COLLABORATION AND SALE/LICENSE AGREEMENT
By and Between
BAUSCH & LOMB PHARMACEUTICALS, INC.
and
SYMBOLLON CORPORATION
---------------------------------
Dated as of August 4, 1997
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TABLE OF CONTENTS1
Page No
Article 1 Definitions........................................ 1
Article 2 Joint Development Committee........................ 6
2.1 Formation.......................................... 6
2.2 Responsibilities................................... 6
2.3 Disagreements...................................... 7
2.4 Market Opportunity Prior to First Commercial Sale.. 7
2.5 Market Opportunity After First Commercial Sale..... 7
Article 3 Research and Development Efforts................... 8
3.1 Efforts............................................ 8
3.2 Funding............................................ 8
3.3 Sharing of Information............................. 9
3.4 Material Samples................................... 9
Article 4 B&L License........................................ 9
4.1 Basic Grant........................................ 9
4.2 Specific Limitations............................... 9
4.3 Symbollon Retained Rights.......................... 10
4.4 Otic Infections.................................... 10
4.5 Rest of World...................................... 10
4.6 Recording.......................................... 10
Article 5 Clinical Trials and Regulatory Filings............. 11
Article 6 Sale of Patent..................................... 11
6.1 Transfer of Patent Rights.......................... 11
6.2 Installment Sale Payments.......................... 12
6.3 Orphan Drug Products............................... 12
6.4 Cosmetic Eye Scrub Product......................... 13
6.5 Negative Covenants................................. 13
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1 This Table of Contents is for convenience of reference only and is not part
of this Agreement.
Page No.
Article 7 Royalties.......................................... 13
7.1 Royalties.......................................... 13
7.2 Sublicense Fees.................................... 13
7.3 Overall Value...................................... 14
Article 8 Symbollon Sale of Products Outside Territory....... 14
Article 9 Payments........................................... 14
9.1 Timing of Royalty Payments......................... 14
9.2 Records of Net Sales............................... 15
9.3 Payments........................................... 15
Article 10 B&L's Exclusivity Obligations...................... 15
Article 11 Confidentiality and Publications................... 16
11.1 Proprietary Information............................ 16
11.2 Joint Disclosures.................................. 16
Article 12 Ownership of Intellectual Property................. 17
12.1 General Intent..................................... 17
12.2 New Inventions..................................... 17
12.3 Symbollon's Rights in B&L's Joint Inventions....... 17
12.4 License Upon Termination........................... 18
12.5 Patent Applications................................ 18
12.6 Disputes........................................... 18
Article 13 Warranties/Indemnification/Insurance............... 18
13.1 Representations and Warranties..................... 18
13.2 Disclaimer......................................... 19
13.3 Additional Covenants............................... 19
13.4 Indemnification.................................... 19
13.5 Insurance.......................................... 19
13.6 Additional Indemnification Obligations............. 20
Page No.
Article 14 Infringement and Trademarks........................ 20
14.1 Notice of Infringement............................. 20
14.2 Control, Cost and Cooperation in Infringement Actions 21
14.3 Recoveries Against Infringer....................... 21
14.4 Trademarks......................................... 21
Article 15 Assignability...................................... 21
Article 16 Term and Termination............................... 22
16.1 Term............................................... 22
16.2 Termination Events ................................ 22
16.3 Termination by B&L................................. 23
16.4 Effects of Termination............................. 23
16.5 Survival........................................... 24
Article 17 Supply and Manufacture............................. 24
Article 18 Miscellaneous...................................... 24
18.1 Notices............................................ 24
18.2 Governing Law; Jurisdiction and Venue.............. 26
18.3 Limited Arbitration................................ 26
18.4 Waiver............................................. 26
18.5 Enforceability..................................... 26
18.6 Entire Agreement and Amendment..................... 27
18.7 Independent Contractor............................. 27
18.8 Headings........................................... 27
18.9 Further Instruments................................ 27
18.10 Force Majeure...................................... 27
18.11 Counterparts....................................... 28
18.12 Exhibits and Schedules............................. 28
Exhibits and Schedules
A -- Patent Applications and Patents
B -- Project Plan
C -- Initial Members of the JDC
D -- Form of Patent Assignment
1.16 -- Exceptions to the Licensed Patents
COLLABORATION AND SALE/LICENSE AGREEMENT
This Agreement is made as of this 4th day of August, 1997 by and
between Bausch & Lomb Pharmaceuticals, Inc. ("B&L") and Symbollon Corporation
("Symbollon").
Symbollon is the owner of certain proprietary technology relating to
topical iodine. B&L has resources and expertise useful in the development and
marketing of ocular pharmaceuticals. The parties wish to collaborate in a
designated field on research and development of novel pharmaceutical agents
which incorporate Symbollon's proprietary topical iodine technology, and B&L
wishes to purchase a patent and obtain a license from Symbollon under
Symbollon's proprietary technology for the manufacture, use and sale of products
in such designated field, all on the terms and conditions set forth in this
Agreement. Accordingly, the parties hereby agree as follows:
Article 1 - Definitions
For purposes of this Agreement, the following capitalized terms shall
have the following definitions:
1.01 "Affiliate" means any individual, corporation, partnership,
proprietorship or other entity controlled by, controlling, or
under common control with a party through equity ownership,
ability to elect directors or direct management and policies,
or by virtue of a majority of overlapping directors, and shall
include (a) any individual, corporation, partnership,
proprietorship or other entity directly or indirectly owning,
owned by or under common ownership with such party to the
extent of fifty percent (50%) or more of the equity or voting
shares, including shares owned beneficially by such party and
(b) each officer, director or partner of such party.
1.02 "AADA" means an Abbreviated Antibiotic Drug Application filed with
the FDA.
1.03 "ANDA" means an Abbreviated New Drug Application filed with the
FDA.
1.04 "Collaborative Project" means the development and
commercialization of the Products pursuant to this Agreement
supervised and overseen by the JDC.
1.05 "Drug Master File" means those files maintained from time to
time by Symbollon with the FDA regarding its technology.
1.06 "Effective Date" means the date first written above.
1.07 "Field" means the topical treatment of human ocular
infections, inclusive of an eye scrub product which may be
used in the periocular region to resolve conditions related to
or arising from an ocular infection; provided that, prior to
the first commercial sale of a Product, the Field may be
permanently reduced in scope from time to time by the Joint
Development Committee pursuant to Section 2.4, and after the
first commercial sale of a Product, the Field may be further
permanently reduced in scope from time to time pursuant to
Section 2.5.
1.08 "FDA" means U.S. Food and Drug Administration or any successor
entity thereto.
1.09 "FDA Compliance Costs" means the reasonable out-of-pocket
costs relating to the manufacturing facility incurred by B&L
in connection with or as a result of FDA product approvals,
inspections or compliance with FDA regulations, orders,
directives or suggestions.
1.10 "Generic" means any product in the Field approved by the FDA
pursuant to an ANDA, AADA or an NDA (including a supplemental
or amended NDA) which is a pharmaceutical equivalent,
pharmaceutical alternative or therapeutic equivalent (each as
defined by the FDA) to a Product.
1.11 "Gross Profit" means Net Sales less cost of goods sold, as
determined under generally accepted accounting principles.
1.12 "IND" means an Investigational New Drug Application filed with the
FDA.
1.13 "Inventions" means all discoveries, inventions, concepts,
ideas or intangible property, whether patentable or not, made,
conceived, or reduced to practice in the course of or related
to Product research and development performed pursuant to
Article 3.
1.14 "Joint Development Committee" or "JDC" means a committee of
officers, employees or consultants of Symbollon and B&L as
described in Article 2 of this Agreement.
1.15 "Joint Invention" has the meaning set forth in subsection
12.2(b).
1.16 "Licensed Patents" means all of Symbollon's rights in and
under patents and patent applications applicable to the Field
and one or more valid claims of which covers any Product or
method of using or manufacturing any Product, as follows: (a)
the patents and patent applications listed in Exhibit A, as
well as all patents issuing therefrom in which Symbollon has a
property interest or under which Symbollon acquires license
rights (except as disclosed on Schedule 1.16 attached hereto,
Symbollon has the right and authority to license or
sublicense, as the case may be, such property interests or
license rights), (b) any patent or patent application covering
an Invention or Joint Invention assigned to Symbollon pursuant
to Section 12.2, (c) any other future iodine-based patent or
patent application in which Symbollon acquires any property
interest or license rights (but only to the extent such rights
may by their terms be further assigned to B&L hereunder;
provided that Symbollon agrees to exercise Reasonable
Commercial Efforts to obtain the right to sublicense any
license rights that may be acquired in the future), and (d)
any divisions, continuations or continuations in part of the
patents or patent applications set forth above or of the
Patent Rights, including any reissue, re-examination,
re-registration or extension. Symbollon shall promptly notify
B&L from time to time as new patent applications are filed or
patents are issued which fall within the definition of
Licensed Patents. Exhibit A shall be updated from time to time
to reflect any Licensed Patents which arise following the date
hereof, and to delete any patent rights, whether owned or
licensed, which do not include one or more valid claims
covering any Product or method of using any Product.
1.17 "Manufacturing Costs" shall mean B&L's standard cost of
manufacturing the Product, which shall include direct labor,
direct and variable materials (including scrap), freight,
variable overhead, an allocation of fixed overhead, and yield
losses, plus or minus reasonable manufacturing variances; all
determined in accordance with generally accepted accounting
principles applied consistently and in accordance with
existing and demonstrable B&L practices; but provided that, in
determining such allocation, B&L shall use the lowest and most
favorable method of allocation used by B&L for any proprietary
product manufactured by B&L at its manufacturing facility (in
volumes similar to the quantity of Product manufactured by B&L
for Symbollon) exclusively for sale to, and distribution by,
an unrelated third party.
1.18 "NDA" means a New Drug Application filed with the FDA.
1.19 "Net Sales" means the sum of all amounts received and all
other consideration received (when in a form other than cash
or its equivalent, the fair market value thereof when
received) by a party (and in the case of B&L, a third party
sublicensee pursuant to Section 4.2(b)) or any of their
Affiliates from persons or entities who are not Affiliates or
(in the case of B&L, sublicensees pursuant to Section 4.2(b))
by reason of the sale, distribution or use of Product less,
without duplication: (a) discounts and rebates, if any,
actually given in the ordinary course of business, (b) credits
or allowances, if any, actually given or made on account of
price adjustments, returns, rejections, recalls or destruction
of such Products, (c) any insurance and prepaid freight
expenses actually incurred in connection with the shipment of
such Products if included in the billed amount and (d) any
sales, value-added or excise tax. "Net Sales" shall not be net
of any amounts paid or deductions made for (y) commissions or
fees paid to any person, whether they be with independent
sales agencies, regularly employed by a party or its
Affiliates, or under a co-promotion arrangement as
contemplated under subsection 4.2(b) or (z) discounts or
rebates, if any, actually allowed, if any such discount or
rebate has been granted on any basis other than the purchase
of Products. Any overpayment of royalties due to an allowable
deduction for discounts under clause (a), above, applicable to
periods for which royalties have already been paid may be
credited against future royalty obligations.
1.20 "Non-Orphan Drug Products" mean Product(s) developed and
commercialized pursuant to this Agreement which do not qualify
for "orphan drug" status (as defined by the FDA).
1.21 "Orphan Drug Products" mean Product(s) developed and
commercialized pursuant to this Agreement which qualify for
"orphan drug" status (as defined by the FDA).
1.22 "Other Costs" shall mean in each case set forth in a
reasonably detailed statement delivered to Symbollon by B&L
with each invoice for Product manufactured and supplied by B&L
to Symbollon: (i) a reasonable and customary allocation of FDA
Compliance Costs pertaining to the Product; (ii) a reasonable
and customary allocation as between B&L and Symbollon of any
fees or royalties incurred by B&L to a unrelated third party
related to the manufacture of the Product; and (iii) an
allocation of B&L's direct cost of research and development
and other technical services relating to the Product
reasonably, necessarily and actually rendered, following FDA
approval of the NDA for the Product.
1.23 "Patent Rights" mean a United States patent number 5,639,481
issued June 17, 1997 entitled, "Method for the Therapeutic
Treatment of a Mammalian Eye Using an Admixed Composition
Containing Free Molecular Iodine", identifying Xxxx X. Xxxxxxx
and Xxxxx X. Xxxxxxxx as the inventors, but excluding all
continuations, continuation-in-parts, divisions and
extensions, and excluding all foreign counterparts thereof.
1.24 "Product" means any product in the Field which is based on the
Patent Rights, the Licensed Patents, a Joint Invention owned
by B&L or Proprietary Information of Symbollon.
1.25 "Project Plan" means the written plan (initially to be
developed by the parties within sixty (60) days of the date of
this Agreement and attached hereto as Exhibit B, as the same
may be revised in writing from time to time pursuant to
Section 2.2.) for the research and development of Products
which sets forth (a) the research and development work to be
performed by the respective parties, (b) the schedule of
agreed upon milestones and completion of such work, and (c) an
annualized budget.
1.26 "Proprietary Information" means all technical information,
data, techniques, knowledge, skill, know-how, experience,
trade secrets, developments, formulae, processes, materials
and other information of a party which is disclosed or
transferred from one party to the other or developed in the
course of performance under, or during the term of, this
Agreement, including by way of illustration and not
limitation, designs, drawings, documents, models and other
similar information and shall include Inventions and Joint
Inventions. "Proprietary Information" shall not include any of
the foregoing that are (i) in the possession of the receiving
party at the time of disclosure as shown by the receiving
party's files and records immediately prior to the time of
disclosures; (ii) prior to or after the time of disclosure
becomes part of the public knowledge or literature, not as a
result of any improper inaction or action of a party under an
obligation of confidentiality; or (iii) lawfully obtained by
the receiving party from sources independent of the disclosing
party, which sources have a lawful right to disclose such
information. Nothing herein shall in any way affect the rights
of an Affiliate to claim a trade secret independently
developed by such Affiliate without in any way relying on or
having knowledge of any relevant Proprietary Information
covered by this Agreement.
1.27 "Reasonable Commercial Efforts" means efforts no less diligent
than either party customarily exercises under similar
circumstances of its own consistent with good business
judgment, or if no prior similar circumstances have occurred,
then such efforts should be commercially reasonable in light
of existing circumstances and consistent with good business
judgment.
1.28 "Regulatory Approvals" has the meaning set forth in Article 5.
1.29 "Regulatory Filings" has the meaning set forth in Article 5.
1.30 "Right of First Negotiation" shall mean B&L's exclusive option
to negotiation for rights as specified herein. Such option may
be exercised by B&L by providing written notice to Symbollon
prior to expiration of such option. If such written notice is
timely provided, then the parties agree to negotiate in good
faith for a period of three months a definitive agreement for
the rights covered by such option. If the parties are not able
to execute a definitive agreement for the relevant rights
within such three-month period, then for a period of twelve
(12) months following such three-month period Symbollon agrees
not to execute an agreement covering the relevant rights with
a third party on terms more or as favorable as those last
offered thereunder without B&L's prior written consent.
1.31 "Territory" means the United States, including its
territories, possessions and military bases outside the United
States. Further, on a Product by Product basis, the Territory
shall include Canada, if within one (1) year of the first
commercial sales of any Product, B&L initiates commercial
sales of the Product in Canada.
1.32 "Warehousing Costs" shall mean B&L's direct warehousing
costs of Product purchased by Symbollon and raw materials
held by B&L to produce such Product, including labor,
freight, inventory write-offs due to such Product or raw
materials expiration and costs associated with destroying
expired Product or raw materials, plus normal and customary
allocable warehousing overhead costs; all determined in
accordance with generally accepted accounting principles
applied consistently and in accordance with existing and
demonstrable B&L practices; but provided that, in determining
such allocation, B&L shall use the lowest and most favorable
method of allocation used by B&L for any proprietary product
stored by B&L at its manufacturing facility for sale to, and
distribution by, an unrelated third party.
Article 2 - Joint Development Committee
2.1 Formation. The Joint Development Committee will be comprised of
five (5) members with three (3) being appointed and replaced by B&L and two (2)
being appointed and replaced by Symbollon. The initial members of the JDC are
set forth on Exhibit C. Any changes to the size of the JDC must be unanimously
agreed upon by that committee. Meetings of the JDC may be held so long as at
least one (1) representative of each party is present. The JDC will meet at
least once per fiscal quarter. Such meetings will be telephonic meetings, or
will alternate at B&L's or Symbollon's headquarters, or as otherwise agreed by
the parties. A chair of the JDC will be appointed alternately by B&L and
Symbollon to six-month terms.
2.2 Responsibilities. Each party will report to the JDC regularly on
its progress with respect to its respective work assignments under the Project
Plan. The JDC shall supervise and oversee the development and commercialization
of the Products (the "Collaborative Project"). Without limitation, the JDC shall
be responsible for (i) approving the product definitions; (ii) coordinating the
research and development activities with respect to the Collaborative Project;
(iii) approving modifications and updates to the Project Plan for the
implementation of the Collaborative Project; (iv) monitoring performance and
expenditures under the Collaborative Project in relation to the Project Plan;
(v) appointing the party or parties to conduct the clinical development and
testing of the Products and the filing of any IND therefor in the Territory; and
(vi) the determination of which party or parties shall perform any task required
under the Collaborative Project not otherwise assigned hereunder.
2.3 Disagreements. If the members of the JDC are unable to reach
unanimous agreement on a matter, the top executive officer of each party will
confer as soon as reasonably practicable to thoroughly consider such matter, and
each use his Reasonable Commercial Efforts to effect resolution. Should such
conference not resolve the disagreement, subject to the provisions of Sections
2.5 and any other contract provisions to the contrary, B&L will, in good faith,
make the final decision to accept or to reject such proposed resolution,
provided that, in no event shall the Project Plan be revised without the mutual
agreement of B&L and Symbollon with respect to (a) any matter which conflicts
with a provision specifically set forth in this Agreement and (b) the research
and development work to be performed by Symbollon.
2.4 Market Opportunity Prior to First Commercial Sale. Prior to the
first commercial sale of a Product, if Symbollon reasonably believes that the
Collaborative Project is not addressing the full market opportunity within the
Field, then Symbollon may request the JDC to address its concerns regarding
Product development and/or commercialization. Should the JDC decide that certain
Product opportunities in the Field are not being pursued, then the Field shall
thereafter be reduced in scope to exclude such Product opportunities. Section
2.3 shall govern if the JDC can not reach unanimous agreement on this matter. As
part of the determination of whether the full market opportunity within the
Field is being addressed, consideration should be given to present development
efforts, planned future development efforts, any other iodine-based products
under development or commercialization by B&L pursuant to Article 10, and a
commercially reasonable level of resource commitment by B&L to development of
Products pursuant to this Agreement.
2.5 Market Opportunity After First Commercial Sale. After the first
commercial sale of a Product, if Symbollon reasonably believes that the
Collaborative Project is not addressing the full market opportunity within the
Field, then Symbollon may request the JDC to address its concerns regarding
Product development and/or commercialization. Should the JDC decide that certain
Product opportunities in the Field are not being pursued, then the Field shall
thereafter be reduced in scope to exclude such Product opportunities. If the
members of the JDC are unable to reach unanimous agreement on a matter, the top
executive officer of each party will confer as soon as reasonably practicable to
thoroughly consider such matter, and each use his commercially reasonable
efforts to effect resolution. Should such conference not resolve the
disagreement, then the parties agree to submit this matter to arbitration
pursuant to Section 18.3. The arbitration process shall take into consideration
any valid business or economic considerations the parties may present in defense
of their position, including possible encroachment by any such new Product
opportunity of an existing or planned Product developed, or being developed,
pursuant to this Agreement. As part of the determination of whether the full
market opportunity within the Field is being addressed, consideration should be
given to present development efforts, planned future development efforts, any
other iodine-based products under development or commercialization by B&L
pursuant to Article 10, and a commercially reasonable level of resource
commitment by B&L to development of Products pursuant to this Agreement.
Article 3 - Research and Development Efforts
3.1 Efforts. Each party will perform its respective research and
development efforts as initially set forth in the Project Plan. It is the
parties' intent that (a) B&L will be primarily responsible for taking all steps
necessary to commercialize Products in the Territory, including, without
limitation, formulating Products, conducting animal studies and clinical trials,
making all Regulatory Filings, identifying manufacturing processes, and
otherwise commercializing Products, and (b) Symbollon will actively consult with
B&L and be available to assist in Product formulations, as reasonably requested
by B&L.
3.2 Funding. B&L will (a) bear all of its own costs and expenses
incurred in connection with its performance under the Project Plan and (b)
should B&L request any assistance from Symbollon, pay Symbollon for its work
under the Project Plan at the rates of [* INDICATES THAT MATERIAL HAS BEEN
OMITTED AND CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH OMITTED
MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2.],
plus reimbursement for all materials and third party costs reasonably incurred
by Symbollon in accordance with the following: (i) on the Effective Date (with
respect to the first partial fiscal quarter during the term of this Agreement)
and, thereafter, on or before the first day of each fiscal quarter, B&L shall
deliver to Symbollon a purchase order setting forth B&L's and Symbollon's
mutually agreed estimate of the work hours and materials required under the
Project Plan for completion of Symbollon's assigned work for such quarter,
together with the payment to Symbollon therefor, (ii) as each fiscal quarter
progresses, Symbollon shall issue an invoice to B&L, if its hours and/or costs
exceed the purchase order amounts previously paid to it at the beginning of such
fiscal quarter, and B&L shall pay Symbollon the amount of such excess within
thirty (30) days of receipt from Symbollon of an invoice therefor, and (iii) on
or before the end of each fiscal quarter, Symbollon shall notify B&L of any
excess payment for such quarter, and any excess shall be credited against the
amounts due under the next fiscal quarter's purchase order. Symbollon shall
provide B&L with monthly summaries of its time and expenses incurred hereunder
and an estimated projection of its time and expenses for the next month.
Notwithstanding the above, Symbollon shall not charge B&L for (i) any time and
expenses associated with Symbollon's participation in the JDC, (ii) any time
incurred by Xx. Xxxx X. Xxxxxxx and (iii) any time associated with the initial
technical meetings between the parties' staffs after the signing of this
Agreement. Any dispute relating to Symbollon's invoices which can not be decided
by good faith negotiations between the parties, shall be resolved by arbitration
pursuant to Section 18.3.
3.3 Sharing of Information. B&L and Symbollon will take reasonable
efforts to make available and disclose to each other all information known by
B&L and Symbollon concerning the Field as of the Effective Date and at any time
during the term of this Agreement which relates to Product development. Except
as otherwise provided herein, the parties agree that neither party shall share
any of the other party's Proprietary Information with any third party or any of
its Affiliates, except certain employees serving staff service functions (i.e.
chief medical officer, legal, etc.), and consultants and advisors, subject to
confidentiality obligations. All Inventions made by B&L pertaining to iodine or
by Symbollon pertaining to the Field will be promptly disclosed to the other, it
being understood that the obligation to disclose will have no bearing on the
issue of ownership of such discoveries or inventions. Prior to each meeting of
the JDC, each party will deliver to the other a verbal or written report
presenting a meaningful summary of research done by that party to date under
this Agreement. Each party will make regular presentations to the other of its
research through the JDC to inform the other party of research done under this
Agreement. Each party will provide the other with raw data in original form or a
photocopy thereof for any and all work carried out in the course of the Product
research, development and commercialization as reasonably requested by the other
party.
3.4 Material Samples. All materials believed by either party to be
useful in the design of Products and prepared by such party in the course of any
of its research under this Agreement will be discussed with the other party and
samples of such materials will be submitted to the other party upon request.
Article 4 - B&L License
4.1 Basic Grant. Subject to the terms and conditions of this Agreement,
Symbollon grants to B&L a sole and exclusive license under the Licensed Patents
and Symbollon's Proprietary Information relating to iodine to make, have made on
behalf of B&L, use, offer to sell, sell and import Products in the Territory for
use in the Field, with the right to grant sublicenses limited to co-promotion or
co-marketing arrangements pursuant to Section 4.2(b).
4.2 Specific Limitations.
(a) Off-Label Use. B&L shall, without limitation, (i) promote
any Product only to wholesale and retail distribution channels and
physicians or other medical practitioners for use within the Field
(expressly including physicians who treat outpatients within
hospital-based clinics, departments, residency programs, physician
offices, and managed care systems), (ii) not promote any Product
through distribution channels servicing only the market(s) for
applications outside the Field, and (iii) not promote, either directly
or indirectly, the use of any Product for any applications outside the
Field.
(b) Co-Promotion. B&L will discuss with Symbollon any
opportunity to enter into an arrangement, be it in the form of a joint
venture, sublicense or otherwise, with a third party pursuant to which
B&L and such third party would co-promote or co-market any Product(s).
After such discussion and giving due consideration to any concerns of
Symbollon, B&L may enter a co-promotional or co-marketing arrangement,
provided that, any such co-promotional or co-marketing agreement, be it
in the form of a joint venture, sublicense or otherwise, shall include
provisions requiring (a) compliance by the third party with all of the
terms and conditions set forth in this Agreement, (b) that a copy of
the true and complete agreement and all amendments thereto be delivered
to Symbollon upon execution thereof, and (c) that Symbollon shall
receive one-half of (i) any and all amounts received and (ii) all other
consideration received (when in a form other than cash or its
equivalent, the fair market value thereof when received) by B&L or its
Affiliates directly or indirectly in or from such third party to such
co-promotional or co-marketing agreement, be it in the form of a joint
venture, sublicense or otherwise; provided, that amounts received as
Net Sales, or advances thereon, shall be excluded. As contemplated in
the definition of "Net Sales", it is the parties' intent that any and
all consideration paid to or incurred by any joint venture, third party
sublicensee or other form of entity which is selling Product(s)
hereunder shall be at the sole cost and expense of B&L or such
co-promoter or co-marketer, as the case may be, and shall not result in
any reduction of the royalty due to Symbollon under this Agreement. To
the extent any payment is made by B&L to Symbollon pursuant to this
Section 4.2(b) which relates to an advance of a royalty, then no
payment shall be made by B&L to Symbollon on the corresponding future
credit against royalties of such advance.
4.3 Symbollon Retained Rights. Subject to Sections 4.4 and 4.5,
Symbollon shall be free to pursue the research, development, manufacture and
distribution of any product which incorporates Symbollon's proprietary iodine
technology, independently or in cooperation with a third party, in any way
whatsoever outside of the exclusive license granted to B&L.
4.4 Otic Infections. B&L shall have a Right of First Negotiation to
include within the Field the topical treatment of human otic infections in the
Territory for a period of twenty-four (24) months after the Effective Date.
4.5 Rest of World. B&L shall have a Right of First Negotiation for
rights in the Field outside the Territory for a period of thirty-six (36) months
after the Effective Date.
4.6 Recording. B&L shall have the right to index a summary of this
Agreement acceptable to both parties in the assignment records of the U.S.
Patent and Trademark office.
Article 5 - Clinical Trials and Regulatory Filings
B&L shall, at its sole cost and expense, conduct all clinical trials
for Products in the Territory. Symbollon will cooperate with B&L in the conduct
of any such clinical trials. B&L shall, at its sole cost and expense, secure any
and all licenses, permits, approvals and other authorizations (the "Regulatory
Approvals") needed to commercialize Products in the Territory. Subject to
termination of this Agreement by Symbollon pursuant to Section 16.2 or by B&L
pursuant to Section 16.3, all submissions and regulatory filings, including,
without limitation, all documents, data and other information forming a part
thereof (the "Regulatory Filings"), made by or on behalf of B&L in order to gain
the Regulatory Approvals, and the Regulatory Approvals themselves, shall be
owned and maintained by B&L at its sole cost and expense. Upon termination of
this Agreement by Symbollon pursuant to Section 16.2 or by B&L pursuant to
Section 16.3, all Regulatory Filings and Regulatory Approvals, subject to B&L's
right to maintain the confidentiality of its manufacturing know-how that
constitutes Proprietary Information, shall be transferred to Symbollon to be
maintained thereafter at Symbollon's sole cost and expense. B&L grants to
Symbollon, and/or its sublicensee(s), at no cost (except as stated in Article 8)
the right of full access to, use of, reliance on and reference to the Regulatory
Approvals and the Regulatory Filings. B&L shall take all legally available
measures, including, without limitation, providing waivers of confidentiality to
Symbollon, and/or its sublicensee(s), at the time of filing any Regulatory
Filings and thereafter to secure for Symbollon, and/or its sublicensee(s),
rights equal to B&L's rights of access, use, reliance and reference to the
Regulatory Approvals and Regulatory Filings, subject to B&L's right to maintain
the confidentiality of its manufacturing know-how. Symbollon shall be allowed to
place any data or other information contained in the Regulatory Filings in its
Drug Master File, subject to B&L's right to maintain the confidentiality of its
manufacturing know-how. Copies of all documents, data or other information
(including all minutes of meetings held or memoranda of conversations with)
filed with, or received from, any regulatory agency pursuant to the terms of
this Article 5 shall be provided to Symbollon when filed with, or received from,
any such agency. Symbollon agrees to use its Reasonable Commercial Efforts to
provide B&L with equivalent rights from any other licensee of Symbollon's
intellectual property.
Article 6 - Sale of Patent
6.1 Transfer of Patent Rights. Subject to the terms and conditions of
this Agreement, on the Effective Date Symbollon shall assign all right, title
and interest in the Patent Rights to B&L by executing and delivering to B&L the
patent assignment in the form attached hereto as Exhibit D. Symbollon agrees to
execute any and all documents necessary to effectuate such transfer of the
Patent Rights to B&L.
6.2 Installment Sale Payments. In partial consideration of the transfer
of all right, title and interest in the Patent Rights to B&L hereunder, B&L will
pay the following amounts to Symbollon:
(a) [* INDICATES THAT MATERIAL HAS BEEN OMITTED AND
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH OMITTED
MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE
24b-2.] upon the execution of this Agreement; plus
(b) [* INDICATES THAT MATERIAL HAS BEEN OMITTED AND
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH OMITTED
MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE
24b-2.] upon the earlier of (i) the twelve (12) month anniversary of
the Effective Date or (ii) ten (10) days after the first filing of an
IND for any indication of a Product; plus
(c) [* INDICATES THAT MATERIAL HAS BEEN OMITTED AND
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH OMITTED
MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE
24b-2.] upon the earlier of (i) the twenty-four (24) month anniversary
of the Effective Date, (ii) ten (10) days after the completion of a
Phase I clinical trial of a Product signified by the submission of the
Phase I data to FDA, or (iii) ten (10) days after the enrollment of a
first patient in a Phase I/II or Phase II clinical trial of a Product;
plus
(d) [* INDICATES THAT MATERIAL HAS BEEN OMITTED AND
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH OMITTED
MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE
24b-2.] upon the earlier of (i) the thirty-six (36) month anniversary
of the Effective Date, (ii) ten (10) days after the completion of a
Phase II clinical trial of a Product signified by the submission of the
Phase II data to FDA, or (iii) ten (10) days after the enrollment of a
first patient in a Phase II/III or Phase III clinical trial of a
Product; plus
(e) [* INDICATES THAT MATERIAL HAS BEEN OMITTED AND
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH OMITTED
MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE
24b-2.] upon the earlier of (i) the forty-eight (48) month anniversary
of the Effective Date or (ii) ten (10) days after the enrollment of a
first patient in a Phase III or Phase II/III clinical trial of a
Product; plus
(f) [* INDICATES THAT MATERIAL HAS BEEN OMITTED AND
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH OMITTED
MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE
24b-2.] upon the earlier of (i) the seventy-two (72) month anniversary
of the Effective Date or (ii) ten (10) days after the first filing of
an NDA for any indication of a Product; plus
(g) [* INDICATES THAT MATERIAL HAS BEEN OMITTED AND
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH OMITTED
MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE
24b-2.] upon the earlier of (i) the eighty-four (84) month anniversary
of the Effective Date or (ii) ten (10) days after the first approval to
market by the FDA of a Product which approval is for any indication(s).
It is the parties intent that multiple payments will be made by B&L if two or
more milestones occur simultaneously.
6.3 Orphan Drug Products. To the extent that B&L pursues the
development and commercialization of Orphan Drug Product(s) in parallel with the
development and commercialization of Non-Orphan Drug Product(s) which requires
FDA's approval to market, the parties agree that the installment sale payments
in Section 6.2 shall be governed by the development and commercialization
activities relating to the Non-Orphan Drug Product(s). Notwithstanding the
above, on each anniversary of the Effective Date after the first commercial sale
of an Orphan Drug Product the then aggregate future unpaid installment sale
payments shall be paid by B&L to Symbollon in accordance with the following: the
sum of (i) the aggregate future unpaid installment sale payments less any
portion of such installment sales payments previously paid pursuant to this
Section 6.3 multiplied by (ii) the aggregate Net Sales relating to off-label
uses of the Orphan Drug Product(s) divided by [* INDICATES THAT MATERIAL HAS
BEEN OMITTED AND CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH
OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE
24b-2.]. B&L's obligation to accelerate the payment of installment sale payments
in this Section 6.3 shall not in any way be construed to delay B&L's obligation
to make installment sale payments in accordance with any other Section of this
Agreement.
6.4 Cosmetic Eye Scrub Product. To the extent that B&L pursues the
development and commercialization of a Product which is sold as an eye scrub and
does not require FDA's approval to market the parties agree that the development
and commercialization activities relating to such a non-regulated eye scrub
Product will not accelerate B&L's obligation to make the installment sale
payments in Section 6.2, as and if required, in accordance with any other
Section of this Agreement.
6.5 Negative Covenants. Except as otherwise permitted herein, without
Symbollon's prior written consent which shall not be unreasonably withheld, B&L
shall not, directly or indirectly, sell, transfer or assign the Patent Rights or
any interest therein except in conjunction with an assignment of this Agreement
pursuant to Article 15, and B&L shall not, directly or indirectly, create,
incur, assume or suffer to exist any lien, security interest or encumbrance of
any nature on the Patent Rights other than as may be incurred (and removed) in
the ordinary course of business.
Article 7 - Royalties
7.1 Royalties. In addition to all other amounts due hereunder, B&L will
pay Symbollon with respect to each calendar quarter a royalty equal to [*
INDICATES THAT MATERIAL HAS BEEN OMITTED AND CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED THEREFOR. ALL SUCH OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE
COMMISSION PURSUANT TO RULE 24b-2.] of Net Sales of Products during such
quarter. Such royalties shall be payable as prescribed in Article 9.
Notwithstanding anything in this Agreement to the contrary, if (i) a Product is
not at any time covered by a valid claim under the Patent Rights, the Licensed
Patents or a patented Joint Invention and (ii) a Generic to such Product is
being lawfully sold in the Territory by third party apart from the license
granted pursuant to this Agreement (and such Generic is not being sold in
contravention of any governmental, judicial or private regulatory rules,
regulations, laws, orders or judgments in effect in the Territory), B&L shall
have the right to sell a Generic to such Product in the Territory royalty free;
provided that the original Product sold by B&L shall remain subject the above
referenced royalty.
7.2 Sublicense Fees. In addition to all other amounts due hereunder,
B&L will reimburse Symbollon with respect to each calendar quarter for [*
INDICATES THAT MATERIAL HAS BEEN OMITTED AND CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED THEREFOR. ALL SUCH OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE
COMMISSION PURSUANT TO RULE 24b-2.] of any amounts that Symbollon is required to
pay to any third party due to B&L's sublicense of such third party's patent
rights during such quarter; provided that if, on a product-by-product basis, the
amount that Symbollon is required to pay (less any amounts reimbursed by B&L)
third parties due to B&L's sublicense of such third parties' patent rights
during such quarter exceeds [* INDICATES THAT MATERIAL HAS BEEN OMITTED AND
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH OMITTED MATERIAL
HAS BEEN FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2.] of the
royalties that B&L is required to pay Symbollon for such quarter pursuant to
Section 7.1, then, in addition to the amount determined above that B&L will
reimburse Symbollon, B&L will also reimburse Symbollon for the amount by which
such third parties' payments exceeds [* INDICATES THAT MATERIAL HAS BEEN OMITTED
AND CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH OMITTED
MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2.]
of the royalties that B&L is required to pay Symbollon for such quarter pursuant
to Section 7.1. If B&L and Symbollon mutually agree, which agreement shall not
be unreasonably withheld, to license any additional third party Proprietary
Information related to a Product's composition of matter (excluding packaging),
then any and all amounts due with respect to such license (regardless of which
party is responsible for payment of such amounts) shall be governed by this
Section 7.2.
7.3 Overall Value. Because Symbollon's Proprietary Information is an
integral part of the license granted to B&L under this Agreement, precise
apportionment of royalties and other considerations with respect to the Patent
Rights, the Licensed Patents and Symbollon's Proprietary Information is
impossible. Accordingly, royalties and other consideration have been agreed upon
as set forth herein.
Article 8 - Symbollon Sale of Products Outside Territory
If Symbollon sells Products and/or any other product(s) which
incorporate and/or rely on a Joint Invention and/or B&L's Regulatory Filings or
Regulatory Approvals outside the Territory, either directly or in conjunction
with a third party, Symbollon shall pay B&L with respect to each calendar
quarter a royalty equal to [* INDICATES THAT MATERIAL HAS BEEN OMITTED AND
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH OMITTED MATERIAL
HAS BEEN FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2.] of (i)
the amount received by Symbollon from the Gross Profits of such Products(s) or
product(s) and, without duplication, (ii) all amounts received and all other
consideration received (when in a form other than cash or its equivalent, the
fair market value thereof when received) by Symbollon by reason of the sale,
license, distribution or use of such Product(s) or product(s), in each case
during such quarter and subject to the following limitations: (a) for purposes
of calculating the preceding royalty amount no royalties shall be paid on any
moneys paid to Symbollon by a third party expressly intended for the additional
direct formulation and/or technical development, nor on any manufacturing costs
of Product(s) or product(s) and (b) in no event shall Symbollon's royalty
payments owed under this Article 8 exceed [* INDICATES THAT MATERIAL HAS BEEN
OMITTED AND CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH OMITTED
MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2.]
in the aggregate.
Article 9 - Payments
9.1 Timing of Royalty Payments. Royalties payable under Section 7.1 and
Article 8 will be paid without deduction, counterclaim or set-off not later than
forty-five (45) calendar days following the end of each calendar quarter and
each such payment shall be accompanied by a report in writing showing the
calendar quarter for which such payment applies, the applicable Net Sales for
the calendar quarter, the calculations used to compute said amounts, including
the quantity and description of the Product(s) (and/or products), and the
royalties due on such Net Sales.
9.2 Records of Net Sales. Each party shall keep and cause its
Affiliates and permitted sublicensees to keep, true and accurate records and
books of account containing data reasonably required for the computation and
verification of payments to be made as provided by this Agreement, which records
and books shall be open for inspection upon reasonable notice during business
hours by either the other party's auditor(s) or an independent certified
accountant selected by such party, except one to whom the party whose records
are being inspected has a reasonable objection, for the purpose of verifying the
amount of payments due and payable. Such auditor(s) or independent certified
accountant shall keep confidential (under written obligation of confidentiality
reasonably acceptable to the other party) any information obtained during such
examination and shall report to the party auditing such records only that
information required to be provided hereunder. Said right of inspection may be
exercised not more than once in any calendar year, but will exist for three (3)
years from the date of origination of any such record, and this requirement and
right of inspection shall survive any termination of this Agreement. The
inspecting party shall be responsible for all expenses of its auditor(s) or
independent accountants associated with such inspection. However, in the event
that such inspection reveals an underpayment of amounts due hereunder in excess
of ten percent (10%), then said inspection shall be at the expense of the party
whose records are being inspected and the amount of such underpayment shall bear
interest at the rate of ten percent (10%) annually, commencing on the date the
obligation to pay such underpayment initially accrued hereunder. If such
inspection reveals an overpayment hereunder, the parties shall credit such
overpayment against the next payment due hereunder.
9.3 Payments. Any payments to be made by one party to the other under
this Agreement will be paid in U.S. dollars at a rate of exchange as of the last
business day of the period to which such payment applies as quoted in the Wall
Street Journal or an equivalent published rate as agreed by the parties.
Article 10 - B&L's Exclusivity Obligations
During the term of this Agreement, B&L will not directly or indirectly
research, develop and/or commercialize iodine-based products for use in the
Field except with Symbollon pursuant to this Agreement; provided, that B&L may
further develop and commercialize iodine-based products not covered by this
Agreement which are developed by an existing Affiliate of B&L, so long as prior
written notice is provided by B&L to Symbollon of such iodine-based product
development and commercialization efforts. Furthermore, nothing herein shall
prohibit existing Affiliates of B&L from developing and/or commercializing
iodine-based products not covered by this Agreement. After B&L has made the
payments required pursuant to Section 6.2(a) through (g), B&L may develop and/or
commercialize iodine-based products for use in the Field not covered by this
Agreement which are based on technology in-licensed by B&L from an unrelated
third party. If B&L decides to in-license an unrelated third party's technology
to develop and/or commercialize iodine-based products for use in the Field, B&L
will provide Symbollon will prior written notice of such action. If B&L
commercializes an iodine-based product for use in the Field not covered by this
Agreement which is based on technology in-licensed by B&L from an unrelated
third party, Symbollon will, in its sole discretion, have the right to terminate
this Agreement either in whole or in part (by reducing the scope of the Field on
a Product by Product basis), and such termination shall be deemed to be by
Symbollon pursuant to Section 16.2 for purposes of this Agreement.
Article 11 - Confidentiality and Publications
11.1 Proprietary Information. All Proprietary Information which is
disclosed by one party to the other during the term of this Agreement shall be
maintained in confidence by the receiving party and shall not be disclosed by
the receiving party to any other person, firm, or agency, governmental or
private, without the prior written consent of the disclosing party, except to
the extent that such Proprietary Information:
(a) with regard to Inventions assigned to Symbollon pursuant to
Section 12.2(a) and Joint Inventions, is necessary to be
disclosed by Symbollon to agents, consultants and/or other
third parties for the research, development and/or marketing
of products, which entities first agree in writing to be bound
by the confidentiality obligations contained in this
Agreement, or
(b) is required to be disclosed to governmental agencies in order
to gain approval to sell Products, or
(c) is necessary to be disclosed to agents, consultants and/or
other third parties for the research, development and/or
marketing of Products, which entities first agree in writing
to be bound by the confidentiality obligations contained in
this Agreement.
The confidentiality obligations of the parties hereunder shall continue in full
force and effect for a period of five (5) years following the termination of
this Agreement.
11.2 Joint Disclosures. B&L and Symbollon will jointly discuss and
agree on the release of any statement to the public regarding the execution and
the subject matter of this Agreement, the details of research to be conducted
under this Agreement, or any other material term of this Agreement, subject in
each case to disclosure otherwise required by law or regulation, including
applicable securities laws.
Article 12 - Ownership of Intellectual Property
12.1 General Intent. In furtherance of the research and development
work to be conducted pursuant to the Project Plan and subject to the terms set
forth herein, the parties will exchange Proprietary Information. Except as
expressly set forth herein, no licenses or other transfers of ownership are
granted under this Agreement, and each party shall retain all right, title and
interest to its Proprietary Information.
12.2 New Inventions. All Inventions which are made, or acquired, by B&L
during the term of this Agreement will be owned as follows:
(a) Inventions by B&L. Any Invention made by B&L during the term
of this Agreement shall be owned by and assigned to Symbollon
if, and only if, such Invention pertains to (i) any multi-part
system which forms a composition containing from 5 to in
excess of 300 ppm of diatomic iodine (I2), or (ii) the use of
excipients used in combination with such compositions that
modify the properties of said compositions including, by way
of example, decolorizers, reducing agents, sequestrants,
potentiators or viscosifiers; provided, that any Invention
related solely to technology acquired by B&L from an unrelated
third party, other than Symbollon, shall not be included. Any
and all such Inventions will be included within the license
granted to B&L pursuant to Section 4.1.
(b) Joint Inventions. Any Invention which is made by B&L's
personnel in conjunction with Symbollon's personnel and not
covered by subsection (a) of this Section 12.2 (a "Joint
Invention") shall be owned by and assigned to (i) Symbollon,
if, and only if, such Invention pertains to iodine, and any
and all such Inventions will be included within the license
granted to B&L pursuant to Section 4.1 or (ii) B&L, if, and
only if, such Invention pertains to any Joint Invention not
covered by the preceding clause (i).
12.3 Symbollon's Rights in B&L's Joint Inventions. B&L hereby grants
Symbollon a permanent, exclusive license (which license shall survive any
termination of this Agreement) to practice under the Patent Rights transferred
to B&L pursuant to Section 6.1 and to make, use and sell products utilizing such
Patent Rights outside the Field subject to Sections 4.4 and 4.5 on a
royalty-free basis. Further, B&L hereby grants Symbollon a permanent,
non-exclusive license (which license shall survive any termination of this
Agreement) to practice any Joint Invention owned by B&L and to make, use and
sell products utilizing any such Joint Invention outside the exclusive license
granted to B&L hereunder for all other applications (excluding contact lens
care) on a royalty-free basis. In addition, B&L agrees to disclose and hereby
grants a permanent, non-exclusive, license to Symbollon to practice any patented
invention (including any Invention) of B&L relating to a method of dispensing
iodine compositions developed or acquired by B&L during the term of this
Agreement outside the Field (as defined on the Effective Date), excluding
contact lens care, in the Territory and for any application outside the
Territory for a royalty of [* INDICATES THAT MATERIAL HAS BEEN OMITTED AND
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH OMITTED MATERIAL
HAS BEEN FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2.] of Net
Sales of products received by Symbollon or its sublicensees incorporating such
invention.
12.4 License Upon Termination. In the event this Agreement is
terminated by B&L for cause pursuant to Section 16.2, Symbollon hereby grants
B&L a fully paid-up, permanent, non-exclusive license to practice under any
Invention covered by Section 12.2(a) or Joint Invention covered by Section
12.2(b) owned by Symbollon and to make, use and sell products utilizing any such
Invention covered by Section 12.2(a) or Joint Invention covered by Section
12.2(b) in the Field in the Territory.
12.5 Patent Applications. Each party shall have the right, in its sole
discretion, and at its sole expense, to file, prosecute and maintain patent
applications and the patents relating thereto with respect to Inventions owned
by it. During the term of this Agreement, each party will notify the other
before it files any patent application that makes claims within the Field. Each
party shall cooperate with the other to execute all lawful papers and
instruments and to make all rightful oaths and declarations as may be necessary
in the preparation and prosecution of all such patents and other applications
and protections relating to an Invention referred to in Section 12.2.
12.6 Disputes. Any dispute relating to the ownership of Inventions or
any other issue relating to a party's rights or obligations under this Article
12 which can not be decided by good faith negotiations between the parties,
shall be resolved by arbitration pursuant to Section 18.3.
Article 13 - Warranties/Indemnification/Insurance
13.1 Representations and Warranties. Each party represents and warrants
to the other that (a) it has the full right, power and authority to execute,
deliver and perform this Agreement, and (b) the terms of this Agreement do not
conflict with any other agreement, order or judgment to which such party is a
party or by which it is bound. Symbollon represents and warrants to B&L that, to
the best of its knowledge as of the Effective Date, there are no third parties
who are infringing the Patent Rights or the Licensed Patents existing as of the
Effective Date; the practice of the Patent Rights, the Licensed Patents and/or
Symbollon's Proprietary Information in the Territory does not infringe any
rights of third parties; and Symbollon has prosecuted all patent applications
within the Patent Rights in good faith and has no reason to believe that any
claims within the Patent Rights and the Licensed Patents would be invalid.
13.2. Disclaimer. No license is granted except as expressly provided
herein, and no license in addition thereto shall be deemed to have arisen or be
implied by way of estoppel or otherwise. EXCEPT AS OTHERWISE PROVIDED HEREIN,
SYMBOLLON DOES NOT WARRANT THE VALIDITY OF THE PATENT RIGHTS OR THE LICENSED
PATENTS AND MAKES NO REPRESENTATION WHATSOEVER WITH REGARD TO THE SCOPE OF THE
PATENT RIGHTS OR THE LICENSED PATENTS.
13.3 Additional Covenants.
(a) B&L. B&L covenants and agrees with Symbollon that (a) B&L
shall take all Reasonable Commercial Efforts within its control to
develop and commercialize Products, (b) all Products manufactured by
B&L shall conform to applicable Regulatory Approvals and Good
Manufacturing Practices of the FDA, (c) B&L shall exert its Reasonable
Commercial Efforts to manufacture, promote, sell and distribute each
and every Product which receives Regulatory Approval for marketing in
the Territory, and (d) B&L shall take all Reasonable Commercial Efforts
within its control to prohibit use of any Product for any application
outside the Field.
(b) Symbollon. Symbollon covenants and agrees with B&L that
Symbollon shall take all Reasonable Commercial Efforts within its
control (including requiring its licensee(s) to so agree) to prohibit
use of any of its products in the Territory for any application inside
the Field.
13.4 Indemnification. Each party shall indemnify, defend and hold
harmless the other party, its directors, officers, employees and agents and
their respective successors, heirs and assigns (the "Indemnitees") against any
liability, damage, loss or expense (including reasonable attorneys' fees and
expenses of litigation) incurred by or imposed upon the Indemnitees, or any one
of them, in connection with any claims, suits, actions, demands or judgments
relating to, or arising out of (a) any breach of the indemnifying party's
representations, warranties, agreements or covenants in this Agreement,
including without limitation the confidentiality obligations set forth in
Article 11, and (b) any other activities to be carried out by the indemnifying
party, its Affiliate(s) or agents under this Agreement (including, without
limitation, with respect to B&L, the design, clinical testing, production,
manufacture, sale, use, release or promotion by B&L or by any Affiliate or agent
of B&L, of any Product or process or service relating thereto).
13.5 Insurance. At all such times as any Product is being tested,
distributed or sold by B&L or any Affiliate, sublicensees or agents of B&L, B&L
shall, at its sole cost and expense, procure and maintain policies of product
liability insurance in such scope and coverage consistent with commercially
reasonable practices normally exercised under similar circumstances consistent
with good business judgment. B&L shall provide Symbollon with written notice of
such insurance coverage upon request by Symbollon. B&L shall provide Symbollon
with written notice immediately upon receipt by B&L of notice of any pending
cancellation, non-renewal or material change in such insurance, and shall obtain
replacement insurance providing comparable coverage prior to any such
cancellation, non-renewal or material change. B&L shall maintain such product
liability insurance beyond the expiration or termination of this Agreement
during (a) the period that any Product or process or service relating thereto is
being tested, distributed or sold by B&L or by any Affiliate, sublicensee or
agent of B&L and (b) a reasonable period after the period referred to in the
preceding clause (a).
13.6 Additional Indemnification Obligations. In the event any action is
commenced or claim made or threatened against one or more of the Indemnitees as
to which a party to this Agreement may be obligated to indemnify it or them or
hold it or them harmless, such Indemnitee(s) shall promptly notify such party of
such event. Such party shall assume the defense of, and may settle (with the
applicable Indemnitee's consent, such consent not to be unreasonably withheld),
with counsel of its own choice (reasonably acceptable to the other party to this
Agreement and the applicable Indemnitee(s)) and at its sole expense such claim
or action. Any Indemnitee may participate in the defense of any such claim or
action with counsel of its own choice at its own expense. No party shall be
liable to the other party or other Indemnitee(s) on account of any settlement of
any such claim or action effected without its prior written consent, which shall
not be unreasonably withheld. Notwithstanding any provision herein to the
contrary, B&L shall take no action relating to, and Symbollon may withhold its
consent in its sole discretion to, the settlement of any matter which may affect
the Patent Rights, the Licensed Patents or Symbollon's Proprietary Information;
provided that if Symbollon withholds its consent, then Symbollon agrees to share
thereafter 50/50 in any subsequent expenses attributable to such claims made or
settlement paid by B&L, including without limitation fees paid to outside
counsel or a consultant, and reasonable travel expenses, but not including any
part of any salary of any employee of B&L.
Article 14 - Infringement and Trademarks
14.1 Notice of Infringement. Each party shall promptly notify the other
in writing of any infringement of a patent within the Patent Rights or the
Licensed Patents of which they become aware in the Field. During the term of
this Agreement, Symbollon shall have the first right at its expense to institute
and control all actions brought for infringement of the Patent Rights or the
Licensed Patents when, in Symbollon's sole judgment, such action may be
reasonably necessary, proper and justified. In the event Symbollon declines
within ninety (90) days of its receipt of such notice of infringement to either
(a) cause infringement to cease or (b) initiate legal proceedings against the
infringer, B&L may upon notice to Symbollon initiate legal proceedings against
the infringer in the Field in the Territory at B&L's expense.
14.2 Control, Cost and Cooperation in Infringement Actions. In the
event either party shall initiate or carry on legal proceedings to enforce the
Patent Rights or the Licensed Patents covered by this Article 14, the other
party shall be offered at the outset of such proceedings an opportunity to share
50/50 in all related expenses of such proceedings, including without limitation
fees paid to outside counsel or a consultant, and reasonable travel expenses,
but not including any part of any salary of any employee of such party. In the
event either party shall initiate or carry on legal proceedings to enforce the
Patent Rights or the Licensed Patents against an alleged infringer, the other
party shall fully cooperate with, and supply all reasonable assistance requested
by, the party initiating or carrying on such proceedings. The party that
institutes any suit to protect or enforce the Patent Rights or the Licensed
Patents shall have control of that suit, subject to the rights of the other
party to be kept informed of all material decisions relating to such suit prior
to their implementation, and shall bear the reasonable expenses incurred by said
other party in providing such assistance and cooperation as is requested
pursuant to this Section. Notwithstanding any provision herein to the contrary,
(a) legal proceedings initiated or carried on by B&L shall be in B&L's name,
provided that Symbollon shall permit proceedings to be brought and maintained in
its name or shall permit Symbollon to be joined as a party to an action if
required by law and (b) in no event shall there be a settlement of an
infringement action relating to the Patent Rights or the Licensed Patents
without the prior written consent of Symbollon, which consent shall not be
unreasonably withheld.
14.3 Recoveries Against Infringer. Any recovery obtained by either
party as the result of legal proceedings covered by this Article 14 to enforce
the Patent Rights or the Licensed Patents in the Field in the Territory against
an alleged infringer, whether obtained by settlement or otherwise, shall
allocated between the parties in accordance with their sharing of the expenses
of such proceedings.
14.4 Trademarks. During the term of this Agreement, B&L shall have the
right to promote and sell Products under the license granted to it pursuant to
Section 4.1 under trademarks selected by B&L, which trademarks shall be and
remain, subject to Section 16.4, the property of B&L. Symbollon agrees not to
register and own any such trademarks outside the Territory.
Article 15 - Assignability
Except as expressly set forth in this Agreement, this Agreement shall
not be assignable by B&L without the prior written consent, which consent shall
not be unreasonably withheld, of Symbollon and any attempt to assign (directly
or indirectly) this Agreement, without such consent shall be void from the
beginning. B&L may assign this Agreement without Symbollon's consent to any
purchaser of, or successor in interest to, all or substantially all of B&L's
business to which this Agreement relates if, and only if, the intended successor
or purchaser agrees in writing (a) to accept and be bound by all of the terms
and conditions of this Agreement and (b) to devote at least the same efforts and
resources to performance hereunder as B&L exerted immediately before the
assignment. Symbollon may assign this Agreement if such assignee agrees in
writing to accept and be bound by all of the terms and conditions of this
Agreement.
Article 16 - Term and Termination
16.1 Term. This Agreement will become effective on the Effective Date
and, unless terminated under another specific provision of this Agreement, will
remain in effect until, and terminate upon the later to occur of (i) the
expiration of the Patent Rights or the Licensed Patents (excluding any patent or
patent application covering an Invention assigned to Symbollon pursuant to
Section 12.2(a)) or (ii) the seventeenth (17th) anniversary of this Agreement
(the "Initial Term"); provided that the Initial Term of this Agreement will be
further extended if an Invention is assigned to Symbollon pursuant to Section
12.2(a) which Invention was conceived by B&L prior to the fifth anniversary of
this Agreement by the earlier to occur of (a) the expiration of any patent or
patent application covering such Invention assigned to Symbollon pursuant to
Section 12.2(a) which Invention was conceived by B&L prior to the fifth
anniversary of this Agreement or (b) the fifth (5th) anniversary of the Initial
Term of this Agreement. If, and only if, this Agreement terminates pursuant to
this Section 16.1, B&L shall be entitled to sell Products developed and
commercialized during the term of this Agreement in the Field in the Territory
royalty free of any license for Symbollon's know-how to develop such Products.
16.2 Termination Events . Upon the occurrence of any of the events set
forth below, either party, as applicable, shall have the right to terminate this
Agreement by giving written notice of termination, to be effective as described
herein:
(a) non-payment of any amount payable to such party hereunder
continuing ten (10) calendar days after receipt of written notice of
such non-payment;
(b) failure by the other party in any material respect (other
than matters which are covered by clause (a) above) to observe or
perform any of the provisions of this Agreement on the other party's
part to be observed or performed, if such failure is not remedied
within thirty (30) calendar days after receipt of notice specifying
such failure;
(c) if the other party (i) applies for or consents to the
appointment of a receiver, trustee or liquidator of it or of all or a
substantial part of its assets, (ii) admits in writing its inability to
pay its debts as they mature, (iii) makes a general assignment for the
benefit of creditors, (iv) is adjudicated a bankrupt or insolvent, (v)
files a voluntary petition in bankruptcy or a petition or an answer
seeking reorganization or an arrangement with creditors to take
advantage of any insolvency law or any answer admitting the material
allegations of the petition filed against it in any bankruptcy,
reorganization or insolvency proceeding or (vi) takes corporate action
for the purpose of effecting any of the foregoing; and
(d) an order or judgment or decree shall be entered, without
the application, approval or a consent of the other party by any court
of competent jurisdiction, approving a petition seeking reorganization
of such party or appointing a receiver, trustee or liquidator of such
party, or all or a substantial part of its assets and such order,
judgment or decree shall continue unstayed and in effect for any period
of sixty (60) consecutive days.
16.3 Termination by B&L. B&L may terminate this Agreement by giving
Symbollon a notice of termination to be effective upon a termination date set
forth by B&L in such notice, which termination date shall not be sooner than
sixty (60) days after the date of the written notice if given prior to being
obligated to make the payment required in Section 6.2(b), ninety (90) days after
the date of the written notice if given after the payment required in Section
6.2(b) and prior to being obligated to make the payments required in Section
6.2(c) through (g), and anytime after being required to make all of the
foregoing payments, B&L shall not have any rights to terminate this Agreement
pursuant to this Section 16.3. Such notice shall be deemed by the parties to be
final and, immediately upon receipt of such notice of termination, Symbollon
shall have the right to begin negotiations, and enter into agreements, with
others concerning Products, the Patent Rights, the Licensed Patents and
Symbollon's Proprietary Information in the Field.
16.4 Effects of Termination. If this Agreement is terminated by
Symbollon pursuant to Section 16.2 or by B&L pursuant to Section 16.3, upon such
termination, the Patent Rights, and all Regulatory Filings and Regulatory
Approvals then owned by B&L with respect to any Product being developed or
commercialized shall be assigned to Symbollon without charge and free of any and
all liens, claims, security interests and other encumbrances (except as may have
been incurred in the ordinary course of business and if so incurred, must be
removed by B&L, at its sole cost and expense, prior to transfer or upon notice
thereof), and B&L agrees to execute all such further documents as may be
reasonably required to effect such assignment. If this Agreement is terminated
by B&L pursuant to Section 16.2, upon such termination, the Patent Rights then
owned by B&L shall be assigned to Symbollon without charge and free of any and
all liens, claims, security interests and other encumbrances (except as may have
been incurred in the ordinary course of business and if so incurred, must be
removed by B&L, at its sole cost and expense, prior to transfer or upon notice
thereof), and B&L agrees to execute all such further documents as may be
reasonably required to effect such assignment. No exercise by either party of
any right of termination shall constitute a waiver of any right of that party
for recovery of any monies then due to it hereunder or any other right or remedy
such party may have at law, in equity or under this Agreement.
16.5 Survival. Termination of this Agreement for whatever reason shall
be without prejudice to the settlement of the rights and obligations of the
parties arising out of this Agreement prior to the date of termination,
including, without limitation: (a) obligations to pay royalties and other sums
accruing hereunder, (b) the right to complete the manufacture and sale of
Products which qualify as "work in process" under generally accepted cost
accounting standards or which are in stock at the date of termination or
returned to stock after the date of termination, and the obligation to pay
royalties on Net Sales of such Products, (c) obligations for record keeping and
accounting reports for so long as Products are sold pursuant to the preceding
clause (b), (d) the right to inspect books and records as described in Section
9.2, (e) obligations of insurance, defense and indemnity under Article 13, (f)
any cause of action or claim accrued or to accrue because of any breach or
default by the other party hereunder, (g) obligations of confidentiality under
Article 11, (h) obligations upon termination to transfer the Patent Rights, and
all trademarks, Regulatory Filings and Regulatory Approvals then owned by B&L
under Section 16.4 and (g) all of the terms, provisions, representations, rights
and obligations contained in this Agreement that by their sense and context are
intended to survive until performance thereof by either or both parties.
Article 17 - Supply and Manufacture
B&L will have the exclusive right to manufacture or have manufactured
Products in the Field for sale within the Territory. Subject to execution of a
supply agreement mutually acceptable to both parties, Symbollon shall be
entitled to purchase Product from B&L (subject to facility capacity
constraints), if B&L is the manufacturer of such Product, at [* INDICATES THAT
MATERIAL HAS BEEN OMITTED AND CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
THEREFOR. ALL SUCH OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE
COMMISSION PURSUANT TO RULE 24b-2.], without duplication of any expense. If B&L
is not the manufacturer of such Product, B&L will use commercially reasonable
efforts to obtain for Symbollon the right to purchase such Product directly from
B&L's manufacturing source at [* INDICATES THAT MATERIAL HAS BEEN OMITTED AND
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED THEREFOR. ALL SUCH OMITTED MATERIAL
HAS BEEN FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2.].
Notwithstanding any provision in this Agreement to the contrary, Symbollon shall
have the right to manufacture or have manufactured Products inside the
Territory, provided, that such Products are sold outside the Territory.
Article 18 - Miscellaneous
18.1 Notices. Any notice or other communication to be given under this
Agreement shall be in writing and shall be deemed to have been duly given when
delivered personally or deposited in the United States mail, certified or
registered with return receipt, or sent by courier requiring proof of receipt,
addressed as follows:
To Symbollon:
Symbollon Corporation
00 Xxxxxx Xxxxx
Xxxxxxxxxx, XX 00000
Telephone: (000)-000-0000
Fax: (000)-000-0000
Attention: President
With a copy to:
Xxxxxxx X. Xxxxxx, Xx., Esq.
Xxxxxx, Hall & Xxxxxxx
Exchange Place
00 Xxxxx Xxxxxx
Xxxxxx, XX 00000
Telephone: (000)-000-0000
Fax: (000)-000-0000
To B&L:
Bausch & Lomb Pharmaceuticals, Inc.
0000 Xxxxxx Xxxxx Xxxxxxx
Xxxxx, XX 00000
Telephone: (000) 000-0000
Fax: (000) 000-0000
Attention: President
With copy to:
Bausch & Lomb, Incorporated
Xxx Xxxxxx & Xxxx Xxxxx
Xxxxxxxxx, X.X. 00000-0000
Telephone: (000) 000-0000
Fax: (000) 000-0000
Attention: General Counsel
or to such other address as either party shall designate by written notice,
similarly given, to the other party. If sent by telex, facsimile or other
electronic media, an original confirmation copy must be sent within thirty days
by means listed above.
18.2 Governing Law; Jurisdiction and Venue. With regard to any claim or
controversy initiated by B&L related to this contract or any breach thereof,
this Agreement shall be governed by the internal laws of The Commonwealth of
Massachusetts (without regard to conflict of law provisions), and with regard to
any claim or controversy initiated by Symbollon related to this contract or any
breach thereof, this Agreement shall be governed by the internal laws of the
State of New York (without regard to conflict of law provisions); except that
questions affecting the construction and effect to any patent shall be
determined by the law of the country in which the patent has been granted. Any
claim or controversy arising out of or related to this contract or any breach
thereof, except as provided under Section 18.3, shall be submitted to United
States District Court, District of Massachusetts if such claim or controversy if
initiated by B&L and to United States District Court, District of New York if
such claim or controversy if initiated by Symbollon, and the parties hereby
consent to the jurisdiction and venue of such courts.
18.3 Limited Arbitration. Disagreements under Sections of this
Agreement which make specific reference to this Section 18.3 shall be settled by
arbitration in accordance with the licensing arbitration rules of the American
Arbitration Association by a board of arbitrators consisting of one arbitrator
appointed by B&L, one arbitrator appointed by Symbollon, and a third arbitrator
chosen by the mutual agreement of B&L and Symbollon, which third arbitrator
shall be unrelated either to B&L or Symbollon. Any arbitration hereunder shall
be held in Boston, Massachusetts if initiated by B&L and in Rochester, New York
if initiated by Symbollon. In such arbitration proceedings, this Agreement shall
be governed by and construed according to Massachusetts or New York law as
provided in Section 18.2. Arbitration may be commenced at any time by either
party hereto giving written notice to the other party to a dispute that such
dispute has been referred to arbitration. Any judgment or decision rendered by
the panel shall be binding upon the parties and shall be enforceable by any
court of competent jurisdiction. Each party shall pay its own expenses of
arbitration and the expenses of the arbitrators shall be equally shared,
provided, however, that if in the opinion of the arbitrators any claim hereunder
or any defense or objection thereto was unreasonable, the arbitrators may
assess, as part of their reward, all or any part of the arbitration expenses of
the other party (including reasonable attorneys' fees) and of the arbitrators
against the party raising such unreasonable claim, defense or objection.
18.4 Waiver. Except as specifically provided for herein, the waiver
from time to time by either party of any of its rights or a party's failure to
exercise any remedy shall not operate or be construed as a continuing waiver of
same or of any other of such party's rights or remedies provided in this
Agreement.
18.5 Enforceability. If any term, covenant or condition of this
Agreement or the application thereof to any party or circumstance shall, to any
extent, be held to be invalid or unenforceable, then (a) the remainder of this
Agreement, or the application of such term, covenant or condition to the parties
or circumstances other than those as to which it is held invalid or
unenforceable, shall not be affected thereby and each term, covenant or
condition of this Agreement shall be valid and be enforced to the fullest extent
permitted by law; and (b) the parties covenant and agree to renegotiate any such
term, covenant or application thereof in good faith in order to provide a
reasonably acceptable alternative to the term, covenant or condition of this
Agreement or the application thereof that is invalid or unenforceable, and in
the event that the parties are unable to agree upon a reasonable acceptable
alternative, then the parties agree that a submission to arbitration shall be
made in accordance with Section 18.3 to establish an alternative to such invalid
or unenforceable term, covenant or condition of this Agreement or the
application thereof, it being the intent that the basic purposes of this
Agreement are to be effectuated.
18.6 Entire Agreement and Amendment. This Agreement contains the entire
understandings of the parties with respect to the matters contained herein, and
supersedes all prior agreements, oral or written, and all other communication
between them relating to the subject matter hereof. The parties hereto may, from
time to time during the continuance of this Agreement, modify, vary or alter any
of the provisions of this Agreement, but only by an instrument duly executed by
authorized officers of both parties hereto.
18.7 Independent Contractor. Nothing herein shall be deemed to
establish a relationship or principal and agent between B&L and Symbollon, nor
any of their respective agents or employees, for any purpose whatsoever. This
Agreement shall not be construed as constituting B&L and Symbollon as partners,
or as creating any other form of legal association or arrangement which would
impose liability upon one party for the act or failure to act of the other
party.
18.8 Headings. The headings of the several Articles and sections of
this Agreement are intended for convenience of reference only and are not
intended to be a part of or to affect the meaning or interpretation of this
Agreement.
18.9 Further Instruments. Each party agrees to execute, acknowledge and
deliver such further instruments and to do all such further acts as may be
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.
18.10 Force Majeure. Performance of a party's obligations hereunder
(other than the payment of money or the failure by B&L to provide insurance
pursuant to Section 13.5) may be delayed if (a) such performance is delayed by
causes beyond that party's reasonable control, including, but not limited to,
acts of God, war, riot, epidemics, fire, flood, insurrection, or acts of civil
or military authorities, and (b) such delaying party is at all times working
diligently to correct the matter causing the delay and otherwise performing as
required under the Agreement. Notwithstanding the foregoing, the parties shall
remain liable for all obligations incurred by them prior to any termination of
this Agreement.
18.11 Counterparts. This Agreement may be executed in one or more
counterparts, all of which shall be considered one and the same agreement. One
or more counterparts may be delivered via telecopier and any such telecopied
counterpart shall have the same force and effect as an original counterpart
hereto.
18.12 Exhibits and Schedules. The following Exhibits and Schedules are
attached hereto and incorporated herein by reference:
Exhibits Subject Matter
-------- --------------
A Patents and Patent Applications
B Project Plan
C Initial Members of the JDC
D Form of Patent Assignment
Schedules Subject Matter
--------- --------------
1.16 Exceptions to the Licensed Patents
[Signatures Appear on the Following Page.]
IN WITNESS WHEREOF the parties have executed this Agreement as an
instrument under seal as of the date and year first written above.
SYMBOLLON CORPORATION BAUSCH & LOMB PHARMACEUTICALS, INC.
By:/s/ Xxxx X. Xxxxxxxxx By: /s/ Xxxxxx Xxxxxxxxxx
--------------------- ----------------------
Xxxx X. Xxxxxxxxx, Xxxxxx Xxxxxxxxxx,
Executive Vice President and President
Chief Financial Officer
EXHIBIT A
Patent Applications and Patents
[* INDICATES THAT MATERIAL HAS BEEN OMITTED AND CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED THEREFOR. ALL SUCH OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH
THE COMMISSION PURSUANT TO RULE 24b-2.]
EXHIBIT B
Project Plan
[To be developed by the parties]
EXHIBIT C
Initial Members of the JDC
Symbollon: 1. Xxxx Xxxxxxx
2. Xxxx X. Xxxxxxxxx
B&L: 1. Xxxxx Xxxxxx
2. Xxxxxx Schlevin
3. Xxxxx Xxxxxxxxx
EXHIBIT D
Form of Patent Assignment
PATENT ASSIGNMENT
WHEREAS, Symbollon Corporation located and doing business at 00 Xxxxxx
Xxxxx, Xxxxxxxxxx, Xxxxxxxxxxxxx 00000, hereinafter referred to as the
"assignor", is the owner of United States Letters Patent No. 5,639,481 issue
date June 17, 1997 and entitled "Method for the Therapeutic Treatment of a
Mammalien Eye Using an Admixed Composition Containing Free Molecular Iodine";
and
WHEREAS, Bausch & Lomb Pharmaceuticals, Inc. located and doing business
at 0000 Xxxxxx Xxxxx Xxxxxxx, Xxxxx, Xxxxxxx 00000, hereinafter referred to as
the "assignee", is desirous of acquiring the entire right, title and interest in
the same;
NOW THEREFORE, in consideration of the sum of ten dollars ($10.00) the
receipt of which is hereby acknowledged, and other good and valuable
consideration we, the assignor, by these present do sell, assign and transfer
unto said assignee all right, title and interest in and to said United States
Letters Patent No.
5,639,481 with the right to xxx for past infringement of said patent.
SYMBOLLON CORPORATION
By________________________________
Xxxx X. Xxxxxxxxx, Exec. Vice President
Dated: July ___, 1997
Attest:
------------------------
Xxxx X. Xxxxxxx, Secretary
Corporate Seal
SCHEDULE 1.16
Exceptions to the Licensed Patents
None.