EXHIBIT 10.42
CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTIONS.
ISV-403 TECHNOLOGY LICENSE AGREEMENT
NOTE: THE LICENSE GRANTED HEREIN INCLUDES A SUBLICENSE BY INSITE VISION
INCORPORATED OF RIGHTS UNDER THE JOINT SS732/SS734 PRODUCT DEVELOPMENT AND
CROSS-LICENSE AGREEMENT, DATED APRIL 15, 2001 (AS AMENDED), ENTERED INTO BETWEEN
INSITE VISION INCORPORATED AND SSP CO. LTD., AND MUST BE READ IN CONJUNCTION
WITH SUCH AGREEMENT.
THIS LICENSE AGREEMENT ("Agreement") is made as of the 7th day of August, 2002
("Effective Date") by and between INSITE VISION INCORPORATED, a Delaware
corporation with an office at 000 Xxxxxxxx Xxxxxx, Xxxxxxx, XX 00000
("Licensor") and BAUSCH & LOMB INCORPORATED, a New York corporation with an
office at One Bausch and Lomb Place, Rochester, NY 14604 ("B&L").
WHEREAS, Licensor owns, alone and jointly with others, and has rights under
licenses from third parties certain patent rights and other intellectual
property and know-how relating to ISV-403, a fluoroquinolone in DuraSite
formulation which is stable without refrigeration (defined below as
"Technology");
WHEREAS, B&L desires to acquire, and Licensor is willing to grant to B&L, a
license under such proprietary rights and related know-how under the terms and
conditions set forth herein.
THEREFORE, in consideration of these premises and the promises in this
Agreement, the parties agree as follows:
1.0 DEFINITIONS
The following defined terms are used in this Agreement.
1.1 "Affiliate" of either party means all Persons that directly or
indirectly are controlled by, control or are under common control
with B&L or Licensor as the case may be.
1.2 "Control" means the possession, directly or indirectly, of the
power to direct or cause the direction of management of a Person,
whether through ownership of voting securities, by contract or
otherwise.
1.3 "Clinical Intellectual Property" or "Clinical IP" means (i)
pre-clinical or clinical protocols and data resulting from or
relating to pre-clinical or clinical trials incorporating the
Technology and that were performed before the Effective Date or
are performed or developed during the term of this Agreement and
(ii) all Investigational New Drug Applications ("INDs"), New Drug
Applications ("NDAs") and other regulatory applications and
approvals.
1.4 "Development Activities" means work carried out by Licensor or
B&L or their agents, consultants or contractors, to implement or
support the Development Plan.
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1.5 "Development Plan" means a proposed program to establish the
efficacy and scope of the Technology (as the Parties may agree)
and to obtain regulatory approval for the Technology. Exhibit 1.5
provides the schedule of major Development Activities, from which
the Joint Committee will prepare the Development Plan.
1.6 "FDA" means the United States Food and Drug Administration or any
successor entity thereto.
1.7 "First Commercial Sale" means with respect to any Product, the
first sale or other commercial disposition for value (including
goodwill generated by distribution of free or discounted trade
size product in conjunction with the sale or promotion of other
products or services offered by B&L or a Sublicensee) generating
"Net Sales" by B&L or a Sublicensee for use or consumption by the
general public in any country.
1.8 "Field" means [***].
1.9 "Intellectual Property" means the Patent Rights and Know-How, but
it shall not include any intellectual property right invented,
discovered, authored, or otherwise wholly-owned by B&L or any
other intellectual property right of Licensor.
1.10 "Joint Review Committee" means a team consisting of [***]
appointed by Licensor and [***] appointed by B&L to review
periodically the progress of the Development Plan. The Joint
Review Committee shall include the Project Coordinators.
1.11 "Know-How" means all technology, engineering data, trade secrets,
technical data, manufacturing information, pre-clinical and
clinical data and any other information or experience (other than
as disclosed in the Patent Rights) that Licensor owns or has the
right to license that is used in or is directly related to the
Technology, as well as any direct improvements or modifications
thereto (other than that disclosed in Patent Rights) developed by
Licensor in the Field during the Term.
1.12 "Net Sales" means, in any case where a Product is sold or
commercially disposed of for value by B&L or any Sublicensee in
an arm's length transaction with a third party (other than an
Affiliate of, respectively, B&L or Sublicensee, it being intended
that royalties accrue only once on the same unit of Product), the
gross invoice price for such Product, less the following:
(a) discounts, charge-backs, [***] actually taken or allowed;
(b) credits or allowances given or made for rejections or
return of any previously sold Products actually taken or
allowed; and
(c) to the extent included in such gross invoice price, any
tax or government charge imposed on the production,
import, export, sale, delivery or use of such Products,
including, without limitation, any value added or similar
tax or government charge, but not including any tax levied
with respect to income.
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(d) to the extent included as a specific line item in such
gross invoice price any reasonable and documented [***].
For the purposes of determining Net Sales, a sale shall be deemed
to have occurred as determined by B&L in accordance with the
published revenue recognition policies of its Corporate
Accounting Department.
Notwithstanding any other provision of this Section 1.12, Net
Sales shall not include the transfer without consideration of any
Product by B&L or a Sublicensee:
(i) for use in any clinical trial or in any
pre-clinical or other research;
(ii) [***]; or
(iii) [***],
provided; however, that [***]
In the event of any free or discounted distribution of Product
expressly as part of a transaction involving the sale or
promotion of other products or services offered by B&L or a
Sublicensee, the value of Net Sales shall be [***].
1.13 "Patent Rights" means any patents or patent applications relating
to the Technology (as defined below in Section 1.23) that
Licensor owns or has the right to license that claim or relate to
the Technology, but only to the extent of Licensor's rights under
the SSP License with respect to rights licensed under the SSP
License. The term "Patent Rights" includes any continuations,
continuations in part, divisions, re-examinations, re-issues,
extensions, and improvement patents of any of the patents or
patent applications listed in Exhibit 1.13 and any foreign
equivalents thereof, but only to the extent of Licensor's rights
under the SSP License with respect to rights licensed under the
SSP License. Patent Rights shall include any patent or patent
application that claims any improvement or enhancement related to
the Technology made or discovered by Licensor, its agents,
consultants or contractors in the course of the Development
Activities during the Term, but only to the extent of Licensor's
rights under to the SSP License with respect to rights licensed
under the SSP License.
1.14 "Person" means any natural person, corporation, partnership,
firm, organization, limited liability company, trust, business
trust, association, joint stock company, joint venture, pool,
syndicate, sole proprietorship, unincorporated organization, any
government or agency or political subdivision thereof, or any
other entity.
1.15 "Product" means an item offered for sale that embodies the
Technology or is covered by the Patent Rights.
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1.16 "Project Coordinators" mean those individuals designated in
writing by each party from time to time to coordinate Development
Activities set forth in Section 3.
1.17 "Quarter" means B&L fiscal quarters, currently based on the fifty
two or fifty three week period ending on the last Saturday in
December, as published by the B&L Finance Department annually.
1.18 "Regional Regulatory Authority(ies)" means the competent
authority for each country of the world, or for any relevant
grouping of countries, legally responsible for authorizing the
sale, supply or distribution of Products in that country or
group.
1.19 "Royalty Period" means the period beginning on the date of the
First Commercial Sale in a particular country and terminating
upon the later of (i) the last to expire of any issued and
enforceable patent within the Patent Rights which covers the
actual manufacture, use, sale or importing of such Product in
such country, and (ii) [***] from the First Commercial
Sale of such Product in the applicable country.
1.20 "SSP License" shall mean the Joint SS732/SS734 Product
Development and Cross-License Agreement, dated April 15, 2001,
(as amended) entered into between InSite Vision Incorporated and
SSP Co., Ltd. ("SSP"), a full and complete copy of which is
attached as Exhibit 1.20 hereto.
1.21 "Sublicense" means any sublicense of, or other agreement
permitting the commercial exploitation of some or all of the
rights granted to B&L under this Agreement, except that no
agreement in the nature of a "Distributor Agreement" (i.e., the
other party to the agreement takes title to Product from B&L for
resale to a third party), or a "Sales Agency Agreement" (i.e.,
the other party to the agreement secures orders for Product to be
sold by B&L, and receives a commission in exchange therefore)
shall be deemed a Sublicense.
1.22 "Sublicensee" means any Person with whom B&L enters into a
Sublicense.
1.23 "Technology" means technology developed, acquired or licensed by
Licensor for Licensor's ISV-403 fluoroquinolone product
containing SS734 in development, in DuraSite platform which is
stable without refrigeration, as well as any improvements or
modifications to the inventions disclosed in the patents or
patent applications listed in Exhibit 1.13 as developed by
Licensor, its agents, consultants or contractors during the Term,
but, with respect to Technology which is subject to the SSP
License, only to the extent of Licensor's rights under the SSP
License.
1.24 "Term" means the period commencing upon the Effective Date and
extending until the termination of this Agreement pursuant to
Article 19.
1.25 "Territory" means anywhere in the world except Japan.
Where words and phrases are used herein in the singular, such usage is
intended to include the plural forms where appropriate to the context,
and vice versa. The words "including" and "includes" are used in their
non-limiting sense and have the same meaning as "including without
limitation" and "including but not limited to." References to Articles,
Sections, and clauses are to the same with all their subparts as they
appear in this Agreement. "Herein" means anywhere in this Agreement.
"Hereunder" and "hereto"
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mean under or pursuant to any provision of this Agreement. Other
initially capitalized terms used in this Agreement, including all
Exhibits attached hereto, which are incorporated fully by this reference
as if set forth herein, shall have the meanings described within the
text of this Agreement.
2.0 LICENSE GRANTS
2.1 Subject to the terms and conditions of this Agreement and the
reservations set forth in Section 2.4, Licensor grants to B&L,
and B&L accepts, an exclusive, royalty bearing license, with the
right to Sublicense, under Licensor's interest in (i.e., subject
to the SSP License) the Patent Rights and Know-How, to make, have
made, use, market, promote, sell, offer to sell, import, and
distribute Products in the Field throughout the Territory. B&L
acknowledges and agrees that the grant of rights set forth herein
are subject to the applicable terms of the SSP License, and that
B&L takes such grant of rights subject to all of the applicable
terms of the SSP License. Without limiting the generality of the
preceding sentence, B&L acknowledges the co-exclusive rights of
SSP under the SSP License in respect of all countries,
territories and protectorates in Asia (including the South East
Asian countries such as Korea, China, Hong Kong, Singapore,
Malaysia, Thailand, Indonesia, Taiwan and their neighborhoods,
but not including the Middle Eastern countries such as Turkey and
Saudi Arabia, Russia and ex-USSR countries, South Asia such as
India).
2.2 B&L shall have the right to Sublicense, in whole or in part, the
license granted in Section 2.1, except that Licensor shall have
the right to approve in advance and in writing any Sublicensee
who will be Sublicensed the right to manufacture the Product, as
reasonably necessary to protect Licensor's rights in the
Know-How, which approval shall not be unreasonably withheld.
2.3 Except as expressly set forth herein, this Agreement shall not be
construed as granting by implication, estoppel or otherwise, any
right in or license under any present or future inventions,
know-how, trade secrets, trademarks, service marks, trade names,
trade dress, copyrights, or patents owned or controlled by B&L or
by Licensor.
2.4 Licensor reserves all such rights under its interest in the
Patent Rights and the Know-How to use same and to administer the
Products, and sublicense third parties to do same, for the
purpose of conducting the Development Activities hereunder,
provided that Licensor shall notify B&L in writing promptly upon
the grant of any such sublicense.
3.0 PRODUCT DEVELOPMENT
3.1 Licensor shall, at its sole expense and in consultation with B&L
through the Joint Review Committee, develop the Product in
accordance with the Development Plan, except in the event that
B&L's option under Section 3.9 shall have come into existence and
have been duly exercised.
3.2 The Joint Review Committee shall meet either telephonically or in
person at least [***] to review strategies, projects and
timelines in view of the Development Plan. Minutes shall be
maintained of the proceedings of the Joint Review Committee. All
decisions of the Joint Review Committee shall be made by an
affirmative vote of [***]. The Joint Review Committee may not
enter into any contract or other arrangement imposing any binding
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obligation upon a Party. The Joint Review Committee may take such
other actions as it may reasonably decide to facilitate the
approval and commercial success of the Products.
3.3 It is understood that Development Activities are by their nature
difficult to specify and, accordingly, the parties acknowledge
that it may be necessary to modify the Development Activities or
the Development Plan from time to time. [***]
3.4 At each meeting of the Joint Review Committee, Licensor shall
present a project development summary (including timelines) that
outlines the expected Development Activities for the subsequent
Twelve (12) month period. Licensor shall issue written Quarterly
reports during Development Activities and a final report within
thirty (30) days of completion of the Development Activities. The
final report will contain a summary of all development progress,
test methods and results, drawings and specifications.
3.5 In the event the Joint Review Committee, after using reasonable
efforts to resolve any dispute amicably based on the achievement
of the objectives of the development efforts, is unable to
resolve any disagreement, the dispute resolution mechanisms in
Section 21.4 shall apply.
3.6 An expected timing of Development Activities is contained as part
of the Development Plan. Both Licensor and B&L agree to make all
reasonable efforts to keep the Development Activities on
schedule. The Development Plan is designed, and any future
modifications to the Development Plan will be designed, to
achieve regulatory approvals in the shortest time practicable,
consistent with clinical and regulatory end-points and to provide
for the successful commercialization of the Products described in
the Development Plan, all of which will be reviewed and approved
by the Joint Review Committee but which shall at a minimum,
include the characteristics identified on Exhibit 4.1 hereto.
3.7 Licensor shall maintain good engineering and scientific records
of the methods, experiments, tests, procedures, results and
conclusions prepared in the process of conducting the Development
Activities. B&L shall have reasonable access to these records.
3.8 Except as stated otherwise specifically herein, or in the
Development Plan, Licensor shall be responsible for all costs of
Development Activities. Attached as part of the Development Plan
is the Project Budget Estimate for Development Activities, as
estimated by Licensor as of the date hereof, including agreed
upon labor costs for key individuals expected to be involved in
such activities.
3.9 [***]
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4.0 LICENSOR OBLIGATIONS
4.1 Licensor Development Obligations. Licensor shall use commercially
reasonable efforts (which shall, in the absence of further
definition, equal or exceed the efforts expended by Licensor on
its own proprietary research and development projects) to develop
the Products and to perform on its own or through third parties,
all Development Activities for which Licensor is responsible as
set forth in the Development Plan. It is expected that the
Development Activities will result in a Product meeting the
characteristics identified on Exhibit 4.1.
4.2 Regulatory Filings.
(a) Licensor will be responsible for completing all regulatory
filings to the FDA or a central Regulatory Authority in
Europe with respect to the Products. All such filings
shall be submitted in Common Technical Document (CTD)
format. Licensor will provide to B&L copies of records
summarizing any clinical trial data and other
correspondence that Licensor collects or is required to
submit to the FDA or Regulatory Authority to secure market
approval for the Products as such records or
correspondence becomes available to Licensor. Licensor
shall also provide to B&L copies of records comprising raw
clinical trial data or patient data as requested by B&L to
the fullest extent permissible under the Health Insurance
Portability and Accountability Act of 1996 ("HIPAA") or
any other applicable statute or regulation, and shall take
such action in the design of clinical trials and patient
consent forms as is reasonable to allow for the provision
of such records under HIPAA or other applicable statute or
regulation.
(b) Upon approval of the Product by the Regulatory Authority
in a particular country or upon abandonment of same by
Licensor, Licensor shall, at Licensor's cost and expense,
transfer such approval to B&L, and shall, within fifteen
(15) days of B&L's written request, execute and file with
such Regulatory Authority all such documents and
materials, and pay any applicable fees as are required to
effect such transfer. After transfer to B&L of any such
approval, B&L shall make no material modification to the
Product without the express written approval of Licensor,
which approval shall not be unreasonably withheld. Upon
termination of this Agreement by Licensor pursuant to
Section 19.3 or termination by B&L pursuant to Section
19.4, B&L shall at its expense transfer to Licensor all
Regulatory Authority approvals of the Product and execute
and file all such documents and do all such other things
as may be required to effect all such transfers. This
provisions shall survive any termination of this Agreement
pursuant to the provisions noted in the foregoing
sentence.
4.3 Other Regulatory Obligations. Licensor shall receive and
coordinate reports from B&L and other sources and promptly report
to the FDA and/or Regional Regulatory Authority any and all of
the following events or experiences: adverse events; "serious
adverse drug experience", "unexpected adverse drug
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experience", "life-threatening adverse drug experience", or fatal
events that may be experienced by any subject in a clinical study
designated to support regulatory approval of the Products or
components thereof, where any such event or experience is
"associated with the use" of the Products as those terms are
defined in 21 C.F.R. 314.80, 314.81, and 803, or as otherwise
required by any other applicable FDA regulations or the similar
regulations and requirements in jurisdictions outside the United
States. Licensor will comply with other requirements for the
submission of reports and notices to the FDA or Regional
Regulatory Authority, including reports and notices to the FDA as
required under 21 CFR Sections 202, 203 and 207 and the similar
regulations and requirements in jurisdictions outside the United
States. Within the one (1)-year period before the reasonably
anticipated First Commercial Sale, and from time to time
thereafter at either party's request, the parties will discuss
and seek to establish standard operating procedures for the
collection, monitoring and reporting of all product complaints,
and the prompt exchange of information as contemplated by this
paragraph and Section 5.5, and Licensor shall also thereafter
comply with all such mutually agreed standard operating
procedures.
4.4 As between B&L and Licensor, Licensor shall be responsible for
conducting and managing Product recalls where Licensor is the
holder of the NDA or other relevant governmental approval
required to market the Product in the country as to which such
recall pertains. In all other cases, B&L shall be responsible for
conducting and managing Product recalls with respect to Product
sold by B&L and its distributors and Sublisensees in accordance
with Section 5.6.
4.5 Technical Support. Licensor shall provide technical support to
B&L at the reasonable request of B&L in those instances where
such support requires the unique expertise pertaining to the
Products.
4.6 SSP Licenses. Licensor shall maintain the SSP Licenses in full
force and effect, including (without limitation) making all
royalty payments, and shall not amend or modify the SSP Licenses
without B&L's prior written consent, which consent shall not be
unreasonably withheld. [***]
5.0 B&L OBLIGATIONS
5.1 Preferred Equity Investment.
(a) In conjunction with the arrangements contemplated by this
Agreement,
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B&L shall invest up to [***] ([***] United States Dollars)
in successive purchases of Licensor's preferred equity
capital, [***] (the "Preferred Stock") all pursuant to the
Preferred Stock Purchase Agreement, dated of even date
herewith, and attached as Exhibit 5.1 hereto.
(b) Upon First Commercial Sale, assuming B&L exercises
reasonable efforts to commercialize the Product following
NDA approval, but in no event later than six (6) months
after NDA approval, two-thirds, or 66.667%, of the total
shares of Preferred Stock purchased by B&L shall be
redeemed by Licensor for one dollar, paid to B&L. Such
redemption shall occur upon thirty (30) days written
notice from Licensor to B&L following satisfaction of the
above condition, and shall include, with respect to each
share of Preferred Stock so redeemed, all accumulated and
unpaid dividends thereon.
(c) The remaining one-third, or 33.333%, of the total shares
of Preferred Stock purchased by B&L shall be redeemed and
converted, simultaneously with the redemption identified
in Section 5.1(b) above, into pre-paid royalties, which
may be credited against B&L's obligation to pay the
Running Royalty in accordance with Article 7 hereof. The
total value of such pre-paid royalty (the "Prepaid Royalty
Value") shall equal the purchase price of the shares of
Preferred Stock so converted, plus all accumulated and
unpaid dividends thereon.
5.2 Manufacture of Clinical Trial Materials and Stability Batches.
B&L shall manufacture (or contract for the manufacture of) all
Products required for Phase III clinical trials, and all Products
as may be required for any stability testing or verification
(stability batches) in connection with submissions to regulatory
authorities for purpose of obtaining approvals or registrations
of the Product. Prior to manufacture, B&L shall submit to the
Joint Review Committee for its approval a budget for the
manufacturing costs. Licensor shall reimburse B&L upon
presentation of quarterly invoices for [***] incurred by B&L in
the manufacture and supply of such Product and material to
Licensor.
5.3 European Clinical Trials and Regulatory Filing Support. B&L shall
provide support for the conduct of pivotal clinical trials in
Europe necessary to support the registration of the product in
Europe and which will be structured as necessary to support use
in the regulatory filing in the U.S. The variable costs of such
clinical trials incurred by B&L (including, for example, [***]
incremental headcount) shall be reimbursed by the Licensor, and
B&L shall submit to the Joint Review Committee for its approval
its budget for such variable costs in advance of commencement of
such trials. B&L shall also provide the Licensor guidance in the
preparation and submission of regulatory filings to the central
regulatory authority in Europe.
5.4 Market Development and Commercialization. B&L shall use
commercially reasonable efforts (which shall not be less than the
efforts expended by B&L on its own proprietary commercialization
projects) to (1) make, have made, market, promote, sell,
distribute and support the Products for use in all such markets,
as soon as practical and consistent with reasonable business
practices, after
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Licensor has obtained all required regulatory approvals in such
markets and notified B&L in writing that such approvals have been
obtained and (2) keep Licensor informed of any material
developments in the markets where Products are being sold. All
such development and commercialization efforts shall be
undertaken by B&L at its own cost and expense.
5.5 Regulatory Obligations. B&L will, as soon as practicable, contact
Licensor's Regulatory Affairs Department by telephone and will
also provide a written report of any and all of the following
events or experiences of which B&L has knowledge: "adverse
events", "serious adverse drug experience", "unexpected adverse
drug experience", "life-threatening adverse drug experience", or
fatal events that may be experienced by any subject in a clinical
study designated to support regulatory approval of the Products,
or components thereof, where any such event or experience is
"associated with the use" of the Approved Products as those terms
are defined in 21 C.F.R. Sections 314.80, 314.81, and 803, and as
required by any other applicable FDA regulations or the
equivalent regulations and requirements in jurisdictions outside
the United States. B&L will cooperate and respond to all
reasonable requests for follow-up information from Licensor to
enable Licensor to carry out its obligations under this
Agreement. Within the one (1) year period before the reasonably
anticipated First Commercial Sale, and from time to time
thereafter at either party's request, the parties will discuss
and seek to establish standard operating procedures for the
collection, monitoring and reporting of all product complaints,
and the prompt exchange of information as contemplated by this
paragraph and Section 4.3, and B&L shall also thereafter comply
with all such mutually agreed standard operating procedures.
5.6 Recalls. Except as provided in Section 4.4, B&L shall respond to
inquiries from and report to the FDA and/or Regional Regulatory
Authority concerning the recall of any Products that are marketed
and sold and B&L and /or its Sublicensees will promptly notify
Licensor if B&L is subject to any such inquiries or reporting
requirements. B&L will investigate and determine any cause of
such recall. All costs associated with such recall or field
corrective action will be borne by B&L. If Licensor retains the
regulatory filing, B&L will keep Licensor fully apprised of the
status of any recall or field corrective action.
6.0 ROYALTIES
6.1 During the Royalty Period in each country, B&L shall pay to
Licensor a running royalty of [***] of Net Sales (the "Base
Royalty") plus the lower of (i) [***] of Net Sales and (ii) the
actual royalty on Net Sales paid by Licensor to SSP, licensor to
Licensor of technology rights covering the Products (the lower of
which shall be referred to as the "Extra Royalty"). The aggregate
of the Base Royalty and the Extra Royalty are referred to herein
as the "Running Royalty".
Notwithstanding the foregoing, the Base Royalty shall be reduced
to [***] of Net Sales for each Quarter to a purchaser or end user
of the Products which is located in a country where (a) no
Product sold in such country is covered by a valid claim of the
Patent Rights, and there is Competing Product (as defined below)
sold in such country or (b) after consultation with each other,
Licensor and B&L elect not to pursue individually or jointly
action seeking to stop the sale of Competing Product in such
country, or (c) B&L is not entitled to bring or able to initiate
an action to or otherwise able to, stop any Person from selling
Competing Product in such country.
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For purposes of this provision, "Competing Product" shall mean
any product that incorporates the Technology, if the aggregate
sales of such product in the country in question exceed [***] of
the total market for sales of products in the same therapeutic
class and of the same type (fluoroquinolones) in such country, as
reasonably demonstrated by B&L.
6.2 Royalties based upon Net Sales shall begin to accrue on the date
of the First Commercial Sale.
6.3 Internal Sales. Sales of Products between or among B&L, its
Affiliates and sublicensees shall not be subject to any royalty
hereunder, and in such cases royalties shall be calculated upon
B&L or its Affiliates' or sublicensees' Net Sales to an
independent third party. B&L shall be responsible for payment of
any royalty accrued on Net Sales of Products to such independent
third party through B&L's Affiliates or sublicenses. Royalties
shall accrue hereunder only once in respect of the same unit of
the Products.
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FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24B-2.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS.
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6.4 Following the end of the Royalty Period in a particular country,
the licenses granted by Licensor to B&L in Section 2.1 then in
effect, shall continue in such country on a non-exclusive basis
in perpetuity on a fully paid up basis.
7.0 TIMING OF ROYALTY PAYMENTS; RECORDS
7.1 Timing of Payments. Within forty-five (45) days after the end of
each Quarter, B&L shall pay to Licensor the royalty payment due
for each Quarter in readily available U.S. dollars or, at B&L's
option, by the application of credits as set forth below in
Section 7.3.
7.2 Currency Conversion. Any royalty due shall be converted, where
applicable, from the currency of the country in which the sale
was made into U.S. dollars at the month-end exchange rates for
such Quarter as calculated based on the daily exchange rate
published in The Wall Street Journal.
7.3 (a) B&L shall be entitled to credit the Pre-paid Royalty Value
established pursuant to Section 5.1(c) hereof against its
obligation to pay Running Royalties, provided that the
application of such Pre-paid Royalty Value shall not
exceed [***] of any single periodic royalty payment.
(b) In the event B&L exercises its rights pursuant to Section
3.9 hereof to complete the Development Activities for
which Licensor is responsible, [***].
7.4 Record Keeping. During the period beginning on the date of the
First Commercial Sale and for two years after the last
royalty-bearing sale in any country, B&L shall keep full and
accurate records relating to its payment obligations hereunder
including, without limitation, data used in arriving at the
payments of Section 7.1 ("Royalty Records").
7.5 Examination of Records. B&L shall permit Licensor to have B&L's
Royalty Records examined no more often than once per calendar
year by an independent certified public accountant, retained and
paid by Licensor and reasonably acceptable to B&L, during regular
business hours and upon Fifteen (15) days' advance written
notice. Such independent accountant shall keep confidential
(under a written confidentiality agreement reasonably acceptable
to B&L) any information obtained during such examination, and
shall report to Licensor only the amounts of payments which the
independent accountant believes to be due and payable hereunder
and the data from which such determination is made. A copy of the
report of such independent accountant shall be made available to
B&L upon request.
7.6 Audit Results. If an audit of Royalty Records conducted under the
terms of Section 7.5, above, shows that B&L has underpaid
royalties by more than Ten Percent (10%) for any calendar year,
B&L shall pay the amount due to Licensor within Forty-five (45)
Days and shall reimburse Licensor for the reasonable costs of
such audit.
8.0 WARRANTIES
[***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24B-2.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS.
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8.1 Each party represents and warrants to the other that it:
(a) is a corporation duly organized, validly existing and in
good standing under the laws of the state in which it is
incorporated; and
(b) is and shall remain in compliance with all requirements of
applicable laws, rules and regulations including, without
limitation, federal import and export requirements, rules
and regulations of the FDA and counterpart agencies in
other countries, except to the extent that noncompliance
does not materially adversely affect such party's ability
to perform its obligations and exercise its rights under
this Agreement.
8.2 Each party represents and warrants that it:
(a) has all requisite power and authority and the legal right
to enter into this Agreement and to perform its
obligations hereunder;
(b) has taken all necessary corporate action on its part to
authorize the execution and delivery of this Agreement and
the performance of its obligations hereunder; and
(c) has duly executed and delivered this Agreement which, in
turn, constitutes a legal, valid, binding obligation,
enforceable against such party in accordance with its
terms.
8.3 Licensor represents and warrants that:
(a) except as set forth in the SSP License, it owns the entire
right, title and interest in and to the Patent Rights free
of any lien, contractual commitment; or other encumbrance,
that such entire right, title and interest is not
encumbered in any manner, and that no licenses have ever
been granted by Licensor under the Intellectual Property;
(b) it has no knowledge of any intellectual property rights of
others that would interfere with the manufacture, use,
sale, or import of Products by B&L or any Sublicensee;
(c) it has not assigned or conveyed any interest in any
Intellectual Property inconsistent with the rights granted
under this Agreement;
(d) it is not aware that any third party has infringed any of
the Intellectual Property as of the Effective Date;
(e) to the extent it has prosecuted any patent applications
covered by any Intellectual Property rights, it has
prosecuted such applications in good faith;
(f) it has taken all reasonable precautions to protect the
secrecy, confidentiality and value of the Know-How which
is within its reasonable control, and is not aware of any
failure on the part of SSP Co. Ltd. to take such
reasonable precautions with respect to any portion of the
Know-How as is the subject of the SSP License;
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(g) except as set forth in the SSP License, it owns, has an
absolute right to use the Know-How, and has the
unrestricted right to convey such rights to B&L to use the
Know-How, and to the best of its knowledge the Know-How is
not part of the public knowledge or literature and has not
been used, divulged, or appropriated either for the
benefit of any Person, and no Know-How is subject to any
adverse claim or has been challenged or threatened in any
way;
(h) all employees and consultants of Licensor who are or have
been involved in the design, review, evaluation or
development of the Intellectual Property have executed a
nondisclosure and assignment of inventions agreement
("Confidentiality Agreement"), and that none of the
employees or consultants of Licensor is subject to any
contractual or legal restriction that might interfere with
the use of his or its best efforts to perform his or its
obligations hereunder;
(i) to Licensor's knowledge, no employee or consultant of
Licensor is, or is currently expected to be, in default
under any term of any employment contract, agreement or
arrangement relating to the Intellectual Property, any
Confidentiality Agreement, or any other contract or any
restrictive covenant relating to the Intellectual
Property, or the development or exploitation thereof;
(j) to its best knowledge, all of the issued Patents are as of
the Effective Date in compliance with formal legal
requirements (including payment of filing, examination,
and maintenance fees);
(k) it has the ability to grant to B&L the licenses granted in
Section 2.1 and has obtained all consents required to be
obtained in connection therewith.
9.0 INDEMNIFICATION; LIMITATION OF LIABILITY
9.1 Indemnification of B&L. Subject to Section 9.2, Licensor shall
indemnify, defend and hold B&L and each of its officers,
directors, employees, agents and consultants (each a "B&L
Indemnitee") harmless from and against all costs, claims, suits,
expenses (including reasonable attorneys' fees and expenses,
whether incurred as a result of a third party claim or a claim to
enforce this provision), liabilities and damages of any kind
(collectively, "Losses") to the extent arising out of or
resulting from (i) any material breach or failure by Licensor in
the performance or non-performance of its obligations or
covenants under this Agreement; (ii) any breach by Licensor of
any representation or warranty hereunder; (iii) the development
of any Product except to the extent such Losses arise or result
from any negligence of B&L; and (iv) FDA enforcement actions,
inspections, product recalls or market withdrawals relating to a
Product to the extent arising out of or resulting from any acts
or omissions of Licensor. In each case, the indemnity hereunder
shall not extend to matters as to which Licensor is entitled to
be indemnified by B&L hereunder.
9.2 Indemnification of Licensor. Subject to Section 9.1, B&L shall
indemnify, defend and hold Licensor and each of its officers,
directors, employees, agents and consultants (each a "Licensor
Indemnitee") harmless from and against all Losses to the extent
arising out of or resulting from (i) any material breach or
failure by B&L in the performance or non-performance of its
obligations or covenants under this Agreement; (ii) any breach by
B&L of any representation or warranty
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hereunder; (iii) the manufacturing, marketing, possession, use,
sale or other disposition of any Product by B&L or any
Sublicensee except to the extent such Losses arise or result from
any negligence of Licensor; and (iv) FDA enforcement actions,
inspections, product recalls or market withdrawals relating to a
Product to the extent arising out of or resulting from any acts
or omissions of B&L. In each case, the indemnity hereunder shall
not extend to matters as to which B&L is entitled to be
indemnified by Licensor hereunder.
9.3 Procedure for Indemnification. If an event occurs which a Party
believes requires indemnification ("Indemnification Event"), the
Party seeking indemnification ("Indemnified Party") shall give
prompt written notice to the other Party ("Indemnifying Party")
providing reasonable details of the nature of the event and the
basis of the indemnity claim. The Indemnifying Party shall then
have the right, at its expense and with counsel of its choice, to
defend, contest, or otherwise protect against any such action.
The Indemnified Party shall also have the right, but not the
obligation, to participate at its own expense in the defense with
counsel of its choice. The Indemnified Party shall cooperate as
requested by the Indemnifying Party to assist it in defending or
contesting any such action. If the Indemnified Party fails to
promptly notify the Indemnified Party of the occurrence of an
Indemnification Event, to the extent, but only to the extent,
that such failure results in a material adverse effect on the
Indemnifying Party, the Indemnified Party shall not be entitled
to indemnification with respect to such Indemnification Event. If
the Indemnifying Party fails within thirty (30) days after
receipt of such notice: (a) to notify the Indemnified Party of
its intent to defend, or (b) to defend, contest, or otherwise
protect against such suit, action, investigation, claim or
proceeding, or fails to diligently continue to provide such
defense after undertaking to do so, the Indemnified Party shall
have the right, upon ten (10) days' prior written notice to the
Indemnifying Party, to defend, settle and satisfy any such suit,
action, claim, investigation or proceeding and recover the costs
of the same from the Indemnifying Party.
9.4 NOTWITHSTANDING ANYTHING ELSE IN THIS AGREEMENT OR OTHERWISE,
NEITHER PARTY SHALL BE LIABLE WITH RESPECT TO ANY SUBJECT MATTER
OF THIS AGREEMENT UNDER ANY CONTRACT, NEGLIGENCE, STRICT
LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR ANY INDIRECT,
INCIDENTAL, SPECIAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES, LOST
PROFITS OR LOST DATA.
9.5 Each Party shall obtain and maintain at all times during the term
of this Agreement and for three (3) years thereafter, commercial
general liability insurance, including without limitation
coverage for products liability/completed operations, contractual
liability and personal injury liability, with a limit per
occurrence of not less than One Million Dollars ($1,000,000) and
an aggregate limit in an amount of not less than Five Million
Dollars ($5,000,000). Each such policy shall be endorsed to
include Licensor as an additional insured, and shall include a
provision whereby the insurance company will notify Licensor in
writing thirty (30) days prior to the effective date of any
cancellation, termination or material change in any such policy.
Each Party shall, upon request from the other Party, provide the
other Party with certificates evidencing the insurance required
under this Section 9.5.
10.0 CONFIDENTIALITY
10.1 Licensor and B&L and their respective Affiliates (as applicable,
each a "receiver")
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shall each use all reasonable steps to keep confidential any
Know-How, and any other proprietary or business information
provided or made available by the other party or its Affiliates
(as applicable, each a "discloser") hereunder ("Confidential
Information"), which steps shall include, without limitation,
those steps the receiver employs to protect its own Confidential
Information. Without the prior written consent of discloser,
receiver shall not use (except as contemplated by this
Agreement), or disclose to any third party, any Confidential
Information of discloser; provided, however, that the foregoing
shall not apply to Confidential Information that receiver can
establish by written documentation:
(a) was publicly known at the time of disclosure by receiver;
(b) becomes publicly known, without receiver's breach of this
confidentiality restriction subsequent to such disclosure;
(c) was otherwise known by receiver from a source (other than
discloser) lawfully having the right to possess and
disclose such information without restriction;
(d) was developed by receiver independently of the disclosure
by discloser;
(e) was known by receiver without restriction prior to
receiving such information from discloser; or
(f) was furnished by discloser to a third party without
similar restriction on that Party's right of disclosure.
10.2 The foregoing shall not preclude the disclosure of Confidential
Information by receiver:
(a) to its legal representatives, affiliates, agents,
consultants, directors, outside contractors, and
prospective investors under like confidentiality
obligations on the part of the recipients;
(b) to the extent required by law or regulation, provided that
to the extent reasonably possible, receiver shall give
prompt written notice of the proposed disclosure to
discloser so as to allow discloser an opportunity, at its
own cost and expense, to object to such requirement and,
if applicable, assure that confidential treatment will be
accorded to such Confidential Information;
(c) to the extent that such Confidential Information is
reasonably required to be disclosed for the purpose of
securing necessary governmental authorization for the
clinical testing or marketing of Products or for the
purpose of conducting clinical testing or marketing;
(d) to the extent that such Confidential Information is
reasonably required to be disclosed for the purpose of
prosecuting or defending litigation.
10.3 Both parties shall treat all information concerning the
Development Plan and Development Activities (including both
experimental and clinical activities) as Confidential Information
as defined in Section 10.1. Notwithstanding any other terms of
this Article 10 (other than Section 10.2(a), with respect to
legal representatives only and Section 10.2(b)), neither Licensor
nor its affiliates,
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agents,consultants, directors, outside contractors, directors,
outside contractors, prospective investors or Licensees shall
disclose (including publishing or lecturing) the Development
Activities or any associated results without B&L's prior written
approval, and such approval shall not be unreasonably withheld.
10.4 The terms of this Agreement shall not be disclosed by either
party to any third party (other than as provided in Sections 10.2
and 10.3) or be published unless both parties expressly agree in
writing.
11.0 PUBLICITY
11.1 Neither party shall use the name of the other party or its
Affiliates in any publication or promotional activity without the
other party's prior written consent, which consent shall be
either granted or denied within five (5) business days following
written request therefore.
11.2 If a party wishes to disclose information concerning or arising
out of this Agreement in the form of a press release, the party
proposing the disclosure shall submit the substance and timing of
the proposed press release in writing to the other party for
review. Review and comment on such proposed press release will be
provided within Five (5) business days of receipt. No press
release shall be published unless both parties agree in writing
upon the substance and timing of the press release.
11.3 If a party wishes to make a disclosure to the Securities and
Exchange Commission, to a securities exchange or to the National
Association of Securities Dealers, the party proposing the
disclosure shall cooperate with the other party to obtain:
(a) confidential treatment of the existence and terms of this
Agreement under the Securities Act of 1933 or the
Securities Exchange Act of 1934 or other applicable law or
regulation in substance reasonably satisfactory to the
party proposing the disclosure;
(b) a protective order or other judicial or quasi-judicial
protection for the confidentiality of the existence and
terms of this Agreement; and
(c) such other protections as the other party may reasonably
require.
12.0 PATENTS
12.1 Ownership. The parties acknowledge and agree that the SSP License
provides for ownership of patents and other intellectual property
based on discoveries made during the term of that agreement as
between SSP and Licensor as set forth therein, and that as a
sublicensee thereunder, B&L's rights with respect to discoveries
and inventions made during the term of this Agreement and the SSP
License shall be subject to the terms of the SSP License. B&L
agrees to perform any reasonable act necessary to assist Licensor
in perfecting and enforcing any rights of Licensor or SSP under
the SSP License. Subject to the foregoing, the following shall
apply. Ownership of patents based on discoveries made during the
term of this Agreement shall be based on inventorship.
Inventorship of all inventions will be determined in accordance
with United States patent law. Any and all patents and patent
applications containing claims covering inventions made during
the term of this Agreement solely by Licensor's employees or any
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other Person(s) under the direction and control of Licensor shall
be the property of and will be solely owned by Licensor and shall
be licensed to B&L hereunder to the extent same is part of Patent
Rights hereunder. Any and all patents and patent applications
containing claims covering inventions made during the term of
this Agreement solely by B&L's employees or any other Person(s)
under the direction and control of B&L shall be the property of
and will be solely owned by B&L. Any and all patents and patent
applications ("Joint Patent Rights") containing claims covering
inventions made during the term of this Agreement by one or more
employees or Person(s) under the direction and control of
Licensor and by one or more employees or Person(s) under the
direction and control of B&L will be the property of, and will be
owned by, Licensor and B&L jointly and subject to this Agreement
to the extent same is part of Patent Rights hereunder.
12.2 Prosecution and Maintenance. As between the parties, Licensor
shall prosecute and maintain Patent Rights at its own expense.
Notwithstanding the foregoing, Licensor shall fully involve B&L
in all of Licensor's decisions and/or actions relating to Patent
Rights, including, but not limited to, drafting, filing,
prosecuting, enforcing, and licensing patents and patent
applications. Furthermore, Licensor shall fully involve B&L in
all of Licensor's decisions and actions relating to legal
opinions concerning Products, however provided all such actions
are in accordance with the SSP License. If Licensor elects not to
pursue patent protection in any country, Licensor shall notify
B&L and B&L shall have the right, subject to the SSP License,
where applicable, but not the obligation, to file, in its own
name, prosecute and maintain such patent(s) in such country at
its own expense, and Licensor shall take such further action,
including the execution of documents of assignment, as is
reasonably necessary to support B&L's actions hereunder. With
respect to Joint Patent Rights, Licensor and B&L shall, prior to
filing any patent application, review the invention and determine
which party should be responsible for coordinating the filing.
All filings, prosecution and maintenance of Joint Patent Rights
shall be subject to review and approval of both parties. All
costs of filing, prosecution and maintenance of Joint Patent
Rights will be shared equally by the Parties.
12.3 Reports. Licensor shall provide to B&L a written report on the
status of Patent Rights each calendar quarter.
13.0 CLINICAL INTELLECTUAL PROPERTY
13.1 Clinical IP. Licensor shall be the owner of all Clinical IP
resulting from clinical or pre-clinical trials or studies
conducted by Licensor. Licensor shall use its best efforts to
guarantee that B&L has complete access to and use of any Clinical
IP existing or generated pursuant to any clinical or pre-clinical
trial arrangement in effect as of the date of this Agreement,
including without limitation, seeking to obtain from those
parties having any interest in such Clinical IP agreements in a
form acceptable to B&L. Except as otherwise determined by the
Joint Review Committee, all clinical and pre-clinical trials or
studies relating to the Development Plan shall be conducted by
Licensor or by Persons contracted with by Licensor to perform
such trials or studies who have assigned all ownership rights to
any Clinical IP resulting therefrom to Licensor. Licensor shall
take all action necessary to insure that B&L shall have complete
access to and use of any such Clinical IP during the term of this
Agreement.
13.2 Clinical IP Upon Termination. If B&L terminates this Agreement
for any cause as provided in Section 19.3 hereof, B&L shall have
the option (exercisable at any
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time and from time to time within two (2) years of such
termination) to require Licensor to transfer to B&L, Licensor's
right, title and interest in any Clinical IP related to this
Agreement. Upon the exercise of such option, Licensor shall take
any and all action necessary, including without limitation the
execution of all documentation deemed necessary or appropriate by
B&L, to effect the transfer of such Clinical IP to B&L.
14.0 TRADEMARKS
14.1 All logos, trade names, copyrights, trademarks, service marks,
trade dress and other commercial symbols ("Marks") developed or
used in connection with any and all Products shall be determined
by B&L, in its sole discretion, after consultation with Licensor.
The Marks shall not include the Licensor Marks (as defined in
Section 14.6). All such Marks (which do not include the "Licensor
Marks", as defined in Section 14.6) and the goodwill thereto
shall be solely and exclusively owned by B&L. B&L, at its sole
expense, shall exploit and seek registration protection in its
sole discretion. Licensor acknowledges that it derives no right,
title or interest in or to the Marks or the goodwill thereto.
14.2 The designation "Bausch & Lomb" may appear on the Product
packaging, or elsewhere in connection with the promotion,
marketing and sale of the Product by or on behalf of B&L.
However, the use of such designation with the Marks shall not
create any composite trademark, nor shall Licensor have any
rights in such designation, or any variation thereof.
14.3 During and after the term of this Agreement, neither party shall
directly or indirectly contest the ownership, validity or
originality of the Marks, the Licensor Marks or any trademark
applications or registrations covering the Marks or the Licensor
Marks for the Products, and the goodwill represented by any of
the foregoing Marks, or take any action in derogation of the
other's right, title and interest in and to the Marks, the
Licensor Marks or any other logos, trade names, copyrights,
trademarks, service marks, trade dress and any other commercial
symbols of the other party or any Affiliate thereof. During the
term of this Agreement, Licensor shall promptly inform B&L of any
unauthorized use of any of the Marks of which Licensor becomes
aware.
14.4 Licensor will not use any name or other symbol confusingly
similar to or, in the reasonable judgement of B&L, suggestive of
any of the Marks or any other B&L logos, trade names, copyrights,
trademarks, service marks, trade dress and any other commercial
symbols of B&L or any Affiliate thereof.
14.5 Termination Rights. If the agreement is terminated, other than by
B&L under Section 19.3, Licensor will have the right to use
packaging developed under this agreement and the royalty free
right to use any trademarks developed for the Product, including
without limitation, the Marks, subject to the remainder of this
Article 14, and subject further, to the fact that Licensor shall
have no rights whatsoever to use "Bausch & Lomb", and any
packaging used by Licensor shall be altered to remove same. Under
such circumstances, B&L shall have the option to transfer to
Licensor, at Licensor's expense, all or any portion of the Marks
which are the subject of the foregoing right.
14.6 B&L shall have a royalty free license to use the names "InSite
Vision" and "DuraSite" (collectively, the "Licensor Marks") in
connection with the marketing, promotion, distribution and sale
of the Product. Licensor represents and
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warrants that it has all right, title and interest in and to the
Licensor Marks and the goodwill thereto, free of any lien,
contractual commitment or other encumbrance, that such entire
right, title and interest is not encumbered in any manner, that
no licenses have ever been granted by Licensor that would limit
B&L's rights hereunder, and that the Licensor Marks do not
infringe the rights of any third party. The use of the Licensor
Marks together with the Marks, or the Bausch & Lomb designation
shall not create any composite trademark, nor shall B&L have any
rights in the Licensor Marks other than as set forth herein. B&L
will use the Licensor Marks only in while this Agreement is in
effect, only in association with the Product and only in
accordance with the policies, specifications and standards issued
by Licensor from time to time. Upon Licensor's reasonable written
request, B&L will provide Licensor with reasonable access during
business hours and no more than once per any twelve month period
during the term of this Agreement to its premises where B&L uses
the Licensor Marks or stores material bearing the Licensor Marks
to observe B&L's activities relating to the Licensor Marks for
the purpose of inspecting material on which the Licensor Marks
appear. B&L agrees that the benefit and goodwill associated with
use of the Licensor Marks by B&L will inure entirely to Licensor.
During the term of this Agreement, B&L shall promptly inform
Licensor of any unauthorized use of any of the Licensor Marks of
which B&L becomes aware.
15.0 NONCOMPETITION; FAVORED TREATMENT
15.1 Except to the extent that the license granted to B&L becomes
non-exclusive with respect to a Product, Licensor shall not,
alone or with others for a period of [***] following such
termination, introduce into any market [***]. In the event of a
termination by Licensor under Section 19.3, or by B&L under
Section 19.4, the foregoing restriction on competition shall not
apply.
15.2 If B&L's rights under this Agreement with respect to a Product
become non-exclusive in accordance with the terms and provisions
of this Agreement, and the Licensor enters into an agreement with
a person or entity other than B&L ("Subsequent Agreement"),
granting a license to any of the Patent Rights in the Field
[***].
15.3 ISV-401 Rights InSite is currently pursuing an antibiotic program
named ISV-401, and may enter into the development of other [***]
products which shall be excluded from the scope of any of the
provisions of this Article 15. Without limiting the generality of
the foregoing, the Product noncompetition provisions of Section
15.1, above shall only apply to [***].
16.0 ENFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS
16.1 Infringement Notice. If either party becomes aware of any
infringement or threatened infringement of any Intellectual
Property Right, then the party becoming aware of the infringement
shall give notice to the other party within Ten (10) days of
becoming aware of such infringement or threat.
[***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24B-2.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS.
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16.2 Enforcement Actions. The parties acknowledge and agree that the
enforcement of certain of the Patent Rights may be subject to the
SSP License. Subject to the foregoing, Licensor shall have the
right, but not the obligation, subject to obtaining any consent
required to be obtained under the SSP License to bring an
enforcement action and take any other reasonable steps to defend
the Patent Right against infringement; which steps may include
the negotiation of appropriate settlements and cross-licenses.
Licensor shall have the right to approve any settlement,
cross-license, etc., such approval not to be unreasonably
withheld or delayed. Licensor hereby agrees, in addition to its
obligations under the last sentence of this Section 16.2, to be
joined as a party to any such action. The costs of such
enforcement action shall be borne by B&L, and any recovery shall
go first to reimburse the expenses of B&L and the remainder shall
be treated as Net Sales and allocated accordingly, except as
otherwise required by the SSP License. If B&L does not initiate a
response to any infringement within thirty (30) days after it has
received notice thereof, then Licensor shall have the right to
undertake such action itself at its own expense. B&L shall have
the right to approve any settlement, cross-license, etc., such
approval not to be unreasonably withheld or delayed. Recovery
from any settlement or judgment from any such action undertaken
and funded by Licensor shall go first to reimburse the expenses
of Licensor and the remainder shall be divided equally between
the parties. Notwithstanding the foregoing, if the monetary
recovery is less than the out-of-pocket expenses of Licensor and
B&L, reimbursement shall be on a pro rata basis, based upon costs
incurred. Licensor and B&L shall assist one another and
reasonably cooperate in any such litigation at the other's
request without charge to the requesting party.
17.0 INFRINGEMENT OF THIRD PARTY PATENTS
17.1 Infringement of Third Party Patents. Each Party shall promptly
send the other Party a copy of any notice or communication from a
third party alleging any infringement or other violation of such
third party's intellectual property rights ("Notice"). Licensor
shall have the first right, but shall not be obligated, to
respond to the Notice, and shall take such further action as is
required under the SSP License. If Licensor does not elect to
respond, Licensor shall promptly inform B&L and permit it to
respond to the Notice, subject to compliance with the SSP
License. B&L shall have the right, but shall not be obligated, to
take any legal action at its own expense in response to the
Notice. B&L shall have the right to name Licensor as a party in
connection with any action in response to the Notice.
Each Party shall cooperate fully with the other Party in any
action resulting from or in connection with the Notice. Unless
the Parties are separately defending themselves, the Party
defending any such proceedings shall have sole control of such
proceedings and shall bear the reasonable expenses (excluding all
legal fees) incurred by the other Party in providing such
assistance and cooperation as is requested pursuant to this
paragraph. The Party defending such proceedings shall consult
with and keep the other Party informed of the progress of such
proceedings, including, without limitation, furnishing copies of
communications, pleadings and other documents and keeping the
other Party informed of settlement efforts and developments, and
such other Party shall be entitled to participate with counsel in
such proceedings but at its own expense. If B&L defends such
proceedings, it may offset its reasonable expenses, including
reasonable legal expenses, incurred in regard thereto against the
Base Royalty
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owed to Licensor under Article 6 of this Agreement. B&L shall
continue to perform its reporting obligations under this
Agreement and otherwise continue to perform its obligations
hereunder.
Neither Party shall settle any infringement, misappropriation, or
other claim subject to this Article 17 without the consent of the
other Party, which consent shall not be unreasonably withheld, if
it would adversely affect B&L's rights hereunder.
If any Invention claimed in a Patent Right or any Know-how is
covered by an issued patent or other intellectual property right
held by one or more third parties and it becomes necessary for
B&L to obtain a license from such third party or parties under
such patent, and/or other intellectual property right and
accordingly to pay royalties, upfront payments or damages to such
third party(ies), then B&L may reduce the Base Royalty or other
payments otherwise due Licensor, other than the Extra Royalty, by
the amount of royalty payment, upfront payments or damages due to
such third party.
-22-
18.0 NOTICES
18.1 All notices required or permitted hereunder shall by given in
writing and mailed postage prepaid by first class certified or
registered mail, or sent by a nationally recognized express
courier service, or hand delivered at the following addresses, or
faxed to the fax numbers set forth below:
To B&L:
Bausch & Lomb Incorporated
Xxx Xxxxxx & Xxxx Xxxxx
Xxxxxxxxx, Xxx Xxxx 00000
Attn: Vice President -- Business Development
Fax No.: (000) 000-0000
With a copy to:
Bausch & Lomb Incorporated
Xxx Xxxxxx & Xxxx Xxxxx
Xxxxxxxxx, Xxx Xxxx 00000
Attn: Senior Vice President & General Counsel
Fax No.: (000) 000-0000
To Licensor:
InSite Vision Incorporated
000 Xxxxxxxx Xxx.
Xxxxxxx, XX 00000
Attn: CEO
Fax No.: (00) 000-0000
With a copy to:
Xxxxxxx, Xxxxxxx & Xxxxxxxx
0000 Xxxxxxxxxx Xxx.
Xxxx Xxxx, XX 00000
Attn: Xxxxxxx Xxxxx, Esq.
Fax. No.: (000) 000-0000
18.2 Any notice shall be deemed given, if mailed properly addressed,
postage prepaid, three days after the date of mailing as
indicated on the certified or registered mail receipt, or on the
next business day if sent by express courier service, or on the
date of receipt if hand delivered, or on the next business day
following the date of error-free fax transmission by sender.
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19.0 TERM AND TERMINATION
19.1 Expiration of Royalty Obligations. Subject to Section 6.1 hereof,
B&L's obligation to pay a Running Royalty under this Agreement
shall terminate on a Product-by-Product and country-by-country
basis at the end of the Royalty Period. At the end of each such
term, and on a country-by-country basis, B&L shall have an
irrevocable, fully paid up license under the Patent Rights and
Know-How in the applicable Field to make, have made, use, sell,
offer to sell, import and distribute such Product in such
country.
19.2 Term. The term of this Agreement shall begin on the Effective
Date and shall remain in effect until the expiration of the last
to expire Patent Right, unless earlier terminated as provided for
hereunder ("Term").
19.3 Termination. Either Party may terminate this Agreement upon
written notice to the other Party upon the happening of any of
the following events:
(a) if the other Party fails to pay or cause to be paid any
amount which has become due under this Agreement, within
thirty (30) days after written notice from the
non-breaching Party of such failure,
(b) if the other Party has materially breached or defaulted
under any other provision of this Agreement and has not
cured such breach or default within sixty (60) days after
written notice from the non-breaching Party specifying the
nature of the breach or default in reasonable detail,
except as provided in Section 19.5 below, or
(c) if the other Party files a petition under any foreign,
State or United States bankruptcy act, receivership
statute or the like, as they now exist or as they may be
amended, or any such petition is filed against the other
Party by a third Party, or the other Party enters into an
assignment for the benefit of its creditors or
participates in any similar proceeding, or a receiver is
appointed for substantially all of the assets of such
other Party that is not dismissed within sixty (60) days,
or such other Party becomes insolvent or admits in writing
its inability to pay its debt as they become due. In the
event, however, that the alleged breaching or defaulting
Party has invoked the dispute resolution provisions set
forth in Article 21 hereof, this Agreement may not be
terminated until such dispute resolution procedure has
been completed.
19.4 Termination by B&L Without Cause. B&L may terminate this
Agreement at any time without cause on ninety (90) days' written
notice to Licensor.
19.5 Effect of Termination.
(a) All rights and obligations under this Agreement (including
without limitation any licenses granted hereunder) shall
immediately end upon termination of this Agreement for any
reason; provided however, that termination of this
Agreement shall not release either party from any payment
obligation that has accrued as of the effective date of
the termination. Neither Party shall be liable to the
other for damages of any sort resulting solely from
termination of this Agreement in accordance with its
terms.
-24-
(b) If Licensor terminates this Agreement pursuant to Section
19.3 at any time, or B&L terminates this Agreement
pursuant to Section 19.4 and notice of such termination is
given after the later to occur of (i) ----- commencement
of enrollment of Phase III clinical trials for ISV-403 and
(ii) January 1, 2004, in addition to any other rights
available to Licensor hereunder, B&L shall be required to
forfeit in favor of Licensor, all equity capital of
Licensor which has been purchased by B&L prior to such
date pursuant to the Preferred Stock Purchase Agreement.
In all other circumstances, B&L shall be entitled to
retain all equity investments in Licensor.
(c) If B&L terminates this Agreement pursuant to Section 19.3
at anytime, or pursuant to Section 19.4, on or before the
later to occur of (i) commencement of enrollment of Phase
II/III clinical trials for ISV-403 and (ii) January 1,
2004, in addition to any other rights available to B&L
hereunder, B&L shall be entitled to exercise its right to
convert each share of Preferred Stock plus all accumulated
and unpaid dividends, into such number of shares of the
common stock of Licensor and into other securities of
Licensor, as is determined in accordance with the
Certificate of Designation of the Series A-1 Preferred
Stock of Licensor and the Preferred Stock Purchase
Agreement.
19.6 Sell-Off Period. Notwithstanding anything to the contrary
contained herein, in the event of termination after First
Commercial Sale, B&L, its Affiliates and its Sublicensees shall
have [***] from the effective date of termination to complete the
manufacture of any work-in-progress and to sell any Product in
inventory, subject to royalty and other obligations to Licensor
under this Agreement.
19.7 Remedies Not Exclusive. The rights and remedies provided in
Sections 19.3, 19.5 and 19.6 shall not be exclusive and are in
addition to any other rights and remedies provided by law or this
Agreement.
20.0 FORCE MAJEURE
20.1 Neither party shall be responsible or liable to the other
hereunder for failure or delay in performance of this Agreement
due to any war, fire, accident or other casualty, or any labor
disturbance or act of God or the public enemy, or any other
contingency beyond such party's reasonable control. In addition,
the party affected by such force Majeure shall use reasonable
efforts, consistent with good business judgment, to eliminate,
cure and overcome any of such causes and resume performance of
its obligations and to keep the other party informed of such
efforts. In no event will this provision apply to excuse a party
from any payment obligation under this Agreement.
[***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24B-2.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS.
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21.0 MISCELLANEOUS
21.1 Assignment. This Agreement and all rights and obligation
hereunder are personal to the parties hereto, and may not be
assigned without the express prior written consent of the other
(which consent shall not be unreasonably withheld). Any
assignment or attempt at same not in accordance with the
foregoing shall be void and without effect. Notwithstanding the
foregoing, B&L or InSite Vision shall be entitled to assign this
Agreement to a purchaser of substantially all of the assets of
the business to which this Agreement applies without consent of
the other party.
21.2 Severability. If any provision of this Agreement is held to be
invalid, illegal or unenforceable, the validity, legality or
enforceability of the remaining provisions shall not in any way
be affected or impaired thereby and the parties shall use their
best efforts to substitute a valid, legal and enforceable
provision which, insofar as possible, implements the purposes
hereof. Furthermore, the court may, to the fullest extent
permitted by law, substitute a provision that most closely
conforms to the parties' intent as determined by such court.
21.3 No Waiver. The failure of any party at any time to require
performance of any provision shall in no manner affect its rights
to enforce such provision at a later time.
21.4 Dispute Resolution. If any dispute arises between Licensor and
B&L with respect to the interpretation or breach of this
Agreement (including disputes concerning decisions or failure to
decide by the Joint Review Committee), either party may notify
the other of the dispute in writing and the parties shall attempt
to resolve the dispute through discussions between Licensor's
Chief Executive Officer and B&L's Vice President -- Business
Development. If such officers are unable to resolve the dispute
within Thirty (30) days after the date written notice of the
dispute is delivered, either party may seek such other remedy, at
law or in equity, as it may deem necessary or appropriate.
21.5 Governing Law. This Agreement shall be governed by New York law,
without regard to its principles governing conflicts of laws.
21.6 Survival. Articles 1, 7-15, 19 and 21 shall survive termination
of this Agreement.
21.7 Bankruptcy. All licenses granted under this Agreement by Licensor
to B&L, for all purposes of Section 365(n) of Title XI of the
United States Code ("Title XI"), are licenses of rights to
"intellectual property" as defined in Title XI. During the Term,
Licensor shall create and maintain current copies to the extent
practicable of all such intellectual property. If a bankruptcy
proceeding is commenced by or against Licensor under Title XI,
B&L shall be entitled to a copy of any and all such intellectual
property, and the same, if not in the possession of B&L, shall be
promptly delivered to it (a) upon B&L's written request following
the commencement of such bankruptcy proceeding, unless Licensor,
or its trustee or receiver, elects within Thirty (30) days to
continue to perform all of its obligations under this Agreement,
or (b) if not delivered as provided under clause (a) above, upon
B&L's request following the rejection of this Agreement by or on
behalf of Licensor. If B&L has taken possession of all applicable
embodiments of the intellectual property of Licensor pursuant to
this Section and the trustee in bankruptcy of Licensor does not
reject this Agreement, B&L shall return such embodiments upon
request. If Licensor seeks or involuntarily is placed under
-26-
Title XI and the trustee rejects this Agreement as contemplated
under 11 U.S.C. 365(n)(1), B&L hereby elects pursuant to Section
365(n) to retain all rights granted to B&L under this Agreement
to the extent permitted by law.
21.8 Merger. This Agreement (a) sets forth the entire agreement
between the parties hereto and any parties who have in the past
or who are now representing either the parties hereto and merges
all discussions between them; (b) annuls and replaces every other
agreement which may have existed between Licensor and B&L; and
(c) is separate and distinct from any other agreement which may
have existed in the past or may now exist.
21.9 Integration. This Agreement contains the entire understanding
between the parties and no other understandings, representations
or warranties are in force or in effect.
21.10 Conformity with SSP License. The parties acknowledge and agree
that the license granted herein includes a sublicense by Licensor
to B&L of rights under the SSP License. Accordingly, the parties
acknowledge and agree that Licensor cannot under Article 2
(License Grants) of this Agreement grant to B&L any right which
Licensor is not legally entitled to grant to the extent of
limitations on Licensor's rights as are set forth in the SSP
License. Further, the parties acknowledge and agree that the
rights and obligations of the parties under Articles 12
(Patents), Article 16 (Enforcement of Intellectual Property
Rights) and Article 17 (Infringement of Third Party Patents) of
this Agreement are, with respect to such portions of the
Technology as are subject to the SSP License, specifically
subject to the rights of SSP as set forth in the SSP License.
Neither party shall be held to be in breach or default of this
Agreement to the extent that any such purported breach or default
is a result of conflict or inconsistency between this Agreement
and that party's obligations under the SSP License as noted in
this Section 21.10. Beyond the scope of its subject matter, the
SSP License shall not be construed to affect the rights or
obligations of B&L and Licensor, either under this Agreement or
otherwise.
21.11 Condition Precedent. All obligations of the parties hereunder
shall be subject to the receipt by B&L of (i) the written consent
of SSP Co. Ltd., copied to B&L, to the sublicense by Licensor to
B&L of Licensor's rights under the SSP License (as contained
herein) and (ii) a copy of an amendment to the SSP License that
requires [***]. In each case, the form and substance of the
documents referred to in (i) and (ii) above shall be acceptable
to B&L, which shall be evidenced by B&L's written acknowledgment
to Licensor. If the conditions set forth herein are not achieved
on or before
[***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24B-2.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS.
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August 11, 2002, this Agreement shall be of no further effect.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by
their duly authorized representatives as of the day and year first above
written.*
BAUSCH & LOMB INCORPORATED INSITE VISION INCORPORATED
By: By:
--------------------------------- ------------------------------
Name: Name:
-------------------------------- -----------------------------
Title: Title:
--------------------------------- ----------------------------
* See Section 21.11, Condition Precedent.
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EXHIBIT 1.5
DEVELOPMENT PLAN
Milestones: Estimated Timing:
---------- -----------------
(a) [***] Q1 2003
(b) [***] Q4 2003
(c) [***] Q3 2004
(d) [***] Q2 2004
(e) [***] Q1 2005
(f) [***] Q3 2005
(g) [***] Q3 2005
(h) [***] Q2 2006
[***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24B-2.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS.
-29-
EXHIBIT 1.13
PATENTS AND APPLICATIONS
DuraSite is a polymer formulation composed of Polycarbophil, a lightly
cross-linked acrylic acid polymer, and salts adjusted to make a formulation that
has a pH and osmolality compatible in the eye. When DuraSite formulations are
instilled into the cul-de-sac of the eye, the residence time is increased which
enhances transport and bioavailability of the drug substance into the eye
tissues. The ophthalmic drug delivery technology described here is described in
the following U.S. patents along with their foreign counterparts:
U.S. Patent Number:
4,615,697
4,983,392
5,225,196
5,192,535
5,814,655
6,159,458
SSP TECHNICAL INFORMATION
The technical information on SS734 is described in the following US Patent and
foreign counterparts:
5,447,926
JOINT PATENT RIGHTS
A patent application has been filed on the SS734-DuraSite combination and is
described in the following United States Application and foreign counterparts:
US Patent Application No. [***] (application in progress)
US Patent Application [***], continuation-in-part of US Application No.
[***] (application in progress)
[***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24B-2.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS.
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EXHIBIT 1.20
SSP LICENSE
INSITE VISION INCORPORATED
and
SSP CO., LTD.
JOINT SS732/SS734 PRODUCT DEVELOPMENT
AGREEMENT
-1-
TABLE OF CONTENTS
Page
1. DEFINITIONS
1.1 Affiliate........................................................5
1.2 Confidential Information.........................................5
1.3 Delivery System..................................................6
1.4 Drug Substance...................................................5
1.5 Drug Product.....................................................6
1.6 First Commercial Sale............................................6
1.7 Field............................................................6
1.8 Know-How.........................................................6
1.9 INSITE Technology................................................6
1.10 INSITE Territory.................................................6
1.11 Joint Patent Rights..............................................6
1.12 Joint Territory..................................................6
1.13 Net Sales........................................................6
1.14 Patent Rights....................................................7
1.15 SSP Technology...................................................7
1.16 SSP Territory....................................................8
1.17 Technology.......................................................8
1.18 Technology Disclosure............................................8
1.19 Valid Claim......................................................8
1.20 Derivative.......................................................8
2. DEVELOPMENT AND TECHNOLOGY EXCHANGE
2.1 Research and Development.........................................8
2.2 Clinical Trials..................................................8
2.3 Manufacture and Supply...........................................8
3. LICENSE
3.1 License to INSITE................................................8
3.2 License to SSP...................................................8
3.3 Joint Territory..................................................8
3.4 Sublicense.......................................................8
4. CONSIDERATION
4.1 Royalties........................................................9
4.2 Combination Products.............................................9
4.3 Payments.........................................................9
4.4 Foreign Sales....................................................9
4.5 Foreign Taxes....................................................9
4.6 Royalty Period...................................................9
5. RECORDS AND REPORTS
5.1 Reports..........................................................9
5.2 Records.........................................................10
5.3 Audit Rights....................................................10
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Page
6. PATENT PROSECUTION AND MAINTENANCE
6.1 Separate Patent Rights..........................................10
6.2 Joint Patent Rights.............................................10
7. PATENT ENFORCEMENT AND DEFENSE
7.1 Infringement Notice.............................................11
7.2 Infringement of Separate Patent Rights..........................11
7.3 Infringement of Joint Patent Rights.............................11
7.4 Expenses and Recovery...........................................11
8. THIRD PARTY CLAIMS OF INFRINGEMENT
8.1 SSP Patent Rights...............................................11
8.2 INSITE Patent Rights............................................12
9. COMMERCIALIZATION
9.1 Governmental Approvals and Marketing........................... 12
9.2 U.S. Manufacture................................................12
9.3 Foreign Registration............................................12
9.4 Trademark and Trade Name Usage..................................12
10. WARRANTIES AND DISCLAIMER
10.1 Mutual Warranties...............................................12
10.2 Disclaimer......................................................13
11. LIMITATION OF LIABILITY
11.1 Direct Damages..................................................13
11.2 Indirect Damages................................................13
11.3 Qualification...................................................13
12. INDEMNIFICATION
12.1 SSP Indemnification.............................................13
12.2 INSITE Indemnification..........................................13
12.3 Notice..........................................................13
12.4 Joint Defense...................................................14
13. CONFIDENTIALITY
13.1 Treatment of Confidential Information...........................14
13.2 Publications....................................................14
13.3 Publicity.......................................................14
14. TERM AND TERMINATION
14.1 Term............................................................14
14.2 Termination Upon Default........................................14
14.3 Termination Upon Bankruptcy or Insolvency.......................15
14.4 Rights Upon Termination or Expiration...........................15
14.5 Not Sole Remedy.................................................15
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Page
15. ASSIGNMENT/SUCCESSORS
15.1 Assignment......................................................16
15.2 Binding Upon Successors and Assigns.............................16
16. DISPUTE RESOLUTION
16.1 Executive Mediation.............................................16
16.2 Arbitration.....................................................16
16.3 Exceptions......................................................16
17. GENERAL PROVISIONS
17.1 Independent Contractors.........................................16
17.2 Entire Agreement: Modification..................................16
17.3 California Law..................................................16
17.4 Headings........................................................16
17.5 Severability....................................................17
17.6 No Waiver.......................................................17
17.7 Notices.........................................................17
17.8 Compliance to U.S. Laws.........................................17
17.9 Force Majeure...................................................17
17.10 Counterparts....................................................17
EXHIBIT A......................................................................19
EXHIBIT B......................................................................21
EXHIBIT C......................................................................23
EXHIBIT D......................................................................24
-4-
PRODUCT DEVELOPMENT
&
CROSS - LICENSE AGREEMENT
THIS PRODUCT DEVELOPMENT AND LICENSE AGREEMENT (this "Agreement") is
entered into and made effective as of this 15th day of April, 2001 (the
"Effective Date"), by and between INSITE Vision Incorporated ("INSITE") with an
office at 000 Xxxxxxxx Xxxxxx, Xxxxxxx, Xxxxxxxxxx 00000 and SSP CO., LTD.
("SSP") with an office at 12-4, 2-Chome, Xxxx-Xxx, Xxxxxxxxxx, Xxxx-Xx, Xxxxx
000-0000 XXXXX (INSITE and SSP individually, a "Party", together, the
"Parties".)
RECITALS
A. WHEREAS, INSITE has developed a drug delivery system for various
ophthalmic applications and owns certain intellectual property rights with
respect thereto.
B. WHEREAS, SSP has developed certain drug substances for the prevention
and treatment of diseases of the eye and owns certain intellectual property
rights with respect thereto;
C. WHEREAS, the Parties desire that INSITE develop a formulation of its
delivery system for use in connection with SSP's drug substances and that each
Party should have the right to make, distribute, and sell the combined Drug
Product as defined below, and to conduct certain activities related thereto, on
the terms and conditions set forth herein.
NOW THEREFORE, based on the foregoing, and in consideration of the
mutual promises and covenants set forth herein, and other good and valuable
consideration the receipt and sufficiency of which is hereby acknowledged, the
Parties agree as follows:
AGREEMENT
1. Definitions. Capitalized terms not otherwise defined herein shall have
the meaning set forth below.
1.1. "Affiliate" means any entity which is directly or indirectly
controlled by or is under common control by Licensee. The term "control"
as used herein means the possession of the power to direct or cause the
direction of the management and the policies of an entity, whether
through the ownership of a majority of the outstanding voting securities
or by contract or otherwise. The parties agree that as of the effective
date Dojin Pharmaceutical Products Inc. shall be deemed and treated as
an Affiliate of SSP.
1.2. "Confidential Information" means any and all proprietary or
confidential information of either Party which may be exchanged between
the Parties at any time and from time to time during the term of this
Agreement or pursuant to the Letter of Intent dated December 7, 2000 or
the Bilateral Confidential Disclosure Agreement dated, March 17, 2000.
Information shall not be considered confidential to the extent that it:
(a) is publicly disclosed through no breach of fault of any
confidentiality obligation by either Party, either before or after it
becomes known to the receiving Party; (b) was known to the receiving
Party prior to the date of this Agreement, which knowledge was acquired
independently and not from another Party or such Party's employees,
consultants or other agents; (c) is subsequently disclosed to the
receiving Party in good faith by a third party without breach of an
obligation of confidentially with respect thereto; or (d) has been
published by a third party as a matter of right.
-5-
1.3. "Delivery System" means INSITE's proprietary polycarbophil drug
delivery vehicle.
1.4. "Drug Substance" means SSP's drug substances identified as SS732
[***] and/or SS734 [***].
1.5. "Drug Product" means a product combining the Drug Substance
together with a formulation of Delivery System which formulation is
developed by INSITE hereunder for use with the Drug Substance.
1.6. "First Commercial Sale" means, with respect to the Drug Product in
any country the first sale for use or consumption by the general public
of such Drug Product in such country after all applicable regulatory
approvals have been obtained in such country.
1.7. "Field" means [***].
1.8. "Know-How" means all technology, engineering data, trade secrets,
technical data, manufacturing information, pre-clinical and clinical
data and any other information, experience or intellectual property that
a Party owns or has the right to sublicense that is used in or relates
to the use or sale of its Technology, as well as any improvements or
modifications thereto developed by such Party with respect thereto
during the Term, other than as covered by Valid Claims within such
Party's Patent Rights.
1.9. "INSITE Technology" means the (a) Delivery System and other INSITE,
information, data, materials technology as set forth in the Technology
Disclosure; and (b) all modifications, improvements and derivatives
thereof whether or not the same are made pursuant to or during the term
of this Agreement.
1.10. "INSITE Territory" means anywhere in the world excluding the Joint
Territory and SSP Territory.
1.11. "Joint Patent Rights" means solely those Patent Rights covering
the Drug Product as a combination of the Drug Substance and Delivery
System and excluding any Patent Rights covering the INSITE Technology or
SSP Technology.
1.12. "Joint Territory" means all countries, territories and
protectorates in Asia which, for purposes of this Section 1.12 includes
the South East Asian countries such area as Korea, China, Hong Kong,
Singapore, Malaysia, Thailand, Indonesia, Taiwan, and their
neighborhoods, but does not include the Middle Eastern countries, Russia
and ex-USSR countries, South Asia such as India, and Middle East such as
Turkey, Saudi Arabia.
1.13. "Net Sales" means the gross amount invoiced by either Party, or
its Affiliates and sublicensees, or any of them, on all sales of Drug
Products, less: (a) all trade, cash and quantity credits, discounts,
refunds or rebates or retroactive price reductions, (b) credits for
claims, allowances for returned or rejected products, (b) handling fees
and restocking expenses for returned or rejected products, (c) freight
handling and transportation as well as freight insurance paid by the
selling Party, (d) sales taxes, tariffs, duties and other governmental
charges actually paid in connection with sales of Drug Products (but
excluding what is commonly known as income or franchise taxes), and (e)
uncollectible amounts determined in accordance with reasonable
accounting practices, consistently applied to all products of the
selling Party. For purposes of determining Net Sales, a sale shall be
deemed to have occurred when an invoice therefore shall be generated or
the Drug Product shipped for delivery. Sales of Drug Products by either
Party, or an Affiliate or sublicensee of either Party to any Affiliate
or sublicensee which is a reseller thereof shall be excluded, and only
the subsequent sale of such Drug Products by Affiliates or sublicensees
of either Party to unrelated Parties shall be deemed Net Sales
hereunder. In addition "sale" will not include transfers or dispositions
for [***]
[***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24B-2.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS.
-6-
or for preclinical, clinical, regulatory or governmental purposes prior
to receiving marketing approval.
1.14. "Patent Rights" means rights arising out of or resulting from (i)
any and all U.S. and foreign patent applications claiming Technology;
(ii) the patents issuing from such applications, including provisionals,
divisionals, continuations and continuations-in-part (to the extent the
claims of such continuations-in-part are directed solely toward
Technology); and (iii) reissues, reexaminations, and extensions of any
patent set forth in (i)-(ii) or other government action which provides
exclusive rights to an Invention beyond the original patent expiration
date.
1.15. "SSP Technology" means the (a) the Drug Substance and other SSP,
information, data, materials technology as set forth in the Technology
Disclosure; and (b) all modifications, improvements and Derivatives
thereof whether or not the same are made pursuant to or during the term
of this Agreement.
1.16. "SSP Territory" means the country of Japan.
1.17. "Technology" means the SSP Technology or INSITE Technology, as
applicable.
1.18. "Technology Disclosure" means the document describing the Parties
respective Technology attached hereto as Exhibit A.
1.19. "Valid Claim" means a claim of an issued and unexpired patent
which patent has not lapsed, been abandoned and which claim has not been
canceled or declared invalid by an unreversed and unappealable decision
or judgment of a court or other appropriate body of competent
jurisdiction, and which has not been admitted to be invalid or
unenforceable through reissue or disclaimer.
1.20 "Derivative" shall mean any and all compounds covered by SSP's
current patents listed in Exhibit A.
2. DEVELOPMENT AND TECHNOLOGY EXCHANGE
2.1. Research and Development. Each Party's rights and responsibilities
with respect to research and development related to the Drug Product
shall be as set forth in Exhibit B hereto.
2.2. Clinical Trials. Each Party's rights and responsibilities with
respect to clinical trial activity related to the Drug Product shall be
as set forth in Exhibit B hereto.
2.3. Manufacture and Supply. Each Party's rights and responsibilities
with respect to the manufacture and supply of Drug Product shall be as
set forth in Exhibit C hereto.
3. LICENSE.
3.1. License to INSITE. Subject to the terms and conditions of this
Agreement, SSP hereby grants to INSITE under the SSP Patent Rights and
SSP Know-How, for the Term of this Agreement, a license to: (a) develop
the Drug Product for use in the Field as contemplated in Section 2.1,
(b) conduct its clinical trial activities with respect to the Drug
Product as contemplated in Section 2.2; (c) make, have made, use, sell,
offer for sale and import the Drug Product for use in the Field as
contemplated in Section 2.3; and (d) sublicense any or all of the
foregoing through multiple tiers of sublicensees. The foregoing license
shall be exclusive including as to SSP in the INSITE Territory and, to
the extent set forth in Section 3.3 , shall be non-exclusive in the
Joint Territory.
3.2. License to SSP. Subject to the terms and conditions of this
Agreement, INSITE hereby grants to SSP under the INSITE Patent Rights
and INSITE Know-How, for the Term of this Agreement, a license to: (a)
conduct its clinical trial activities with respect to the Drug Product
as contemplated in Section 2.2; (b) make, have made, use, sell, offer
for sale and import the Drug Product for use in the Field as
contemplated in Section 2.3; and (c) sublicense any or all of the
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foregoing through multiple tiers of sublicensees. The foregoing license
shall be exclusive including as to INSITE in the SSP Territory and, to
the extent set forth in Section 3.3 shall be non-exclusive in the Joint
Territory.
3.3. Joint Territory. Each Party may, with respect to the rights granted
to it in the Joint Territory under Section 3.1 (License to INSITE) or
Section 3.2 (License to SSP), grant a sublicense to some or all such
rights. Notwithstanding the foregoing, a Party may only sublicense all
such rights to a single third party: (a) with the prior written consent
of the other Party, which consent shall not be unreasonably withheld or
delayed; (b) if such Party does not reserve for itself right to exercise
such rights in the Joint Territory during the term of the sublicense.
3.4. Sublicense. A Party may only grant a sublicense as permitted under
this Section 3 pursuant to a written agreement that: (a) is at least as
protective of the Party owning the rights and technology licensed as the
provisions of this Agreement (b) provide for such reports and other
documentation as may be necessary for the Party granting such sublicense
to fulfill its obligations hereunder with respect to the activities of
such sublicensee including without limitation such Party's record
keeping and Royalty payment obligations.
4. CONSIDERATION.
4.1. Royalties. As consideration for rights and licenses granted
hereunder, each Party (the "Selling Party") shall pay to the other Party
(the "Non-Selling Party") a royalty, calculated on a country-by-country
basis, in the amount of: (a) [***] of Net Sales for Drug Products sold
by the Selling Party in a country which could not at the time be made,
used, sold, offered for sale or imported in such country without
infringing one or more Valid Claims under the Joint Patent Rights; and
(b) [***] of Net Sales for all other Drug Products sold by the Selling
Party. The Net Sales of a Party shall be aggregated with the Net Sales
of its Affiliates and sublicensees for purposes of determining the Net
Sales upon which Royalties are to be paid to the other Party.
4.2. Combination Products. In the event a Drug Product is sold in the
form of a combination product containing one or more active ingredients
which are themselves not Drug Products, the Net Sales will be calculated
by multiplying the sales price of such combination product by the
fraction A/(A+B) where A is the invoice price or Fair Market Value,
whichever is greater, of the Drug Product and B is the total invoice
price or Fair Market Value, whichever is greater, of the other
product(s). In the event the Parties cannot agree on any such valuation
issues, the Parties shall resolve their dispute pursuant to Section 16 .
4.3. Payments. Except as set forth in Section 14.3 each Party shall pay
Royalties: (a) with regard to Net Sales of such Party or its Affiliates,
within [***] after the end of each calendar quarter during the Term for
the Net Sales of Drug Products during such quarter; and (b) with regard
to Net Sales made by sublicensees of a Party or its Affiliates, within
[***] after the end of each calendar quarter during the Term, for Net
Sales of Drug Products by such sublicensee during such quarter.
4.4. Foreign Sales. The remittance of Royalties payable to INSITE on
sales of Drug Product(s) outside the United States shall be payable in
United States Dollar equivalents at the official rate of exchange of the
currency of the country from which the royalties are payable as quoted
in the Wall Street Journal for the last business day of the calendar
quarter in which the royalties are payable. If the transfer of or the
conversion into the United Sates Dollar equivalents of any such
remittance in any such instance is not lawful or possible, the payment
of such part of the Royalties as is necessary shall be made by the
deposit thereof, in the currency of the county where the sale was made
on which the royalty was based to the credit and account of INSITE or
its nominee in any commercial bank or trust company of its choice
located in that country, prompt written notice of which shall be given
by SSP to INSITE.
4.5. Foreign Taxes. Any tax required to be withheld by either Party
under the laws of any foreign country for the accounts of the other
shall be promptly paid by the first Party for and on behalf of the other
to the appropriate governmental authority, and each Party shall use its
best efforts to
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furnish the other with proof of payment of such tax together with
official or other appropriate evidence issued by the applicable
government authority. Any such tax actually paid on behalf of the other
Party shall be deducted from royalty payments due the other Party.
4.6. Royalty Period. The Royalty obligations of either Party as to each
Drug Product shall expire on a country-by-country basis: (a)
concurrently with the expiration of the last to expire of Valid Claims
within the Joint Patent Rights excluding any joint patent rights
covering Drug Products sold in such country; or (b) with respect to Drug
Products never covered in such country by a Valid Claim within the Joint
Patent Rights, [***] after the date of the First Commercial Sale of such
Drug Product in such country
5. RECORDS AND REPORTS.
5.1. Reports. Each Party shall furnish to the other Party at the same
time as each royalty payment is made, a detailed written report of Net
Sales of the Drug Products sold by such Party and its Affiliates and
sublicensees as applicable and the Royalty due and payable thereon,
including a description of any offsets or credits deducted therefrom, on
a product-by-product and country-by-country basis, for the calendar
quarter upon which the royalty payment is based.
5.2. Records. Each Party shall keep, and cause its Affiliates and
sublicensees to keep, full complete and proper records and accounts of
all sales of Drug Products in sufficient detail to enable the royalties
payable on Net Sales of each Drug Product to be determined by examining
the records and accounts of such Party. Each Party, its Affiliates and
sublicensees shall preserve and maintain all such records for a period
of three (3) years after the calendar quarter to which the record
applies.
5.3. Audit Rights. Each Party shall have the right to appoint an
independent certified public accounting firm approved by the other
Party, which approval shall not be unreasonably withheld or delayed, to
audit the records and reports of the other Party previously unaudited
hereunder, solely as necessary to verify the royalties payable pursuant
to this Agreement. Such Party, its affiliates and sublicensees shall pay
to the other Party an amount equal to any additional royalties to the
other Party is entitled as disclosed by the audit, plus interest thereon
at the rate of one and one-half percent (1.5%) per month. Such audit
shall be at initiating Party's expense; provided, however, that if the
audit discloses that was underpaid royalties with respect to any Drug
Product by at least ten percent (10%) for any calendar quarter, then the
other Party, its Affiliates or sublicensee, as the case may be shall
reimburse the initiating Party for any such audit costs. The Parties may
exercise its right of audit as to each of the other, its Affiliates or
sublicensees no more frequently than once in any calendar year during
the Term. The accounting firm shall disclose to the other Party only
information relating to the accuracy of the royalty payments.
6. PATENT PROSECUTION AND MAINTENANCE.
6.1. Separate Patent Rights. INSITE and SSP shall have the exclusive,
worldwide right, but not the obligation to pursue and control the
filing, prosecution and maintenance of any Patent Rights that have been
or may be obtained with respect to the INSITE Technology and SSP
Technology, respectively. Each Party shall pay its own expenses with
respect to such filing, prosecution and maintenance of its patents and
confidential information relating to the Drug Product and Drug
Substances, respectively. Each Party agrees to keep the other reasonably
informed with respect to the issuance of patents covering such Party's
Technology and any changes with respect to the status of such patents.
6.2. Joint Patent Rights.
(a) With respect to any Patent Rights that may be obtained for
the Joint Technology: (i) INSITE shall have the exclusive right
but not the obligation to pursue and control the filing,
prosecution and maintenance of such Patent Rights in the INSITE
Territory and the Joint Territory; and (ii) SSP shall have the
exclusive right but not the obligation to pursue and control the
filing, prosecution and maintenance of such Patent Rights in the
SSP Territory.
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS.
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(b) With respect to the filing, prosecution and maintenance
efforts set forth above, the non-filing Party shall (i) provide
all reasonable assistance, information, data and records
reasonably requested by the filing Party to support such efforts,
and (ii) have the right to consult with the filing Party with
respect to such efforts.
(c) With respect to the filing, prosecution and maintenance
efforts set forth above, the filing Party shall keep the
non-filing Party reasonably informed with respect to such efforts
and shall use reasonable efforts to provide copies of all patent
applications, amendments and other significant filings in advance
of the applicable filing deadlines.
(d) If a Party is entitled to file for, prosecute and maintain a
Joint Patent Right elects not to file for such right or to
continue the prosecution and maintenance thereof then the other
party shall the right to do so.
7. PATENT ENFORCEMENT AND DEFENSE.
7.1. Infringement Notice. Each Party shall promptly notify the other
Party if: (a) such Party reasonably believes that any Patent Rights
subject to this Agreement may be infringed by a third party in a
particular country or jurisdiction, or (b) any Patent Rights subject to
this Agreement has become subject to a declaratory judgment action
seeking invalidity of such Patent Right.
7.2 Infringement of Separate Patent Rights. Each Party shall have the
worldwide right but not the obligation to attempt to xxxxx any suspected
infringement of Patent Rights covering its Technology by commercially
appropriate means including, without limitation, the initiation of an
infringement suit or other preceding, and may enter into settlements,
stipulated judgments or other arrangements respecting such infringement,
at its own expense. If required to effectively prosecute such suit or
action, the other Party shall join such suit or action as a party
thereto.
7.3 Infringement of Joint Patent Rights.
(a) SSP shall have the right but not the obligation to attempt to
xxxxx any suspected infringement of the Joint Patent Rights in
the SSP Territory by commercially appropriate means including,
without limitation, the initiation of an infringement suit or
other proceeding, and may enter into settlements, stipulated
judgments or other arrangements respecting such infringement.
(b) INSITE shall have the right but not the obligation to attempt
to xxxxx any suspected infringement of the Joint Patent Rights in
the INSITE Territory and Joint Territory by commercially
appropriate means including, without limitation, the initiation
of an infringement suit or other proceeding, and may enter into
settlements, stipulated judgments or other arrangements
respecting such infringement.
(c) If required to effectively prosecute such suit or action, the
non initiating Party shall join such suit or action as a party
thereto.
7.4. Expenses and Recovery. With respect to any infringement action
undertaken pursuant to Section 7.2 and 7.3:
(d) the non-initiating party shall reimburse the initiating party
on a quarterly basis for expenses incurred in or in connection
therewith in accordance with the following allocation of such
expenses: (i) [***] to the initiating Party, and (ii) [***] to
the non-initiating Party.; and
(e) any damages or other recovery received in connection
therewith shall first be used to reimburse the Parties for the
costs and expenses incurred in or in connection with such action,
and shall thereafter be allocated between the Parties as follows;
(i) [***] to the initiating Party, and (ii) [***] to the
non-initiating Party.
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FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24B-2.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
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8. THIRD PARTY CLAIMS OF INFRINGEMENT
8.1. SSP Patent Rights. If a claim if infringement is brought against
INSITE, an Affiliate or any sublicensee in any country in the INSITE
Territory or Joint Territory alleging infringement of any patent in such
country owned by a third party by reason of the manufacture use or sale
of the Drug Product except to the extent that alleged infringes arises
solely with respect to the Delivery System included with such Drug
Product, INSITE shall promptly give notice thereof to SSP and make
reasonable efforts to provide SSP with all information in INSITE's
possession regarding such claim. SSP shall indemnify, defend and hold
INSITE harmless against any damages, costs, expenses and liabilities
including reasonable attorneys' fees and expenses, but not lost profits
or other consequential damages arising out of such claim. SSP shall
conduct the defense of any suite for infringement at its expense
provided that INSITE may participate in such defense at its option and
expense. INSITE shall furnish to SSP such assistance as SSP may
reasonably need and request in connection with the defense of such
claim. SSP shall not dispose of or settle any such claim in any manner
which may adversely affect INSITE's rights or interests without INSITE's
prior written consent, which consent shall not be unreasonably withheld
or delayed. Without limiting any obligation of SSP hereunder or any
remedies otherwise available to INSITE, if SSP fails to so defend such
claim or suit, INSITE shall have the right to do so and SSP hereby
agrees to reimburse INSITE for all reasonable costs and expenses,
including attorneys' fees incurred by INSITE in connection with such
defense.
8.2 INSITE Patent Rights. If a claim if infringement is brought against
SSP, an Affiliate or any sublicensee in any country in the SSP Territory
or Joint Territory alleging infringement of any patent in such country
owned by a third party by reason of the manufacture use or sale of the
Drug Product except to the extent that alleged infringes arises solely
with respect to the Drug Substance included with such Drug Product, SSP
shall promptly give notice thereof to INSITE and make reasonable efforts
to provide INSITE with all information in SSP's possession regarding
such claim. INSITE shall indemnify, defend and hold SSP harmless against
any damages, costs, expenses and liabilities including reasonable
attorneys' fees and expenses, but not lost profits or other
consequential damages arising out of such claim. INSITE shall conduct
the defense of any suite for infringement at its expense provided that
SSP may participate in such defense at its option and expense. SSP shall
furnish to INSITE such assistance as INSITE may reasonably need and
request in connection with the defense of such claim. INSITE shall not
dispose of or settle any such claim in any manner which may adversely
affect SSP's rights or interests without SSP's prior written consent,
which consent shall not be unreasonably withheld or delayed. Without
limiting any obligation of INSITE hereunder or any remedies otherwise
available to SSP, if INSITE fails to so defend such claim or suit, SSP
shall have the right to do so and INSITE hereby agrees to reimburse SSP
for all reasonable costs and expenses, including attorneys' fees
incurred by SSP in connection with such defense
9. COMMERCIALIZATION
9.1. Commercial Development Obligations. INSITE shall be responsible for
obtaining all necessary approvals for the development, production,
distribution, sale, and use of any Drug Product, at its expense,
including all safety and efficacy studies in INSITE Territory and the
Joint Territory. SSP shall be responsible for obtaining all necessary
approvals for the development, production, distribution, sale, and use
of any Drug Product, at its expense, including all safety and efficacy
studies in SSP Territory. Notwithstanding the foregoing, SSP shall be
solely responsible for the pre-clinical systemic toxicology for the Drug
Substance and the establishment of the Drug Master File (DMF) for the
Drug Substance which shall be referenced by INSITE.
9.2. U.S. Manufacture. To the extent required by applicable United
States laws, if at all, the Parties agree that Drug Products will be
manufactured in the United States, or its territories, subject to such
waivers as may be required, or obtained, if at all, from the United
States Department of Health and Human Services, or its designee.
9.3. Foreign Registration. Each Party agrees to register this Agreement
with any foreign governmental agency in it respective territory, which
requires such registration, and shall pay all
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costs and legal fees in connection therewith. In addition, each Party
shall assure that all foreign laws affecting this Agreement or the sale
of Drug Products are fully satisfied, within its territory.
9.4. Trademark and Trade Name Usage. The use of the Trademarks in the
territory shall be determined between the parties before the first
commercial sale.
10. WARRANTY AND DISCLAIMER
10.1. Mutual Warranties. Each party hereby represents and warrants as
follows:
(a) the execution, delivery and performance of this Agreement by
such Party has been duly authorized by all requisite corporate
action;
(b) it has the full right, power and authority to execute and
deliver this Agreement and to perform its obligations hereunder.
10.2. DISCLAIMER. EXCEPT TO THE EXTENT EXPRESSLY SET FORTH ABOVE EACH
PARTY MAKES NO OTHER WARRANTIES CONCERNING PATENT RIGHTS, TECHNOLOGY OR
CONFIDENTIAL INFORMATION COVERED BY THIS AGREEMENT, INCLUDING WITHOUT
LIMITATION, ANY EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT.
11. LIMITATION OF LIABILITY
11.1. DIRECT DAMAGES. EXCEPT AS SET FORTH IN SECTION 11.3 THE TOTAL,
CUMULATIVE LIABILITY OF THIS AGREEMENT OF EACH PARTY ARISING OUT OF OR
RELATED TO, THIS AGREEMENT, ITS INTERPRETATION, AND SERVICES PERFORMED
HEREUNDER, SHALL NOT EXCEED THE ROYALTY DUE THE PARTY FOR THE PREVIOUS
TWELVE MONTHS PRIOR TO THE DATE SUCH CLAIM AROSE.
11.2. INDIRECT DAMAGES. EXCEPT AS SET FORTH IN SECTION 11.3, IN NO EVENT
WILL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL,
INCIDENTAL, OR PUNITIVE DAMAGES INCURRED BY SUCH PARTY ARISING UNDER OR
AS A RESULT OF THIS AGREEMENT OR THE TERMINATION HEREOF INCLUDING, BUT
NOT LIMITED TO, THE LOSS OF PROSPECTIVE PROFITS OR ANTICIPATED SALES, OR
ON ACCOUNT OF EXPENSES, INVESTMENTS, OR COMMITMENTS IN CONNECTION WITH
THE BUSINESS OR GOODWILL OR OTHERWISE.
11.3. QUALIFICATION. THE FOREGOING LIMITATION OF LIABILITY SHALL (A)
APPLY REGARDLESS OF WHETHER THE LIABLE PARTY HAS BEEN APPRISED OF THE
POSSIBILITY OF SUCH DAMAGES AND NOT WITHSTANDING THE FAILURE OF ANY
OTHER REMEDY HEREUNDER TO SERVE ITS ESSENTIAL PURPOSE; AND (B) NOT APPLY
WITH EXCEPT WITH RESPECT TO A BREACH OF SECTION 3, OR SECTION 13, TO THE
PARTIES OBLIGATIONS UNDER SECTION 12 OR TO THE EXTENT PROHIBITED BY LAW.
12. INDEMNIFICATION
12.1. SSP Indemnification. SSP shall indemnify and hold INSITE, its
directors, officers, employees, agents, Affiliates and sublicensees
harmless against all claims, damages, liabilities, losses, costs and
expenses arising from: (a) any negligent or willful acts or omissions of
SSP, its contractors or permitted licensees, in connection with the
manufacture of any Drug Product, or the exercise or performance by SSP
of any right or obligations under this Agreement; (b) the failure of any
Drug Product or any component thereof supplied by SSP to comply with all
agreed upon specifications and with all applicable laws, regulations and
government orders; or (c) otherwise arising from any acts or omissions
of SSP, its contractors or licensees in connection with the sale or
provision of any Drug Product to any third party; in each case except to
the e extent subject to indemnification of INSITE under Section 12.2
12.2. INSITE Indemnification. INSITE shall indemnify and hold SSP, its
directors, officers,
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employees, agents, Affiliates and sublicensees harmless against all
Claims arising from: (a) any negligent or willful acts or omissions of
INSITE, its contractors or permitted licensees, in connection with the
manufacture of any Drug Product, or the exercise or performance by
INSITE of any right or obligations under this Agreement; (a) the failure
of any Drug Product or any component thereof supplied by INSITE to
comply with all agreed upon specifications and with all applicable laws,
regulations and government orders; or (c) otherwise arising from any
acts or omissions of INSITE, its contractors or licensees in connection
with the sale or provision of any Drug Product to any third party; in
each case except to the e extent subject to indemnification of SSP under
Section 12.1.
12.3. Notice. As a condition to the indemnified Parties right to
indemnification under this Section, the indemnified Party must give
prompt written notice to the indemnifying Party of any suits, claims or
demands by third parties to the indemnified Party which my give rise to
any Claim the indemnifying Party shall be entitled to assume the defense
and control of any Claim at its own cost and expense provided, however,
that the other Party shall have the right to be represented by its own
counsel at its own cost in such matters. In the event that the
indemnifying Party declines to assume control of the defense of any
Claim, the other Party shall be entitled to assume such control, conduct
the defense of a and settle such Claim all at the sole cost and expense
of the indemnifying Party. The indemnifying Party shall not settle or
dispose of any Claim in any manner that would adversely impact the their
rights or interests of the indemnified Party without the prior written
consent of the indemnified Party, which shall not be unreasonably
withheld or delayed.
12.4 Joint Defense. In the event that a claim is made by a third party
against both e Parties, an it cannot be ascertained with certainty which
Party bears the ultimate liability for such claim pursuant to this
Agreement, each Party may proceed to conduct its own defense of such
Claim. The ultimate allocation of responsibility for defense and other
damages arising out of such claim shall be determined on the basis of
the other provisions of this Section 12.
13. CONFIDENTIALITY
13.1. Treatment of Confidential Information. The Parties agree that
during the term of this Agreement, and for a period of five (5) years
after this Agreement terminates, 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; (b) not disclose such Confidential
Information to any third party without prior written consent of the
other Party; and (c) not use such Confidential Information for any
purpose except those permitted by this Agreement. Notwithstanding the
foregoing, a Party receiving Confidential Information of the other Party
may disclose such information (i) pursuant to any court order or
requirement under law or regulation, provided that the Party disclosing
such information uses its reasonable efforts to obtain confidential
treatment of such information, or (ii) to its advisors in evaluating a
merger, acquisition, strategic alliance or securities offering, provided
that the Party disclosing such information enters into nondisclosure
agreements with such advisors.
13.2. Publications. Each Party agrees that it shall have a right to
publish in accordance with its general policies, and the consent of the
other Party. In the event of a possible patentable invention, the Party
wishing to publish shall wait 90 days for patent counsel to review the
publication for inventions.
13.3. Publicity. Except as otherwise provided herein or required by law,
no Party shall originate any publication, news release or other public
announcement, written or oral, whether in the public press,
stockholders' reports, or otherwise, relating to this Agreement or to
any sublicense hereunder, or to the performance hereunder, any such
agreements, without the prior written approval of the other Party, which
approval shall not be unreasonably withheld. Scientific publications
published in accordance with Section 13.2 of this Agreement shall not be
construed as publicity governed by this Section 13.3.
14. TERM AND TERMINATION
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14.1. Term. Unless terminated sooner in accordance with the terms set
forth herein, this Agreement, and the license granted hereunder, shall
on a country-by-country basis concurrently with the expiration of the
Royalty obligations in such country as set forth in Section 4.6.
14.2. Termination Upon Default. Any one or more of the following events
shall constitute an event of default hereunder: (a) the failure of a
Party to pay any amounts past due within thirty (30) days after receipt
of a written notice requesting the payment of such amount; (ii) the
failure of a Party cure any other breach of its obligation hereunder
within sixty (60) days after receipt of notice from the other Party
specifying in reasonable detail the nature of such default. Upon the
occurrence of any event of default, the non-defaulting Party may deliver
to the defaulting Party written notice of intent to terminate, such
termination to be effective upon the date set forth in such notice.
14.3. Termination Upon Bankruptcy or Insolvency. In the event that SSP
or INSITE (i) becomes insolvent; (ii) files a petition in bankruptcy or
has such a petition filed against it under the United States Bankruptcy
Code or foreign equivalent thereof and fails to lift any stay imposed
thereby within sixty (60) days after such stay becomes effective; (iii)
has a receiver appointed with respect to all or substantially all of its
assets; (iv) makes an assignment for the benefit of creditors or (v)
ceases to do business in the ordinary course, the other Party may
terminate this Agreement immediately by notifying the other thereof.
14.4. Rights Upon Termination or Expiration. Upon the expiration or
termination of this Agreement all rights, obligations and licenses
granted hereunder and all sublicenses grander pursuant to this Agreement
shall also terminate. Each Party shall, (a) within sixty (60) days of
the termination date, (i) pay all undisputed amounts due and payable to
the other Party as of the termination date, and (ii) make any reports
required pursuant to Section 5.1, with respect to the period between the
report immediately preceding the termination date and the termination
date; and (b) promptly return all Confidential Information of the other
Party then in such Party's possession, custody or control, Any such
termination shall not relieve either Party from any obligations accrued
to the date of such termination.
14.5. Not Sole Remedy. The termination rights set forth herein, shall be
in addition to and not in substitution for any other remedies that may
be available to the non-defaulting Party. Such termination shall not
relieve the defaulting Party from liability and damages to the other
Party for breach of this Agreement. Waiver by either Party of a single
default or a succession of defaults shall not deprive such Party of any
right to terminate this Agreement arising by reason of any subsequent
default.
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15. ASSIGNMENT/SUCCESSORS
15.1. Assignment. Neither this Agreement nor any rights granted
hereunder may be assigned by either Party with out the prior written
consent of the other Party except: (a) to an Affiliate of such Party,
(b) to a successor in interest to all or substantially all of its
business assets, whether by merger, consolidation, sale of all or
substantially all of such Party's assets, change of control or a similar
transaction, (c) to a successor in interest of all or substantially all
of the assigning Party's line of business associated with this
Agreement, or (d) as expressly permitted hereunder. Any assignment in
violation of the foregoing shall be void and without effect.
15.2. Binding Upon Successors and Assigns. Subject to the limitations on
assignment herein, this Agreement shall be binding upon and inure to the
benefit of any successors in interest and assigns of both Parties. Any
such successor or assignee of any interest shall expressly assume in
writing the performance of all the terms and conditions of this
Agreement to be performed.
16. DISPUTE RESOLUTION
16.1. Executive Mediation. The Parties recognize that a bona fide
dispute as to certain matters may from time to time arise during the
Term of this Agreement that relates to either Party's rights o
obligations hereunder. In the event of such dispute, either Party may,
by written notice to the other have such dispute referred to their
respective officer designated below or their successors, for attempted
resolution by goods faith negotiations within sixty (60) days (the
"Negotiation Period") after such notice is received. The designated
officers for are: (a) for INSITE, the CEO, and (b) for SSP, the CEO;
each party may replace their respective designated officers from time to
time on written notice to the other Party. Subject to Section 16.3, in
the event the designated officers are not able to resolve such dispute
within the Negotiation Period, either Party may invoke their rights
under Section 16.2.
16.2. Arbitration. All disputes, controversies, or differences which may
arise between the parties, out of or in relation to or in connection
with this Agreement, or for the breach thereof, shall be finally settled
by arbitration pursuant to the Japan-American Trade Arbitration
Agreement by which each party hereto is bound. The place of arbitration
shall be in Tokyo, Japan, if such arbitration proceeding is first
instituted by INSITE against SSP and California, U.S.A., if such
arbitration proceeding is first instituted by SSP against INSITE.
16.3. Exceptions. Not withstanding the foregoing, either party will have
the right to apply at any time to a judicial or other applicable
authority: (a) with respect to any question, dispute related to (i) the
intellectual property rights of a Party, or (ii) a breach of Section 3
or Section 13; (b) for appropriate injunctive or other interim or
provisional relief, or (c) for any other relief as may be necessary to
avoid any applicable limitations period.
17. GENERAL PROVISIONS
17.1. Independent Contractors. The relationship between INSITE and SSP
is that of independent contractors. The Parties are not joint venturers,
partners, principal and agent, master and servant, employer or employee,
and have no other relationship other than independent contracting
Parties. No Party shall have the power to bind or obligate each other in
any manner other than as is expressly set forth in this Agreement.
17.2. Entire Agreement: Modification. This Agreement sets forth the
entire agreement and understanding between the Parties as to the subject
matter hereof. There shall be no amendments or modifications to this
Agreement, except by a written document which is signed by both Parties.
17.3. California Law. This Agreement shall be construed and enforced in
accordance with the laws of the State of California.
17.4. Headings. The headings for each article and section in this
Agreement have been
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inserted for convenience of reference only and are not intended to limit
or expand on the meaning of the language contained in the particular
article or section.
17.5. Severability. Should any one or more of the provisions of this
Agreement be held invalid or unenforceable by a court of competent
jurisdiction, it shall be considered severed from this Agreement and
shall not serve to invalidate the remaining provisions thereof. The
Parties shall make a good faith effort to agree upon an acceptable
replacement for any invalid or unenforceable provision with a valid and
enforceable one such that the objectives contemplated by them when
entering this Agreement may be realized.
17.6. No Waiver. Any delay in enforcing a Party's rights under this
Agreement or any waiver as to a particular default or other matter shall
not constitute a waiver of such Party's rights to the future enforcement
of its rights under this Agreement, excepting only as to an express
written and signed waiver as to a particular matter for a particular
period of time.
17.7. Notices. Any notices required by this Agreement shall be in
writing, shall specifically refer to this Agreement and shall be sent by
registered or certified airmail, postage prepaid, or by telefax (receipt
confirmed), telex or cable, charges prepaid, or by overnight courier,
postage prepaid and shall be forwarded to the respective addresses set
forth below unless subsequently changed by written notice to the other
Party:
To SSP:
Attention: CEO
SSP CO., LTD
12-4, 2-Chome
Hama-Cho, Xxxxxxxxxx
Xxxx-Xx, Xxxxx 000-0000
Xxxxx
Fax Number: 00-00-0000-0000
To InSite:
Attention: CEO
Insite Vision Incorporated
000 Xxxxxxxx Xxxxxx
Xxxxxxx, XX 00000
XXX
Fax Number: 000-000-0000
Notice shall be deemed delivered upon the earlier of: (a) when received; (b) the
date notice is sent via telefax, telex or cable; or (c) the day immediately
following delivery to overnight courier except Sunday and holidays.
17.8. Compliance with U.S. laws. Nothing contained in this Agreement
shall require or permit either Party or any Licensee to do any act inconsistent
with the requirements of any United States or Japan law, regulations or
executive order as the same may be in effect from time to time.
17.9. Force Majeure. Neither Party shall be deemed in default of this
Agreement to the extent that performance of its obligations or attempts to cure
any breach are delayed, restricted or prevented by reason of any act of God,
fire, natural disaster, act of government, strikes or labor disputes, inability
to provide power or supplies, or any other act or condition beyond reasonable
control of the parties provided that such Party gives the other Party written
notice thereof promptly.
17.10. Counterparts. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
IN WITNESS WHEREOF, the Parties have executed this Agreement by their duly
authorized representatives as of the date set forth above.
INSITE VISION INCORPORATED SSP CO., LTD.
--------------------------------
Signature
X. Xxxxx Xxxxxxxxxxxxxx, Ph.D
-------------------------------- --------------------------------
Printed Name Printed Name
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Chairman/Chief Executive Officer
---------------------------------
Title
March 23, 2001
--------------------------------- ---------------------------------
Date Date
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PRODUCT DEVELOPMENT & CROSS - LICENSE AGREEMENT
EXHIBIT A
TECHNICAL DISCLOSURE
DURASITE DELIVERY SYSTEM DESCRIPTION
DuraSite is a polymer formulation composed of polycarbophil, lightly
cross-linked acrylic acid polymer, and salts adjusted to a make a formulation
that has a pH and osmolality compatible in the eye. When DuraSite formulations
are instilled into the cul-de-sac of the eye, the residence time is increased
which enhances transport and bioavailability of the drug substance into the eye
tissues. The drug delivery technology described here is covered by the following
U.S. patents and applications along with their foreign counterparts:
U.S. Patent Number/Application:
4,615,697
4,983,392
5,225,196
5,192,535
6,159,458.
SSP TECHNICAL INFORMATION
The technical information on SS732/ and SS734 is included in the following US
Patents and their foreign equivalents:
5,385,900
5,447,926
JOINT PATENT RIGHTS
SS732-DuraSite and SS734-DuraSite (Application in Progress)
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PRODUCT DEVELOPMENT & CROSS - LICENSE AGREEMENT
EXHIBIT B
RESEARCH AND CLINICAL DEVELOPMENT AGREEMENT
The Parties hereby agree to continue to negotiate in good faith and enter into a
Research and Clinical Development Agreement as necessary to effectuate the
rights and obligations of this Development Agreement. Such agreement shall
contain reasonable and customary provisions consistent with this Exhibit A and
shall establish such other provisions as reasonable and customary for such
research and clinical development agreements including but not limited to:
I. DEVELOPMENT COMMITTEE
SSP and INSITE agree to form a development committee to oversee the
development plan for the SS734/DuraSite ophthalmic formulation. This
committee will be composed of [***] and will meet every [***] to monitor
to progress on the development plan and to address technical issues from
drug substance to clinical trials.
II. DEVELOPMENT PLAN
The development plan for the SS734/DuraSite formulation for use in [***]
attached as Exhibit D.
III. CLINICAL TRIALS
INSITE AND SSP will work together on the clinical trial designs to
ensure as is reasonable possible that studies conducted in the United
States may be used to support regulatory filing in Japan.
IV. RESPONSIBILITIES
1. SSP will be responsible for manufacturing the Drug Substance,
which meets cGMP compliance and for filing a DMF with the U.S.
FDA.
2. INSITE may reference the Drug Substance on its Master Drug File.
3. SSP shall supply to INSITE all necessary Drug Substance for
clinical trials in the USA and the manufacture of the Drug
Substance for this purpose. INSITE shall supply SSP with the Drug
Product, which has the same specifications to those used in the
USA clinical studies for clinical trial supplies in Japan.
4. SSP shall be responsible for all non-clinical systemic
toxicology/pharmacology costs for the Drug Substance as provided
in EXHIBIT D. However, the both parties shall amicably discuss to
decide how to share of the costs for the non-clinical tests and
studies which are not required but will in case be required by
the US health authorities such as carcinogenicity studies and
longer-term toxicity studies.
5. INSITE shall be responsible for all Drug Product development
costs through in its Territory and Joint Territory including,
without limitation, performance of clinical trials on the Drug
Product in Insite Territory and Joint Territory. SSP may
reference the development data for its Territory.
6. INSITE and SSP shall provide the support requested by the other
Party in response to
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS.
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questions from regulatory agencies. INSITE shall provide to SSP
the support, including without limitation, by collection of,
searching, and obtaining any data on the "additive" materials
which are used in the DuraSite formulation and which have not
been approved as "additive" within Japan in order to send them to
SSP upon request by SSP only for the purpose of obtaining
approval of the said "additive" within Japan.
7. INSITE AND SSP agree to jointly publish the results of
pre-clinical and clinical development on the Drug Product.
8. INSITE will develop the SS734/DuraSite product. In the event that
problems occur with this combination, a SS732/DuraSite product
will be pursued.
9. INSITE shall supply to SSP copies of all regulatory documents
filed including IND's and NDA filed in the United State on the
Drug Product and, in case, other information on the Drug Product,
which will be required for drug approval in Japan.
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PRODUCT DEVELOPMENT & CROSS - LICENSE AGREEMENT
EXHIBIT C
MANUFACTURING AND SUPPLY AGREEMENT
The Parties hereby agree to continue to negotiate in good faith and enter into a
Manufacture and Supply Agreement as necessary to effectuate the rights and
obligations of this Development Agreement. Such agreement shall contain
reasonable and customary provisions consistent with this Exhibit B and shall
establish such other provisions as reasonable and customary for such supply and
manufacture agreements including but not limited to:
1. SSP shall have the right to manufacture the Drug Product or have it
manufactured in SSP Territory, using polycarbophil supplied by INSITE
supplied by INSITE.
2. INSITE shall have the right to manufacture the Drug Product or have it
manufactured in INSITE TERRITORY using Drug Substance supplied by either SSP
or Dojin.
3. INSITE and SSP shall negotiate in good faith a cost of the Drug Substance in
the INSITE Territory and for polycarbophil in the SSP Territory. Both
Parties hereto shall agree that the said supply costs of the Drug Substance
and polycarbophil to be supplied to either party in accordance with this
Section, shall be [***].
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FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24B-2.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS.
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PRODUCT DEVELOPMENT & CROSS - LICENSE AGREEMENT
EXHIBIT D
SS734/DURASITE DEVELOPMENT PLAN
(THE PLAN TO BE INCLUDED HERE AT SIGNING WILL BE THE STATE OF THE PROJECT AT
THAT TIME AND WILL BE CONSTANTLY UPDATED BY THE DEVELOPMENT COMMITTEE AS MORE
INFORMATION IS RECEIVED.). A BASIC UNDERSTANDINGS UPON START OF THE DURASITE
DEVELOPMENT IS SHOWN BELOW:
[***]
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FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24B-2.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS.
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EXECUTED VERSION
AMENDMENT NO. 1
THIS AMENDMENT NO. 1 (this "AMENDMENT") to the Product Development and
Cross-License Agreement dated April 15, 2001 (the "AGREEMENT") is made effective
as of August 6, 2002 (the "EFFECTIVE DATE") by and between INSITE Vision
Incorporated ("INSITE") with an office at 000 Xxxxxxxx Xxxxxx, Xxxxxxx,
Xxxxxxxxxx 00000, X.X.X. AND SSP CO., LTD ("SSP") with an office at 12-4,
2-Chome, Xxxx-Xxx, Xxxxxxxxxx, Xxxx-Xx, Xxxxx 000-0000 XXXXX, (INSITE and SSP
individually, a "PARTY", together, the "PARTIES").
RECITALS
A. WHEREAS, SSP and INSITE previously entered into the Agreement
pursuant to which INSITE developed a formulation of its delivery system for
use with SSP's drug substances, and each party acquired the right to make,
distribute and sell the combined product in certain territories throughout the
world;
B. WHEREAS, INSITE wishes to sublicense its rights under the Agreement
to Bausch & Lomb Incorporated ("B&L") pursuant to a Technology License
Agreement;
C. WHEREAS, SSP and INSITE desire that [***] under the Agreement.
NOW THEREFORE, for and in consideration of the mutual promises of the
Parties set forth herein, and other good and valuable consideration, the receipt
and sufficiency of which is hereby acknowledged, SSP and INSITE agree as
follows:
Amendment
1. Defined Terms. All capitalized terms used in this Amendment and not otherwise
defined shall have the meanings set forth in the Agreement.
2. [***]. To the end Section 14.2 of the Agreement is added the following:
[***]
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FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24B-2.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS.
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[***]
IN WITNESS WHEREOF, the parties hereto have caused this Amendment No. 1
to be executed and delivered by their duly authorized representatives as
of the Effective Date.
SSP CO., LTD
By:
---------------------------------------
Name:
-------------------------------------
Title:
------------------------------------
INSITE VISION INCORPORATED
By:
---------------------------------------
Name: Kumar Chandrasekaran, Ph.D.
-------------------------------------
Title: Chairman / Chief Executive Officer
------------------------------------
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FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24B-2.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS.
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EXECUTED VERSION
AMENDMENT NO. 2 TO PRODUCT DEVELOPMENT
&
CROSS-LICENSE AGREEMENT
THIS AMENDMENT NO. 2 TO PRODUCT DEVELOPMENT AND CROSS-LICENSE AGREEMENT
(this "Amendment") is entered into and made effective as of this 8th day of
August 2002, by and between INSITE VISION INCORPORATED ("INSITE") with an office
at 000 Xxxxxxxx Xxxxxx, Xxxxxxx, Xxxxxxxxxx 00000 and SSP CO., LTD. ("SSP") with
an office at 12-4, 2-Chome, Xxxx-Xxx, Xxxxxxxxxx, Xxxx-Xx, Xxxxx 000-0000 Xxxxx
(INSITE and SSP individually, a "Party," and together, the "Parties").
RECITALS
A. WHEREAS, the Parties entered into a Product Development and
Cross-License Agreement as of April 15, 2001, as amended in Amendment No. 1
effective as of August 6, 2002 (the "Agreement"), which set forth the Parties'
respective rights and obligations relating to the development of Drug Products
that combine INSITE's proprietary Delivery System with SSP's proprietary Drug
Substances; and
B. WHEREAS, the Parties desire to amend the Agreement as set forth in
this Amendment to reflect more accurately the intent of the Parties with respect
to certain matters.
NOW THEREFORE, based on the foregoing, and in consideration of the
mutual promises and covenants set forth herein, and other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the
Parties agree to amend the Agreement as set forth below.
1. Definitions Generally. Capitalized terms used and not defined in this
Amendment have the meanings given to them in the Agreement.
2. Definition of Affiliate. Section 1.1 of the Agreement is deleted in its
entirety and replaced with the following:
1.1 "Affiliate" means any entity which is directly or indirectly
controlled by or is under common control with a Party. The term
"control" as used herein means the possession of the power to direct or
cause the direction of the management and the policies of an entity,
whether through the ownership of a majority of the outstanding voting
securities or by contract or otherwise. The parties agree that as of the
Effective Date Dojin Pharmaceutical Products Inc. shall be deemed and
treated as an Affiliate of SSP.
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3. Definition of Drug Substance. Section 1.4 of the Agreement is deleted in its
entirety and replaced with the following:
1.4 "Drug Substance" means any of (a) the drug substance identified as
SS732 [***], (b) the drug substance identified as SS734 [***] or (c) the
[***] in addition to those specified in (a) and (b) that are set forth
in the SSP patents identified in Exhibit A, and any combinations of any
of the foregoing (a), (b) and (c).
4. Definition of Drug Product. Section 1.5 of the Agreement is deleted in its
entirety and replaced with the following:
1.5 "Drug Product" means a product combining a Drug Substance together
with a formulation of the Delivery System for use with the Drug
Substance.
5. License to Insite. Section 3.1 of the Agreement is deleted in its entirety
and replaced with the following:
3.1 License to INSITE. Subject to the terms and conditions of this
Agreement, SSP hereby grants to INSITE under the SSP Patent Rights and
SSP Know-How, for the term of this Agreement, a license to: (a) develop
the Drug Product for use in the Field; (b) conduct its clinical trial
activities with respect to the Drug Product; (c) make, have made, use,
sell, offer for sale and import the Drug Product for use in the Field;
and (d) sublicense any or all of the foregoing through multiple tiers of
sublicensees. The foregoing license shall be exclusive including as to
SSP in the INSITE Territory and, to the extent set forth in Section 3.3,
shall be non-exclusive in the Joint Territory.
6. License to SSP. Section 3.2 of the Agreement is deleted in its entirety and
replaced with the following:
3.2 License to SSP. Subject to the terms and conditions of this
Agreement, INSITE hereby grants to SSP under the INSITE Patent Rights
and INSITE Know-How, for the term of this Agreement, a license to: (a)
conduct its clinical trial activities with respect to the Drug Product;
(b) make, have made, use, sell, offer for sale and import the Drug
Product for use in the Field; and (c) sublicense any or all of the
foregoing through multiple tiers of sublicensees. The foregoing license
shall be exclusive including as to INSITE in the SSP Territory and, to
the extent set forth in Section 3.3 shall be non-exclusive in the Joint
Territory.
7. Royalty Period. Section 4.6 of the Agreement is deleted in its entirety and
replaced with the following:
4.6 Royalty Period. The Royalty obligations of either Party as to each
Drug Product shall expire on a country-by-country basis: (a)
concurrently with the
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PORTIONS.
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expiration of the last to expire of Valid Claims within the Joint Patent
Rights (i.e., excluding any Patent Rights covering only INSITE
Technology when INSITE is the Party from whom royalties would otherwise
be due, and excluding any Patent Rights covering only SSP Technology
when SSP is the Party from whom royalties would otherwise be due)
covering Drug Products sold in such country; or (b) with respect to Drug
Products never covered in such country by a Valid Claim within the Joint
Patent Rights, [***] after the date of the First Commercial Sale of such
Drug Product in such country.
8. Separate Patent Rights. Section 6.1 of the Agreement is deleted in its
entirety and replaced with the following:
6.1 Separate Patent Rights. INSITE and SSP shall have the exclusive,
worldwide right, but not the obligation, to pursue and control the
filing, prosecution and maintenance of any Patent Rights that have been
or may be obtained with respect to the INSITE Technology and SSP
Technology, respectively. Each Party shall pay its own expenses with
respect to such filing, prosecution and maintenance of its patents and
confidential information relating to the Delivery System and Drug
Substances, respectively. Each Party agrees to keep the other reasonably
informed with respect to the issuance of patents covering such Party's
Technology and any changes with respect to the status of such patents.
9. Joint Patent Rights. Section 6.2(a) of the Agreement is deleted in its
entirety and replaced with the following:
6.2 Joint Patent Rights.
(a) With respect to any Joint Patent Rights that may be sought or
obtained for the Drug Product: (i) INSITE shall have the exclusive right
but not the obligation to pursue and control the filing, prosecution and
maintenance of such Patent Rights in the INSITE Territory and the Joint
Territory; and (ii) SSP shall have the exclusive right but not the
obligation to pursue and control the filing, prosecution and maintenance
of such Patent Rights in the SSP Territory.
10. No Further Amendment. Except as expressly set forth in this Amendment, no
other terms or conditions of the Agreement are modified, and the Agreement
remains in full force and effect as modified herein.
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FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24B-2.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS.
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IN WITNESS WHEREOF, the Parties have executed this Amendment by their
respective duly authorized representatives as of the date set forth above.
INSITE VISION INCORPORATED SSP CO., LTD.
------------------------------------ ----------------------------------------
Signature Signature
------------------------------------ ----------------------------------------
Printed Name Printed Name
------------------------------------ ----------------------------------------
Title Title
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EXECUTED VERSION
EXHIBIT 4.1
PRODUCT CHARACTERISTICS
[***]
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FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24B-2.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED
PORTIONS.
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EXHIBIT 5.1
PREFERRED STOCK PURCHASE AGREEMENT
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