License Agreement - OII International Inc. and Eye Technology Inc.
LICENSE AGREEMENT
THIS AGREEMENT is dated as of this 31st day of January, 1997, by and
between OII International, Inc., a Delaware corporation ("OII" or "Licensee"),
and Eye Technology, Inc., a Delaware corporation ("Eye Tech").
W I T N E S S E T H
WHEREAS, OII desires to license from Eye Tech the right to manufacture
and distribute certain intraocular lenses for which Eye Tech holds a Pre Market
Approval Application (together with all supplements and amendments thereto, the
"PMA") granted by the United States Food and Drug Administration (the "FDA"),
as described in detail on Exhibit A to this Agreement.
WHEREAS, Eye Tech is willing to grant said license for consideration and
subject to applicable FDA requirements.
NOW, THEREFORE, in consideration of the premises and the mutual
agreements and covenants hereinafter set forth, and for other good and valuable
consideration the receipt and sufficiency of which are hereby acknowledged, OII
and Eye Tech agree as follows:
Section 1. Grant of Nonexclusive License.
Upon the terms and subject to the conditions of this Agreement, at a
closing (the "Closing") being held on the date hereof (the "Closing Date"), Eye
Tech grants to OII as Licensee, and Licensee hereby accepts, a nonexclusive,
non-transferrable license under the PMA to manufacture and market intraocular
lenses designed and manufactured in compliance with the PMA, said license to be
transferable only in the event of merger, sale, or other change in ownership,
the result of which is that OII is not the surviving entity. All rights in and
to any patents owned by Eye Tech not specifically licensed herein to Licensee,
as well as the technology licensed by Eye Tech under the patents commonly
referred to as the Jenson and the Shearing patents, are exclusively reserved to
Eye Tech. This Agreement shall not be deemed to grant any rights, either
express or implied, in such reserved rights, and no use or license to anyone
else of such reserved rights by Eye Tech shall be deemed to violate or
interfere with the Licensee's right under this Agreement.
Section 2. Cash Consideration.
The license contemplated by this Agreement shall be granted in
consideration of a non-refundable one time payment of $325,000.00 cash to Eye
Tech by OII as well as OII's agreements to supply lenses and consultation as
set forth hereinafter.
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Section 3. Term and Termination.
3.1 Term. The Term of the License granted in this Agreement shall
commence as of the date of this Agreement and shall continue, unless sooner
terminated, pursuant to the terms of this Agreement, so long as the subject PMA
is in effect.
3.2 Termination. This Agreement may be terminated by the parties
prior to the expiration of the Term as follows:
(a) By mutual agreement of the parties at any time.
(b) By either party in the event the other party hereto
is in default hereunder and such default shall continue uncured by the
defaulting party for a period of thirty (30) days after such defaulting
party is given notice of such default by the other party, provided,
however, that if such default results from a party engaging in conduct in
knowing violation of any law or regulation relating to the manufacture
and/or sale of products, the other party may terminate this Agreement
immediately and the defaulting party shall have no opportunity to cure
such breach.
(c) Immediately by either party in the vent the
continuance of the activities contemplated by this Agreement would result
in a violation of any law or regulation relating to the manufacture
and/or sale of products, provided, however, that in such event,
subsequent to terminating this Agreement, the parties shall negotiate in
good faith to, as promptly as practicable, enter into a new agreement
which would provide the parties with obligations and benefits as nearly
as practicable to those provided by this Agreement.
Section 4. Assignment and Sublicensing.
This Agreement and the License granted herein are personal to the
Licensee, and Licensee may not assign or sublicense any of the rights granted
to the Licensee under this Agreement, except as set forth in Section 1. Any
purported assignment or sublicense by Licensee (or by operation of law) that is
not approved in writing by Eye Tech shall be null and void and of no legal
effect whatsoever, except if made under the circumstances set forth in Section
1.
Section 5. FDA Notification.
Immediately following the closing, Eye Tech, with the assistance of OII,
shall deliver to the FDA the submission of a PMA supplement setting forth the
licensing of OII to manufacture and distribute intraocular lenses under the
Licensee's private label. Eye Tech and OII shall each, as promptly as
practicable, cooperate with each other, prepare, execute, and file with FDA
such documents and take all such other actions as shall be required to obtain
from FDA the approval requested in the PMA supplement in the most expeditious
manner as practicable. All documents set forth on Exhibit B, not previously
supplied to OII by Eye Tech, shall be promptly made available in order to
enable OII to complete the FDA filing. All costs of completing such procedure
and obtaining such approval shall be paid by OII.
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Section 6. Compliance with Laws.
OII, as a condition of the continuation of the License, shall comply with
all laws and regulations, including those related to packaging and labeling,
sale of the product to third parties, filing of all reports, applications,
notifications, and other documents required by governmental authorities, as
well as the payment of any taxes or other governmental charges lawfully imposed
in connection with Licensee's activities.
Section 7. Confidentiality.
It shall be the responsibility of each of the parties hereto to keep the
other party's confidential information in strict confidence, except when
disclosure of certain confidential information is required to be disclosed to
governmental authorities.
Section 8. Supply of Lenses to Eye Tech.
At such time as OII has proven equivalence and validated its procedures
and processes to those of Eye Tech and is approved as a manufacturing site for
polymethylmethacrylate ("PMMA") hard lenses, then OII agrees to supply Eye Tech
PMMA lenses pursuant to the terms and conditions set forth in the Supply
Agreement attached hereto as Exhibit C.
Section 9. Consulting Arrangements.
As additional consideration for Eye Tech's agreement to grant the License
hereunder, OII agrees to render consulting and advisory services to Eye Tech
with respect to (i) improvement of Eye Tech's production and manufacturing
techniques and procedures for intraocular lenses at its current manufacturing
facilities located in Mexicali, Mexico, and (ii) other business matters within
the special competence, knowledge, and experience of OII's personnel, all in a
manner directed toward improving the efficiency and quality of such production
and manufacturing processes and reducing Eye Tech's costs and expenses. In
order to accomplish the purposes of this consulting arrangement, the parties
shall mutually develop a plan which will enable Eye Tech to have the benefits
intended without creating any unreasonable demands on the time of OII personnel
or the incurring of excessive out-of-pocket expenses. Any time devoted to this
consulting arrangement shall be at the sole discretion of OII, and all
out-of-pocket expenses directly attributable to such consultation incurred by
OII shall be reimbursed by Eye Tech.
Section 10. Representations and Warranties.
10.1 Eye Tech hereby warrants and represents to OII as follows:
(a) This Agreement has been duly authorized, executed,
and delivered by Eye Tech and constitutes a valid and binding obligation
of Eye Tech, enforceable in accordance with its terms. The execution,
delivery, and performance of this Agreement by Eye Tech and the
consummation of the transactions contemplated hereby do not and will not
conflict with or result in any material breach of any of the provisions
of, or constitute a material default under, or result in a material
violation of, or require any authorization, consent, or approval
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under the provisions of any agreement or instrument to which Eye Tech is
bound or affected, or any law, statute, rule, regulation, judgment, order,
or decree to which Eye Tech is subject.
(b) Eye Tech owns all rights with respect to the subject
Pre Market Approval Application and the products covered thereunder and
licensed patents.
(c) To Eye Tech's knowledge, its products do not infringe
any patent, copyright, or other intellectual property right of any third
party.
(d) Eye Tech has not received notice of any claims,
actions, suits, or proceedings pending or threatened affecting Eye Tech
and its patents or products, which, if adversely determined, would have a
material adverse effect upon OII's ability to manufacture, have
manufactured, use, or sell the products or otherwise utilize the PMA
licensed to OII by Eye Tech under this Agreement, and to Eye Tech's
knowledge, there is no reasonable basis for anyone to bring such claims,
actions, suits, or proceedings.
(e) Eye Tech has not received any claim from any third
party proceedings relating to its patents and products which are based
upon infringement of any patent or misappropriation or misuse of trade
secrets.
(f) Eye Tech specifically represents and warrants that
all funds received hereunder will be applied in accordance with any and
all applicable loan covenants and related security agreements previously
entered into with any financial institution and currently in effect.
It is further agreed that the funds payable to Eye Tech under
this Agreement and currently held in escrow at Messerli & Kramer P.A.
shall, with the exception of funds payable for legal fees not to exceed
$25,000.00, continue to be escrowed until such time as a consent to the
issuance of the license hereunder is obtained from Republic Acceptance
Corp. or such financial institution as may succeed to the obligations and
security agreements currently held by Republic Acceptance Corp.
Notwithstanding the pendency of a final consent from the applicable
financial institution, the parties shall upon execution of this Agreement
immediately commence all cooperative efforts set forth herein to
accomplish the purposes and intent of this Agreement.
10.2 OII hereby warrants and represents to Eye Tech as follows:
(a) OII is a corporation duly organized, validly
existing, and in good standing under the laws of the State of Delaware.
(b) This Agreement has been duly authorized, executed,
and delivered by OII and constitutes a valid and binding obligation of
Eye Tech enforceable in accordance with its terms. The execution,
delivery, and performance of this Agreement by OII and the consummation
of the transactions contemplated hereby do not and will not conflict with
or result in any material breach of any of the provisions of, or
constitute a material default under, or result in a material violation
of, or require any authorization, consent, or approval under the
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provisions of OII's Certificate of Incorporation or Bylaws or any other
agreement or instrument to which Licensee is bound or affected, or any
law, statute, rule, regulation, judgment, order, or decree to which OII
is subject.
Section 11. Miscellaneous.
11.1 Further Assurances. Each of the parties hereto shall use its
reasonable best efforts to take, or cause to be taken, all appropriate action,
do or cause to be done all things necessary, proper, or advisable under
applicable law, and to execute and deliver such documents and other instruments
or papers as may be required or may be reasonably requested by the other party
hereto to carry out the provisions of this Agreement and to consummate and
render effective the transactions contemplated by this Agreement.
11.2 Notices. All notices, requests, claims, demands, and other
communications hereunder shall be in writing and shall be given or made (and
shall be deemed to have been duly given or made upon receipt) by delivery in
person, by courier service, by cable, by telecopy, by telegram, by telex, or by
registered or certified mail (postage prepaid, return receipt requested) to the
respective parties at the following addresses (or at such other address for a
party as shall be specified in a notice given in accordance with this Section
11.2:
(a) If to OII or the Company following the Closing:
OII International, Inc.
550 North Claremont Boulevard
Claremont, California 91711
Attn: Sammie D. Cobb, President and CEO
Telecopy No.: (909) 626-7338
(b) If to Eye Tech or to the Company prior to the Closing:
Eye Technology, Inc.
1983 Sloan Place
St. Paul, Minnesota 55117
Attn: Robert J. Fitzsimmons, Chairman and CEO
Telecopy No.: (612) 774-6271
with a copy to:
Messerli & Kramer P.A.
1800 Fifth Street Towers
150 South Fifth Street
Minneapolis, Minnesota 55402
Attn: Joseph W. Lawyer, Esq.
Telecopy No.: (612) 672-5777
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11.3 Headings. The descriptive headings contained in this
Agreement are for convenience of reference only and shall not affect in any way
the meaning or interpretation of this Agreement. All references herein to
Sections or clauses refer to specific provisions of this Agreement.
11.4 Severability. If any term or other provision of this
Agreement is invalid, illegal, or incapable of being enforced by any Law or
public policy, all other terms and provisions of this Agreement shall
nevertheless remain in full force and effect so long as the economic or legal
substance of the transactions contemplated hereby is not affected in any manner
materially adverse to any party. Upon such determination that any term or
other provision is invalid, illegal, or incapable of being enforced, the
parties hereto shall negotiate in good faith to modify this Agreement so as to
effect the original intent of the parties as closely as possible in an
acceptable manner in order that the transactions contemplated are consummated
as originally contemplated to the greatest extent possible.
11.5 No Third Party Beneficiaries. This Agreement shall be binding
upon and inure solely to the benefit of the parties hereto and their permitted
assigns and nothing herein, express or implied, is intended to or shall confer
upon any other person or entity any legal or equitable right, benefit, or
remedy of any nature whatsoever under or by reason of this Agreement.
11.6 Amendment. This Agreement may not be amended or modified
except by an instrument in writing signed by, or on behalf of, OII and Eye
Tech.
11.7 Governing Law. This Agreement shall be governed by, and
construed in accordance with, the laws of the State of Minnesota, applicable to
contracts executed in and to be performed entirely within that state (without
giving effect to its principles of conflicts of laws of that state or any other
jurisdiction).
11.8 Counterparts. This Agreement may be executed in one or more
counterparts, and by the different parties hereto in separate counterparts,
each of which when executed shall be deemed to be an original but all of which
taken together shall constitute one and the same agreement.
11.9 Specific Performance. The parties hereto agree that
irreparable damage would occur in the event any provision of this Agreement is
not performed in accordance with the terms hereof and that the parties shall be
entitled to specific performance of the terms hereof in addition to any other
remedy at law or equity.
11.10 Entire Agreement. This Agreement constitutes the entire
agreement of the parties hereto with respect to the subject matter hereof and
thereof and supersedes all prior agreements and undertakings, both written and
oral, between OII and Eye Tech with respect to the subject matter hereof and
thereof.
11.11 Facsimile Signatures. Until such time as this Agreement has
been duly executed by the Company officers of the respective parties and the
original documents have been exchanged by the parties, a facsimile copy with
signatures of Company officers thereon cross delivered shall be binding on the
parties.
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11.12 Release of Funds. The execution of this document by the
parties, including facsimile signatures, shall authorize the release of the
$325,000.00 held in escrow by Messerli & Kramer P.A. for payment to Eye Tech by
OII.
IN WITNESS WHEREOF, each of OII and Eye Tech has executed this Agreement
or caused this Agreement to be executed by its duly authorized officer as of
the date first written above.
OII INTERNATIONAL, INC.
By: /s/ Sammie D. Cobb
--------------------------------------
Sammie D. Cobb
President and CEO
EYE TECHNOLOGY, INC.
By: /s/ Robert J. Fitzsimmons
--------------------------------------
Robert J. Fitzsimmons
President and CEO
AGREE TO ESCROW PROVISIONS SET
FORTH IN SECTION 10-1 (F)
/s/ Messerli & Kramer, P.A.
---------------------------------
Messerli & Kramer P.A.
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Exhibit A
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Exhibit B
Documents Required for PMA Supplement
1. Signed License Agreement for PMA
2. Document Receipt Letter
3. Letter to FDA from President of ETI re: PMA in good standing and OII
rights to access PMA files
4. Letter to President of OII from President of ETI re: PMA in good standing
and OII rights to access PMA files
5. Notice of Acceptance of PMA by OII to FDA
6. Copy of PMA
7. PMA Submission Documentation (all applicable PMAs)
o all drawings required
o applications for IDEs
o PMA amendments
o supplemental amendments
o requests for manufacturing at Mexican and St. Paul facility
o PMA approval letter from FDA
o PMA applications and all supporting documentation (copies of
clinical trial forms) for all applicable PMAs
Manufacturing Documents
o Model characteristics
o Intended use and administration
o Components
o Type of manufacturing
o Standard operation procedures
o Receiving and inspection
o Quality control documents
o Sterilization validation
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Exhibit C
SUPPLY AGREEMENT
This Agreement for the supply of Goods ("Agreement") is made and
effective this January 31, 1997, by and between OII International, Inc., a
Delaware Corporation ("Seller"), and Eye Technology, Inc., a Delaware
Corporation ("Buyer").
Seller desires to sell to Buyer, and Buyer desires to purchase from
Seller, certain tangible personal property (PMMA Intraocular Lenses) after
approval has been obtained from the FDA granting Seller rights to domestic
distribution under the licensed PMA.
NOW, THEREFORE, in consideration of the mutual promises herein contained,
the parties hereto agree as follows:
1. Sale.
Seller agrees to sell, transfer and convey to Buyer, and Buyer agrees to
purchase, the following tangible personal property (the "Goods"): Approved
Sterile prepackaged (Tyvek pouch only) PMMA Intraocular Lenses, manufactured to
Sellers GMPs under subject PMA.
2. Price.
Buyer shall pay Seller for the Goods the sum of $10.00 per unit FOB
Claremont, California. Buyer shall make payment of the purchase price in full
within sixty (60) days following delivery of the Goods by Seller as provided
herein, subject to Buyer's right of inspection as set forth in Section 5 below.
In the event that the purchase price is not timely paid, in addition to its
other remedies, Seller may impose, and Buyer shall pay, a late payment charge
equal to one percent (1%) of the overdue amount each month. Seller guarantees
this price for a period of 24 months from the time Seller is first able to
supply PMMA lenses under the subject PMA and that any subsequent increase in
price shall be limited to actual increases in incremental costs incurred by
Seller in its own production of lenses.
3. Minimum Order Quantity.
Buyer agrees to purchase a minimum of 200 units per purchase order and a
minimum of 10 units per diopter.
4. Shipping.
Seller shall deliver the goods to Buyer as follows: Eye Technologies,
Inc., at either St. Paul, Minnesota, or Mexicali, Mexico, at Buyer's
discretion. Buyer shall be solely responsible for the expenses associated with
shipping. The risk of loss from any casualty to the Goods during shipment,
regardless of the cause, shall be upon Buyer upon the delivery of the Goods to
Buyer's address as set forth herein. When practicable, Seller will follow
Buyer's requested shipping instructions. If none are requested, Seller will
use its discretion in selecting an appropriate transportation method.
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5. Right of Inspection.
Buyer shall have the right to inspect the goods on arrival at Buyer's
facility. Within fifteen (15) business days after delivery, Buyer must give
notice to Seller of any claim with respect to the condition, quality or grade
of the Goods or non-conformance to this Agreement, specifying the basis of the
claim in detail. Seller may, at its option, inspect the Goods at Buyer's
facilities to confirm that the Goods do not conform to this Agreement. Buyer's
sole remedy, and Seller's sole obligation, shall be at Seller's option to
replace the Goods at Seller's expense for the non- conforming goods. Return
shipping shall be the responsibility of Seller.
6. Identification of Goods.
Identification of the Goods shall not be deemed to have been made until
both Buyer and Seller have specified that the Goods are to be appropriated to
the performance of this Agreement.
7. Warranty.
Supplier warrants that all products delivered to Eye Technologies, Inc.,
under this Agreement shall, at the time of delivery, be of merchantable quality
and fit for their intended purposes, be free of defects in materials and
workmanship, meet the requirements set forth in the subject PMA, and have been
manufactured, packages, sterilized, and maintained in conformance with FDA's
current Good Manufacturing Practices regulations. This warranty shall not
apply to any products damaged during shipping. Eye Technology, Inc., shall,
within ten (10) days after the receipt of defective product, provide a written
notice containing a specific and detailed explanation of the circumstances and
nature of the claim or claims regarding the defective nature of the products.
OII shall rework or replace the defective products at OII's expense. EXCEPT AS
SET FORTH HEREIN, SELLER MAKES NO WARRANTY TO BUYER WITH RESPECT TO THE GOODS,
AND BUYER DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING,
WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.
8. Limitation of Liability.
In no event shall Seller be liable for any special, indirect, incidental
or consequential damages arising out of or connected with this Agreement or the
Goods, regardless of whether a claim is based on contract, tort, strict
liability or otherwise, nor shall Buyer's damages exceed the amount of the
purchase price of the Goods.
9. Notices.
Any notice required by this Agreement or given in connection with it
shall be in writing and shall be given to the appropriate party by personal
delivery or by certified mail, postage prepaid, or recognized overnight
delivery services.
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If to Seller:
OII International, Inc.
550 North Claremont Blvd.
Claremont, California 91711
Attn: Sammie D. Cobb, President and CEO
If to Buyer:
Eye Technology, Inc.
1983 Sloan Place
St. Paul, Minnesota 55117
Attn: Robert J. Fitzsimmons, Chairman and CEO
10. Governing Law.
This Agreement shall be construed and enforced in accordance with the
laws of the State of California.
11. Final Agreement.
This Agreement terminates and supersedes all prior understandings or
agreements on the subject matter hereof. This Agreement may be modified only
by further writing that is duly executed by both parties.
12. Severability.
If any term of this Agreement is held by a court of competent
jurisdiction to be invalid or unenforceable, then this Agreement, including all
of the remaining terms, will remain in full force and affect as if such invalid
or unenforceable term had never been included.
13. Headings.
Headings used in this Agreement are provided for convenience only and
shall not be used to construe meaning or intent.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed as of the date first above written.
OII International, Inc. Eye Technology, Inc.
By: /s/ Sammie D. Cobb By: /s/ Robert J. Fitzsimmons
------------------------------------------ ------------------------------------------
Sammie D. Cobb Robert J. Fitzsimmons
President/CEO President/CEO
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