CONFIDENTIAL TREATMENT REQUESTED
MANUFACTURING AND MARKETING AGREEMENT
-------------------------------------
This Manufacturing and Marketing Agreement is dated May 14, 1999 (the
"Effective Date") between Becton Xxxxxxxxx Ophthalmic Systems, a division of
Becton, Xxxxxxxxx and Company, a New Jersey corporation ("BD") and LASERSIGHT
TECHNOLOGIES, INC., a Delaware corporation ("LASERSIGHT").
RECITALS
A. BD and LASERSIGHT desire to work together to enhance the
development and sale of microkeratome products and refractive surgery
accessories which are to be branded and sold utilizing the names of both BD and
LASERSIGHT.
B. BD is engaged in the business of and possesses the
expertise to perform the manufacturing, processing and packaging of ophthalmic
and other specialty surgical products including without limitation,
microkeratome blades.
C. BD and LASERSIGHT desire to enter into this Agreement
providing for BD to manufacture, on behalf of LASERSIGHT, those products
described on Exhibit A (the "Products") pursuant to the specifications described
on Exhibit B (the "Specifications") and certain other refractive surgery
accessories to be identified by BD and LASERSIGHT.
ARTICLE I
OBLIGATIONS OF PARTIES
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1.1 Nature of LASERSIGHT's Obligations. LASERSIGHT agrees during the
term of this Agreement to purchase from BD at least that number of the Products
set forth on Exhibit C (the "Purchase Minimum"), all pursuant to the terms of
this Agreement.
1.2 Nature of BD's Obligations. BD agrees that during the term of this
Agreement BD will:
1.2.1 Manufacture the Products in accordance with the
Specifications;
1.2.2 Manufacture and supply the Purchase Minimum in
accordance with purchase orders submitted by
LASERSIGHT;
1.2.3 Maintain quality systems in compliance with ISO
9002, CE and FDA/GMP requirements, as applicable;
1.2.4 Participate with LASERSIGHT quality assurance
employees in periodic quality and regulatory reviews
to determine if enhancements to the Specifications
are necessary, and if so to adopt such enhanced
specifications in BD's manufacturing process; as are
jointly agreed to by the parties in writing.
** CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT. THE
REDACTED MATERIAL HAS BEEN INDICATED WITH A DOUBLE ASTERISK AND FILED
SEPARATELY WITH THE COMMISSION.
1.3 BD Product Warranty. BD warrants that Products manufactured
pursuant to this Agreement shall meet the Specifications and be free from
defects in material and workmanship. The foregoing warranty shall not extend to
any Products which have been subject to accident or abuse or which are not used,
operated or maintained in the manner prescribed in the Products' instructions or
with respect to which unauthorized repair or alteration has taken place. Subject
to the foregoing and during the term of this warranty, BD shall replace
defective Products or parts thereof without charge within 30 days following
receipt of such defective Products by BD. BD shall bear all shipping costs for
the return of defective Products to BD and of shipping replacement Products to
LASERSIGHT or LASERSIGHT's customers, as applicable. BD shall have the right to
designate the carrier for the return of defective Products. BD makes no other
warranties either express or implied concerning the Products.
1.4 Other Manufacturing Activities. During the term of this Agreement,
without LASERSIGHT'S prior written consent, which shall not be unreasonably
withheld, BD agrees not to manufacture any other products or items which are the
same as or substantially similar to the Products.
1.5 CE Xxxx of BD. During the term of this Agreement, to the extent
permitted by applicable laws and regulations, BD will allow LASERSIGHT to
utilize BD's CE Xxxx in connection with the sale of the Products. BD and
LASERSIGHT will take all actions reasonably necessary to allow the Products to
be sold under BD's CE Xxxx.
1.6 Joint Activities of the Parties. The parties agree to undertake the
following activities:
1.6.1 Develop the branding under which the Products will be
sold, such branding to incorporate the names of BD
and LASERSIGHT. The parties will execute such
licensing agreements as may be reasonably necessary
to authorize such joint branding.
1.6.2 Develop and market a "kit" of instruments and supplies
(the "LASIK Kit") to be utilized in connection with
the performance of laser in situ keratomileusis
("LASIK") which will include the Products, other
supplies and products manufactured by BD and
supplies and products from other manufactures
mutually agreed to by the parties. The parties
acknowledge that BD has certain existing customer
agreements that are in effect as of the date of this
Agreement and which may not allow BD to comply with
the terms of this Section 1.6.2, therefore these
existing customer agreements will not be deemed a
violation of the terms of this Section 1.6.2
provided that at the time such agreements are renewed
such agreements will be made to comply with
the terms of this Section 1.6.2.
1.6.3 LASERSIGHT and BD will work together to market and
sell Products and LASIK Kits to entities that operate
refractive clinics/centers.
1.6.4 Initially all Products will be sold through
LASERSIGHT'S distribution channels. LASERSIGHT and BD
will work together to determine the most effective
method for distributing the Products. If LASERSIGHT
desires to market and sell Products directly or
through BD's distribution channels, BD and LASERSIGHT
will enter into a mutually acceptable agreement
addressing pricing, commission and such other terms
deemed necessary by either party.
1.6.5 Within 90 days after the date of this Agreement, and
then periodically thereafter, BD and LASERSIGHT will
meet to discuss joint marketing and sales efforts for
the Products and other products manufactured by
LASERSIGHT both domestically and internationally. In
addition, BD agrees to use commercially reasonable
efforts to assist LASERSIGHT in marketing the
Products by making available data that may be used to
demonstrate product superiority.
1.6.6 If during the term of this Agreement BD develops new
technology or enhances existing technology in the
refractive surgery field, then such new technology or
enhancement will be marketed by the parties in
accordance with the terms of this Agreement.
1.7 Term of Agreement. The term of this Agreement shall be five (5)
years from the Effective Date, unless otherwise sooner terminated as provided
herein. This Agreement may be renewed thereafter upon mutual written agreement
of the parties.
ARTICLE II
PRICING, ORDERING, DELIVERY, PAYMENT
------------------------------------
2.1 Pricing. The price per Product that will be utilized in
LASERSIGHT's UniShaper(TM) microkeratome is $**, the price per Product for
all other microkeratome blades is $**. These prices are based on LASERSIGHT
purchasing the Purchase Minimum. If LASERSIGHT purchases more than 200,000
Products in any twelve month period then BD and LASERSIGHT will negotiate in
good faith to reduce the per Product price for the following 12 months provided
that the prior 12 months' purchases become the new purchase minimum going
forward.
2.2 Shipment and Delivery. All Products delivered by BD under this
Agreement shall be shipped F.O.B. Waltham, Massachusetts to LASERSIGHT's
facility in Winter Park Florida. If LASERSIGHT designates any other location for
the delivery of Products, LASERSIGHT shall bear all shipping costs and
LASERSIGHT shall designate the carrier.
2.3 Payment. Payment shall be net 30 days upon shipment. All
payments shall be made in United States Dollars.
ARTICLE III
BD's REPRESENTATIONS AND WARRANTIES
-----------------------------------
3.1 Authority. BD has full power and authority to enter into
this Agreement and to perform its obligations hereunder. None of the
obligations to be performed by BD for other persons will limit in any way BD's
performance of its obligations hereunder.
3.2 Enforceable Obligation. This Agreement has been duly authorized
and executed by BD and constitutes a valid and enforceable obligation of BD.
3.3 Good Standing. BD has been duly incorporated, and is in good
standing, under laws of New Jersey.
ARTICLE IV
LASERSIGHT'S REPRESENTATIONS AND WARRANTIES
-------------------------------------------
4.1 Authority. LASERSIGHT has full power and authority to enter
into this Agreement and to perform its obligations hereunder. None of the
obligations to be performed by LASERSIGHT for other persons will limit
in any way LASERSIGHT's performance of its obligations hereunder.
4.2 Enforceable Obligation. This Agreement has been duly authorized
and executed by LASERSIGHT and constitutes a valid and enforceable obligation of
LASERSIGHT.
4.3 Good Standing. LASERSIGHT has been duly incorporated, and is in
good standing, under laws of Delaware.
ARTICLE V
INDEMNITIES AND WARRANTIES
--------------------------
5.1 BD's Indemnity. BD agrees to indemnify, defend and hold
LASERSIGHT, its officers, directors, shareholders and employees 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 subsidiaries, divisions, affiliates, officers,
directors, shareholders or employees arising out of or with respect to (i) BD's
breach of the terms of this Agreement, or (ii) defects in the manufacture of the
Products.
5.2 LASERSIGHT'S Indemnity. LASERSIGHT agrees to indemnify, defend
and hold BD, its officers, directors, shareholders and employees harmless
against any and all liability, loss, damages, cost or expenses (including
reasonable attorneys' fees and legal disbursements) that BD may incur,
suffer or be required to pay as a consequence of a third party claim or suit
brought against BD or its subsidiaries, divisions, affiliates, officers,
directors, shareholders or employees arising out of or with respect to (i)
LASERSIGHT's breach of the terms of this Agreement, defects in products
manufactured by or for LaserSight(other than the Products), or (ii) any alleged
violation by Products of patents, trademarks or tradenames of a third party,
or arising from the promotion, labeling, distribution or sale of Products.
5.3 Indemnification Process. The obligations of the indemnifying
party under this Article V 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 is
made without the prior written consent of the indemnifying party; such consent
shall not be unreasonably withheld.
ARTICLE VI
COVENANTS
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6.1 Obligations Surviving Termination. Termination of this
Agreement for any reason shall not release either party from any payment or
liability which at the time of termination had already accrued to the other
party or which thereafter may accrue with respect to any error or omission prior
thereto.
6.2 Confidentiality. 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 available to
the public through no fault of the disclosing party;
(ii) information which is required to be
disclosed or divulged by law; and
(iii) information which the parties hereto
mutually agree in writing to disclose.
Upon the expiration or termination of this Agreement, each party shall promptly
return to the other all documents and materials proprietary to it.
6.3 Product Recalls. If (i) any governmental authority issues
a request, directive or order that Products be recalled, (ii) a court of
competent jurisdiction orders such a recall, or (iii) LASERSIGHT and
BD, after consultation, reasonably determine that Products should be recalled
or otherwise returned, the parties agree to take all appropriate corrective
action. If such recall results from any cause or event solely attributable to
BD's negligence or breach of the terms of this Agreement, BD 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 the
Products, (ii) destruction or return of the recalled or returned Products,
and (iii) LASERSIGHT's costs for the Products recalled, but not any direct and
normal recurring expenses of LASERSIGHT or BD.
ARTICLE VII
TERMINATION
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7.1 Termination Due to Breach. Either party may terminate
this Agreement by providing at least 30 days notice to the other party if such
other party is in material breach of this Agreement unless such other party,
within such 30 day period, remedies such breach to the reasonable satisfaction
of the non-defaulting party.
7.2 Termination Due to Insolvency. If either party goes
into liquidation, has a receiver appointed for all or any portion of its
property or estate, is adjudged bankrupt or insolvent, files a voluntary
petition or insolvency, has a petition in bankruptcy filed against it or makes
an assignment for the benefit of its creditors, and whether any such event is
the outcome of the voluntary act of such party or otherwise, the other party,
at its option, may terminate this Agreement immediately by providing
notice of such termination.
ARTICLE VIII
MISCELLANEOUS
-------------
8.1 Force Majeure. Neither party shall be liable to the other for
any failure to perform any obligation hereunder by reasons of events outside
the reasonable control of such party, including without limitation, acts of
God, regulations or laws of any government, war, civil commotion,
destruction or production facilities or materials by fire, earthquake or
storm, labor disturbances, epidemic and general failure of public
utilities or common carriers. 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. Either party may terminate this
Agreement upon 10 days advance written notice given to the other party, if
the other party has invoked this Section to excuse its performance for a
continuous period of at least 30 days. Suspension of a party's performance for
such cause as described herein shall not affect the running of the term of this
Agreement.
8.2 Governing Law. This Agreement shall be governed by and construed
in accordance with the laws of the state of Massachusetts, without regard
to conflict of laws principals.
8.3 No Partnership. The relationship established hereby is in
all respects a commercial relationship. Nothing herein shall be construed
as imposing any fiduciary obligations on either party, or as establishing
any partnership or joint venture between the parties, or as rendering one
party an agent of the other.
8.4 Assignment. This Agreement shall not be assignable by either
party without the prior written consent of the other, except that either
party may assign this Agreement in whole or in part, to any affiliate and
that either party may assign this Agreement, in whole or part, to the successor
(including the surviving company in any acquisition, consolidation,
reorganization or merger) or assignee of all or substantially all of its
business.
8.5 Successors. This Agreement shall be binding on BD and
LASERSIGHT and their respective successors.
8.6 Headings. The section headings contained in this Agreement
have been inserted for identification and reference purposes and shall not
determine the construction or interpretation of this Agreement.
8.7 Notices. Any notice or other communication required or
permitted hereunder shall be deemed given on the date delivered if delivered
personally or by facsimile with proper evidence of transmission, or five
(5) days after deposit in the United States mail, by registered or certified
mail, postage prepaid, addressed:
if to BD: Becton Xxxxxxxxx Ophthalmic Systems
000 Xxxxxxx Xxxx Xxxx
Xxxxxxxx 0, Xxxxx 000
Xxxxxxx, Xxxxxxxxxxxxx 00000-0000
Attention:__________________
Facsimile: (000) 000-0000
if to LASERSIGHT: LaserSight Technologies, Inc.
0000 Xxxxxxxxxx Xxxxxxxxx, Xxxxx 000
Xxxxxx Xxxx, Xxxxxxx 00000
Attention: President
Facsimile: (000) 000-0000
or at such other address as any party may designate by 10 days advance written
notice to the other party.
8.8 Entire Agreement. This Agreement constitutes the entire
agreement between the parties with reference to the subject matter hereof,
supersedes any prior agreements with respect to such subject matter and may
not be changed or modified orally, but only by a subsequent instrument in
writing, signed by the parties, which states that it is an amendment to this
Agreement. The invalidity or unenforceability of any term or provision of this
Agreement shall not affect the validity or enforceability of any other term or
provision.
8.9 Waiver. 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.
8.10 Public Announcements. This Agreement and the terms and
transactions contemplated hereby shall be kept confidential until the parties
hereto mutually agree upon the language and timing of a press release or until
such time as one such party determines, based on the advice of outside
securities counsel, that a public announcement is required by law, in which case
the parties hereto shall use reasonable best efforts to agree on any public
announcements or public statements with respect thereto. If the parties are
unable to so agree, a party will not be deemed in violation of this section for
subsequent public announcements or public statements.
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed in multiple counterparts, each of which shall be deemed an original
instrument but all of which together shall constitute one and the same document,
by their duly authorized representatives as of the Effective Date.
BECTON XXXXXXXXX OPHTHALMIC
SYSTEMS, a division of:
BECTON, XXXXXXXXX AND COMPANY
By: /s/Xxxxxx X. Xxxxxxxxx
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Name: Xxxxxx X. Xxxxxxxxx
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Title Vice President/General Manager
--------------------------------------------------
LASERSIGHT TECHNOLOGIES, INC.
By: /s/Xxxxxxx X. Xxxxxx
--------------------------------------------------
Name: Xxxxxxx X. Xxxxxx
--------------------------------------------------
Title: Chief Executive Officer/President
--------------------------------------------------
Manufacturing and Marketing Agreement
Becton Xxxxxxxxx - LaserSight Technologies
ADDENDUM TO MANUFACTURING AND MARKETING AGREEMENT
-------------------------------------------------
This addendum to the Manufacturing and Marketing Agreement, dated May
14, 1999, between Becton Xxxxxxxxx Ophthalmic Systems ("BD") and LaserSight
Technologies, Inc. ("LASERSIGHT") is intended accommodate LaserSight's Quality
Systems Requirements under 21 CFR, Part 820 regulations and ISO9002 / EN46002
standards. This addendum incorporates all defined terms used in The Agreement.
It is agreed by the parties that the following requirements be adhered
to during the term of the Agreement:
1.1 Change Control. All changes in the Specifications, shall be
documented through BD's change control process, as well as LaserSight's change
control process, where approval authorization by LASERSIGHT's management is
required by at least the following departments: Engineering, Quality
Assurance, Regulatory Affairs. All changes must be approved by LaserSight and
BD's management prior to change implementation.
1.2 Facilities Inspection. BD agrees that during the term of this
Agreement:
1.2.1 LASERSIGHT shall have the right during normal business
hours, and providing BD with at least twenty-four (24)
hours notice, to enter BD's facilities and inspect the
quality records and quality systems of any of the Products
pursuant to 21 CFR 820 regulations and ISO 9001 /
EN 46001 standards. Should LASERSIGHT reasonably find
objectionable conditions as related to these standards,
LASERSIGHT shall notify BD in writing and BD shall take
action to correct such objectionable conditions
within ten (10) working days of such notice. Failure to
take adequate actions necessary to eliminate the
objectionable conditions within ten (10) working days shall
give LASERSIGHT the right to terminate this Agreement
without further obligation to BD, except as provided, after
thirty (30) days of LaserSight's original notice to BD.
1.2.2 In the event that BD facilities are inspected by employees
of the US Food and Drug Administration as relates to the
Products (See Exhibit A), BD agrees to provide LASERSIGHT
with copies of all FDA Form 483, or other regulatory
notifications, received by BD resulting from such
inspections.
1.3 Certificate of Compliance. BD will prepare a certificate of
compliance (CoC) for each lot / batch of Product manufactured for and shipped to
LASERSIGHT. A copy of said certificate shall be maintained by BD for the life of
the Product manufactured by BD. The information contained within the CoC shall
include at least the following information: (1) Production Lot / Batch No., (2)
declaration that the Product was manufactured in accordance with LASERSIGHT
specifications (see "Exhibits B(1) and B(2)"), and (3) declaration that no
changes in Product components have occurred without prior authorization by
LASERSIGHT (See Amendment Section 1.1, "Change Control"), and (4) each CoC shall
be signed and dated by BD Quality Assurance personnel. Said original of the CoC
shall be supplied with each lot / batch of product shipped to LASERSIGHT.
IN WITNESS WHEREOF, the parties have caused this Amendment to the
Agreement to be executed in multiple counterparts, each of which shall be deemed
an original instrument but all of which together shall constitute one and the
same document, by the duly authorized representatives as the Effective Date.
BECTON XXXXXXXXX OPHTHALMIC
SYSTEMS, a division of:
BECTON XXXXXXXXX AND COMPANY
By: /s/Xxxx X. Xxxxxxxx
----------------------------------------
Name: Xxxx X. Xxxxxxxx
----------------------------------------
Title: Senior Vice President
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LASERSIGHT TECHNOLOGIES, INC.
By: /s/Xxxxxxx X. Xxxxxx
----------------------------------------
Name: Xxxx Xxxxxx
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Title: Chief Executive Officer
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EXHIBIT C
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Purchase Minimum
The following will be considered the "Purchase Minimum:"
Except as provided elsewhere in this Agreement, during each year of
this Agreement LASERSIGHT agrees to purchase at least an average of
16,667 of the Products per month or a total of at least 200,000 blades
for each such year.
The parties acknowledge that (i) the actual purchase and shipment of
Products will be made in accordance with the terms of purchase orders
delivered to BD from LASERSIGHT quarterly, and (ii) the volume of
Products purchased may vary from time to time but that over the five
year term of this Agreement LASERSIGHT commits to purchase at least
1,000,000 units of the Products.
