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THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
EXHIBIT 10.1
SUPPLY AGREEMENT
THIS AGREEMENT is made effective as of Effective Date between Anika
Therapeutics, Inc., a Massachusetts corporation (the "Seller"), and Bausch &
Lomb Surgical, Inc., a Delaware corporation (the "Buyer" and together with the
Seller, the "Parties"). Unless the context otherwise requires, all references to
Buyer and Seller shall include their respective Affiliates (as defined below).
BACKGROUND
A. Seller is engaged in the business of manufacturing Products, as defined
in Section 1.16, and Buyer would like to purchase Products from Seller.
B. Seller and Buyer were parties to a Supply Agreement dated August 1,
1994, as amended, ("1994 Supply Agreement") and a Distribution Agreement
(defined in Section 1.8) each of which are intended to be superceded by this
Agreement; and
C. The parties hereby agree to the early termination of the 1994 Supply
Agreement and acknowledge that, subject to the terms of this Agreement, Seller
shall (i) become the exclusive supplier of Products to Buyer in the Territory,
(ii) subject to certain restrictions, be permitted to sell products containing
hyaluronic acid within the Ophthalmic Field, and (iii) be relieved of all of the
noncompetition covenants in the 1994 Supply Agreement and only be subject to the
noncompetition covenants in this Agreement.
NOW, THEREFORE, in consideration of the mutual promises, covenants and
agreements hereinafter set forth, the parties hereto agree as follows:
1. DEFINITIONS
The following terms shall, except where the context otherwise requires,
have the meanings set forth below:
1.1 "Affiliate" shall mean, with respect to any Person, any other Person
controlling, controlled by or under common control with, such Person. The term
"control" of a Person shall mean beneficial ownership of securities or other
interests in such Person constituting fifty percent (50%)(or, if lower, any
applicable maximum foreign ownership percentage allowed under the laws of any
jurisdiction) or more of the Voting Power in such Person. "Beneficial Ownership"
shall be determined in compliance with Rule 13d-3 of the Securities Exchange Act
of 1934.
1.2 "Amvisc" shall refer to the medical device meeting the specifications
described on Exhibit A attached hereto or as otherwise changed in accordance
with Section 4.5.
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THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
1.3 "Amvisc Plus" shall refer to the medical device meeting the
specifications described on Exhibit A attached hereto or as otherwise changed in
accordance with Section 4.5.
1.4 "Amvisc Products" shall mean Amvisc and Amvisc Plus in the form of a
clear viscous organic material used in the human eye as an aid in the surgical
implantation of intraocular lenses as a substitute for human vitreous or in
other ophthalmic applications, including, except as provided in Section 4.6, any
subsequent combinations, improvements or modifications of Amvisc or Amvisc Plus
for ophthalmic applications. Amvisc Products shall include Amvisc and Amvisc
Plus sold by Buyer under different brand names in the Territory.
1.5 "Anika Manufactured Ophthalmic HA Product" shall mean those ophthalmic
products containing HA (defined below) where the HA is manufactured by Seller
and where such products are first commercially sold by Seller after the
Effective Date, but this definition shall exclude the Amvisc Products sold to
Buyer.
1.6 "Current Product Specifications" shall mean the product specifications
for Amvisc and Amvisc Plus attached as Exhibit "A" to this Agreement or as
otherwise changed in accordance with Section 4.5. Seller shall have *** days
from the Effective Date to begin manufacturing Amvisc Products in accordance
with the Current Product Specifications contained in Exhibit A; prior to that
time, Seller shall continue to manufacture Amvisc Products in accordance with
the Current Product Specifications under the 1994 Supply Agreement.
1.7 "Current Manufacturing Processes" shall mean the manufacturing
processes utilized by Seller on the Effective Date for Amvisc and Amvisc Plus
(including but not limited to, quality control/quality assurance procedures and
packaging) or as otherwise changed in accordance with Section 4.5.
1.8 "Distribution Agreement" shall mean the Distribution Agreement dated
as of November 17, 1981, as amended, between Medchem Products, Inc. ("Medchem")
and Iolab Corporation. Seller's obligations under the Distribution Agreement
were assigned to Seller by Medchem and Iolab's obligations were assumed by Buyer
in Buyer's acquisition of Chiron Vision Corporation in December 1997.
1.9 "Effective Date" shall mean the date the last party executed this
Agreement.
1.10 "HA" shall mean hyaluronic acid.
1.11 "Health Care Market" shall mean the worldwide human health care
industry, including without limitation, the medical, surgical, dental, nursing
professions and practices, as well as research and teaching relating to these
professions and practices. Any products used in and for the diagnosis,
monitoring, treatment or prevention of disease, sickness or other physical
condition shall be considered products intended for use
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in the Health Care Market, provided, however, that the Health Care Market shall
exclude, for all purposes of this Agreement, products used for "cosmetic"
applications, as such term is defined under applicable laws and regulations of
the U.S Food and Drug Administration.
1.12 ***
1.13 "Nine Month Anniversary Date" shall mean the date that falls nine (9)
months after the Effective Date of this Agreement.
1.14 "Non-Anika Manufactured Ophthalmic HA Product" shall mean those
ophthalmic products containing HA where the HA is manufactured by a party other
than Seller and where the products are first commercially sold anywhere in the
Territory by Seller after the Effective Date.
1.15 "Ophthalmic Field" shall mean that part of the Health Care Market
dealing with the structure, functions, diseases and conditions of the eye.
1.16 "Parent" shall mean a business enterprise that owns directly or
indirectly at least 50% of the capital stock of the Buyer or Seller, as the case
may be.
1.17 "Person" means an individual, partnership, limited liability company,
business association, trust, corporation or other entity, whether de jure or
defacto.
1.18 "Products" shall mean Amvisc, Amvisc Plus, and all other ophthalmic
HA containing products manufactured by Seller for Buyer and included as
"Products" in accordance with Section 4.5.
1.19 "Territory" shall mean all countries and territories of the world.
1.20 "Testing Methods" shall mean the laboratory methods used to determine
whether Products meet the Current Product Specifications.
1.21 "Units" shall mean the single use packages of Amvisc and Amvisc Plus
that are marketed on the Effective Date or other approved sizes that may be
introduced from time to time as mutually agreed upon.
1.22 "Voting Power" means (i) if the Person is a corporation, the right to
vote in the election of directors of the corporation in the ordinary course,
(ii) if the Person is a trust, the right to appoint trustees of the trust, (iii)
if the Person is a limited liability
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WITH ASTERISKS.
company, the right to name managing members of the limited liability company and
(iv) if the Person is any other type of entity, any concepts similar to the
foregoing relating to the power to control the business and affairs of such
Person.
2. MANUFACTURE AND SALE OF PRODUCTS
2.1 Supply. The Seller agrees to manufacture and supply all of Buyer's
requirements of Products for sale to the Buyer in the Territory for the
Ophthalmic Field on the terms and conditions hereinafter set forth.
2.2 Purchase Obligations. Commencing January 1, 2001, and except as
otherwise provided in this Agreement, Buyer shall be obligated to purchase from
Seller all of Buyer's requirements for Amvisc Products in the Territory for the
Ophthalmic Field, provided, however, Buyer may purchase viscoelastic products
containing HA from other suppliers for any country where Seller's product has
not already received regulatory approval, provided that, Buyer shall have
notified Seller in writing of its intent to sell in each such country and shall
have advised Seller of any special regulatory requirements which became known to
Buyer in the regulatory process for Amvisc Products. Buyer shall use reasonable
commercial efforts to obtain regulatory approvals for the Amvisc Products in
such countries. Buyer shall use reasonable commercial efforts to avoid entering
into contractual supply arrangements that exceed the anticipated time for
regulatory approval in those countries with these other suppliers; however,
Buyer shall be permitted to purchase from these suppliers for the duration of
any such contractual relationship, regardless of when regulatory approval for
Sellers Product is received. Notwithstanding the above, through December 31,
2000, Buyer may continue to purchase Products from all of Buyer's current
suppliers as of the Effective Date and may, after January 1, 2001, continue to
sell existing inventory from those suppliers until such inventory is exhausted.
2.3 Sale of HA Products by Seller. Seller shall have the nonexclusive
right to manufacture and sell products containing HA for use in any market
including within the Health Care Market; provided, however, that Seller shall
not, either directly or indirectly manufacture or sell or take any steps
designed to lead to the active manufacturing or sale, for use within the
Ophthalmic Field, of products containing HA that fall within the following
specifications: ***
2.4 Royalty Payments. Seller shall pay Buyer a royalty of *** percent
(***%) of *** to customers other than Buyer for use in the Ophthalmic Field for
the duration of the term of this Agreement (regardless of termination, other
than by breach of Buyer, in which case no such royalty shall be payable), or for
the life of any Buyer patent relating to the Amvisc Products, whichever is
longer. In the event an Anika Manufactured Ophthalmic HA Product is commercially
sold on or before December 31, 2001, the royalty payable to Buyer shall be
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WITH ASTERISKS.
*** percent (***%) through and including *** and shall decrease to *** percent
(***%) thereafter. Within *** days after the end of each calendar quarter,
Seller shall pay to Buyer the royalty payment due for such quarter in U.S.
dollars ("Royalty Payment"). For any sales made in currencies other than the
U.S. dollar, such Royalty Payment shall be converted from the currency in which
the sale was made into U.S. dollars at the exchange rate published in the Wall
Street Journal for the last business day of the calendar quarter during which
such sale occurs. Together with the delivery of each such Royalty Payment,
Seller shall deliver to Buyer a written accounting showing its computation of
royalties due under this Agreement for such quarter. Such accounting shall set
forth *** and, the exchange rate applied, if any, and the total royalties due
for the quarter in question. Buyer shall have the right, at its expense, on a
periodic basis, but no more frequently than once in any twelve (12) month
period, to appoint an independent certified public accountant to audit the sales
records of Seller for the purpose of confirming the accuracy of Seller's Royalty
Payment computation. In the event Buyer's audit is not consistent with the
accounting provided by Seller, Seller shall have thirty (30) days to dispute
Buyer's figures. If Seller does not dispute such figures, Seller shall
immediately remit any underpayment to Buyer or Buyer shall return any
overpayment to Seller. If Seller disputes Buyer's figures and the parties are
unable to resolve any discrepancies, the parties shall submit the dispute to the
process in Section 10.13.
3. ORDERS AND DELIVERY
3.1 Forecasts. Forecasts provided hereunder shall be updated if there is a
material change in any information on which the forecast is based.
3.1.1 Annual Forecasts. The Buyer shall furnish the Seller with a
written general order forecast for each Product on or before each *** for
the following calendar year, such forecast to be broken down by months
("Annual Forecast"). The first Annual Forecast shall be provided within
ten (10) days after the Effective Date.
3.1.2 Quarterly Forecasts. At least *** days in advance of each
quarter, Buyer shall advise Seller in writing of (a) its binding forecast
for such quarter (the "Quarterly Forecast") setting forth the expected
order date(s), quantity on each order, the "Put-Up" Mix (as defined in
Section 3.2)of Units and expected shipping date(s) and (b) its nonbinding
forecast for the *** months thereafter ("the Rolling Annual Forecast").
The Seller shall have *** days after receipt of each such Quarterly
Forecast to object in writing that it is unable to manufacture the
quantities specified and shall provide demonstrable evidence that the
production cycle cannot accommodate the quantities specified. Failure to
object shall be deemed to constitute acceptance of the Quarterly Forecast.
If the Seller so objects to a Quarterly Forecast, the parties shall
negotiate in good faith to resolve their differences.
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THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
3.1.3. Purchases Against Forecasts. The Buyer shall, subject to the
provisions of Section 10.10, be required to purchase from the Seller
during each quarterly period not less than *** percent (***%) of the total
number of Units of each Product (not broken down by size) contained in the
Quarterly Forecast. If, subject to the provisions of Section 10.10, within
*** days prior to the end of any quarterly period, Seller shall not have
received orders from Buyer for at least *** percent (***%) of the total
number of Units of each Product (but not broken down by size) contained in
the applicable Quarterly Forecast, Seller shall notify Buyer of such fact.
If, within *** days prior to the end of such quarterly period, Seller
shall not have received orders from Buyer for delivery during such
quarterly period of at least *** percent (***%) of the total number of
Units of each Product (but not broken down by size) contained in the
applicable Quarterly Forecast and Seller and Buyer shall not have reached
a mutually acceptable agreement with respect to such shortfall, Seller may
ship such number of Units as shall equal the difference between the number
of Units of each Product ordered by Buyer for delivery during such
quarterly period as of the date *** days prior to the end of the quarterly
period and the number of Units of each Product equaling *** percent (***%)
of Buyer's Quarterly Forecast. The Product sizes for any Product so
shipped shall be in the same proportion as specified in the Quarterly
Forecast. In any such event, Buyer shall be obligated to pay for such
Units shipped by Seller but not ordered by Buyer on the same terms and
conditions as if such Units had been ordered by Buyer on the date *** days
prior to the end of the quarterly period. Upon *** working days notice
prior to shipment, Seller may ship up to *** percent (***%) in additional
Units against any order. Buyer shall be invoiced at the actual number of
Units shipped.
3.2 Orders. The Buyer shall issue firm, noncancelable purchase orders for
Products to the Seller from time to time, which orders shall be consistent, to
the extent practicable and subject to Section 3.1.3, with the applicable
Quarterly Forecast. The Seller agrees to fill such orders for Products submitted
by the Buyer up to the amount stated in the applicable Quarterly Forecast and to
use its *** efforts to fill all orders for Products in excess of the quantity
stated in the Quarterly Forecast. Seller shall not be required to sell in excess
of *** percent (***%) of the amounts forecasted in the most recent Quarterly
Forecast set forth in the Rolling Forecast. Any amounts exceeding *** percent
(***%) of the most recent Quarterly Forecast shall require notice to and
confirmation of Seller. Buyer shall place orders such that the scheduled
delivery date indicated in a Purchase Order (the Purchase Order Delivery Date)
is at least *** days from the date of the placement of the order, provided, that
Buyer may change the Put-Up Mix of the Units with respect to such order (but not
the total Unit quantity) at least *** days prior to the Purchase Order Delivery
Date by providing a written change order to Seller within such period (a "Change
Order"). "Put Up Mix" shall mean the Unit packaging sizes (***) within each
category of Amvisc Products. If Buyer provides Seller with a Change Order less
than *** days prior to the Purchase Order Delivery Date, Seller and Buyer shall
have first agreed upon the additional amount, if any, to be paid by Buyer to
Seller to
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offset any increased incremental costs (including materials, labor and variable
overhead) incurred by Seller in order to comply with the Change Order.
3.3 Inventory Maintenance. Commencing January 1, 2001, Seller shall use
commercially reasonable efforts to maintain, based on the number of Units
estimated in the updated Quarterly Forecasts, work in progress ("WIP") inventory
of bulk HA in an amount sufficient ***.
3.4 Delivery and Inspection. Seller shall be responsible for delivering
the Products to a carrier specified by Buyer, F.O.B. Seller's plant. Buyer shall
have the right to inspect all Products delivered by Seller and to reject (by
batch, lot or Unit) any Products which fail to conform to the purchase order
thereof or to be in the condition warranted under this Agreement, which failure
to conform is determined not to be due to damage to the Products caused
subsequent to delivery of the Products to a carrier at the Seller's plant. The
Buyer shall notify the Seller and confirm in writing if any nonconforming
Products are rejected and shall hold the rejected Products until receipt of the
Seller's written instructions for the disposal or return to the Seller of the
rejected Products which written instruction shall be given promptly by the
Seller. The Buyer shall be entitled to receive a refund of the purchase price or
any portion thereof actually paid to the Seller for the rejected Products (plus
applicable freight). The costs of any agreed upon reworking by the Buyer of
nonconforming Products shall be borne by the Seller. Any Products not rejected
within *** days after the Seller's delivery to the Buyer shall be deemed to be
accepted by the Buyer. At Seller's request, Buyer shall provide a sample of the
Product alleged to be defective together with a copy of the records pertaining
to Buyer's testing of the Product, which records shall have been made at the
direction of Buyer's quality control group using the Testing Methods. If, after
its own analysis of the sample, which analysis shall be completed within ***
days of receipt of the sample, Seller confirms such non-conformity, Seller shall
replace such shipment at its expense. If, after its own analysis, Seller does
not confirm such non-conformity, the Parties shall agree to retest the shipment
or otherwise attempt in good faith to agree upon a settlement of the issue. In
the event that the Parties cannot resolve the issue, the Parties shall submit
the disputed Product to an independent testing laboratory, to be mutually agreed
upon by the Parties, for testing using the Testing Methods. The findings of such
laboratory shall be binding on the Parties, absent manifest error. Expenses of
such laboratory testing shall be borne by the Party adversely affected by such
findings. In the event that any such shipment or batch thereof is ultimately
agreed or found not to meet the Current Product Specifications, Seller shall
replace such shipment at *** expense, including charges incurred by Buyer for
shipping and/or storage, if applicable. If instructed by Seller, Buyer shall
return any such rejected shipment to Seller at *** expense. In the event that
any such shipment or batch thereof is ultimately agreed or found to meet the
Current Product Specifications, Buyer shall retain such shipment or
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batch, and all the terms and conditions of this Agreement shall continue to
apply to such Product.
3.5 Title and Risk of Loss. Title and ownership to the Products shall pass
to the Buyer upon delivery of the Products to a carrier F.O.B. Seller's
manufacturing plant. The Seller shall cooperate with the reasonable request of
the Buyer in processing all claims for loss or damage to the Products. The Buyer
shall be responsible for and shall pay for any and all demurrage, storage and
other charges accruing after the arrival of any shipment at the Buyer designated
destination. Except as provided in section 3.4, if the Buyer shall fail or
refuse for any reason to accept delivery of any of the Products ordered by it,
the Buyer shall pay Seller the amount of all expenses incurred by Seller in
returning the Products to the original shipping point or diverting them to
another destination as the case may be.
3.6 On Time Delivery.
3.6.1 ***
3.6.2 In the event *** consecutive quarters, then, immediately upon
written notice to Seller, Seller shall become a nonexclusive supplier of
Products for the remainder of the term of this Agreement and Buyer may
immediately begin to purchase Products from a second source of supply. The
provisions of this Section
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shall apply regardless of whether Buyer actually chooses to *** upon a
triggering event.
3.7 Second Source of Supply. In addition to the triggering event in
Section 3.6.2, in the event Seller fails to deliver *** percent (***%) of
ordered Products for *** business days beyond any Purchase Order Delivery Date,
Buyer shall, immediately upon written notice to Seller, have the option of
purchasing Products from a second source of supply and Seller shall
automatically become a nonexclusive supplier of Products to Buyer for the
remainder of the term of this Agreement. Buyer may, at any time after the
Effective Date, begin qualifying a second source of supply for producing the
Products. In order to assist Buyer in qualifying a second source of supply,
Seller shall, upon Buyer's written request, within *** days of receiving the
written agreement of Buyer's proposed second source of supply to confidentiality
provisions substantially similar to those contained in Section 7 of this
Agreement, deliver to Buyer copies of technical, manufacturing, and other
written information, including but not limited to process sheets, process
specifications, manuals, vendor lists, equipment information, and other writings
required in order for Buyer to qualify a second source to manufacture and
package Products according to the Current Product Specifications and Current
Manufacturing Processes. Notwithstanding the foregoing, Seller shall only be
required to deliver materials in its actual possession and shall not be required
to produce or create any additional materials. Seller shall also be required to
provide such assistance to Buyer or its designees as might be reasonably
necessary to instruct Buyer or its designees in the manufacturing technique and
procedures to manufacture Products for the validation of the first three (3)
lots of Products by the proposed second source supplier. Notwithstanding the
foregoing, Seller shall not be required to provide information listed in this
Section to Buyer unless a triggering event in either Section 3.6.2, this Section
3.7, or Section 4.5 is implicated.
3.8 Equivalent Product. In the event Seller fails to deliver ordered
Products to Buyer for *** consecutive business days beyond any Purchase Order
Delivery Date, Seller shall supply, at no cost to Buyer, equivalent commercially
available ophthalmic HA products acceptable to Buyer within *** business days of
Buyer's request until the outstanding purchase orders are fulfilled.
4. PRICE, PAYMENT, AND SPECIFICATION CHANGES
4.1 General. Commencing April 1, 2000, the price to the Buyer for each
Unit of an Amvisc Product throughout the term of this Agreement shall be
determined in accordance with Sections 4.2, 4.3 and 4.5 below.
4.2 Price.
4.2.1 Pricing Schedule. The purchase price for the current put-ups
of Amvisc and Amvisc Plus shall be based on total Unit volume per calendar
year
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and, subject to the provisions of Sections 4.3 and 4.5 below, shall be
subject to the following Pricing Schedule:
***
Prices for the first quarter in any calendar year shall be based
upon the Annual Forecast. Thereafter, prices for each quarter of each
calendar year shall be determined based on the cumulation of the Confirmed
Purchase Orders, the Quarterly Forecast, and the Rolling Annual Forecast
for the remaining months of the calendar year (together, "Volume
Forecast"). The forecasts and orders shall be made pursuant to Sections
3.1 and 3.2. At such time as ***, Seller shall issue a credit to Buyer
equal to the difference between the actual price per Unit paid for the
Products and the new per Unit purchase price, multiplied by the total
Units purchased to date. Except as set forth in Section 4.2.2 with respect
to guaranteed Unit volume levels, if, at the end of the calendar year, the
Unit volumes fall short of the Volume Forecast and would justify higher
pricing under the Pricing Schedule, Buyer shall issue a rebate to Seller
equal to the difference between the actual price per Unit paid for the
Products and the higher per Unit purchase price, multiplied by the total
Units purchased at the end of the calendar year. The rebate shall be
payable within *** days of the end of the calendar year. For purposes of
determining Unit prices for Units shipped during the period from the
Effective Date to December 31, 2000, the pricing set forth in *** shall
apply; however, such pricing shall be adjusted up or down based on the
total number of Units ordered for all of calendar year 2000.
4.2.2 Anika Manufactured Ophthalmic HA Products and Non-Anika
Ophthalmic Manufactured Ophthalmic HA Products. ***
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***
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Ophthalmic HA Product. The following example is intended for clarification
purposes:
Example:
Year "n" Scenario
***
Year "n Subsequent" Scenario
***
4.2.3. ***
4.3 Price Adjustments. The prices set forth in Section 4.2 shall remain in
effect for calendar year 2000. The prices shall thereafter be subject to
increase or
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decrease if the Producer Price Index for Finished Goods published by the U.S.
Bureau of Labor Statistics (the "Index") increases by more than *** percent
(***%) above the 1999 ("Base Year") level. Prices shall increase or decrease by
an amount equal to ***.
4.4 Invoice and Payment. The Seller shall issue an invoice accompanying
each shipment of Products to the Buyer, which invoice shall set forth the Unit
price in accordance with the provisions of this Section 4. The Buyer shall pay
such invoices in U.S. dollars in full within *** days after receipt of such
invoice.
4.5 Changes to Product Specifications; Bacterial Fermented HA Product.
4.5.1. pH Changes. On or before the Nine Month Anniversary Date,
Seller shall be able to demonstrate to Buyer's reasonable satisfaction,
including the production of accelerated stability data for three validated
batches each of Amvisc and Amvisc Plus, that Seller is capable of
manufacturing buffered Amvisc Products meeting the specifications set
forth in Exhibit A1. Seller shall provide validation and stability data to
Buyer for regulatory submission on or before the Nine Month Anniversary
Date. Thereafter, once Buyer notifies Seller it has received regulatory
approval for the Amvisc Products as specified in Exhibit A1, the
specifications in Exhibit A1 shall be considered the Current Product
Specifications, which may be changed in accordance with this Section 4.5.
In the event Seller is unable, as of the later of the Nine Month
Anniversary Date, or the date Buyer notifies Seller it has received
regulatory approval for the Amvisc Products as specified on Exhibit A1, to
manufacture Product for commercial sale that meets the specifications set
forth on Exhibit A1, Buyer shall have the option, on *** days notice to
Seller, to make this Agreement nonexclusive and, at the end of the *** day
notice period, immediately begin purchasing Products from a second source
of supply.
4.5.2 Product Specification/Manufacturing Process Changes. In the
event Buyer requests changes be made (a) to the Current Manufacturing
Processes to the extent such changes do not unreasonably impair Seller's
manufacturing process for other hyaluronic acid products, or (b) to the
Current Product Specifications, Buyer and Seller shall in good faith
discuss such requested changes and Seller shall, to the extent
technologically feasible, accommodate Buyer's requested changes, provided
that Buyer shall reimburse Seller for any one-time incremental costs
associated exclusively with such changes which are agreed upon in writing
by Seller and Buyer. In addition, the per Unit price for such Products
shall be revised to reflect all ongoing incremental variable material
and/or direct labor costs (and variable overhead costs) due exclusively to
such change and agreed upon in writing by Seller and Buyer. Buyer shall be
the owner of and take title to any machinery or equipment that were part
of incremental one-time costs referred to above which were funded solely
by Buyer. Buyer shall have
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
the right once during each calendar year (or more often in the event of a
dispute) to have independent auditors audit Seller's one-time incremental
and ongoing variable costs and direct labor costs. In the event of a
dispute regarding such costs, the dispute shall be submitted to the
dispute resolution process in Section 10.13. Seller shall not make any
changes to or deviate from the Current Manufacturing Processes or the
Current Product Specifications (as either may be revised from time to time
by mutual agreement of Seller and Buyer) without Buyer's prior written
consent. Notwithstanding anything contained in this Section 4.5, any costs
resulting from changes to the Current Product Specifications or Current
Manufacturing Processes which are necessary for Seller to comply with its
warranties pursuant to Section 5.1, (other than Section 5.1(a)(i) if ***
requests a change pursuant to this Section), or that do not relate
exclusively to the sale of Amvisc Products to Buyer, shall be borne by the
***.
4.5.3 Bacterial Fermented HA Product.
4.5.3.1 Development and Regulatory Matters. The parties acknowledge
that Product manufactured under the Current Product Specifications uses HA
sourced from avian tissue. The parties further acknowledge that, in some
markets, the customer, regardless of regulatory requirements, prefers
products using HA sourced from bacterial fermentation. In recognition of
this fact, upon the Effective Date, Seller shall, at *** expense, use its
*** efforts to begin qualifying a source of bacterial-fermented raw
material that will meet the Current Product Specifications on Exhibit A1
and the regulatory requirements of those countries where Buyer, in its
discretion, desires to sell bacterial fermented HA products. ***
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*** CONFIDENTIAL INFORMATION HAS BEEN OMITTED PURSUANT TO RULE 24b-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
4.5.3.2 Supply of BF Product.***
4.6. New Viscoelastic Products; Rights of First Refusal. The Parties acknowledge
that subsequent combinations, improvements, or modifications of Amvisc Products
for ophthalmic applications developed by Seller, either alone or jointly with
Buyer, shall automatically be available to Buyer and shall be subject to the
terms of this Agreement. The Parties further acknowledge that they may, on their
own, or with third parties, develop new viscoelastic products (which may or may
not be patentable) for ophthalmic applications that are not subsequent
combinations, improvements, or modifications to
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
Amvisc Products ("New Viscoelastic Products"). This section is intended to
govern the Parties' rights to such New Viscoelastic Products.
4.6.1 Buyer's Rights. Seller hereby grants to Buyer the right to
first negotiate an exclusive agreement for the development and
commercialization of any New Viscoelastic Product, which may or may not
contain HA, conceived of or otherwise developed by Seller. Seller shall
provide Buyer with written notice describing such New Viscoelastic Product
in reasonable detail to permit Buyer to evaluate the opportunity. Buyer
shall have *** days following receipt of such notice, extendable to ***
days on written notice, to advise Seller in writing of Buyer's election to
exercise its rights of first negotiation for the rights to develop and
commercialize the new viscoelastic product ("Option Period"). If Buyer
does not so notify Seller within the Option Period, or if Buyer fails for
any reason to negotiate and execute a written arrangement within *** days
after Buyer notifies Seller of exercise of its rights, then Seller shall
be free to develop the New Viscoelastic Product on its own or enter into
an agreement with any third party on terms and conditions no more
favorable, as a whole, to such third party than the most favorable terms
offered to Seller by Buyer. In the event Buyer either (i) decides not to
exercise its rights of first negotiation or (ii) the parties are unable to
reach an agreement, and (iii) Seller thereafter develops a marketable New
Viscoelastic Product, Seller hereby grants to Buyer, to the extent
Seller's rights are not prohibited by contractual arrangements or
intellectual property rights of third parties, the right to first
negotiate an exclusive arrangement for the commercialization of the New
Viscoelastic Product. In such event, Buyer shall provide Seller with
written notice specifying the terms and conditions for a license, sale or
other arrangement for the commercialization of the New Viscoelastic
Product. Buyer shall have *** days following receipt of such notice,
extendable to *** days on written notice, to advise Seller in writing of
Buyer's election to exercise its rights of first negotiation for the
rights to commercialize the new viscoelastic product ("Second Option
Period"). If Buyer does not so notify Seller within the Second Option
Period, or if Buyer fails for any reason to negotiate a written
arrangement within *** days after Buyer notifies Seller of exercise of its
rights, then Seller shall be free to enter into an agreement with any
third party on terms and conditions no more favorable, as a whole, to such
third party than the most favorable terms offered to Seller by Buyer.
4.6.2 Seller's Rights. To the extent not prohibited by contractual
arrangements or intellectual property rights of third parties, Buyer
hereby grants to Seller the right to first negotiate an exclusive
agreement for the manufacture of any New Viscoelastic Product developed by
Buyer or jointly developed by Buyer and a third party. Subject to any
contractual or intellectual property rights of third parties, if at any
time during the term of this Agreement Buyer desires to have a third party
manufacture a New Viscoelastic Product, Buyer shall provide Seller with
written notice, specifying the terms and conditions under which Buyer
would
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
like to have the New Viscoelastic Product manufactured. Seller shall have
*** days following receipt of such notice, extendable to *** days on
written notice, to advise Buyer in writing of Seller's election to
exercise its rights of first negotiation for manufacture of the New
Viscoelastic Product ("Option Period"). If Seller does not so notify Buyer
within the Option Period, or if Seller fails for any reason to negotiate
and execute a supply arrangement within *** days after Seller notifies
Buyer of exercise of its rights, then Buyer shall be free to enter into an
agreement with any third party on terms and conditions no more favorable,
as a whole, to such third party than the most favorable terms offered to
Buyer by Seller.
4.7 Manufacturing Equipment.
4.7.1 Buyer has provided Seller with the equipment, tools and dies
listed as "in use" or "storage" on Exhibit B (the "Equipment") for
Seller's use in manufacturing the Products or otherwise preparing the
Products for delivery. Seller shall have no ownership or leasehold
interest of any nature in the Equipment or any future equipment, tools or
dies provided by Buyer and all right, title and interest in the Equipment
shall remain with Buyer. From time to time at the request of Buyer and in
connection with the Equipment, Seller will execute one or more information
statements and/or continuation statements, with respect to the ownership
of the Equipment, pursuant to the Uniform Commercial Code in such form or
forms as Buyer may request for filing in such public offices as Buyer
shall determine.
4.7.2 Subject to the last sentence of this Section 4.7.2, Buyer
shall have the right to enter Seller's facilities in order to (i) inspect
the Equipment, (ii) inspect and copy all records relating to the repair,
maintenance and servicing by Seller of the Equipment and (iii) affix tags,
stickers or other items to the Equipment indicating Buyer's status as
owner thereof. Buyer shall be given access to such facilities, on
reasonable notice, during normal business hours and at any other time when
work is performed pursuant to this Agreement, not to exceed two (2) times
in any twelve (12) month period.
4.7.3 During the term of this Agreement, Seller shall (i) be
responsible for any damage (normal wear and tear excepted) to the
Equipment, (ii) keep the Equipment free of all pledges, liens,
encumbrances, levies, attachments, security interests or other claims that
could affect title to the Equipment or Buyer's interest therein, (iii) not
modify or alter the Equipment in any way without the consent of Buyer,
(iv) not remove, or cause or permit to be removed, the Equipment from the
premises of Seller's facilities without the consent of Buyer, (v) not
remove, conceal or deface any tags, stickers or other items affixed to the
Equipment that indicate Buyer's status as owner thereof, (vi) operate the
Equipment in accordance with good business practice and in compliance with
all written and verbal instructions provided to Seller by Buyer to the
extent not inconsistent with this
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
Agreement and (vii) not use the Equipment for any purpose except to
provide Products to Buyer pursuant to this Agreement or in accordance with
the provisions of Section 4.7.
4.7.4 During the term of this Agreement, Seller shall, at its own
expense, service, repair and maintain (collectively, "Service") the
Equipment as may be necessary to keep the Equipment in good working order.
Buyer shall have no obligation to purchase replacement Equipment or
otherwise pay for rebuilds of the Equipment once it has, in Seller's
determination, reached the end of its useful life.
4.7.5 Seller shall be responsible for training its employees to
properly operate the Equipment and shall supervise all operations thereof.
Seller shall be responsible for all damages or injuries to persons or
property resulting from (i) Seller's operation of the Equipment or (ii)
Seller's failure to provide or arrange for Service of the Equipment.
4.7.6 In the event that this Agreement is terminated for any reason,
and as long as Buyer determines it does not need the Equipment to exercise
its manufacturing rights under Sections 9.4 and 9.5, Seller may elect
either: (i) to lease the Equipment for up to *** months subsequent to the
termination or (ii) to buy the Equipment at the net book value of the
Equipment. Buyer shall have the right to enter, upon reasonable notice and
during regular business hours, and shall be given access to Seller's
facilities so that Buyer may retrieve the Equipment and all records
maintained in connection with the Equipment. Seller agrees to cooperate
with Buyer to ensure the timely and safe return of the Equipment to Buyer
after termination of this Agreement. Seller's obligations under this
Section shall survive the termination of this Agreement until the
Equipment is returned to Buyer.
4.7.7 Seller shall have the right to use Buyer's Equipment in the
manufacture of HA materials or non-HA materials for other purchasers
provided that such use shall not interfere with satisfying in a timely
manner Seller's supply obligations under this Agreement. Any costs
associated with such use, including without limitation, machine cleaning
(and validation thereof) and accelerated replacement cost of the
Equipment, shall be borne by Seller. Any new equipment, tools, dies, etc.
used in the manufacture of Products shall be purchased and owned by
Seller. If Buyer requests a modification of Seller's equipment and the
modification relates exclusively to the manufacture of Amvisc Products,
*** shall bear the reasonable cost of such modification, but *** shall own
such modification.
5. WARRANTIES AND INDEMNITIES
5.1 Representations and Warranties.
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
5.1.1 Warranties by Seller. The Seller represents and warrants to
Buyer with respect to the sale of Products as follows:
(a) at the time of delivery to a carrier at the Seller's plant, (i)
all Products shall conform to the Current Product Specifications and shall
have been manufactured in accordance with the Current Manufacturing
Processes (as either may be revised from time to time by mutual written
agreement of Seller and Buyer), (ii) the production of such Products shall
conform to QSR standards published by the United States Food and Drug
Administration and the International Standards Organization Rules 9,000 et
seq. in effect at the time of such production and applicable to the
Products, (iii) no Product shall be "adulterated" or "misbranded" within
the meaning of Section 5.01 of the Federal Food Drug and Cosmetic Act, as
amended (21 U.S.C. 5351), (iv) Seller's manufacturing process and
facilities shall conform to the applicable regulatory requirements of the
United States, the Major Countries in the EEC (defined as the United
Kingdom, France, Spain, Germany and Italy) and Japan with respect to
Products sold in such countries; and (v) no HA products sold to third
parties for use within the Ophthalmic Field shall fall within the
following specifications: ***
(b) the manufacture and sale of Products, including but not limited
to the bacterial fermented HA Product, made by Seller in accordance with
the Current Product Specifications and Current Manufacturing Processes in
the Territory and the proper use of such Products for their intended
purpose within the Territory does not infringe, violate or breach any
United States patent or a patent in any foreign jurisdiction where Seller
is manufacturing the Products (except patents as to which Seller has a
valid license, or covenant against suit from the patent owner) trade
secret or proprietary information based upon the manufacture, use, sale or
disposition of such Products, except that Seller shall have no liability
to Buyer hereunder with respect to any patent, trade secret or other
proprietary information claim based upon (i) use, sale or disposition of
Products where such Products would not be infringing except for changes to
Current Product Specifications or Current Manufacturing Processes
requested by Buyer under Section 4.5, (ii) use of Amvisc or Amvisc Plus
other than as specified by the current Amvisc and Amvisc Plus product
inserts, (iii) use, sale or disposition of Products by Buyer in
combination with devices or products not purchased hereunder whereas such
Products would not themselves be infringing, (iv) use, sale or disposition
of Products by Buyer in or for an application or environment for which
such Products were not approved by the FDA, (v) modifications of Products
by Buyer, or (vi) any claims of infringement of patents, trade secrets, or
other proprietary information in which Buyer has an interest or license.
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
(c) Buyer may have its representatives inspect Seller's production
facility and records from time to time to verify compliance with paragraph
(a) above. Such inspections shall be made on reasonable notice to Seller,
and shall be limited to one per year unless Buyer has delivered written
notice to Seller that, in Buyer's reasonable opinion, a breach of
paragraph (a) above may have occurred.
5.1.2 Warranties by Buyer. The sale of Products, other than the
bacterial fermented HA Product, made by Seller in accordance with the Current
Product Specifications in the Territory and the proper use of such Products for
their intended purpose within the Territory does not infringe, violate or breach
any United States patent or patent in any foreign jurisdiction where Seller is
manufacturing the Products (except patents as to which Buyer has a valid
license, or covenant against suit from the patent owner) trade secret or
proprietary information based upon the manufacture, use, sale or disposition of
such Products, except that Buyer shall have no liability to Seller hereunder
with respect to any patent, trade secret or other proprietary information claim
based upon any claims of infringement of patents, trade secrets, or other
proprietary information in which Seller has an interest or license.
5.2 Indemnification by Seller. Subject to the limitations set forth in
this Section 5, the Seller hereby indemnifies and agrees to defend and hold the
Buyer, including its officers and directors, harmless against and from any and
all damages, liabilities, costs and expenses, including without limitation
reasonable attorney's fees, arising out of or in any way connected with any
claim or claims of breach of the Seller's warranties in Section 5.1.1(b) or any
actual or alleged defect in any Product caused by the negligence, acts or
omissions of Seller. The provisions of Sections 5.1 and 5.2, state the entire
liability of the Seller with respect to infringement of patents, trade secrets
and other proprietary information by the manufacture, use, sale or disposition
of the Products.
5.3 Indemnification by Buyer. Subject to the limitations set forth in
Section 5, the Buyer hereby indemnifies and agrees to defend and hold the
Seller, its officers and directors, harmless against and from any and all
damages, liabilities, costs and expenses, including without limitation,
reasonable attorney's fees, arising out of or in any way connected with any
claim or claims (other than claims arising as the result of a breach by Seller
of the warranties contained in Section 5.1.1 (b)), that (i) the sale or use of
any Products manufactured by Seller and used, sold or otherwise disposed of by
Buyer infringes the rights of any third party in any United States or foreign
patent, or trade secret or other proprietary information or (ii) any process
used by Seller to manufacture Products infringes rights of any third party in
any United States or foreign patent as a result of changes to the Current
Manufacturing Processes requested by Buyer pursuant to Section 4.5.
5.4 Insurance. During the term of this Agreement, Seller shall, at its
sole cost and expense, procure and maintain comprehensive Commercial General
Liability Insurance, including coverage for products/completed operations, with
annual limits of liability of not less than *** dollars ($***) per occurrence,
***
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
dollars ($***) general aggregate, and *** dollars ($***) products/completed
operations aggregate, or their equivalent in non-US locations. Buyer shall, at
its sole cost and expense, procure and maintain comprehensive Commercial General
Liability Insurance, including coverage for products/completed operations, with
annual limits of liability of not less than *** dollars ($***) per occurrence,
*** dollars ($***) general aggregate, and *** dollars ($***) products/completed
operations aggregate, or their equivalent in non-US locations.
5.5 Product Recalls. If any of the Products are subjected to a recall by
any governmental agency, or in the event Buyer, after notification to and
consultation with Seller, elects to make such a recall based on Buyer's good
faith belief that the Products were not in conformity with seller's warranties,
***. However, if it is established that the Product became nonconforming as a
result of actions or omissions on the part of the Buyer, or if following a
recall at Buyer's election, Seller is able to determine that the Products were
not in fact in breach of Seller's warranties, the Buyer shall hold the Seller
harmless and shall bear all reasonable and actual out of pocket costs and
expenses in connection with such recall.
5.6 LIMITATION. THE PROVISIONS OF THE FOREGOING WARRANTIES ARE IN LIEU OF
ANY OTHER WARRANTY, WHETHER EXPRESS OR IMPLIED, WRITTEN OR ORAL, AND SELLER
HEREBY EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES, INCLUDING ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. EXCEPT AS
OTHERWISE PROVIDED FOR IN THIS AGREEMENT, NO PARTY SHALL IN ANY EVENT BE LIABLE
TO THE OTHER FOR INCIDENTAL, SPECIAL OR CONSEOUENTIAL DAMAGES ARISING OUT OF THE
SALE OF THE PRODUCTS, INCLUDING BUT NOT LIMITED TO LOSS OF PROFITS.
5.7 Responsibility for Third Party Claims. In order to distribute between
themselves the responsibility for handling and expense of bodily injury or
property damage claims by third parties arising out of the sale, possession, or
use of the Products, the parties agree as follows:
(a) Seller shall indemnify and hold Buyer, its officers and directors,
harmless against and from any and all damages, liabilities, costs and expenses,
including, without limitation, reasonable attorneys fees in connection with the
possession or use of a Product manufactured by Seller arising out of, based on,
or caused by (i) the failure or alleged failure of such Products to conform with
Seller's warranties contained in Section 5.1 (a) or (ii) any actual or alleged
defect in any Product manufactured by Seller.
(b) Except as to matters for which Seller is alleged to be responsible
under Section 5.7 (a) above, Buyer shall indemnify and hold Seller, its officers
and directors harmless
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
against and from any and all damages, liabilities, costs and expenses, including
without limitation, reasonable attorney's fees, in connection with the sale of
Products manufactured by Seller for Buyer.
5.8 Notice of Claims. The indemnities in Sections 5.2, 5.3 and 5.5 are
subject to the requirement that the party seeking indemnification ("Indemnitee")
shall promptly provide the other party ("Indemnitor") with written notice of
such claim for which indemnification is sought, and the Indemnitee shall provide
its reasonable cooperation, information and assistance in connection therewith.
The Indemnitor shall, after consultation with the Indemnitee, have the sole
control and authority with respect to the defense, settlement or compromise of
such claims.
5.9 Survival. Notwithstanding anything to the contrary contained herein,
the provisions of Sections 5, 7, and 10.6 through 10.15 shall survive the
expiration or termination of this Agreement.
6. REGULATORY SUPPORT IMPROVEMENTS.
6.1 Clinical Support; Regulatory Affairs. Buyer shall assume
responsibility for all clinical support and regulatory activities relating to
Products, and shall bear all costs incurred by it associated therewith. Nothing
contained herein is intended to require Buyer to assume responsibility for any
improvements to Seller's facility or manufacturing processes which may be
necessary to enable Seller to comply with its warranties under Section 5.1 or to
sell products containing HA to third parties.
6.2 ICI Process Know-How. Seller has heretofore licensed certain rights to
the "ICI bacterial fermentation process" to Buyer pursuant to a separate license
agreement ("ICI Agreement"). As used herein the ICI Process shall mean the
hyaluronic acid fermentation process which was the subject of a certain
Development Agreement with ICI and MBL dated March 1, 1987 and all improvements
thereto owned by or licensed to Seller as of the Contract Date. In the event
Seller acquires any right, title or interest (including any licenses or
sublicenses from any other party) in or to any additional know-how, patents, or
improvements relating specifically to the ICI Process during the term of this
Agreement and Seller uses the ICI Process with such additional know-how, patents
or improvements in the manufacture of Amvisc Products for Buyer under this
Agreement, to the extent the ICI Agreement is still in effect, Seller shall
grant a worldwide, royalty free exclusive license to Buyer in the Ophthalmic
Field to make, have made, use and sell products utilizing such additional
know-how, patents or improvements. Buyer shall, however, not practice under such
license until termination or expiration of this Agreement or sooner upon Buyer's
exercise of its right to obtain a second source of supply under Section 2.2,
3.6.2, 3.7 or 4.5 as provided for in Section 9.4. Unless the provisions of
Section 2.2, 3.6.2, 3.7, 4.5 or 9.4 are implicated, Buyer's right to grant
sublicenses thereto shall be limited to Affiliates of Buyer.
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
6.3 Manufacturing Inventions. Throughout the term of this Agreement,
Seller may acquire know-how, inventions or improvements relating to processes or
methods for manufacturing hyaluronic acid or Amvisc Products other than
know-how, inventions or improvements relating to the ICI Process (the
"Manufacturing Inventions").
With respect to any Manufacturing Inventions that are used in connection with
the manufacture of Amvisc Products sold by Seller to Buyer pursuant to this
Agreement, Seller shall grant Buyer (at no cost to Buyer other than the
out-of-pocket cost of accomplishing the same) a worldwide, fully-paid,
royalty-free, non-exclusive license, with the right to sublicense, to use such
Manufacturing Inventions to make, have made, use and sell Amvisc Products,
provided that Buyer shall have no rights under such license until termination or
expiration of this Agreement or sooner upon Buyer's exercise of its right to
obtain an alternate source of supply under Section 2.2, 3.6.2, 3.7, or 4.5.
Unless the provisions of Section 2.2, 3.6.2, 3.7, 4.5 or 9.4 are implicated,
Buyer's right to grant sublicenses to the Manufacturing Inventions shall be
limited to Affiliates of Buyer.
Seller shall keep Buyer advised as to any Manufacturing Inventions within the
scope of this Section 6.3, and shall, from time to time as requested by the
Buyer, execute such documents and other instruments necessary to effectuate such
licenses.
6.4 Product Inventions. Throughout the term of this Agreement, Seller may
acquire know-how, inventions or improvements relating to hyaluronic acid or
Amvisc Products, excluding Manufacturing Inventions and know-how, inventions or
improvements relating to the ICI Process (the "Product Inventions").
With respect to any Product Invention above that is used in connection with an
Amvisc Product sold by Seller to Buyer pursuant to this Agreement, Seller shall
grant Buyer (at no cost to Buyer other than the out-of-pocket cost of
accomplishing the same) a worldwide, fully-paid, royalty-free, exclusive
license, with the right to sublicense, to use such Product Invention to make,
have made, use and sell Amvisc Products. Buyer shall have no rights under such
license until termination of this Agreement or sooner upon Buyer's exercise of
its right to obtain an alternate source of supply under Section 2.2, 3.6.2, 3.7,
or 4.5. Unless the provisions of Sections 2.2, 3.6.2, 3.7, 4.5 or 9.4 are
implicated, Buyer's right to grant sublicenses to the Product Inventions shall
be limited to Affiliates of Buyer.
Seller shall keep Buyer advised as to any Product Inventions within the scope of
this Section 6.4, and shall, from time to time as requested by the Buyer,
execute such documents and other instruments necessary to effectuate such
licenses.
6.5 Buyer's Inventions. In the event Buyer, during the term of this
Agreement, acquires any right, title or interest (including any licenses or
sublicenses from any other party) in or to any additional know-how, patents or
improvements relating specifically to the ICI Process or the HA manufacturing
process of Seller, which are, in either case, utilized by Seller at Buyer's
request in the manufacture of Amvisc Products, Buyer shall
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
grant Seller a world-wide, royalty free, non-exclusive license to make, have
made, use and sell products, utilizing such additional know-how, patents or
improvements within and outside of the Ophthalmic Field; provided, however, that
Seller's right to practice under such license in the Ophthalmic Field shall not
include the right to sell products that fall within the following
specifications.
7. CONFIDENTIALITY AND CONDUCT
7.1 Confidentiality. The parties agree that certain information supplied
to each other during the course of this Agreement may be proprietary, secret or
confidential. All such information when marked or otherwise designated as
proprietary, secret or confidential shall, except as may be otherwise provided
for in this Agreement, be held in strictest confidence by the receiving party
for a period of two years from the termination of this Agreement and shall be
used only for purposes in connection with this Agreement; provided, however, the
foregoing restrictions shall not apply to any such information which:
(a) is or subsequently becomes part of the public domain through no
fault of the receiving party;
(b) is received from a third party under no obligation of
Confidentiality to the disclosing party;
(c) is known by the receiving party at the time of disclosure, which
prior knowledge can be demonstrated by a written or printed document; or
(d) is required by law to be disclosed; or
(e) may be disclosed pursuant to Section 10.6.
The obligations imposed above shall not limit any rights provided to Buyer
pursuant to Section 9.4 to assume responsibility for the manufacturing of the
Products or to use any such confidential information as permitted thereby or in
any license granted by Seller to Buyer or any of its Affiliates.
7.2 Conduct. No party shall participate in or encourage any conduct or
practice that is detrimental or harmful to the good name, goodwill or reputation
of the other party and its products.
8. MARKETING AND REGULATORY PROVISIONS
8.1 Governmental Approvals. Buyer shall have the responsibility of
securing any new regulatory approvals for Products as well as maintaining or
updating existing
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
regulatory approvals for Products in the United States and otherwise throughout
the Territory as Buyer, in its sole discretion, deems necessary or appropriate.
Buyer shall cooperate with and keep Seller generally advised of any of its
activities in this regard. Buyer shall allow Seller to review any material
regulatory filings relating to manufacturing processes or Product specifications
prior to submission and consider any timely suggestions made by Seller with
respect thereto provided, however, that in the event of any disagreement the
decision of Buyer shall prevail. Buyer shall also use reasonable efforts to make
FDA and other regulatory filings necessary to secure approvals required in order
for Seller to implement changes to Seller's manufacturing process that improve
reliability, production or manufacturing time or costs with respect to Products
manufactured for Buyer. The reasonable, documented costs of such regulatory
filings shall be borne by *** to the extent that *** requested such changes, but
otherwise shall be borne by ***. *** shall provide detailed documentation of
such costs. *** shall have the right to appoint an independent certified
accountant to audit and verify such costs. In the event the audit is not
consistent with *** accounting of such costs, if Buyer and Seller cannot resolve
the discrepancy within *** days, the parties will resolve the dispute in
accordance with Section 10.13. All approvals for use of the Products either
inside or outside of the United States shall be owned by and be held in the name
of Buyer. *** shall be responsible for obtaining, at its expense, regulatory
approvals for Anika Manufactured Ophthalmic HA Products and Non-Anika
Manufactured Ophthalmic HA Products.
8.2 Product Identification. All Product labels may, at Buyer's election,
identify the Seller as the manufacturer of the Product. Buyer shall not be
required to utilize Seller's name on product labeling or in connection with the
sale, marketing or distribution of the Products.
8.3 Trademarks and Trade Names of Buyer. Buyer and/or Buyer's Parent is
the owner of (i) the U.S. registration of the trademark "Amvisc" and "Amvisc
Plus", (ii) any "Amvisc" tradename or trademark containing the word "Amvisc"
which is now registered or is hereafter registered in the Territory, and (iii)
the tradenames or trademarks listed on Exhibit C (hereinafter the "Proprietary
Marks").
(a) Except as permitted by Section 8.2, the Buyer shall not use the
Seller's name in connection with any business conducted by the Buyer.
(b) The Seller acknowledges the exclusive right, title and interest
in and to the Proprietary Marks and the goodwill thereto by Buyer and its
Parent and/or Affiliates and agrees not to challenge or take any action in
derogation of Buyer's rights therein.
(c) The Seller agrees that it will not use on other products sold by
it any xxxx which is likely to be similar to or confused with the
Proprietary Marks.
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
8.4 Regulatory Cross Reference Rights. As to any HA or other U.S. or
foreign regulatory approvals specifically relating to Products utilizing HA
manufactured solely by Seller, Seller shall be granted, to the extent permitted
by law or regulation, a right to cross reference (without a right of access)
such regulatory approvals for products for sale to third parties, excluding
products that fall within the following specifications: ***. Buyer agrees to
execute and deliver to Seller, promptly upon Seller's request and on a country
by country basis, such acknowledgements and instruments as may be necessary to
enable Seller to cross reference such approvals as provided for above. As Seller
does not have a right of access to information contained in such approvals,
Buyer shall, upon Seller's request during the term of this Agreement, provide
Seller with a general description of the types of information contained in any
such application. Nothing contained herein shall be construed to permit Seller
to cross-reference any regulatory approvals for products that are manufactured
by Buyer or for Buyer by parties other than the Seller. Except in the case of
termination for breach by Seller under Section 9.2(b), this Section shall
survive termination or expiration of the Agreement.
9. TERM. TERMINATION AND TRANSFER OF SUPPLY OBLIGATIONS
9.1 Term. This Agreement shall remain in effect until December 31, 2007
unless all of its provisions have been sooner terminated pursuant to any other
provisions hereof. Twelve (12) months prior to the end of the term, the parties
may, by mutual written agreement, agree to renew the Agreement for one (1)
additional term of one (1) year.
9.2 Partial Termination. Seller's obligations to manufacture and supply
Products to the Buyer hereunder and Buyer's obligations to purchase such
Products (hereinafter the "Supply Relationship") may be terminated as follows:
(a) by one party in the event the other substantially fails to
perform or otherwise substantially breaches any of its obligations under
this Agreement by giving notice of its intent to terminate and stating the
grounds therefor. The party receiving the notice shall, subject to the
provisions of Section 10.13, have sixty (60) days from the date of receipt
thereof to cure the failure or breach. In the event such breach is cured,
the notice shall be of no effect. In the event it is not cured, the
Agreement shall, without further action, terminate at the end of such
sixty (60) day period, provided, however, if the failure to perform or
other breach is due to circumstances referred to in Section 10.10 and such
party is making all reasonable efforts to perform or cure such breach as
provided in such Section 10.10, this Section 9.2(a) shall not apply unless
or until the failure to perform or other breach shall have lasted
continuously for ninety (90) days from the initial receipt of notice of
breach.
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
(b) By one party in the event (i) the other party shall at any time
seek appointment of a receiver, trustee, custodian, fiscal agent or
similar officer for such party or its assets or make a general assignment
for the benefit of creditors, (ii) is adjudicated a bankrupt or insolvent,
or (iii) if a petition in bankruptcy, or any reorganization shall be
commenced by, against or in respect of such other party seeking (A) to
have an order for relief entered with respect to such party or (B)
reorganization, arrangement, adjustment, winding-up, liquidation,
dissolution, or other relief with respect to such party or its debts and
shall remain undismissed for more than sixty (60) days.
(c) As provided for in Section 9.4 below.
9.3 Effect of Termination. Termination of this Agreement for any reason
shall not affect rights and obligations of the parties accrued through the
effective date of termination, including without limitation indemnification
provisions relating to Products manufactured and sold to Buyer hereunder,
payments for Products shipped by Seller which have not been paid for by Buyer,
and Seller's obligations pursuant to Sections 2.4, 9.4, 9.5, and 9.7.
9.4 Transfer of Supply Obligations. Upon expiration of the term, or upon
such earlier termination of the Agreement as provided for in Section 9.2, the
manufacturing process and responsibility for manufacturing for all, but not less
than all, Products shall be transferred to Buyer in its entirety. Buyer may
thereafter undertake such manufacturing itself or under contract with a third
party. Upon such transfer of manufacturing responsibility to Buyer, all usable
raw materials purchased for use in manufacturing the Products for Buyer for the
succeeding six (6) month period shall be transferred to Buyer at Seller's cost
thereof. Usable work-in-process and saleable finished goods shall be purchased
by Buyer at the applicable Unit price therefore, with work-in-process to be
prorated based on the stage of production. As used herein, "saleable" shall mean
finished goods, including but not limited to packaging, artwork, and other
materials, which meet Current Product Specifications (as may be revised from
time to time by mutual agreement of Buyer and Seller) and which have a remaining
shelf life of at least fifteen (15) months. In addition, Seller shall use
reasonable commercial efforts to assist Buyer in securing a continued supply of
HA at the same cost such HA is obtained by Seller until such time as Buyer is
able to obtain another source. Nothing herein shall be construed to limit any
other remedies which may be available to Buyer under the terms of this
Agreement. Buyer shall have the right to have independent auditors audit
Seller's books and records with respect to the foregoing provisions.
9.5 Duties Upon Transfer of Manufacturing Responsibilities. In order to
facilitate an orderly transition with respect to the transfer of manufacturing
responsibility to the Buyer, as provided for above, Seller shall fully cooperate
in the transfer of manufacturing equipment (FOB Seller's plant) and know-how to
the Buyer. Seller shall also make available to Buyer all know-how and technical
information then in Seller's possession or at its free disposal relating to the
manufacture of the Products and shall
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
provide reasonable assistance to Buyer in the establishment of a manufacturing
facility. All information transferred pursuant to this Section 9.5 shall be
subject to the provisions of Section 7 of this Agreement; provided, however,
that Buyer may provide such information to third party manufacturers that
execute confidentiality agreements containing substantially similar terms as
contained in Section 7. Costs of relocation of equipment and installation shall
be the responsibility of the ***. Costs for travel and time required by Seller's
personnel to assist in the transfer and the establishment of a manufacturing
facility shall be borne by *** until such time as the transfer has been
successfully completed. In order to have been successfully completed, Buyer,
with the assistance of Seller, shall have produced three successive lots of
products meeting the then-Current Product Specifications. After such period,
Buyer shall reimburse Seller for reasonable costs incurred by Seller's personnel
reasonably required for such transfer. Upon the transfer of manufacturing
responsibilities Buyer shall have the right to use such know-how, technical
information and equipment for the manufacture of the Products without
restrictions as to use. In the event the transfer of manufacturing results from
the failure of Seller to supply, the limitations in Sections 6.2, 6.3 and 6.4 on
Buyer's rights to sublicense certain inventions etc. shall no longer apply.
9.6 Limitation of Liability. Upon termination of this Agreement for any
reason whatsoever, except (i) by reason of Section 9.2(a), neither party shall
have any obligation to the other for compensation or damages of any kind, other
than the obligations set forth in this Agreement, and each party waives any
rights which it may have been granted by statute or otherwise which are not
granted by this Agreement.. Furthermore, any claims for compensation or damages
shall be subject to Section 5.6.
10. MISCELLANEOUS
10.1 Payments. In the event either Buyer or Seller shall fail to make any
payment required hereunder in a timely manner, such party shall pay one percent
(1%) per month interest on any unpaid balance which is not disputed in good
faith, provided that such interest obligation shall not limit any other remedies
which may be available to seller or Buyer, as the case may be, under the terms
of this Agreement.
10.2 Status of Parties. The relationship of the parties under this
Agreement shall be and at all times remain one of independent contractors.
Neither party is an employee, agent or legal representative of the other and
neither party shall have any authority to assume or create obligations on the
other's behalf with respect to the Products or otherwise.
10.3 Assignment by Buyer. Buyer shall not transfer or assign this
Agreement or the rights (including licenses) granted or to be granted hereunder
in whole or in part without the prior written consent of Seller, except that:
(a) Buyer may grant sublicenses under the licenses granted to it to
the extent permitted by sections 6.3, 6.4 and 6.5, and
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
(b) Buyer may assign this Agreement and such rights to any Affiliate
of Buyer, or in connection with the sale of that part of its business
relating to the sale of the Products provided that in no event shall any
such assignment release Buyer from its responsibilities under this
Agreement unless the assignee has agreed in writing to assume all the
obligations of Buyer hereunder.
10.4 Assignment by Seller. Seller shall not transfer or assign this
Agreement or the rights (including licenses) granted or to be granted hereunder,
in whole or in part without the prior written consent of Buyer, except that:
(a) Seller may grant sublicenses under the licenses granted to it to
the extent permitted by Section 6.6, and
(b) may assign this Agreement and such rights (i) to any of its
Affiliates or in connection with the sale of substantially all of its
business relating to the sale of the Products; provided that in no event
shall any such assignment release Seller from its responsibilities under
this Agreement unless the assignee has agreed in writing to assume all the
obligations of Seller hereunder, or (ii) to a lender as collateral
securing the performance by Seller of its obligations to such lender,
provided, however, that in no event shall any such assignment under
subparagraph (ii) relieve Seller of liability for its responsibilities
under this Agreement;
10.5 Registration. In the event that this Agreement is required to be
registered with any governmental authority (other than the Securities and
Exchange Commission), the Buyer shall cause such registration to be made and
shall bear any expense or tax payable in respect thereof.
10.6 Publicity and Disclosure. Except as required by law, any securities
exchange, automated quotation system of a registered securities association, the
NASD or other public company reporting obligation, neither Party shall issue any
press releases or make any other public announcement-concerning-this Agreement
or the subject matter hereof without the prior written consent of the other
Party The party making any such announcement shall give the other party an
opportunity to review and comment upon the text and form of the announcement
before it is made.. Notwithstanding the foregoing, Buyer acknowledges that
Seller will be required to file this Agreement with the Securities and Exchange
Commission. Seller shall not use the name of Buyer or any of its Affiliates for
advertising or promotional claims without the prior written consent of Buyer.
10.7 Representations. Each of the parties hereto agrees (i) that no
representation or promise not expressly contained in this Agreement has been
made by the other party hereto or by any of its agents, employees,
representatives or attorneys; (ii) that this Agreement is not being entered into
on the basis of, or in reliance on, any promise or representation, expressed or
implied, covering the subject matter hereof, other than those expressly set
forth in this Agreement; and (iii) that each party has had the
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
opportunity to be represented by counsel of its own choice in this matter,
including the negotiations which preceded the execution of this Agreement.
10.8 Entire Agreement. This instrument constitutes the entire agreement
between Seller and the Buyer concerning the supply of the Products from and
after the Effective Date. Except as provided in Section 1.6, with respect to
Products sold from and after the Effective Date, this Agreement supersedes the
1994 Supply Agreement and the Distribution Agreement in their entirety; however,
the 1994 Supply Agreement governs with respect to Products sold prior to the
Effective Date. This Agreement may not be amended, altered, or changed except by
a written agreement signed by the parties hereto.
10.9 Waivers. No delay or omission on the part of either party to this
Agreement in requiring performance by the other party hereunder, or in
exercising any right hereunder, shall operate as a waiver of any provision
hereof or of any right or rights hereunder; and the waiver or omission or delay
in requiring performance or exercising any right hereunder an one occasion shall
not be construed as a bar to or waiver of such performance or right, or of any
right or remedy under this Agreement, on any future occasion.
10.10 Force Majeure. In the event that any party is prevented from
performing, or is unable to perform, any of its obligations under this Agreement
due to any act of God, fire, casualty, flood, war, strike, lock out, failure of
public utilities, injunction or any act, exercise, assertion or requirement of
governmental authority, epidemic, destruction of production facilities,
insurrection, inability to procure materials, labor, equipment, transportation
or energy sufficient to meet manufacturing needs, or any other cause beyond the
reasonable control of the party invoking this provision, and if such party shall
have used its best efforts to avoid such occurrence and minimize its duration
and has given prompt written notice to the other parties, then the affected
party's performance shall be excused and the time for performance shall except
as otherwise provided for in this Agreement, be extended for the period of delay
or inability to perform due to such occurrence.
10.11 Notification. Any notice required under this Agreement shall be
sufficient if sent by registered or certified mail postage and charges prepaid,
return receipt requested, or by hand delivery including overnight delivery
Service to the following addresses or such address hereinafter specified in
writing:
If to Seller: Anika Therapeutics, Inc.
000 Xxxx Xxxxxxxx Xxxx
Xxxxxx, XX 00000
Xxx: President
With a copy to: Xxxxxxx, Procter & Xxxx LLP
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
Exchange Place
Boston, MA 02109
Attn: H. Xxxxx Xxxxxx, P.C.
If to Buyer: Bausch & Lomb Surgical, Inc.
000 Xxxx Xxxxx Xxxxxxx
Xxxxxxxxx, XX 00000
Attn: President
With a copy to: Bausch & Lomb Incorporated
Xxx Xxxxxx & Xxxx Xxxxx
Xxxxxxxxx, XX 00000
Attn: Senior Vice President and
General Counsel
10.12 Governing Law; Severability. With regard to any claim or controversy
initiated by Buyer related to this Agreement or any breach thereof, this
Agreement shall be governed by the internal laws of the Commonwealth of
Massachusetts (without regard to conflict of laws principles), and with regard
to any claim or controversy initiated by Seller related to this Agreement or any
breach thereof, this Agreement shall be governed by the internal laws of the
State of New York (without regard to conflict of laws provisions). Any claim or
controversy arising out of or related to this Agreement or any breach thereof
shall be submitted to United States District Court, District of Massachusetts if
such claim or controversy is initiated by Buyer and to United States Xxxxxxxx
Xxxxx, Xxxxxxx Xxxxxxxx xx Xxx Xxxx if such claim or controversy is initiated by
Seller, and the Parties hereby consent to the jurisdiction and venue of such
courts. The invalidity or unenforceability of any provision of this Agreement
shall not affect the validity or enforceability at any other provision of this
Agreement, and each other provision of the Agreement shall be severable and
enforceable to the fullest extent permitted by applicable law.
10.13 Dispute Resolution Process. Any dispute between the Parties will be
referred to the Chief Executive Officers of Buyer and Seller (or their
designees) for good faith resolution, for a period of ninety (90) days. If the
Chief Executive Officers (or their designees) are able to resolve the dispute,
the resolution shall be set forth in a written instrument signed by each of
them. If such dispute is not resolved by the end of such ninety (90) day period,
the Parties shall be free to pursue any legal or equitable remedy available to
them. Notwithstanding the above, nothing herein shall prevent either party from
seeking injunctive relief to prevent the unauthorized use or disclosure of
Confidential Information.
10.14 Captions. The captions and section headings set forth in this
Agreement are for convenience only and shall not be used in any way to construe
or interpret this Agreement.
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
10.15 References. Unless otherwise expressly provided herein, all
references herein to sections and paragraphs shall be deemed to refer to
sections and paragraphs of this Agreement.
All exhibits referred to herein are attached hereto and by this reference made a
part hereof.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed
by their respective authorized representatives as of the day and year above
written.
ANIKA THERAPEUTICS, INC. BAUSCH & LOMB SURGICAL, INC.
By: /s/ J. Xxxxxxxx Xxxxx By: /s/ Xxxxxxx X. Xxxxxxxxx
-------------------------------- -------------------------------------
Name: J. Xxxxxxxx Xxxxx Name: Xxxxxxx X. Xxxxxxxxx
Title: Chairman, President and CEO Title: VP Global Operations
Signature Date: 7/25/00 Signature Date: 7/22/00
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
EXHIBIT A
CURRENT AMVISC PRODUCT SPECIFICATIONS
***
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
***
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*** CONFIDENTIAL INFORMATION HAS BEEN OMITTED PURSUANT TO RULE 24b-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
***
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*** CONFIDENTIAL INFORMATION HAS BEEN OMITTED PURSUANT TO RULE 24b-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
EXHIBIT A
CURRENT AMVISC PLUS PRODUCT SPECIFICATIONS
***
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
***
-37-
*** CONFIDENTIAL INFORMATION HAS BEEN OMITTED PURSUANT TO RULE 24b-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
***
-38-
*** CONFIDENTIAL INFORMATION HAS BEEN OMITTED PURSUANT TO RULE 24b-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
EXHIBIT A1
CURRENT AMVISC PRODUCT SPECIFICATIONS
(Revised per Section 4.5.1)
***
*** CONFIDENTIAL INFORMATION HAS BEEN OMITTED PURSUANT TO RULE 24b-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
***
*** CONFIDENTIAL INFORMATION HAS BEEN OMITTED PURSUANT TO RULE 24b-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
***
*** CONFIDENTIAL INFORMATION HAS BEEN OMITTED PURSUANT TO RULE 24b-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
EXHIBIT A1
CURRENT AMVISC PLUS PRODUCT SPECIFICATIONS
(Revised per Section 4.5.1)
***
*** CONFIDENTIAL INFORMATION HAS BEEN OMITTED PURSUANT TO RULE 24b-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
***
*** CONFIDENTIAL INFORMATION HAS BEEN OMITTED PURSUANT TO RULE 24b-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
***
*** CONFIDENTIAL INFORMATION HAS BEEN OMITTED PURSUANT TO RULE 24b-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
Exhibit B
Equipment
*** CONFIDENTIAL INFORMATION HAS BEEN OMITTED PURSUANT TO RULE 24b-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
[List of Equipment Omitted]
*** CONFIDENTIAL INFORMATION HAS BEEN OMITTED PURSUANT TO RULE 24b-2 UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND HAS BEEN FILED SEPARATELY WITH
THE COMMISSION. THE LOCATIONS OF THE OMITTED INFORMATION HAVE BEEN INDICATED
WITH ASTERISKS.
Exhibit C
Trademarks and Tradenames
DomiVisc
DomiVisc Phaco
Storz - Sodico Hyaluranato
Storz - Sodico Hyaluranato Faco
