Exhibit 4.1
[Certain portions of this exhibit have been omitted based on a
request for confidential treatment pursuant to Rule 24b-2
under the Securities Act of 1934, as amended. Omitted
portions: Sections 6.1. (in part), 6.2 (in part), 6.4 (in part), 13.1
(in part), and 18.4 (in part). The omitted portion has been filed
separately with the Securities and Exchange Commission.]
LICENSE AGREEMENT
THIS LICENSE AGREEMENT ("Agreement") is made as of the 25th day of
October, 2001 ("Effective Date") by and between Unilens Corporation, having
offices at ▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇, ▇▇ ▇▇▇▇▇ (hereinafter "Licensor") and
Bausch & Lomb Incorporated, having offices at ▇▇▇ ▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇ ▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ (hereinafter "B&L").
WHEREAS, Licensor owns certain patent rights and other intellectual
property and know-how relating to Licensor's EMA multifocal lens design
("Technology", as defined below);
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 the premises and 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
pre-clinical or clinical protocols and data resulting from or relating to
pre-clinical or clinical trials incorporating the Technology that were performed
before the Effective Date or are performed or developed during the term of this
Agreement.
1.4. "Design Criteria" means the requirements for achieving a
successful commercial design of a cast molded lens as set forth in Exhibit 1
hereof.
1.5. "Equipment" means surgical or diagnostic devices incorporating
the Technology.
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 by B&L or a Sublicensee for use or consumption by the general public
in any country.
1.8. "Field" means ophthalmic applications.
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.
1.10. "Know-How" means all technology, engineering data, trade
secrets, technical data, manufacturing information, Clinical IP, and any other
information or experience that Licensor owns or has the right to license that is
used in or is directly related to Technology as well as any direct improvements
or modifications of the methodology developed by Licensor in the Field during
the Term.
1.11. "Net Sales" means, in any case where a Product is sold or
commercially disposed of for value by B&L, Affiliate of 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), the gross invoice price for
such Product, less the following:
(a) discounts, chargebacks, Medicare or other government rebates,
and rebates to purchasers actually taken or allowed;
(b) credits or allowances given or made for rejections or return of
any previously sold Products actually taken or allowed;
(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; and
(d) to the extent included in such gross invoice price any
reasonable and documented packaging and distribution charges.
(e) Notwithstanding any other provision of this Section 1.11, 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) as samples or other use to promote additional Net Sales in
amounts consistent with the normal business practices of B&L or any
Sublicensee; or
(iii) for compassionate use.
-2-
1.12. "Patent Rights" means any patents or patent applications
relating to the Technology (as defined below in Section 1.20) that Licensor owns
or has the right to license that claim or relate to the Technology. The term
"Patent Rights" includes any continuations, continuations in part, divisions,
re-examinations, re-issues, and extensions, of any of the patents or patent
applications listed in Exhibit 2 and any foreign equivalents thereof, including
any future patents or patent applications B&L acquires right to under Section
3.1 hereof.
1.13. "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.
1.14. "Product(s)" mean an item(s) offered for sale in the Field that
embodies the Technology or is covered by the Patent Rights.
1.15. "Quarter" means B&L fiscal quarters as published by the B&L
Finance Department annually.
1.16. "Royalty Period" means the period beginning on the date of the
First Commercial Sale in a particular country and terminating upon the earlier
of the last expiration or abandonment of Patent Rights claiming or Know-How used
in a Product that is actively marketed by B&L at the time of such expiration or
abandonment.
1.17. "Software" means software developed for use with the Technology.
1.18. "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 identified as a "Distributor
Agreement" (i.e., the other party to the agreement takes title to Product from
B&L) shall be deemed a Sublicense.
1.19. "Sublicensee" means any Person with whom B&L enters into a
Sublicense.
1.20. "Technology" means technology developed or acquired by Licensor
for producing Licensor's EMA multifocal lens design.
1.21. "Term" means the period commencing upon the Effective Date and
extending until the termination of this Agreement pursuant to Article 18.
2.0 LICENSE GRANTS
--- --------------
2.1. Subject to the reservation of Licensor's rights in Section 2.2,
Licensor grants to B&L, and B&L accepts, an exclusive, worldwide, royalty
bearing license, with the right to sublicense, under the Patent Rights and
Know-How to make, have made, use, sell, offer to sell, import, and distribute
Products, Software and Equipment in the Field during the Term. Upon expiration
of the last to expire Patent Rights, B&L will have a fully paid-up, worldwide
license under the Patent Rights and will have an exclusive, worldwide,
royalty-bearing license with the
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right to sublicense under the Know-How during the remainder of the Term as
provided under this Agreement.
2.2. Licensor shall have the right to make, sell, offer to sell, and
distribute lathe cut contact lenses utilizing the Technology during the Term.
2.3. B&L shall have the right to sublicense, in whole or in part, the
license granted in Section 2.1 with Unilens' consent, which would not be
unreasonably withheld. B&L shall be responsible for the obligations of
Sub-licensees.
3.0 RIGHT OF FIRST NEGOTIATION ON IMPROVEMENTS
--- ------------------------------------------
3.1. B&L shall have the right of first negotiation to obtain rights
to any patent or patent application that relates to the Technology made or
discovered by Licensor, its agents, consultants or contractors during the Term.
4.0 DEVELOPMENT
--- -----------
4.1. B&L shall use reasonable commercial efforts:
(a) to develop Products; and
(b) to introduce those Products as soon as practical, consistent
with regulatory approvals and commercially reasonable business practices and
judgments.
5.0 TECHNICAL ASSISTANCE
--- --------------------
5.1. Licensor shall, without charge, make available to B&L, the
Licensor's technological personnel (regarded by Licensor to be competent for the
purpose) to render technological assistance to B&L, to be scheduled at the
mutual convenience of Licensor and B&L during the development process.
5.2. Within Thirty (30) days of Licensor's submission of its invoice,
B&L shall reimburse Licensor for reasonable travel, lodging and other
out-of-pocket expenses associated with providing technical assistance requested
by B&L.
6.0 ROYALTIES
--- ---------
6.1. Subject to royalty payment deductions allowed under Sections 6.4
and 6.5 hereof, B&L shall pay to Licensor a royalty according to the following
schedule. Royalties based upon Net Sales shall begin to accrue upon the date of
First Commercial Sale.
Royalty Payment Schedule:
------------------------
(a) [Omitted based on a request for confidential treatment pursuant
to Rule 24b-2 under the Securities Act of 1934, as amended. The omitted portion
has been filed separately with the Securities and Exchange Commission.] over
the Term;
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(b) [Omitted based on a request for confidential treatment pursuant
to Rule 24b-2 under the Securities Act of 1934, as amended. The omitted portion
has been filed separately with the Securities and Exchange Commission.] over the
Term; and
(c) [Omitted based on a request for confidential treatment pursuant
to Rule 24b-2 under the Securities Act of 1934, as amended. The omitted portion
has been filed separately with the Securities and Exchange Commission.] over the
Term; and
(d) [Omitted based on a request for confidential treatment pursuant
to Rule 24b-2 under the Securities Act of 1934, as amended. The omitted portion
has been filed separately with the Securities and Exchange Commission.] until
the expiration of the last to expire Patent Rights at which time B&L will have a
fully paid-up, exclusive, worldwide license under the Patent Rights; and
(e) [Omitted based on a request for confidential treatment pursuant
to Rule 24b-2 under the Securities Act of 1934, as amended. The omitted portion
has been filed separately with the Securities and Exchange Commission.] upon the
expiration date of the last to expire Patent Rights over the Term for an
exclusive, world-wide, license under the Know-How for B&L, its Affiliates and
Sublicensees to continue to make, have made, use, sell, offer to sell, import,
and distribute Products, Software and Equipment in the Field during the
remainder of the Term.
6.2. B&L shall make minimum royalty payments according to the
following Minimum Royalty Schedule, PROVIDED, that if B&L fails to meet the
minimum royalty requirement for any given twelve (12) month period as measured
from the date of the First Commercial Sale, then B&L shall have the opportunity
within thirty (30) days after making the final royalty payment for the previous
twelve (12) month period, to make up the difference between what was actually
paid and the applicable minimum royalty. If B&L does not make such payment, then
the royalty rate for the next twelve (12) month period will increase by one
percent (1 %) over the applicable rate as defined above, which rate will
decrease (subject to the one percent (1 %) penalty) as volume thresholds are
crossed. If B&L meets the minimum royalty requirement or otherwise makes a
payment for the difference during the next twelve (12) month period, the royalty
rate will drop back to the royalty rate for the applicable net sales volume
without the one percent (1 %) penalty. Moreover, the one percent (1 %) penalty
is a maximum and is not additive year over year.
Minimum Royalty Payment Schedule:
--------------------------------
(a) [Omitted based on a request for confidential treatment pursuant
to Rule 24b-2 under the Securities Act of 1934, as amended. The omitted portion
has been filed separately with the Securities and Exchange Commission.] for the
first twelve (12) months following the First Commercial Sale;
(b) [Omitted based on a request for confidential treatment pursuant
to Rule 24b-2 under the Securities Act of 1934, as amended. The omitted portion
has been filed separately with the Securities and Exchange Commission.] for the
second twelve (12) months following the First Commercial Sale, and
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(c) [Omitted based on a request for confidential treatment pursuant
to Rule 24b-2 under the Securities Act of 1934, as amended. The omitted portion
has been filed separately with the Securities and Exchange Commission.] for each
twelve (12) month period thereafter during the Term until the date of the last
to expire Patent Right.
6.3. B&L shall be responsible for payment of Royalties on Net Sales
to independent third parties through B&L's Affiliates and Sublicensees.
Royalties shall accrue only once for the same unit of Product.
6.4. Upon the date of First Commercial Sale, B&L shall be entitled to
reduce each royalty payment (including the minimum royalty payment) due Licensor
hereunder by [Omitted based on a request for confidential treatment pursuant to
Rule 24b-2 under the Securities Act of 1934, as amended. The omitted portion has
been filed separately with the Securities and Exchange Commission.] until B&L
recovers a total amount of [Omitted based on a request for confidential
treatment pursuant to Rule 24b-2 under the Securities Act of 1934, as amended.
The omitted portion has been filed separately with the Securities and Exchange
Commission.] for Development costs.
6.5. Should a third party commercialize a product which is reasonably
determined by B&L to be substantially the same as the Product licensed hereunder
("Competing Product") in a country where Licensor has no patent protection
covering the Product, and B&L is selling Product in that country, then B&L will
have the right to reduce the applicable Royalty Rate by one percent (1 %) for
Net Sales on Product in that country for so long as such Competing Product is
being sold in that country.
7.0 TIMING OF ROYALTY PAYMENTS; RECORDS
--- -----------------------------------
7.1. Timing of Payments. Within Forty-Five (45) days after the end of
each sequential Quarter following the First Commercial Sale, B&L shall pay to
Licensor the royalty payment due for each Quarter in U.S. dollars.
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 average month-end exchange rates for such Quarter as
calculated based on the daily exchange rate published in The Wall Street
Journal.
7.3. Record Keeping. B&L shall keep full and accurate records
relating to its payment obligations hereunder for the period extending from the
previous two calendar years to the end of the then-current calendar year of the
Term, including, without limitation, data used in arriving at the payments of
Section 6.1 ("Royalty Records").
7.4. 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 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
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payable hereunder and the data from which such determination is made. B&L and
Licensor shall promptly pay any adjustments required between them as a result of
the audit. The expense of each annual audit shall be borne by the Licensor,
unless the audit shall demonstrate an under-reporting greater than ten percent
(10%) of royalties, in which event the audit expenses shall be borne by B&L.
8.0 WARRANTIES
--- ----------
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) 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 except for the security interest and lien of EBC Zurich AG ("EBC"), a
principal shareholder of Licensor, pursuant to the Security Agreement, dated
January 14, 1993, between Licensor and such company. EBC's Letter Of Consent to
this Agreement is attached hereto as Exhibit 4 and Licensor represents and
warrants that the Letter of Consent is a true original signed by an officer of
EBC who is empowered to sign legally binding instruments on behalf of EBC.
(b) it is not aware 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 right inconsistent with the rights granted under this Agreement;
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(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 reasonable precautions to protect the secrecy,
confidentiality and value of the Know-How,
(g) 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 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. No employee of Licensor has entered into any contract (including any
contract that imparts or that imparted an obligation of non-competition,
secrecy, confidentiality or non-disclosure upon Licensor, any employee thereof
or any third party) that restricts or limits in any way the scope or type of
work in which the employee may be engaged or requires the employee to transfer,
assign or disclose information concerning his work to anyone other than
Licensor, and that Licensor has no reason to believe that it or any of its
employees either is or was under any obligation of non-competition, secrecy,
confidentiality or non-disclosure to any third party;
(i) no employee or consultant of Licensor: (1) has used any other
Person's Intellectual Property or other information that is confidential in the
course of his work, or (2) 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) all of the issued Patents are currently in compliance with
formal legal requirements (including payment of filing, examination, and
maintenance fees and proofs of working or use), and are not subject to any
maintenance fees or taxes or actions falling due within ninety (90) days after
the Effective Date;
(k) has the ability to grant to B&L an exclusive license under the
Intellectual Property.
8.4. B&L assumes all responsibility for and all risk of damage or
injury that may occur as a result of its (or its Sublicensees') acts, omissions,
or negligence in making, using, selling, offering to sell, importing or
distributing Products, Software or Equipment arising out of or relating to the
licensing of the Patent Rights or Know-How under this Agreement. Unless due to a
breach of Licensor's representations and/or warranties provided for herein, B&L
agrees to
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indemnify, defend, and hold Licensor harmless for any and all third-party
claims, suits, demands, actions, damages, judgments, costs, liabilities or
expenses (including, without limitation, attorneys fees) arising from the
actions of B&L with respect to any Products, Software or Equipment made, used,
sold, offered for sale, imported, distributed, received or provided as a result
of its licensing the Patent Rights or Know-How under this Agreement, including
without limitation (i) any claim of infringement or misappropriation of any
patent, trademark, copyright, trade secret or other proprietary interest of a
third party; and (ii) any products liability or similar claim for personal
injury or property damage.
9.0 LIMITATION OF LIABILITY
--- -----------------------
9.1. 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.
9.2. IN NO EVENT SHALL EITHER PARTY'S CUMULATIVE LIABILITY TO THE
OTHER PARTY EVER EXCEED THE PAYMENTS MADE AND DUE AND OWING BY B&L TO LICENSOR
HEREUNDER. THE FOREGOING LIMITATION ON LIABILITY SHALL NOT APPLY TO ANY
LIABILITY OF B&L UNDER SECTION 8.4.
9.3. (a) During the term of this Agreement Licensor shall, at its
sole cost and expense, procure and maintain:
(i) Commercial General Liability insurance including coverage
for products/completed operations with annual limits of liability in an
amount not less than $1,000,000 per occurrence; $1,000,000 general
aggregate; and $3,000,000 products/completed operations aggregate, or their
equivalent in non-US locations.
(b) During the term of this Agreement B&L shall, at its sole cost
and expense, procure and maintain:
(i) Commercial General Liability insurance including coverage
for products/completed operations with limits of liability in an amount not
less than $1,000,000 per occurrence; $1,000,000 general aggregate; and
$3,000,000 products/completed operations aggregate, or their equivalent in
non-US locations.
(ii) Workers' Compensation insurance in accordance with
statutory requirements including Employer's Liability with limits in an
amount of not less than $1,000,000 each accident/disease, or its equivalent
in non-US locations.
(c) All policies of insurance required hereunder shall designate
Licensor and B&L as an additional insured, as their respective interests may
appear, and shall be endorsed to provide no less than 30 days prior written
notice in the event of cancellation, non-renewal or material change. The
insurance company(s) providing these policies shall have a current A.M. Best
rating of A- or better, and shall be licensed to do business in the applicable
jurisdiction. A
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certificate of insurance evidencing such insurance coverage(s) will be provided
upon request after execution of this Agreement and no less than fourteen (1)
days prior to renewal of said insurance policies. The certificate(s) of
insurance shall indicate that the above thirty (30) day notice provision
applies.
10.0 PRIVATE LABEL SUPPLY AGREEMENT
---- ------------------------------
10.1. B&L has agreed to sell to Licensor a private label cast molded
polymacon Product for Licensor to sell to Licensor's current lathe cut Product
customer base, including optometrists, ophthalmologists, distributors and
national chains. The Private Label Supply Agreement in its final form is
attached hereto as Exhibit 3. B&L and Licensor will execute the Private Label
Supply Agreement within ten (10) business days of B&L receiving FDA approval for
the 510(k) for the Product. The parties acknowledge that Licensor may continue
manufacturing and selling lathe cut contact lenses which utilize the Technology
during the Term.
Nothing in this Agreement or the Private Label Supply Agreement shall require
B&L to provide Licensor with a lathe cut contact lens or a lens made of material
other than polymacon.
11.0 CONFIDENTIALITY
---- ---------------
11.1. Licensor and B&L and their respective Affiliates (as applicable,
each a "receiver") 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) can be demonstrated by written records to have been developed by
receiver independently of the disclosure by discloser;
(e) can be demonstrated by written records to have been known by
receiver without restriction prior to receiving such information from discloser;
or was furnished by discloser to a third party without similar restriction on
that Party's right of disclosure.
11.2. The foregoing shall not preclude the disclosure of Confidential
Information by receiver:
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(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.
11.3. The terms of this Agreement shall not be disclosed by either
party to any third party (other than as provided in Sections 11.2 and 11.3) or
be published unless both parties expressly agree in writing.
12.0 PUBLICITY
---- ---------
12.1. Subject to Section 12.3, neither party shall use the name of the
other party or its Affiliates without the other party's prior written consent.
12.2. 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. No press release shall be published
unless both parties agree in writing upon the substance and timing of the press
release, such agreements are not to be unreasonably withheld or delayed.
12.3. If a party wishes to make a disclosure to a securities exchange
or to the National Association of Securities Dealers, which disclosure is not
required by applicable law, rules or regulations, that 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.
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13.0 PATENTS
---- -------
13.1. Licensor shall prosecute and maintain Patent Rights. Should
Licensor wish to not enter a country where it otherwise would have the right to
obtain patent protection for any future Patent Right, Licensor shall give B&L
the right to seek such patent protection in the applicable country within a time
frame sufficient for B&L to prepare and file the necessary papers required to
establish a filing date (with priority of any related parent application)
according to the laws of the applicable country. Licensor agrees to fully
cooperate with B&L in preparing the necessary papers to complete the legal
requirements to obtain such patent protection in the applicable country,
including execution of an assignment of all rights, title and interest to such
patent(s) from Licensor to B&L in the applicable country. As B&L would be the
legal owner of any such patent in the applicable country, the [Omitted based on
a request for confidential treatment pursuant to Rule 24b-2 under the Securities
Act of 1934, as amended. The omitted portion has been filed separately with the
Securities and Exchange Commission.] royalty for Know-How would be applicable on
Net Sales of Product under Section 6.1 (d) hereof.
13.2. Licensor shall provide to B&L a written report on the status of
Patent Rights each calendar year.
13.3. B&L will own any patents, patentable inventions or know-how B&L
independently develops related to the Technology or Products.
13.4. Subject to B&L's right of first negotiation as provided for in
Section 3.1 hereof, Licensor will own any patents, patentable inventions or
know-how Licensor independently develops related to the Technology or Products.
13.5. Know-how, inventions and any patent issuing thereon which
include both Licensor and B&L personnel as legal joint inventors shall be
jointly owned by Licensor and B&L.
13.6. B&L shall provide patent marking for Products covered by Patent
Rights that B&L sells in the United States.
14.0 CLINICAL INTELLECTUAL PROPERTY
---- ------------------------------
14.1. Upon execution of this Agreement, Licensor shall disclose all
Clinical IP data to B&L.
14.2. 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 trial arrangement in effect as of the date of this Agreement.
15.0 TRADEMARKS
---- ----------
15.1. B&L shall own the logos, trade names, copyrights, trademarks and
other commercial symbols ("Marks") developed or used in connection with any and
all Products marketed by B&L.
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15.2. During and after the term of this Agreement, Licensor shall not
directly or indirectly contest the ownership, validity or originality of the
Marks for the Products, and the goodwill represented by any of the foregoing
Marks.
15.3. 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
foregoing Marks.
16.0 ENFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS
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16.1. Infringement Notice. If Licensor becomes aware of any
infringement or threatened infringement of any Intellectual Property Right, then
Licensor shall give notice to B&L within Ten (10) days of becoming aware of such
infringement or threat.
16.2. Enforcement Actions. B&L shall have the right, but not the
obligation, 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 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 be retained by B&L. If B&L
does not initiate a response to any infringement within ninety (90) days after
it has received notice thereof, Licensor may request that B&L commence an
infringement action or other appropriate action or response. If B&L declines to
do so or fails to respond to Licensor's request within Sixty (60) days after
receipt 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 B&L shall go first to reimburse the expenses of the parties and the
remainder shall be treated as Net Sales and allocated accordingly.
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 NOTICES
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17.1. 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:
To B&L:
Bausch & Lomb Incorporated
▇▇▇ ▇▇▇▇▇▇ & ▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
Attn: General Counsel
Copy: Senior Vice President, RD&E
To Licensor:
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Unilens Corp., USA
▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Att: President
Copy: Chief Financial Officer
17.2. Any notice, if mailed properly addressed, postage prepaid, shall
be deemed made 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.
18.0 TERM AND TERMINATION
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18.1. Term. Unless earlier terminated as provided for hereunder, the
term of this Agreement shall begin on the Effective Date and shall remain in
effect for so long as B&L, its Affiliates, or Sublicensees, as applicable,
continue to manufacture and sell Product ("Term").
18.2. Termination for Cause
(a) This Agreement will terminate after written notice to a party
of a material breach or default of this Agreement which is not cured (a) in the
event of a breach or default of a payment obligation, within Thirty (30) days
after such payment is due, or (b) in the event of any other a breach or default,
within Sixty (60) days after the breaching party has received such notice.
(b) This Agreement will terminate after written notice by B&L to
Licensor that B&L cannot, in B&L's sole discretion, commercially manufacture
Product that meets the Design Criteria of Exhibit 1, or B&L reasonably believes
that it will not receive FDA approval for the 510(k) for the Product.
(c) This Agreement will terminate upon written notice by Licensor to
B&L if the parties have not executed the Private Label Supply Agreement of
Section 10.0 hereof and/or B&L has failed to manufacture Product for commercial
sale by April 30th, 2003.
18.3. Termination for Convenience. B&L may terminate this Agreement
and the licenses granted hereunder without cause, upon Ninety (90) days written
notice to Licensor.
18.4. Effect of Termination for Cause or Convenience.
(a) Except as expressly set forth in Section 20.6, all rights and
obligations under this Agreement (including without limitation any licenses
granted hereunder) and the Private Label Supply Agreement 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.
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(b) Without limiting the foregoing, if B&L terminates this Agreement
pursuant to Sections 18.2(b), 18.2(c), or 18.3, B&L shall pay Licensor, within
Thirty (30) days after such termination:
(i) amounts equal to all accounts payable with regard to any
reimbursable expenses which were approved by B&L under Section 5.2; and
(ii) If PRIOR to a First Commercial Sale, termination is
pursuant to Section 18.3 , 18.2(b) or 18.2(c) then B&L shall pay to
Licensor a one-time termination fee of [Omitted based on a request for
confidential treatment pursuant to Rule 24b-2 under the Securities Act of
1934, as amended. The omitted portion has been filed separately with the
Securities and Exchange Commission.] and
(iii) If PRIOR to a First Commercial Sale, notice and
termination is effectuated by Licensor as the result of B&L's breach of
Section 4.0 hereof and B&L has not cured the alleged breach as provided
under Section 18.2(a) hereof, then B&L shall pay to Licensor a one time
termination fee of [Omitted based on a request for confidential treatment
pursuant to Rule 24b-2 under the Securities Act of 1934, as amended. The
omitted portion has been filed separately with the Securities and Exchange
Commission.]
(c) Upon termination of this Agreement with or without cause under
Sections 18.2 or 18.3 hereof, B&L, and its Affiliates and Sublicensees, as
applicable, shall return to Licensor within Sixty (60) days of termination all
Know-How and Confidential Information previously disclosed, provided or made
available to B&L by Licensor pursuant to this Agreement except to the extent
necessary for B&L or any Affiliate or Sublicensee to maintain or service any
Product which has been sold and to maintain records in accordance with its then
current company policies.
18.5. Sell-Off Period. Notwithstanding anything to the contrary
contained herein, B&L, its Affiliates and its Sublicensees shall have Ninety
(90) days 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
obligations to Licensor under this Agreement.
19.0 FORCE MAJEURE
---- -------------
19.1. 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.
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20.0 MISCELLANEOUS
---- -------------
20.1. 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 and licensor shall be entitled to assign this Agreement to an Affiliate or a
purchaser of substantially all of the assets to which this Agreement applies.
20.2. 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.
20.3. 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.
20.4. Dispute Resolution. If any dispute arises between Licensor and
B&L with respect to the interpretation or breach of this Agreement, 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, Contact Lens and Lens Care. 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.
20.5. Governing Law; Jurisdiction. Any legal or other action hereunder
shall be brought in the State or federal courts nearest the principal place of
business of the defendant in any such action, and this Agreement shall be
construed and interpreted and its performance shall be governed by the
substantive laws of the State where such courts are located, i.e., New York, if
B&L is the defendant, and Florida, if Licensor is the defendant, without regard
to the state's conflict of laws principles. The Parties consent to the exclusive
personal jurisdiction and venue of such courts in the event of such action.
20.6. Survival. Articles 7, 8, 9, 14 and 20 shall survive termination
of this Agreement.
20.7. 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)
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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 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.
20.8. 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.
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 UNILENS CORPORATION
By: /s/ ▇▇▇▇ ▇. ▇▇▇▇ By: /s/ ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
--------------------------------- -----------------------------------
Name: ▇▇▇▇ ▇. ▇▇▇▇ Name: ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
Title: Corp. Sr. VP RD&E Title: Chairman & CEO
Date: 10-23-01 Date: Oct. 25, 2001
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