to the public through no fault or omission on
the
part of the receiving party or its Affiliates; or
(iv) is
independently developed by or for the receiving party or its Affiliates without
reference to or reliance upon the Confidential Information as demonstrated
by
contemporaneous written records of the receiving party; or
(v) is
required to be disclosed by the receiving party to comply with applicable laws
or to comply with governmental regulations or the regulations or requirements
of
any internationally-recognized stock exchange including the NASDAQ, provided
that the party required to make such disclosure provides prior notice of such
disclosure to the other party (and takes reasonable and lawful actions to avoid
or minimize the degree of such disclosure).
d. “First
Commercial Sale” shall mean the first sale of a Licensed Product to a Third
Party after the first regulatory approval of a Licensed Product by the U.S.
Food
and Drug Administration or foreign counterpart.
e. “Licensed
Patents” shall mean United States Patent No. 6,861,411 and [***]
and
the
foreign counterpart patents and patent applications thereof as well as the
specific patents and patent applications identified in Exhibit A hereto,
together with any reissues, extensions or supplementary protection certificates,
including continuations, divisions or continuation in-part
applications.
f. “Licensed
Products” shall mean the ocular anti-infective product candidate known as
AzaSiteTM
or
ISV-401, containing azithromycin as its sole active ingredient, and
AzaSiteTM
Plus or
ISV-502, an ocular anti-infective product candidate containing azithromycin
and
dexamethasone as its sole active ingredients or other ophthalmic products agreed
to by both parties.
g. “Licensor”
shall mean Pfizer Inc as holder of the United States Licensed Patent and Pfizer
Products Inc as holder of the foreign counterpart patents thereto and all
references to Licensor shall be construed jointly to mean both companies or
individually to mean either company where the context requires.
h. “Net
Sales” shall mean the gross amount of Licensed Products invoiced by Licensee,
any Sublicensee, or any Affiliate of Licensee or any Sublicensee, less sales
returns, and allowances actually paid, granted or accrued, including trade,
quantity and cash discounts, chargebacks, rebates, and customary trade discounts
actually taken, outbound freight, value added tax, sales or use taxes, and
custom or excise duties. Net sales shall be determined from the books and
records or Licensee, Sublicensee or the applicable Affiliate of either Licensee
or a Sublicensee, as maintained in accordance with U.S. generally accepted
accounting principles consistently applied.
*Indicates
that certain information contained herein has been omitted and
filed
separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted
portions.
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i. “Sublicensee”
shall mean any Third Party to whom Licensee or its Affiliates has granted a
sublicense, or other rights, under the Licensed Patents.
j. “Territory”
shall mean the entire world.
k. “Third
Party” shall mean all persons and companies other than Licensor, Licensee, and
their respective Affiliates.
2. License
Grant; Exclusivity.
a. Licensor
hereby grants Licensee, and Licensee accepts from Licensor, an exclusive,
royalty bearing license under the Licensed Patents to make, have made, use,
sell, offer for sale, import and make regulatory filings with respect to
Licensed Products in the Territory and export components of Licensed Products
from any country in the Territory for the purpose of making Licensed Products
outside that country, but not to the extent that such components are covered
by
Pfizer patents other than Licensed Patents, together with the right to grant
sublicenses subject to Section 2(b).
b. Licensee
and its Affiliates shall have the right to grant sublicenses to any of the
rights granted to Licensee under Section 2(a), subject to Licensee’s prior
approval in each instance, such approval not to be unreasonably delayed,
withheld or conditioned.
c. Licensee
shall notify Licensor in writing within ten (10) business days of entering
into
any agreement with a Sublicensee or any agreement whereby a Third Party acquires
all or substantially all of the assets of Licensee or the right through
assignment or sublicense to development or commercialize Licensed Products,
and
shall with such notification provide Licensor with full and complete copies
of
any such agreement, which agreements Licensor shall maintain confidential
pursuant to Section 11 of this Agreement.
3. Royalties
and Payments.
*Indicates
that certain information contained herein has been omitted and
filed
separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted
portions.
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In
consideration of the license granted under this Agreement, Licensee shall pay
Licensor [***]
of
Net
Sales of Licensed Products in each country in the Territory in which a Licensed
Patent is in force.
4.
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Reports
and Payments.
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a. Within
thirty (30) days after the conclusion of each calendar quarter commencing with
the calendar quarter in which the First Commercial Sale of a Licensed Product
occurs, Licensee shall submit to Licensor a written report for such quarter
stating, to the extent applicable:
i. Total
amounts invoiced for Licensed Products, broken down by Licensed Product, the
entity rendering such invoice, and the country in the Territory in which such
sales were made, and showing the details of all deductions taken as part of
the
calculation of Net Sales; and
ii. A
calculation of the amounts due to Licensor.
b. Simultaneously
with the submission of each such report, Licensee shall make payment to Licensor
of the amount due. Each payment hereunder shall be made by electronic transfer
in immediately available funds via either a bank wire transfer, an ACH
(automated clearing house) mechanism, or any other means of electronic funds
transfer, at Licensee’s election, to the bank account set out below or to such
other bank account as Licensor shall designate in a notice at least five (5)
Business Days before the payment is due.
Bank: [***]
Swift
Code:
[***]
Account
Name: [***]
Account
#: [***]
Licensee
also agrees to use best efforts or cause any Sublicensee or the applicable
Affiliate of either Licensee or any Sublicensee to use best efforts to provide
estimated monthly net sales of Licensed Products sufficient for Pfizer to record
royalties in the period earned in accordance with US GAAP and to meet SEC
reporting requirements.
*Indicates
that certain information contained herein has been omitted and
filed
separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted
portions.
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c. Licensee
shall maintain at its principal office usual books of account and records
showing its actions under this Agreement. Upon reasonable notice, and at
Licensor’s sole cost and expense, such books and records shall be open to
inspection and copying not more than once per year, during usual business hours,
by an independent certified public accountant to whom Licensee has no reasonable
objection, for three years after the calendar quarter to which they pertain,
for
purposes of verifying the accuracy of the amounts paid by Licensee under this
Agreement. The determination of such certified public accountant shall be
binding on the parties save for instances of manifest error. Any understatement
of payments due to Licensor shall be made by Licensee within ten (10) business
days after demand by Licensor. Any overstatement of payment due shall be
credited against the next payment due to Licensor under Section 4 hereof. In
the
event that such review reveals that any payment to Licensor was understated
by
more than 5%, Licensee shall also pay, within ten (10) business days after
demand by Licensor, the reasonable cost of such review. Each agreement with
a
Sublicensee shall contain analogous provisions that also allow Licensee to
conduct audits of the Sublicensee. Upon reasonable request by Licensor, Licensee
shall permit an independent accounting firm selected by Licensor to conduct
audits of the Sublicensee on Licensor’s behalf.
d. All
payments due under this Agreement shall be made in U.S. dollars. Payments
arising from transactions conducted in currency other than U.S. dollars shall
first be determined in such currency and then converted to U.S. dollars using
the average exchange rates for the month in which the transactions occurred,
as
published by the U.S. Federal Reserve in Federal Reserve Statistical Release
G5
- Foreign Exchange Rates (xxxx://xxx.xxxxxxxxxxxxxx.xxx/xxxxxxxx/X0).
If the
average exchange rate for a currency is not published by the Federal Reserve,
conversion shall be made based on the average mid closing rate of exchange
quoted by Bloomberg (or its successor) for the same time period.
e. Any
payments made under Section 4 of this Agreement are exclusive of any VAT or
similar tax imposed upon such payments. The parties agree to co-operate with
one
another and use reasonable efforts to avoid or reduce withholding tax or similar
obligations is respect of any royalties, however, in the event any of the
payments made by Licensee pursuant to Section 4 become subject to
withholding taxes under the laws of any jurisdiction, Licensee shall deduct
and
withhold the amount of such taxes for the account of Licensor to the extent
required by law, such amounts payable to Licensor shall be reduced by the amount
of taxes deducted and withheld, and Licensee shall pay the amounts of such
taxes
to the proper governmental authority in a timely manner and promptly transmit
to
Licensor an official tax certificate or other evidence of such tax obligations
together with proof of payment from the relevant governmental authority of
all
amounts deducted and withheld sufficient to enable Licensor to claim such
payment of taxes. Licensee will provide Licensor with reasonable assistance
to
enable Licensor to recover such taxes as permitted by law.
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f. All
payments under any provision of this Agreement shall bear interest from the
date
due until paid at a rate equal to three percentage points above the prime rate
of Citibank, N.A. (or its successor) in New York, New York, as announced on
the
date such payment was due, compounded monthly. In addition, Licensee shall
reimburse Licensor for all reasonable costs and expenses, including without
limitation reasonable attorneys’ fees and legal expenses, incurred in the
collection of late payments.
5. Diligence.
Licensee
shall use reasonable commercial efforts, either itself or in collaboration
with
a Sublicensee, to seek regulatory approval for and market Licensed Products
in
countries in the Territory in which a Licensed Patent is in force.
6.
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Representations
and Warranties; Disclaimer of Warranties; Limitations of
Liability.
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a. Each
party represents and warrants to the other that, as of the date
hereof:
(i) it
is
duly organized and validly existing under the laws of its state of
incorporation, and has full corporate power and authority to enter into this
Agreement and to carry out the provisions hereof;
(ii) it
is
duly authorized to execute and deliver this Agreement and to perform its
obligations hereunder, and the person or persons executing this Agreement on
its
behalf has been duly authorized to do so by all requisite corporate action;
and
(iii) once
executed by an authorized officer, this Agreement is legally binding upon it
and
enforceable in accordance with its terms.
b. Licensee
represents and warrants as of the date hereof that there are no pending or
threatened claims, nor has it previously received any claims, alleging that
use
of a Licensed Product has resulted in death or bodily harm.
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c. Nothing
in this Agreement shall be construed as a warranty or representation by Licensor
as to the validity or enforceability of any Licensed Patent or that Licensed
Products are or shall be free from infringement of domestic or foreign patents
or other proprietary interests (including copyright) of any Third Party.
LICENSOR IS LICENSING THE LICENSED PATENTS TO LICENSEE ON AN "AS
IS"
BASIS.
LICENSOR MAKES NO WARRANTIES EITHER EXPRESS OR IMPLIED OF ANY KIND, AND HEREBY
EXPRESSLY DISCLAIMS ANY WARRANTIES, REPRESENTATIONS OR GUARANTEES OF ANY KIND
AS
TO THE LICENSED PATENTS, THE SUBJECT OF ANY LICENSE HEREUNDER AND/OR LICENSED
PRODUCTS, INCLUDING BUT NOT LIMITED TO, ANY WARRANTIES OF MERCHANTABILITY,
FITNESS, ADEQUACY OR SUITABILITY FOR A PARTICULAR PURPOSE, USE OR RESULT, AND
ANY WARRANTIES OF FREEDOM OF INFRINGEMENT OF ANY PATENTS, COPYRIGHTS, TRADE
SECRETS OR OTHER PROPRIETARY RIGHTS. NEITHER LICENSOR, NOR ANY EMPLOYEE OR
AGENT
OF LICENSOR, SHALL HAVE ANY LIABILITY TO LICENSEE, ITS AFFILIATES, OR
SUBLICENSEES, OR ANY OTHER PERSON ARISING OUT OF THE USE OF LICENSED PATENTS
OR
LICENSED PRODUCTS INCLUDING BUT NOT LIMITED TO THE LACK OF MERCHANTABILITY,
INADEQUACY OR UNSUITABILITY OF THE LICENSED PATENTS OR LICENSED PRODUCTS FOR
ANY
PARTICULAR PURPOSE OR TO PRODUCE ANY PARTICULAR RESULT, OR FOR ANY LATENT
DEFECTS THEREIN.
c. In
no
event shall Licensor be liable to Licensee, its Affiliates, or Sublicensees
for
any loss or damages, consequential, incidental, indirect or otherwise,
including, but not limited to time, money, or goodwill, arising from the use,
operation or application of the Licensed Patents.
7.
Prohibition
Against Use of Licensor’s Name and Trademarks.
a. Except
as
may be required by law or regulation, or in connection with factual reports
of
its license and sublicensing rights hereunder, Licensee shall not use the name,
insignia, or symbols of Licensor for any purpose whatsoever without Licensor's
prior written consent.
b. No
rights
are granted under this Agreement by Licensor to Licensee to the use of
Licensor’s registered trademark Zithromax, or any other trademark confusingly
similar thereto, and all rights to that trademark are expressly reserved by
Licensor.
8. Patent
Prosecution, Maintenance and Infringement.
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a. Licensor
shall have the right to control the prosecution and maintenance of the Licensed
Patents. Licensor shall provide Licensee with copies of all material
correspondence and communications filed with or received from a patent office
in
connection with prosecution and maintenance of the Licensed Patents, and shall
receive and consider in good faith suggestions and comments from Licensee on
prosecution matters. Licensee shall reimburse Licensor for invoiced expenses
incurred following the Effective Date of this Agreement in filing, prosecuting
and maintaining Licensed Patents, including attorneys’ fees, the costs of any
interference proceedings, reexaminations, or any other ex parte or inter partes
administrative proceeding before patent offices, taxes, annuities, issue fees,
working fees, maintenance fees and renewal charges, with payment from Licensee
to Licensor for such reimbursements due ten (10) business days following an
invoice from Licensor to Licensee for such expenses. The reimbursement
obligation in the proceeding sentence is limited to a maximum of USD [***]
in
the aggregate during the term of this Agreement. If Licensee declines to pay
Licensor for such amounts for Licensed Patents a particular country, its license
under the Licensed Patents in such country shall terminate. Any prosecution
costs as described above in excess of the [***] aggregate limit, shall be the
Licensor’s obligation without disturbance to the rights granted to the Licensee
under this Agreement. Licensor shall notify Licensee if it elects to abandon
the
prosecution of any patent application or maintenance of any patent within the
Licensed Patents in any country in the Territory at least 30 days prior to
the
date on which such application or patent will lapse or go abandoned. Licensee
shall then have the option, exercisable upon written notice to Licensor, to
assume full responsibility, at Licensee’s discretion, cost and expense, for
prosecution of such application or maintenance of such patent in such country.
The exercise by the Licensee of this options shall not affect any other
provision of this Agreement, including the obligation to make payments in
Section 3, all of which remain in full force and effect.
b. Licensor
shall have the right, but not the obligation, to enforce the Licensed Patents
and prosecute infringers at its own expense when in its sole judgment such
action may be reasonably necessary, proper, and justified.
c. If
Licensee shall have supplied Licensor with written evidence reasonably
demonstrating the likely infringement or future infringement of a claim of
a
Licensed Patent by a Third Party selling products in competition with Licensee
or any of its Affiliates or Sublicensees, Licensee may by notice request that
Licensor take steps to assert the Licensed Patent against such Third Party.
Unless
Licensor shall within ninety (90) days of the receipt of such notice either:
(i)
cause such infringement to terminate or (ii) initiate legal proceedings against
the infringer, Licensee may, upon notice to Licensor, initiate legal proceedings
against the infringer at the sole expense of Licensee, provided however, that
if
the evidence that Licensee shall have supplied Licensor relates to the filing
of
an Abbreviated New Drug Application (or equivalent regulatory mechanism seeking
approval for authorization to market a generic equivalent to a Licensed Product,
an “ANDA”) in any country within the Territory, Licensee may, following
reasonable notice to Licensor, initiate legal proceedings against the infringer
at the sole expense of Licensee if delay in initiation of proceedings would
result in the loss of rights or other material consequences pursuant to 28
U.S.C. § 355(j)(5)(B)(iii) or other similar statute, rule, or regulation. If
Licensee requests Licensor to commence or to join in any litigation for legal
purposes, Licensor agrees to do so at Licensee’s sole cost and
risk.
*Indicates
that certain information contained herein has been omitted and
filed
separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted
portions.
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d. Except
as
otherwise agreed to by the parties as part of a cost sharing arrangement, any
recovery
realized as a result of assertion of a Licensed Patent against an infringer,
after reimbursement of any litigation expenses of each party, shall
be
treated as though it were Net Sales under this Agreement.
e. In
the
event one party shall initiate or carry on legal proceedings to enforce any
Licensed Patent against an alleged infringer, the other party shall reasonably
cooperate with and supply all assistance reasonably requested by the party
initiating or carrying on such proceedings. The party that institutes any
proceeding to protect or enforce a Licensed Patent shall be responsible for
the
reasonable expenses incurred by said other party in providing such assistance
and cooperation as is requested pursuant to this paragraph. In no event shall
Licensee or Licensor settle any action or claim hereunder without the
other’s written
consent where (i) such settlement would include any admission on the issues
of
patent validity, patent infringement or enforceability or any liability on
the
part of the other, (ii) such settlement would impose any restrictions on the
other’s conduct of its activities, or (iii) such settlement would not include an
unconditional release of the other from all liability of all claim(s) that
are
the subject matter of the settled action or claim.
f. For
the
avoidance of doubt, (i) nothing in this Agreement shall be deemed to grant
Licensee the right to control or direct prosecution of, or legal proceedings
on,
any patent or patent application owned by Licensor that is not a Licensed
Patent, or to grant Licensee a license or other rights in or to any such other
patent or patent application, and (ii) nothing in this Agreement shall be deemed
to grant Licensor the right to control or direct prosecution of, or legal
proceedings on, any patent or patent application owned by Licensee or its
Affiliates, or to grant Licensor a license or other rights in or to any such
other patent or patent application.
g. Licensee
and its Affiliates shall not directly or indirectly challenge or induce any
third party to challenge the validity or enforceability of the Licensed Patents,
or any patent claim(s) therein, or initiate or participate in any re-examination
or other proceeding related to the validity, enforceability or patentability
of
any claim of the Assigned Patents before any tribunal or patent office. This
section shall not prohibit Licensee and its Affiliates from responding to a
subpoena, process, or discovery requests in any litigation or administrative
proceeding provided that Licensee gives prompt notice to Licensor of the receipt
of said subpoena, process or discovery requests. Licensee shall procure that
any
Sublicensee shall agree to a provision in substantially the same terms as
contained in this Section.
*Indicates
that certain information contained herein has been omitted and
filed
separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted
portions.
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h. Licensee
agrees within [***]days
of
the execution of this Agreement to file [***]
substantially
in the form of Exhibit
B
to this
Agreement. Neither Licensor nor Licensee shall seek any award of fees or costs
in the [***].If
reasonably necessary or if required by [***],
the
parties shall modify the form and content of Exhibit
B
to the
extent necessary to effect properly the [***].
i. Pfizer
will take all necessary steps to [***].
9. Indemnity
and Insurance.
a. Licensee
shall indemnify and hold Licensor harmless against any and all third-party
actions, suits, claims, demands, prosecutions, including, without limitation,
those resulting from a Third Party claim for death or bodily harm arising in
connection with use of a Licensed Product, and all resulting liabilities, costs,
expenses, damages, deficiencies, loss or obligations (including reasonable
attorneys’ fees) based on or arising out of this Agreement, including, without
limitation, (i) the development, manufacture, packaging, use, or sale of
Licensed Products, even if the Licensed Products are altered for use for a
purpose not intended, (ii) the use of Licensed Patents by Licensee, its
Affiliates, its Sublicensees or its (or their) customers and (iii) any
representation made or warranty given by Licensee, its Affiliates or
Sublicensees with respect to Licensed Products or Licensed Patents. Licensee
shall reimburse Licensor for any out-of-pocket costs incurred by Licensor in
enforcing this Section 9(a).
b. Licensee
shall maintain, and shall cause each Sublicensee to maintain during the term
of
this Agreement, commercial general liability insurance, including product
liability insurance, with reputable and financially secure insurance carriers,
on commercially reasonable and prudent terms and limits.
10. Patent
Marking.
*Indicates
that certain information contained herein has been omitted and
filed
separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted
portions.
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To
the
extent required by and in conformance with any applicable laws, Licensee shall
xxxx Licensed Products, and shall cause its Sublicensees to xxxx Licensed
Products, with the numbers of the applicable Licensed Patents.
11. Confidentiality
and Publicity.
a. Confidentiality.
The
parties agree that during the term of the licenses granted hereunder, a party
receiving Confidential Information of the other party will (a) maintain in
confidence such Confidential Information to the same extent such party maintains
its own proprietary industrial information of similar kind and value, (b) not
disclose such Confidential Information to any Third Party without prior consent
of the other party (other than as may be required by law, regulation, or
judicial process, in which case all reasonable efforts shall be made to limit
the extent of disclosure or to make disclosure only under a confidentiality
order), provided that disclosure to a Sublicensee is permitted where the
Sublicensee has agreed to confidentiality obligations no less stringent than
contained in this Agreement and (c) not use such Confidential Information for
any purpose except those permitted by this Agreement, except that a party may
disclose this Agreement and its terms (i) as may be necessary to implement
such
terms, (ii) as may be required by law, regulation, or judicial process, in
which
case the other party will be given ten (10) days’ prior written notice of such
disclosure and all reasonable efforts shall be made to limit the extent of
disclosure or to make disclosure only under a confidentiality order), or (iii)
in connection with due diligence disclosures related to a possible acquisition,
divestiture, merger, consolidation, substantial asset transfer, formation of
a
joint venture, or similar transaction, but only pursuant to a written
confidentiality agreement with the recipient.
b. Publicity.
The
public announcement of the execution of this Agreement is set forth in
Exhibit
C
attached
hereto and may be promptly disseminated following the execution of this
Agreement by any party. Except for such announcement, no party may make a public
statement or disclosure (written or oral), including in analyst meetings,
concerning the terms of this Agreement without the other party’s prior written
consent, except where such statement is required by applicable law, stock
exchange rule, or legal proceedings. In the case of any such required public
statement or disclosure pursuant to the immediately preceding sentence, the
party required to make such statement or disclosure shall (i) endeavor to obtain
confidential treatment of economic and trade secret information; (ii) include
in
such statement or disclosure only the information that, after consultation
with
counsel, such party believes is required by applicable law to be disclosed
and
(iii) provide the other party with a copy of such statement sufficiently in
advance of dissemination so that the other party will have the opportunity
to
comment upon the statement, and shall give due consideration to any comments
of
the other party in the final statement.
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12. Export Control Laws.
This
Agreement is made subject to any restrictions concerning the export of products
or technical information from the United States of America which may be imposed
from time to time by the government of the United States of America. Licensee
agrees that it shall not export or re-export, directly or indirectly, Licensed
Products, any technical information acquired from Licensor, or any products
using such technical information to any country for which the United States
government or any agency thereof at the time of export requires an export
license or other governmental approval, without first obtaining the written
consent to do so from the Department of Commerce or other agency of the United
States government when required by an applicable statute or regulation.
13.
Breach
and Cure.
Either
party shall have the right to cure its material breach. The cure shall be
effected within [***] after notice of any breach given by the non-breaching
party, or [***] days in the event of a payment obligation.
14. Term
of Agreement.
a. This
Agreement shall be effective as of the date first set forth above and shall
continue in full force and effect until its expiration or termination in
accordance with this Section 14.
b. Unless
terminated earlier under any provision of this Agreement, the term of the
licenses granted hereunder shall extend, on a country-by country basis, until
the date of expiration of the last to expire of the Licensed Patents in such
country, at which time the licenses granted hereunder for such country shall
become fully paid-up.
c. This
Agreement may be terminated by Licensor: (i) upon written notice to Licensee
for
its material breach of this Agreement and failure to cure such material breach
in accordance with Section 13; or (ii) should Licensee, become bankrupt or
insolvent, file a petition under any bankruptcy or insolvency act or have any
such petition filed against it; or (iii) should Licensee or any Sublicensee
challenge the validity or enforceability of the Licensed Patents notwithstanding
the prohibition against such challenge as provided in Section 8(g).
*Indicates
that certain information contained herein has been omitted and
filed
separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted
portions.
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d. This
Agreement may be terminated by Licensee: (i) upon written notice to Licensor
for
its material breach of this Agreement and failure to cure such material breach
in accordance with Section 13; or (ii) should Licensor become bankrupt or
insolvent, file a petition under any bankruptcy or insolvency act or have any
such petition filed against it.
e. The
provisions of Sections 4(c) (Audit), 6 (Representations and Warranties),
9 (Indemnity and Indemnification), 11 (Confidentiality), and, 20 (Governing
Law and Jurisdiction), as well as any other Sections or defined terms referred
to in such Sections or necessary to give them effect shall survive termination
or expiration of this Agreement and remain in force until discharged in full.
Furthermore, any other provisions required to interpret and enforce the parties’
rights and obligations or to wind up their outstanding obligations under this
Agreement shall survive to the extent required.
15. Notices.
Any
notice required or permitted to be given under this Agreement shall be
sufficient if in writing and shall be considered given: (i) when mailed by
certified mail (return receipt requested), postage prepaid, (ii) when deposited
with a reputable overnight courier (e.g., FedEx, DHL, UPS), or (iii) on the
date
of actual delivery by hand or overnight delivery, with receipt acknowledged,
or
to such other address as a party may specify by notice hereunder.
if
to Licensor, to:
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Pfizer
Inc. and Pfizer Products Inc.
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000
Xxxx 00xx
Xxxxxx
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Xxx
Xxxx, Xxx Xxxx 00000-0000
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XXX
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Attn:General
Counsel
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|||
if
to Licensee, to:
|
InSite
Vision Incorporated
|
||
000
Xxxxxxxx Xxxxxx
|
|||
Xxxxxxx,
Xxxxxxxxxx 00000
|
|||
|
Attn:
Chief Executive Officer
|
*Indicates
that certain information contained herein has been omitted and
filed
separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted
portions.
|
13
copy
to:
|
O’Melveny
& Xxxxx LLP
|
||
0000
Xxxx Xxxx Xxxx
|
|||
Xxxxx
Xxxx, Xxxxxxxxxx 00000
|
|||
Attn:
Xxx Xxxxx, Esq.
|
16. Assignment.
a. Neither
Agreement nor any rights or obligations hereunder may be assigned by Licensee
without Licensor’s written consent; except only notice (and not consent) shall
be required for Licensee to assign to (i) an Affiliate provided that Licensee
shall remain jointly and severally liable with such Affiliate in respect of
all
obligations so assigned and such Affiliate has acknowledged in writing that
it
shall be bound by this Agreement as if it were a party hereto, (ii) any
successor in interest by way of merger, acquisition or sale of all or
substantially all of the assets of Licensee related to the subject matter hereof
provided that such successor agrees in writing to be bound by the terms of
this
Agreement as if it were the Licensee. Any attempt to assign without compliance
with this provision shall be void.
b. This
Agreement and any rights or obligations hereunder may be assigned by Licensor
provided that Licensor provides Licensee with notice of such
assignment.
17. Waiver.
The
failure of any party to insist upon strict adherence to any term of this
Agreement on any occasion shall not be considered a waiver or deprive that
party
thereafter of the right to insist upon strict adherence to that term or any
other term of this Agreement. All waivers must be in writing and signed by
an
authorized representative of the party against which such waiver is being
sought.
18. No
Agency or Joint Venture.
Licensee
is not an agent, joint venturer, or partner of Licensor, and the parties have
not created and do not intend to create an agency, joint venture, or partner
relationship.
19. Entire
Agreement; Amendment.
14
This
Agreement sets forth the entire agreement between the parties concerning the
subject matter hereof and supersedes all previous agreements, written or oral,
concerning such subject matter including the Confidentiality Agreement between
the parties and Inspire Pharmaceuticals, Inc. dated January 12, 2007. This
Agreement may be amended only by written agreement duly executed by the
parties.
20. Governing
Law.
This
Agreement shall be governed by New York law applicable to agreements made and
to
be performed exclusively in the State of New York. Any dispute related to or
arising out of this Agreement or the parties’ relationship hereunder shall be
heard only in the state or federal courts located in New York County, New York,
and the parties, their successors and assigns consent and submit to the
jurisdiction of such courts for such purpose.
21. No
Third Party Beneficiary.
None
of
the provisions of this Agreement shall be for the benefit of or enforceable
by
the Third Party, including any creditor of either party. No such Third Party
shall obtain any right under any provision of this Agreement or shall by reasons
of any such provision make any claim in respect of any debt, liability or
obligation (or otherwise) against either party.
22. Binding
Effect.
This
Agreement shall be binding upon and inure to the benefit of the parties hereto
and their respective heirs, successors and permitted assigns.
15
23. Counterparts.
This
Agreement may be executed in any two or more counterparts, each of which, when
executed, shall be deemed to be an original and all of which together shall
constitute one and the same document.
24.
Headings.
Headings
in this Agreement are included herein for ease of reference only and shall
have
no legal effect.
25.
Severability.
If
and
solely
to
the extent that any provision of this Agreement shall be deemed invalid or
unenforceable by a court or other governmental entity, such offending provision
shall be of no effect and shall not affect the validity of the remainder of
this
Agreement or any of its provisions; provided, however, the parties shall use
their respective reasonable efforts to renegotiate the offending provisions
to
best accomplish the original intentions of the parties.
16
IN
WITNESS THEREOF,
Licensor and Licensee have caused this Agreement to be executed by their duly
authorized representatives as of the day and year first written
above.
PFIZER
INC
By:____________________________
PFIZER
PRODUCTS INC
By:____________________________
INSITE
VISION, INCORPORATED
By:____________________________
17
EXHIBIT
A
The
Licensed Patents
Docket
(PC #) [***]
Descriptive
Title: compositions
for treating ocular infections
Patent
Title: METHOD
OF TREATING EYE INFECTI ONS WITH AZITHROMYCIN
|
Country
Status App
Number Patent
Filing
[***]
|
18
EXHIBIT
B
[***]
19
EXHIBIT
C
InSite
Vision Announces Patent Agreement with Pfizer
ALAMEDA,
Calif. (February X,
2006)
--
(BUSINESS WIRE)--InSite Vision Incorporated (AMEX:ISV) -- an ophthalmic
therapeutics, diagnostics and drug delivery company, today announced that it
has
entered into a worldwide, exclusive royalty bearing licensing agreement with
Pfizer Inc. (NYSE:PFE) under Pfizer’s Patent family titled “Method of Treating
Eye Infections with Azithromycin”. Pfizer’s granting of this license will
enhance the position and marketability of InSite’s AzaSite
franchise.
X.
Xxxxx
Xxxxxxxxxxxxxx, Ph.D., InSite Vision's chief executive officer stated, "The
execution of the Pfizer license represents a significant milestone in the
development of InSite Vision's AzaSite franchise. Combined with our existing
azithromycin and DuraSite drug-delivery patents, this license further broadens
InSite Vision's global patent portfolio.”
Under
the
terms of the agreement, Pfizer will grant InSite a worldwide, exclusive license,
including the right to sublicense, to US and all foreign counterparts patents
on
the parent case titled “Method of Treating Eye Infections with Azithromycin” and
patent applications together with any reissues, extensions, or supplementary
protection certificates of any of the foregoing for use in connection with
InSite’s AzaSite franchise products.
About
InSite Vision Incorporated
InSite
Vision is an ophthalmic company focused on developing therapies that treat
ocular infections, glaucoma and retinal diseases. InSite Vision’s lead product
is AzaSite, which targets infections of the eye. AzaSite contains the drug
azithromycin, a broad-spectrum antibiotic formulated with DuraSite, InSite
Vision's patented drug-delivery vehicle, which offers the benefit of a
low-dosing regimen, attractive to both the eye-care patient and physician.
Pending the approval of its NDA with the FDA, InSite Vision currently expects
AzaSite to be commercially launched in the United States, while seeking to
expand this "technology platform" to include additional product candidates
and
indications for the worldwide market.
In
the glaucoma area, InSite Vision continues to focus genomic research on the
TIGR
gene, among other genes in its genomic portfolio. A portion of this research
has
been incorporated into InSite Vision’s commercially available OcuGene(R)
glaucoma genetic test for disease management, which is a prognostic tool
designed to detect a genetic marker (mt-1) in the promoter region of the
glaucoma-related TIGR gene.
Additional
information can be found at our website, xxx.xxxxxxxxxxxx.xxx.
20
This
news release contains, among other things, certain statements of a
forward-looking nature relating to future events or the future business
performance of InSite Vision, such as the Company's ability to obtain FDA
approval of its NDA for AzaSite and the commercialization of the Company’s
AzaSite product. Such statements entail a number of risks and uncertainties,
including but not limited to: InSite Vision’s ability to obtain substantial
additional immediate funding to continue its operations; the results of InSite
Vision's clinical trials; the ability to obtain FDA approval of its AzaSite
NDA
from the FDA for the commercialization of AzaSite and its other product
candidates; the ability of InSite Vision to enter into a corporate collaboration
for its AzaSite and other product candidates; the ability to launch AzaSite
and
the timing of such a launch; InSite Vision's ability to expand its technology
platform to include additional indications and patent options; the effects
of
its expense control activities on its operations and product development; its
ability to obtain regulatory approval and market acceptance of its products
and
product candidates, including its OcuGene glaucoma genetic test, XxxXxxx,
XXX-000 and ISV-014; InSite Vision's ability to maintain and develop additional
collaborations and commercial agreements with corporate partners, including
those with respect to AzaSite and ISV-205; its reliance on third parties for
the
development, marketing and sale of its products; the initiation and results
of
preclinical and clinical studies; its ability to adequately protect its
intellectual property and to be free to operate with regard to the intellectual
property of others; determinations
by the FDA, including those with respect to OcuGene, AzaSite and ISV-205 as
described in detail in and including the other risks described in InSite
Vision's filings with the Securities and Exchange Commission, including its
annual report on Form 10-K and its quarterly reports on Form 10-Q, under the
caption “Risk Factors” and elsewhere in such reports. Any forward-looking
statements or projections are based on the limited information currently
available to InSite Vision, which is subject to change. Although any such
forward looking statements or projections and the factors influencing them
will
likely change, InSite Vision undertakes no obligation to update the information.
Such information speaks only as of the date of its release. Actual events or
results could differ materially and one should not assume that the information
provided in this release is still valid at any later date.
Note
to Editors: OcuGene(R) is written with a "small cap" G; if doing so is not
possible, please use an upper case G. InSite Vision Incorporated, InSite Vision,
DuraSite(R) and OcuGene(R) are trademarks of InSite Vision Incorporated. Other
trademarks that may be mentioned in this release are the intellectual property
of their respective owners.
#######
Investor
Contact:
Ashton
Partners
Xxxxx
Xxxxxx
000-000-0000
xxx.xxxxxxxxxxxxxx.xxx
21