MANUFACTURING AGREEMENT
-----------------------
Agreement made as of the 10th day of September, 1997 between LaserSight
Technologies, Inc. ("LaserSight"), a Delaware corporation (a wholly owned
subsidiary of LaserSight Incorporated, a Delaware corporation), and ▇▇▇▇▇▇
Medical Development Ltd.
("▇▇▇▇▇▇"), a New York corporation.
R E C I T A L S
A. LaserSight is engaged in the development, manufacture and
marketing of ophthalmic lasers.
▇. ▇▇▇▇▇▇ is engaged in the development and manufacture of various
products, including medical devices.
C. LaserSight has been granted a worldwide limited license (the
"License") to practice the Patents (hereinafter defined) for the manufacture and
sale of Products (hereinafter defined) pursuant to a Licensing and Royalty
Agreement among LaserSight, ▇▇▇▇ ▇. ▇▇▇▇, M.D. and ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ (collectively,
"▇▇▇▇/Lenchig") (the "License Agreement").
D. LaserSight desires to grant a sublicense to ▇▇▇▇▇▇ and ▇▇▇▇▇▇
desires to secure the exclusive worldwide right to manufacture Products
exclusively for LaserSight.
NOW, THEREFORE, in consideration of the mutual promises and covenants
contained the parties agree as follows:
1. Definitions
"Automatic Corneal Shaper System" shall mean the complete system used
to perform LASIK surgery which includes (i) disposable microkeratome with gear
box, suction ring and suction handle, (ii) motor, (iii) motor power cord, (iv)
tonometer, (v) suction and power supply, (vi) foot switch, (vii) tubing, (viii)
user's manual, (ix) sterile packaging, (x) control consoles, (xi) blades, (xii)
replacement parts, (xiii) lid speculum, and other component parts which are
manufactured utilizing the Patents.
"Contract Year" shall mean each 12 consecutive month period beginning
on January 1 and ending on December 31.
"Patents" shall mean U.S. Patent #5,133,726 and Patent Reissue #35,421,
both with respect to a microkeratome device, including all United States and
foreign patents related thereto which may be issued in the future including
amendments, reissues, improvements thereon, etc.
"Product" or "Products" shall mean disposable microkeratomes which are
manufactured utilizing the Patents.
"Purchase" shall mean to order and take delivery of Products.
"Specifications" shall mean the latest specifications for Products
agreed to by LaserSight and ▇▇▇▇▇▇ which have been developed by ▇▇▇▇/Lenchig and
pursuant to which ▇▇▇▇▇▇ is manufacturing Products for LaserSight. The
Specifications may only be amended or changed by written agreement of LaserSight
and ▇▇▇▇▇▇.
2. License To Manufacture Products
LaserSight hereby grants ▇▇▇▇▇▇ an exclusive worldwide sublicense, even
as to LaserSight, under the License Agreement solely for the purpose of
manufacturing Products exclusively for LaserSight.
If Chiron Vision Corporation ("Chiron") as agent, owner, or assignee,
or any other agent, owner or assignee of U.S. Patent 4,840,175 ("Peymen")
institutes any action which causes LaserSight to cease distributing Products in
the United States (a "Trigger Event"), LaserSight and ▇▇▇▇▇▇ agree as follows:
(a) 90 days following its receipt of notice of a Trigger Event, ▇▇▇▇▇▇
shall cease manufacturing Products in the United States.
(b) Within 30 days after ▇▇▇▇▇▇ receives notice of the institution of a
Trigger Event, ▇▇▇▇▇▇ shall determine the feasibility of its manufacturing
Products outside of the United States. In the event ▇▇▇▇▇▇ decides to cause
Products to be manufactured outside of the United States, ▇▇▇▇▇▇ shall:
(i) continue to have full responsibility for the manufacture
of Products, including all quality and warranty requirements as specified in
Paragraph 8; and
(ii) reduce Products price by an amount equal to fifty percent
of any reduction in Product manufacturing costs on a per unit basis resulting
from the change in the location of the manufacturing site to a manufacturing
site located outside of the United States, after any initial transfer or
start-up expenditures.
In all other respects the terms and conditions of this
Agreement shall remain in full force and effect.
(c) In the event ▇▇▇▇▇▇ elects to not manufacture Product outside of
the United States, this Agreement shall terminate and within 60 days after such
election is made, ▇▇▇▇▇▇ shall transfer and cause to be delivered to LaserSight,
at the expense of LaserSight, all molds, engineering drawings and other
properties previously delivered by LaserSight pursuant to Paragraph 4.
(d) If ▇▇▇▇▇▇ elects not to manufacture Product outside of the United
States, ▇▇▇▇▇▇ shall offer reasonable assistance, as ▇▇▇▇▇▇ shall determine, to
LaserSight to establish offshore manufacturing. LaserSight shall pay ▇▇▇▇▇▇ for
any direct, reasonable expenses associated with such assistance. ▇▇▇▇▇▇ shall
offer to sell to LaserSight any confidential properties related to the
manufacture of Product which have been developed at ▇▇▇▇▇▇'▇ sole expense which
may include process, further design, or other know-how proprietary to ▇▇▇▇▇▇
(the "Manufacturing Know-How"). In consideration for the receipt of the
Manufacturing Know-How, LaserSight shall negotiate with ▇▇▇▇▇▇ in good faith to
pay a royalty not to exceed $3.00 per unit of Product produced by or on behalf
of LaserSight utilizing the Manufacturing Know-How for the duration of the
License Agreement. The sum of such contemplated royalty payment and transfer
price to LaserSight shall not exceed the transfer price associated with Products
as were being previously produced in the U.S.
3. Obligations of ▇▇▇▇▇▇
▇▇▇▇▇▇ shall be responsible for the production and manufacture of
Products in accordance with the Specifications, as may be amended from time to
time in accordance with this Agreement. ▇▇▇▇▇▇ acknowledges and agrees that it
shall have a limited supply of Product packaged on or before October 22, 1997.
The parties acknowledge and agree that such supply of Product shall be
considered "pre-production" Product and shall be subject to further modification
as requested by LaserSight. Notwithstanding anything set forth herein to the
contrary, if ▇▇▇▇▇▇ (i) fails to have a limited supply of Product packaged on or
before October 22, 1997, and (ii) such failure was caused solely by ▇▇▇▇▇▇,
LaserSight shall have the option to terminate this Agreement upon 10 days prior
written notice to ▇▇▇▇▇▇, and LaserSight shall be entitled to pursue all legal
and equitable remedies to which it may be entitled in connection with such
breach.
4. Obligations of LaserSight
The parties acknowledge and agree that ▇▇▇▇/Lenchig have undertaken
certain obligations to pay for and/or provide (or cause to be provided) certain
items related to the development of Products. The full and timely performance of
these obligations by ▇▇▇▇/Lenchig and the execution of the License Agreement are
essential elements and conditions precedent to the full and timely performance
by LaserSight and ▇▇▇▇▇▇ of their respective obligations under this Agreement.
LaserSight shall be responsible for the following obligations:
(a) LaserSight shall provide ▇▇▇▇▇▇ with Specifications, design and
design documentation for Products and the Automatic Corneal Shaper System,
including establishing and, thereafter, maintaining the design and associated
documentation. Configuration control shall be maintained by ▇▇▇▇▇▇ utilizing a
formal change control system the same or substantially similar to the standard
procedures used by ▇▇▇▇▇▇.
(b) LaserSight shall provide ▇▇▇▇▇▇ with a complete Automatic Corneal
Shaper System during its production (for a duration of at least one month) to
allow testing and product review by ▇▇▇▇▇▇ of final production Product.
(c) LaserSight shall provide to the mold maker designated by ▇▇▇▇▇▇
purchase orders for (i) dual cavity automatic production molds, and (ii) single
cavity limited production molds, as may be necessary for ▇▇▇▇▇▇ to achieve
project schedules.
(d) LaserSight shall be responsible for the cost of any major repairs
and revisions to molds; provided, however, if such repairs or revisions are the
result of any cause or event attributable to ▇▇▇▇▇▇ (normal wear and tear
excepted), ▇▇▇▇▇▇ shall be responsible for the cost of any such repair or
revision. Such revisions shall be documented and authorized by ▇▇▇▇▇▇'▇ Mold
Revision Route Sheet Procedure.
(e) LaserSight shall provide ▇▇▇▇▇▇ with all documentation, reports,
studies, protocols, and data regarding the quality, manufacture and distribution
of Product and participate in the timely design reviews at each major phase and
as required to support project objectives, as determined by ▇▇▇▇▇▇.
(f) Lasersight shall coordinate the performance of all clinical trials
necessary to assure clinical efficacy of Products. Written reports shall be
provided to ▇▇▇▇▇▇ within 14 days of the completion of such trials.
(g) LaserSight shall (i) provide ▇▇▇▇▇▇ with special tooling and
special equipment required to produce packaging material and packaging for
Products distribution, or (ii) make arrangements for the packaging and
sterilization of Products.
(h) LaserSight shall ensure that all requirements for trademarks,
labeling and package design are satisfied. ▇▇▇▇▇▇ shall be responsible for the
implementation and control of all packaging and labeling that is shipped with
Products.
(i) LaserSight shall provide ▇▇▇▇▇▇ with all instructional inserts that
are required to be shipped with Products.
5. Purchase of Products
(a) No later than October first of each year, LaserSight shall ▇▇▇▇▇▇▇
▇▇▇▇▇▇ with a forecast of the number of Products it expects to order during each
month of the succeeding Contract Year. No later than April first of each year,
LaserSight shall ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ with an updated forecast of the number of
Products it expects to order during each remaining month of such year. Such
forecasts and updates shall merely represent reasonable estimates based upon
LaserSight's then current business plans and shall not be Purchase commitments.
LaserSight's obligation to make firm Purchase commitments for Products shall be
governed by Paragraph 5(b).
(b) During the term of this Agreement, on or before each January 1,
April 1, July 1 and October 1, LaserSight shall place firm Purchase orders for
the quantities of Products to be delivered during April, May and June; July,
August and September; October, November and December; and January, February and
March, respectively (each a "Quarterly Purchase Order"). Upon the issuance of a
Quarterly Purchase Order by LaserSight and receipt by ▇▇▇▇▇▇, the obligation of
LaserSight to Purchase Product shall be firm and noncancellable; provided,
however, 90 days following the receipt of notice of a Trigger Event, ▇▇▇▇▇▇
shall cease manufacturing Products and LaserSight shall be responsible for
taking delivery of Product which is produced in accordance with outstanding
Quarterly Purchase Orders during such 90 day period. Each Quarterly Purchase
Order shall be placed on LaserSight's standard purchase order form. Deliveries
shall be made according to delivery dates identified on such purchase orders,
subject to Paragraph 5(c). All terms and conditions of this Agreement shall
supersede any terms and conditions of any Quarterly Purchase Order to the extent
the same may modify or is inconsistent therewith. ▇▇▇▇▇▇ shall be deemed to have
accepted a Quarterly Purchase Order, except to the extent of the quantities it
expressly rejects in writing within 10 business days of receipt of such order.
▇▇▇▇▇▇ shall not unreasonably reject quantities which are consistent with (i)
the most recent October annual forecast, or (ii) the updated annual forecast
furnished in April, as applicable, to be delivered by LaserSight to ▇▇▇▇▇▇.
(c) No later than September 30, 1997, LaserSight shall issue to ▇▇▇▇▇▇
an initial blanket purchase order for a minimum of 200,000 units of Product for
delivery during the period commencing on the calendar month immediately
following the month during which production of Product commences and terminating
30 months immediately thereafter; provided, however, 90 days following its
receipt of notice of a Trigger Event, ▇▇▇▇▇ shall cease manufacturing Products,
notwithstanding anything set forth herein to the contrary.
(d) Delivery terms shall be F.O.B. ▇▇▇▇▇▇'▇ manufacturing facility or
designated sterilizing facility. ▇▇▇▇▇▇ shall ship Products in the manner
specified in the applicable LaserSight purchase order or as otherwise directed
by LaserSight in writing prior to shipment.
6. Minimum Purchase
LaserSight shall purchase 50,000 units of Product in each Contract
Year. The number of units of Product for any partial Contract Year shall be
prorated by multiplying 50,000 units of Product times a fraction the numerator
of which shall be the number of days the Agreement was in effect during such
Contract Year, and the denominator of which shall be 365.
7. Price and Payment
Initial Product pricing shall be based upon Attachment "A" annexed to
this Agreement.
Any scrap cost incurred by ▇▇▇▇▇▇ over and above 5% of the cost of
goods sold of Products, as determined by ▇▇▇▇▇▇, shall be an extra cost invoiced
to LaserSight on a quarterly basis and shall be due and payable 30 days after
billing; provided, however (i) in no event shall such scrap cost incurred by
▇▇▇▇▇▇ exceed 20% of the cost of goods sold of Products, and (ii) ▇▇▇▇▇▇ shall
notify LaserSight immediately in the event such scrap cost equals or exceeds 5%
of the cost of goods sold of Products. Scrap cost shall have been due to the
inability to meet specific design requirements which are identified as
questionable areas during final design reviews following clinical trials.
Payment for monthly shipments shall be due to ▇▇▇▇▇▇ by bank check or
wire transfer 45 days after the date of invoice or shipment, whichever is later.
Any increase in direct Product costs resulting from a change in Product
Specifications shall be added to the price of Product. Such increase in price
shall include a cost markup of 10%. Any decrease in direct Product costs
resulting from Product design modifications or process improvements, whether
initiated or conceived by ▇▇▇▇▇▇ or LaserSight, shall be shared equally by
▇▇▇▇▇▇ and LaserSight.
Price adjustments shall be made on an annual basis and be based upon
the increase in the current producers price index over the base producers price
index (for finished goods less food and energy as quoted by the U.S. Department
of Labor, Bureau of Labor Statistics). The method for calculation of such price
adjustments are set forth on Attachment "B."
8. Products Quality and Warranties
▇▇▇▇▇▇ shall maintain quality systems in compliance with ISO 9002 and
FDA/GMP requirements, details of which shall be set forth in a Quality Plan for
Products to be provided by ▇▇▇▇▇▇ to LaserSight.
▇▇▇▇▇▇ shall develop a Products Master Checklist/Plan and maintain
elements of Product Master Record in accordance with the requirements defined by
LaserSight.
Engineering changes shall be accomplished using ▇▇▇▇▇▇ change control
procedures.
At least once every six months, LaserSight and ▇▇▇▇▇▇ shall jointly
participate in quality and regulatory reviews to define quality plans and
objectives.
▇▇▇▇▇▇ warrants that Products manufactured pursuant to this Agreement
shall meet the Specifications and be free from defects in material and
workmanship for a period which shall be the lesser of (i) 24 months from
delivery to LaserSight, or (ii) the shelf life of Products as determined by
▇▇▇▇▇▇ based upon tests of verification and validation relating to Sterilization
of Products and adhesives utilized in connection with producing Product. The
foregoing warranty shall not extend to any Products or part which has been
subject to accident or abuse or which has not been used, operated or maintained
in the manner prescribed in Products' instructions or with respect to which
unauthorized repair or alteration has taken place. During the term of this
warranty, ▇▇▇▇▇▇ shall replace defective Products or parts thereof without
charge within 30 days following receipt of such defective Products by ▇▇▇▇▇▇.
▇▇▇▇▇▇ shall bear all shipping costs for the return of defective Products to
▇▇▇▇▇▇ and of shipping replacement Products to LaserSight or LaserSight's
customers, as applicable. ▇▇▇▇▇▇ shall have the right to designate the carrier
for the return of defective Products.
The warranty of ▇▇▇▇▇▇ is limited to replacement of defective Products.
Return authorization must be received prior to the return of any Products.
Products must be cleaned prior to return and be returned in properly identified
biohazard containers.
EXCLUSION OF WARRANTIES- THE FOREGOING WARRANTY IS IN LIEU OF ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, WARRANTIES OF
MERCHANTABILITY. IT IS EXPRESSLY UNDERSTOOD AND AGREED BY THE PARTIES THAT
PURSUANT TO THIS AGREEMENT, ▇▇▇▇▇▇ MAKES NO WARRANTY OF ANY KIND, EXPRESS OR
IMPLIED, TO ANY PURCHASER OF PRODUCTS OTHER THAN LASERSIGHT.
9. Term, Renewal and Termination
Subject to the earlier termination of the License Agreement as set
forth herein, the initial term of this Agreement shall be 60 months commencing
with the first full month of production of Products by ▇▇▇▇▇▇. This Agreement
shall automatically be renewed at the expiration of the initial term for an
additional one-year period, if not terminated in writing by either party at
least three months prior to the expiration of the initial term or any renewal
term, as applicable.
This Agreement may also be terminated by LaserSight or ▇▇▇▇▇▇ upon the
occurrence of any of the following events:
(a) if any party is in default with respect to a material obligation
under this Agreement, the affected party may give written notice of such default
to the defaulting party; thereafter, unless such default is cured or a
substantial effort has been initiated and continued to effect a cure within 30
days after the receipt of such notice, the non-defaulting party, in addition to
its other remedies, may elect to terminate this Agreement by additional written
notice to the defaulting party;
(b) immediately upon notice to the other party, if LaserSight or ▇▇▇▇▇▇
(i) is adjudicated to be insolvent or bankrupt or a
petition in bankruptcy is filed by or against
LaserSight or ▇▇▇▇▇▇ and such petition is not
dismissed within 60 days after it is filed;
(ii) admits in writing its inability to pay its debts as
they become due; or
(iii) executes an assignment for the benefit of its
creditors.
If ▇▇▇▇▇▇, after consultation with LaserSight, reasonably determines
that ▇▇▇▇▇▇ is unable to manufacture Products in a reliable and consistent
manner as required by the clinical performance of Products, then ▇▇▇▇▇▇ shall
continue producing Products for a period of six months, or for such shorter
period as may be approved or directed by LaserSight, immediately following the
date of such determination, and at the conclusion of such period this Agreement
shall be terminated. Within 30 days after the date of such termination, ▇▇▇▇▇▇
shall deliver the Manufacturing Know-How to LaserSight, without charge.
Notwithstanding anything set forth in this Agreement to the contrary, ▇▇▇▇▇▇
shall not be liable to any party for any damages or pecuniary loss suffered by
any party as a result of such decision to terminate except for the obligations
which survive termination as set forth in the next paragraph.
No termination shall affect either party's rights to receive damages or
other legal or equitable relief. The obligations under Paragraphs 8 (Products
Quality and Warranties), 10 (Product Recalls), 11 (Product Liability Insurance),
16 (Confidentiality), 17 (Indemnification), and 18 (Patent Litigation) shall
survive expiration or termination of this Agreement. Neither expiration or
termination of this Agreement shall relieve either party of any liability for a
breach or default which occurred prior to expiration or termination with respect
to any right or obligation which existed prior thereto.
Notwithstanding anything set forth in this Agreement to the contrary,
if the License Agreement terminates for any reason, (i) LaserSight shall be
responsible for taking delivery of Product which is produced in accordance with
outstanding Quarterly Purchase Orders during the period which is 90 days
immediately following the date of such termination; and (ii) after such 90 day
period, LaserSight's obligations pursuant to this Agreement shall terminate and
LaserSight shall not be liable to any party for any damages or pecuniary loss
suffered by any party as a result of such termination except for the obligations
which survive termination as set forth in the immediately preceding paragraph.
10. Return of Property
Within 10 days after the termination of this Agreement for any reason,
▇▇▇▇▇▇ shall return to LaserSight all items which have been previously delivered
to ▇▇▇▇▇▇ pursuant to Paragraph 4.
11. Product Recalls
In the event (i) any governmental authority issues a request, directive
or order that Product be recalled, (ii) a court of competent jurisdiction orders
such a recall, or (iii) LaserSight and ▇▇▇▇▇▇, after consultation, reasonably
determine that Product should be recalled, the parties agree to take all
appropriate corrective action. In the event that such recall results from any
cause or event attributable to ▇▇▇▇▇▇, ▇▇▇▇▇▇ shall be responsible for all
expenses of the recall. In all other cases, LaserSight shall be responsible for
the expenses of recall. For the purposes of this Agreement, the expenses of
recall shall include, without limitation, the expenses associated with (i)
providing notice of recall to purchasers of Product, (ii) destruction or return
of the recalled Product, and (iii) LaserSight's costs for Product recalled, but
not any direct and normal recurring expenses of LaserSight or ▇▇▇▇▇▇.
12. Product Liability Insurance
▇▇▇▇▇▇ shall maintain product liability insurance with single limits of
not less than $2 million in the aggregate per year for use of Products in
surgical procedures. The additional cost to ▇▇▇▇▇▇ of such insurance, if any,
shall be added to the unit price of Product as a separate charge based upon
Product units shipped and such cost shall be reviewed and revised annually, if
required. ▇▇▇▇▇▇ shall cause the insurance policy to name LaserSight as an
insured party.
For a period of two years after termination of this Agreement, each
party shall maintain product liability insurance with single limits of not less
than $2 million in the aggregate per year and provide the other party with
evidence of the continued existence of such insurance.
13. Customer Complaint Procedure
LaserSight (as manufacturer of record) shall provide ▇▇▇▇▇▇, at least
monthly, with customer complaint information and ▇▇▇▇▇▇ shall be provided with
access to all information regarding the clinical performance of Products.
Customer complaints shall be processed by LaserSight. ▇▇▇▇▇▇ shall
cooperate in such processing based upon receipt of written complaints following
the return of Products in question.
14. Regulatory Authority Matters
LaserSight shall have the responsibility for filing form 510(k) with
the FDA.
LaserSight shall have the responsibility to file with the FDA all
medical device incidence reports and provide ▇▇▇▇▇▇ with copies thereof to
support product improvement activities.
LaserSight shall provide ▇▇▇▇▇▇ with all necessary documentation and
information including but not limited to design, manufacturing and Patent
information to meet all regulatory requirements.
15. Force Majeure
The failure of either party to perform an obligation under this
Agreement, except the obligation to make payments, shall not subject such party
to any liability to the other, and the performance of such party may be delayed,
if such failure is caused by circumstances beyond that party's reasonable
control such as acts of God, fire, explosion, flood, drought, war, riot,
sabotage, embargo, strikes or other labor trouble, failure in whole or in part
of suppliers to deliver materials, equipment or machinery on schedule,
interruption of or delay in transportation or compliance with any order or
regulation of any government entity acting with authority (including, without
limitation, the FDA). The party claiming the benefit of this Section shall give
immediate notice to the other party, shall use its best efforts to avoid or
remove such cause or causes of non performance, and shall otherwise continue to
perform hereunder. LaserSight may terminate this agreement upon 30 days advance
written notice given to ▇▇▇▇▇▇, if ▇▇▇▇▇▇ has invoked this Section to excuse its
performance for a continuous period of at least 30 days, provided LaserSight
reasonably determines and submits to ▇▇▇▇▇▇ satisfactory supporting evidence
that it can remedy such non-performance more expeditiously than ▇▇▇▇▇▇.
Suspension of a party's performance for such cause as described herein shall not
affect the running of the term of this Agreement.
16. Notices
Any notice shall be in writing, delivered by hand or sent to the other
party at its address stated below by certified mail, return receipt requested,
postage prepaid, and shall be deemed to be received upon hand delivery or 48
hours after it is deposited in the United States mail, without regard as to when
or whether such notice is actually received, provided that concurrently with the
mailing a copy is sent by telefacsimile. Such notices shall be directed as
follows:
If to LaserSight: LaserSight Technologies, Inc.
▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇
Attn: President
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
And a copy sent
simultaneously to: ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇, Esq.
▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇ & ▇▇▇▇▇▇▇▇▇
▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇
▇▇. ▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
If to ▇▇▇▇▇▇: ▇▇▇▇▇▇ Medical Development Ltd.
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ - ▇▇▇▇ ▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
Attn: President
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
And a copy sent
simultaneously to: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇, Esq.
▇▇▇▇▇, ▇▇▇▇▇ & ▇▇▇▇▇, LLP
▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇ - ▇▇▇▇ ▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
17. Confidentiality
(a) Both during and after the term of this Agreement, each party shall
maintain in confidence all proprietary information obtained from the other
party, and all information concerning the other party, except a party may
disclose:
(i) information which is generally available to the
public through no fault of the disclosing party;
(ii) information which was available to the disclosing
party prior to receipt thereof from the other party
under no obligation of confidentiality either before
entering this Agreement or thereafter;
(iii) information received by the disclosing party from a
third party not under any obligation of
confidentiality to the other party;
(iv) information which is required to be disclosed or
divulged by law; and
(v) information which the parties hereto mutually agree
in writing to disclose.
(b) Upon the expiration or termination of this Agreement, each party
shall promptly return to the other all documents and materials proprietary to
it.
18. Indemnification
LaserSight agrees to indemnify, defend and hold ▇▇▇▇▇▇, its officers,
directors, shareholders, employees, its permitted sublicensees and its
subcontractors harmless against any and all liability, loss, damages, cost or
expenses (including reasonable attorneys' fees and legal disbursements) that
▇▇▇▇▇▇ may incur, suffer or be required to pay as a consequence of a third party
claim or suit brought against ▇▇▇▇▇▇ or its employees, its sublicensees or
subcontractors arising out of or with respect to any alleged violation by
Products of patent, trademark, tradename or proprietary right of a third party,
or promotion, labeling, packaging, distribution or sale of Products or resulting
from other LaserSight activities including physician training, provided,
however, that in no event shall LaserSight be required to pay more than $2
million per year in the aggregate for indemnification under this Paragraph 18.
▇▇▇▇▇▇ agrees to indemnify, defend and hold LaserSight, its officers,
directors, shareholders, employees, its permitted sublicensees and its
subcontractors harmless against any and all liability, loss, damages, cost or
expenses (including reasonable attorneys' fees and legal disbursements) that
LaserSight may incur, suffer or be required to pay as a consequence of a third
party claim or suit brought against LaserSight or its employees, its
sublicensees or subcontractors arising out of or with respect to defects in the
manufacture of Products, provided, however, that in no event shall ▇▇▇▇▇▇ be
required to pay more than $2 million per year in the aggregate for
indemnification under this Paragraph 18.
The obligations of the indemnifying party under this Paragraph 18 are
conditioned upon (i) written notice given to the indemnifying party of a written
claim or lawsuit which is alleged to be covered by this indemnity; such notice
to be given within 15 days after the indemnified party has received written
notice of such claim or lawsuit; and (ii) full cooperation of the indemnified
party with the indemnifying party in any regard in the investigation and defense
of any threatened claim or lawsuit alleged to be covered by this indemnity.
Any indemnity shall be void as to any claim or lawsuit for which
settlement or any offer of settlement is made without the prior written consent
of the indemnifying party, such consent shall not be unreasonably withheld.
19. Patent Litigation
Patent infringement defense and enforcement shall be the responsibility
of LaserSight and shall proceed in accordance with the terms and conditions set
forth in the License Agreement. ▇▇▇▇▇▇ shall cooperate with LaserSight to
support LaserSight's patent position.
20. Assignment
Neither party may assign the Agreement without the prior written
consent of the other party; provided however, LaserSight may assign or transfer
its interest in this Agreement in connection with the sale or transfer of all or
substantially all of its assets.
21. Miscellaneous
This Agreement may only be amended by a written instrument executed by
each of the parties hereto.
This Agreement constitutes the entire agreement of the parties hereto
with respect to the subject matter hereof, and supersedes all prior agreements
and understandings of the parties, oral and written, with respect to the subject
matter hereof.
This Agreement shall be governed by and construed in accordance with
the laws of the State of Ohio.
The headings contained herein are for the sole purpose of convenience
of reference and shall not in any way limit or affect the meaning or
interpretation of any of the terms or provisions of this Agreement.
This Agreement shall inure to the benefit of, and shall be binding
upon, the parties hereto and their respective successors and permitted assigns.
The failure of any of the parties hereto to at any time enforce any of
the provisions of this Agreement shall not be deemed or construed to be a waiver
of any such provision, nor to in any way affect the validity of this Agreement
or any provision hereof or the right of any of the parties hereto to thereafter
enforce each and every provision of this Agreement. No waiver of any breach of
any of the provisions of this Agreement shall be effective unless set forth in a
written instrument executed by the party or parties against whom or which
enforcement of such waiver is sought, and no waiver of any such breach shall be
construed or deemed to be a waiver of any other or subsequent breach.
This Agreement may be executed in one or more counterparts, each of
which shall be deemed an original and all of which shall be deemed one and the
same instrument.
IN WITNESS WHEREOF, the parties have caused the Agreement to be
executed by duly authorized officers as of the date and year first above
written.
LASERSIGHT TECHNOLOGIES, INC.
By:/s/J. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
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J. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
Its: President
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▇▇▇▇▇▇ MEDICAL DEVELOPMENT LTD.
By: /s/▇▇▇▇ ▇. ▇▇▇▇▇▇
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▇▇▇▇ ▇. ▇▇▇▇▇▇, President