Exhibit 10.2


REDACTED COPY

Confidential Treatment Requested(1)


SUPPLY AGREEMENT


among


GALDERMA S.A.


GALDERMA PHARMA S.A.


and


ANIKA THERAPEUTICS,
INC.


(1) Redacted
portions have been marked with brackets containing asterisks ([***]).  The
redacted portions are subject to a request for confidential treatment and have
been filed separately with the Securities and Exchange Commission.















 


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TABLE OF CONTENTS


	
  

  	
   

  	
  Page

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE I -
  DEFINITIONS

  	
   

  	
  1

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE II -
  MANUFACTURE AND SALE

  	
   

  	
  2

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE III -
  PRICING AND PAYMENT TERMS

  	
   

  	
  4

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE IV -
  FORECASTS; ORDERS

  	
   

  	
  4

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE V -
  PURCHASE COMMITMENTS

  	
   

  	
  6

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE VI -
  SECOND SOURCE OF SUPPLY

  	
   

  	
  7

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE VII -
  SPECIFICATIONS; IMPROVEMENTS

  	
   

  	
  8

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE VIII -
  PACKAGING

  	
   

  	
  9

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE IX -
  DELIVERY

  	
   

  	
  10

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE X -
  MANUFACTURING INSPECTIONS

  	
   

  	
  10

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE XI -
  PRODUCT INSPECTION; NON-CONFORMING PRODUCT

  	
   

  	
  12

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE XII -
  CORRECTIVE ACTION

  	
   

  	
  13

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE XIII -
  INSURANCE

  	
   

  	
  14

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE XIV -
  COORDINATION WITH LICENSE AGREEMENT

  	
   

  	
  15

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE XV - GUARANTY

  	
   

  	
  15

  	
   

  



 



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SUPPLY
AGREEMENT


THIS SUPPLY AGREEMENT (this “Agreement”) is
made effective as of June 30, 2006 (“Effective Date”) by and among
GALDERMA S.A., a Swiss corporation having its place of business at Zugerstrasse
8, Cham CH-6330, Switzerland (“GALDERMA”), GALDERMA PHARMA S.A., a Swiss
corporation having its place of business at Zugerstrasse 8, Cham CH-6330,
Switzerland (“PARENT”), for purposes of Article XV only, and ANIKA
THERAPEUTICS, INC., a Massachusetts corporation, having its place of business
at 160 New Boston Street, Woburn, Massachusetts 01801 (“ANIKA”).  ANIKA and GALDERMA are each referred to by
name or as a “Party” or collectively as the “Parties.”


RECITALS


1.             ANIKA
develops, manufactures and packages therapeutic products.


2.             GALDERMA
distributes and markets therapeutic products.


3.             The
Parties are entering into a License and Development Agreement (the “License
Agreement”) concurrently herewith, providing for, among other things, an
exclusive (except as set forth in Article IV of the License Agreement) license
from ANIKA to GALDERMA under the ANIKA Patents to use, promote, sell, offer to
sell, and distribute the Licensed Products in the Field in the Territory.


4.             This
Agreement will be coterminous with the License Agreement.


5.             GALDERMA
desires to have ANIKA manufacture and supply the Licensed Products for GALDERMA
pursuant to the terms of this Agreement.


NOW, THEREFORE, in consideration of the premises and
mutual covenants herein contained and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged,
the Parties agree as follows:


ARTICLE I - DEFINITIONS


1.1.          Each term not
otherwise defined herein shall have the meaning assigned to such term in the
License Agreement.


1.2.          For the purpose of
this Agreement, the following terms shall have the meanings set forth below:


“Additional Amount” shall have the meaning set
forth in Section 5.3.


“Agreement” shall have the meaning set forth in
the preamble.


“ANIKA” shall have the meaning set forth in the
preamble.









 



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“Annual Minimum Purchase Commitment” shall have
the meaning set forth in Section 5.1.


“Facility” means ANIKA’s manufacturing facility
located at 236 West Cummings Park, Woburn, MA 
01801, or any other manufacturing facility certified under Applicable
Law for the manufacture of the Licensed Products and selected by ANIKA from
time to time.


“Forecast” shall have the meaning set forth in
Section 4.1.


“GALDERMA” shall have the meaning set forth in
the preamble.


“License Agreement” shall have the meaning set
forth in the recitals.


“PARENT” shall have the meaning set forth in
the preamble.


“Party” or “Parties” shall have the
meaning set forth in the preamble.


“Purchase Orders” shall have the meaning set forth
in Section 4.2.


“Obligations” shall have the meaning set forth
in Section 15.1.


“Recall” shall have the meaning set forth in
Section 12.4(a).


“Retained Sample” shall have the meaning set
forth in Section 11.1(c).


“Sales Territory” means each of North America,
South America and the rest of the countries in the Territory.


“Second Source Supplier” shall have the meaning
set forth in Section 6.1.


“Shipping Point” shall have the meaning set
forth in Section 9.1(b).


ARTICLE II - MANUFACTURE
AND SALE


2.1.          Supply of
Licensed Products.  Subject to the
provisions of this Agreement and the License Agreement, during the Term, ANIKA
and its Affiliates shall manufacture and supply GALDERMA in the Territory on an
exclusive (except as set forth in the License Agreement or this Agreement)
basis with those quantities of the Licensed Products as ordered by GALDERMA
pursuant to and in accordance with the terms of this Agreement, and GALDERMA
and its Affiliates shall purchase exclusively (except as set forth in the
License Agreement or this Agreement) from ANIKA (which includes permitted
sublicensees of ANIKA pursuant to Section 2.2) 100% of GALDERMA’s requirements
for the Licensed Products to be sold subject to the ordering procedures set
forth in Article IV.  ANIKA’s associated
responsibilities shall include:


(a)           reception, control and storage of raw
materials and work-in process inventory;



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(b)           manufacturing, packaging and storage
of the Licensed Products until delivery pursuant to Article IX;


(c)           control and testing of the finished
Licensed Products to the extent required by Applicable Law or pursuant to the
terms of this Agreement or the License Agreement;


(d)           decision to release batches of the
Licensed Products for delivery;


(e)           delivery of the Licensed Products in
accordance with Article IX;


(f)            storage of batch records and
retention samples to the extent required by Applicable Law or pursuant to the
terms of this Agreement or the License Agreement; and


(g)           file maintenance to the extent required
by Applicable Law or pursuant to the terms of this Agreement or the License
Agreement.


2.2.          Permitted
Sublicensees.  Notwithstanding any
provision in this Agreement or the License Agreement, ANIKA shall be permitted
to sublicense or outsource to Affiliates or Third Parties the manufacturing and
supply of the Licensed Products; provided, however, that ANIKA
shall be responsible for the compliance by such sublicensees with all
applicable terms of this Agreement and the License Agreement and bear all the
related costs that ANIKA is obligated to bear under this Agreement and the
License Agreement.  ANIKA shall consult
with the Steering Committee with respect to the selection by ANIKA of any such
Third Party sublicensees, provided that ANIKA’s sole obligation with
respect to any comments or observations made by the Steering Committee is to
consider such comments or observations in good faith.


2.3.          Compliance with
Applicable Law.  ANIKA shall comply
in all material respects with all Applicable Laws relating to the manufacture
and supply of the Licensed Products being provided hereunder, including,
without limitation, those enforced by the United States Food and Drug
Administration (including compliance with cGMP) and International Standards
Organization Rules 9000 et seq., it being understood by the Parties that, upon
delivery of the Licensed Products to the Shipping Point in accordance with
Article IX, responsibility for compliance with all Applicable Laws with respect
to such delivered Units of Licensed Products shall shift to GALDERMA, and
thereafter GALDERMA shall comply in all material respects with all Applicable
Laws relating to the storage and distribution of the Licensed Products.


2.4.          ANIKA Marketing
Support; Samples.  ANIKA agrees to
assist GALDERMA’s commercialization effort by providing Samples at the Price
Per Sample set forth on Exhibit A and in such quantities as GALDERMA
shall reasonably request and order pursuant to the ordering procedures set
forth in Article IV and pay for pursuant to the payment terms provided for in
Article III; provided, however, that (i) such quantity of Samples
of the Current Licensed Product shall not in the aggregate exceed
[****************]; (ii) such quantity of Samples of the Current Licensed
Product for each calendar year thereafter shall not exceed the greater of (A)
the number of Units in a sampling plan prepared annually by GALDERMA and
approved by the Steering Committee or (B) [****************] of the number of
Units of Current Licensed Product sold worldwide during such calendar year
calculated on a quarterly basis by 



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extrapolating
the actual number of Units of Current Licensed Product sold worldwide year to
date in order to reasonably estimate the number of Units of Current Licensed
Product expected to be sold worldwide during such calendar year (taking into
account expected sales trends); and (iii) ANIKA is not required to provide
Samples with respect to any Sales Territory until at least one Regulatory
Approval has been received in one country in such Sales Territory.  GALDERMA agrees that the Samples shall be
used solely for marketing purposes in accordance with Applicable Law, and
GALDERMA shall not sell, or offer for sale, or otherwise permit its Affiliates
or distributors to sell or offer for sale, the Samples.


ARTICLE III - PRICING AND
PAYMENT TERMS


3.1.          Pricing.  GALDERMA shall pay ANIKA for the Licensed
Products in accordance with the prices set forth in Exhibit A hereto.


3.2.          Payment Terms.


(a)           The Per Unit Price payments shall
become due and payable by GALDERMA no later than thirty (30) days after
GALDERMA has received an invoice for any Licensed Product.  GALDERMA agrees that receipt of an invoice by
facsimile transmission shall be treated as receipt of an original invoice for
purposes of this Agreement.  GALDERMA
shall make the Per Unit Price payments hereunder to ANIKA within the above
referenced thirty (30) day period in accordance with written instructions
delivered to GALDERMA by ANIKA from time to time.


(b)           GALDERMA shall keep accurate records
in sufficient detail to enable the Per Unit Price payments payable hereunder to
be determined.  GALDERMA shall be
responsible for all such payments and late payments that are due to ANIKA
pursuant to the terms of this Agreement. 
Any past due amounts for any overdue payment to either Party pursuant to
any provision of this Agreement will be subject to a late fee of one percent
(1%) per month, or the highest rate allowed by law, whichever is less, with
such interest accrual commencing on the thirtieth (30th) day after the applicable due
date.  All costs of enforcing or
collecting payment hereunder, including attorneys’ fees and expenses and court
costs, shall be paid by the non-prevailing Party.  Breach for non-payment commences on the
forty-sixth (46th) day
following the due date assuming the invoice is materially accurate; provided,
however, that GALDERMA shall promptly notify ANIKA of any material inaccuracies
in any ANIKA invoice received by GALDERMA.


ARTICLE IV - FORECASTS;
ORDERS


4.1.          No later than ninety
(90) days prior to the anticipated date of first delivery of the first Licensed
Product, GALDERMA shall provide ANIKA with its initial written forecast of
GALDERMA’s anticipated requirements for such Licensed Product by SKU for each
of the first twelve (12) months following such date of first delivery (such
initial forecast and all future forecasts herein referred to as a “Forecast”
or the “Forecasts”); provided, however, that such 



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initial Forecast shall not provide for delivery of
more than [****************] Units of such Licensed Product per month in the
first [****************] of such Forecast without ANIKA’s written consent.  From and after the delivery of the initial
Forecast, no later than fifteen (15) days prior to the commencement of each
calendar month during the Term, GALDERMA shall provide ANIKA with a revised
Forecast by SKU covering each of the following twelve (12) months.  With respect to all Forecasts issued to ANIKA
by GALDERMA pursuant to the terms hereof, (i) [****************] of the
first and second months, (ii) [****************] of the third and fourth
months, and (iii) [****************] of the fifth and sixth months, in each
case shall become binding on the Parties on a rolling basis and constitute a
firm order for Licensed Products, regardless of receipt by ANIKA of GALDERMA’s
actual Purchase Orders, it being understood and agreed that each Forecast shall
reflect at least the quantities that are binding on the Parties pursuant to the
foregoing thresholds and no more than the maximum quantities contemplated by
the first sentence of Section 4.2 below. 
For example, if the first Forecast provides for a quantity of [********]
Units in the third month of such Forecast, no subsequent Forecast shall provide
for a quantity with respect to such month of less than [*****] Units or more
than [******] Units.  Each Forecast will
indicate the delivery dates for the Licensed Products, and the delivery dates
for the first [*******************] will be binding on the Parties as indicated
in such Forecast; provided, however, that such delivery dates for the
number of Units of Licensed Product forecasted for a month in the then current
Forecast must fall within such month, unless the Parties otherwise agree in
writing to alternative delivery dates.


4.2.          Subject to the binding commitment
incurred pursuant to each Forecast pursuant to Section 4.1, GALDERMA shall
place specific binding orders for Licensed Product by the issuance of separate purchase
orders to ANIKA, which may be in written or electronic form or by any other
means agreed to by the Parties and shall be binding on ANIKA to the extent that
such purchase orders [*******************] by SKU by month of the applicable
Forecast with respect to the first and second months of such Forecast,
[************] by SKU by month of such Forecast with respect to the third and
fourth months, and [**********] by SKU by month of such Forecast with respect
to the fifth and sixth months (the “Purchase Orders”).  If GALDERMA requests a quantity of Licensed
Product that exceeds the binding portion of a given Forecast, the Parties agree
in good faith to negotiate additional quantities and associated delivery dates.  The Purchase Orders shall designate the
desired SKU’s and quantities of Licensed Products (subject to the requirements
of this Section 4.2), delivery dates (subject to the last sentence of Section
4.1) and destinations.  The minimum
Purchase Order quantity by SKU shall be [*************] Units.  GALDERMA shall issue written Purchase Orders
for Licensed Products to ANIKA at least sixty (60) days prior to the requested
delivery dates.


4.3.          In the event that
GALDERMA shall fail to place sufficient Purchase Orders to satisfy the binding
order commitment incurred pursuant to any Forecast, such Purchase Orders shall
be deemed to have been submitted by GALDERMA, and ANIKA shall deliver such
Licensed Products to GALDERMA.


4.4.          To the extent of any
conflict or inconsistency between this Agreement and any Purchase Order,
purchase order release, confirmation, acceptance or any similar document, the
terms of this Agreement shall govern.



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ARTICLE V - PURCHASE
COMMITMENTS


5.1.          Exclusive of any
Samples and notwithstanding any other provision in this Agreement, but subject
to the satisfaction of the Condition Precedent to Commercial Sale in the United
States and in at least one or more of the countries in Europe within the
Initial Marketing Territory, GALDERMA irrevocably hereby [***************************************

***************************] after the first Date of First Sale, pursuant to
the terms of this Agreement and the License Agreement.


5.2.          In each calendar
year during the Term commencing with [****************], GALDERMA annually
shall purchase the minimum number of Units of Licensed Products that is equal
to [****************] of GALDERMA’s annual corporate sales budget for the
Licensed Products (which budget shall be prepared on a Sales Territory by Sales
Territory basis and in good faith by GALDERMA, is the same budget that GALDERMA
will use for internal reporting purposes and has been delivered to ANIKA no
later than [****************] of the prior year) for each Sales Territory in
which GALDERMA has begun Commercialization by [****************] of such prior
year (as to any such Sales Territory, the “Annual Minimum Purchase
Commitment”).


5.3.          Upon sixty (60) days’
written notice to GALDERMA, ANIKA shall have the right to terminate all of
GALDERMA’s rights and obligations under this Agreement and the License
Agreement with respect to any Sales Territory in which GALDERMA fails to meet
its calendar year Annual Minimum Purchase Commitment and such failure shall not
have been cured in accordance with the provisions of this Section 5.3, and
thereafter the definition of Territory shall not include such Sales Territory
for all purposes under this Agreement and the License Agreement.


(a)           Notwithstanding the foregoing
sentence, ANIKA shall not exercise such termination right with respect to any
Sales Territory if:


(i)            prior to the expiration of such
sixty (60)-day notice period, GALDERMA indicates in writing its commitment to
purchase during the calendar year following the calendar year in which the
default occurred, an amount, in addition to the amounts required to be
purchased by GALDERMA during such following calendar year pursuant to Article
IV, equal to one hundred percent (100%) of the difference in such prior period
between the amount necessary to have been purchased for such Sales Territory
and the amount actually purchased for such Sales Territory (the “Additional
Amount”); provided, however, that if the Additional Amount is
not in fact purchased from ANIKA during such calendar year, then ANIKA shall
have the full power and authority under this Agreement to exercise the
termination right set forth in this Section 5.3 as of the end of such calendar
year, upon sixty (60) days’ written notice; provided, further, however,
that if within such calendar year, ANIKA cannot manufacture and deliver an
additional number of Units of Licensed Product equal to the Additional Amount,
then ANIKA shall extend such period by an additional period of time as is



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necessary to permit ANIKA to produce and
deliver such number of additional Units of Licensed Product; and


(ii)           the Annual Minimum Purchase
Commitment for the Sales Territory at issue for the year following the calendar
year in which the default occurred shall be no less than the Annual Minimum
Purchase Commitment for such Sales Territory for the prior calendar year; provided,
however, that if the market for the Licensed Products in the Sales
Territory (taken as a whole) in which GALDERMA failed to meet its calendar year
Annual Minimum Purchase Commitment has been adversely impacted by events not
primarily caused by GALDERMA or any of its Affiliates (e.g.,
through the introduction of generic alternatives to the Licensed Products) and
such events are materially interfering with the ability of GALDERMA or its
Affiliates to sell the Licensed Products in such Sales Territory, then the
Annual Minimum Purchase Commitment for the Sales Territory at issue for the
year following the calendar year in which such default occurred shall be set by
the Steering Committee.


(b)           Without the prior written consent of
ANIKA, GALDERMA shall avail itself of the relief provided in Section 5.3(a)
only twice per Sales Territory during the Term, but in no event shall such
relief be available for consecutive calendar years.


5.4.          The Parties
acknowledge and agree that to the extent this Agreement or the License
Agreement contemplates relief of GALDERMA’s obligations under this Article V
with respect to a given country, such relief shall be granted by means of a
proportionate reduction in the Annual Minimum Purchase Commitment with respect
to the applicable Sales Territory based on the Net Sales in such country
relative to the Net Sales in all other countries in such Sales Territory, in
each case during the preceding twelve (12) calendar months.


ARTICLE VI - SECOND
SOURCE OF SUPPLY


6.1.          Second Source of
Supply.  Upon GALDERMA’s request but
provided that worldwide Net Sales for the twelve (12) month period immediately
preceding such request exceed [****************], ANIKA within nine (9) months
of such request shall develop a plan and budget for a qualified second source
of supply capable of supplying Licensed Products (the “Second Source
Supplier”) and shall submit such plan and budget to the Steering Committee
for its approval.  Such Second Source
Supplier shall be under the control of ANIKA and may be an alternative Facility
owned by ANIKA or consist of one or more sub contractor relationships with
Third Parties established by ANIKA.  If
such Second Source Supplier involves a Third Party, ANIKA’s obligation to
establish a second source relationship with such Third Party will be subject to
such Third Party agreeing in writing to be bound by the terms of a
confidentiality and non-disclosure agreement satisfactory to ANIKA.  Upon approval by the Steering Committee of
the plan and budget for a Second Source Supplier, GALDERMA shall be responsible
for all reasonable and reasonably documented costs and expenses incurred by
ANIKA in establishing and maintaining such Second Source Supplier.  If such costs exceed the budget approved by
the Steering Committee, then such excess shall be borne by 



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(i) GALDERMA,
if such excess resulted from a change in the agreed plan requested by GALDERMA
or the Steering Committee or requested by ANIKA and agreed to by GALDERMA or
(ii) ANIKA, if such excess resulted from any mismanagement of the agreed upon
budget.


6.2.          Preparedness for
Force Majeure Events.  By
[****************], ANIKA will use commercially reasonable efforts to prepare
and present to GALDERMA for its review a force majeure preparedness and
business continuity plan, the goal of which will be to reduce, to the extent
reasonably practicable, disruptions in the supply of Licensed Products by ANIKA
to GALDERMA.  ANIKA’s sole obligation
with respect to any comments or observations made by GALDERMA pursuant to its
review of such plan is to consider such comments and observations in good
faith.


ARTICLE VII -
SPECIFICATIONS; IMPROVEMENTS


7.1.          Specifications.  ANIKA agrees that it shall manufacture the
Licensed Products in accordance with the Specifications.


7.2.          Change in
Specifications.


(a)           Either Party shall have the right to
request a change to the Specifications during the Term.  In such event, the Party wishing to request a
change shall notify the other Party of its request in writing.  If the receiving Party agrees to such
request, the Parties shall cooperate with each other to have such change to
such Specifications or packaging of the Licensed Product approved by the FDA or
other regulatory agency (if necessary). 
ANIKA shall not be obligated to make any changes to such Specifications
of the Licensed Products requested by GALDERMA, unless such changes are
approved by the Steering Committee in accordance with the License Agreement.  In the case of any approved changes to
Specifications of the Licensed Products requested by GALDERMA or required by
the FDA or other regulatory agency, GALDERMA shall reimburse ANIKA for all
ANIKA’s reasonable and reasonably documented costs related to such changes to
Specifications, including without limitation costs associated with up to six
(6) months (determined by reference to the Forecast then in effect for the
Licensed Product at issue) of Licensed Product inventory rendered obsolete by
the change in Specifications and any necessary Regulatory Approval costs.


(b)           Any disputes arising from a request
for cost-sharing or reimbursement of expenses incurred in connection with a
change in Specifications not resolved by the Parties within thirty (30) days
shall be referred to the Steering Committee for resolution; and, if not
resolved by the Steering Committee, the provisions of Article XVI of the
License Agreement shall apply to such dispute.


7.3.          Records.


(a)           ANIKA shall keep complete, accurate
and detailed original records pertaining to the manufacture, including quality
control, of the Licensed Product.



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GALDERMA shall keep, and will use its
reasonable efforts to the extent required by law to cause other GALDERMA Sellers
to keep, complete, accurate and detailed original records pertaining to the
use, storage, sale, distribution and other disposition of the Licensed Product,
including for each lot number of Licensed Product, the quantity shipped and
where the lot was shipped, so that, among other things, in the event of a
recall, GALDERMA will be able to contact all physicians and/or end users of
Licensed Products.  Each party shall keep
its respective records for at least five (5) years or for such longer period if
and as required by Applicable Law from the date of delivery or receipt, as
applicable, of each batch of Licensed Product to which said records
pertain.  For validation batches, each
Party shall keep the documents throughout the commercial life of the relevant
Licensed Products.


(b)           Each Party shall make available such
records (including making copies thereof) to the other Party for such lawful
purpose as such other Party may reasonably request in writing.


ARTICLE VIII - PACKAGING


8.1.          GALDERMA, with the
approval of the Steering Committee, shall have the right to determine the
appearance of any labeling and packaging consistent with the approved label
used in connection with the Licensed Product in the Territory.


8.2.          GALDERMA shall pay
all of the costs associated with the design of the labeling and packaging for
the Licensed Product.  In determining the
labeling for the Licensed Product, GALDERMA shall have the right to use its
corporate and/or trade name(s) and its own trademark(s) and to determine the
general design and appearance of said labeling. 
ANIKA’s corporate name shall be displayed on Licensed Product
packaging.  ANIKA shall be responsible
for procurement of the packaging materials and ensuring that the appearance of
any labeling and packaging meets the requirements of any approved
specifications.


8.3.          Once the initial
labeling and packaging has been decided upon and confirmed in writing, ANIKA
shall not be required to make subsequent changes to such labeling, including
any changes required by any applicable regulator, unless GALDERMA agrees to pay
all additional costs associated with the implementing of changes and to pay
ANIKA’s reasonable and reasonably documented costs related to such labeling or
packaging changes, including without limitation costs associated with up to six
(6) months (determined by reference to the Forecast then in effect for the
Licensed Product at issue) of packaging inventory rendered obsolete by the
change in labeling or packaging.  Notwithstanding
the foregoing, if any changes are required to be made to the packaging or
labeling as a result of changes requested by ANIKA, ANIKA shall bear the
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ARTICLE IX - DELIVERY


9.1.          Shipment.


(a)           ANIKA shall deliver the Licensed
Products to the Shipping Point and assist in shipping the Licensed Product to
GALDERMA or to such other location as designated in writing by GALDERMA and
acknowledged by ANIKA by such mode of transportation as GALDERMA shall direct
and pursuant to the validated transportation specifications to ensure Licensed
Products’ quality (including packaging and temperature).  At the time of such delivery, (i) [*************************************************************

************], and (ii) each Licensed Product with any other shelf
life shall have at a minimum eighty percent (80%) of such shelf life
remaining.  All charges for packing,
handling, hauling, storage, bar coding and transportation to the Shipping Point
are included in the Per Unit Price unless otherwise agreed to by the Parties in
writing.


(b)           The risk of loss and damage with
respect to Licensed Product shall remain with ANIKA through production until
Licensed Product is picked-up by GALDERMA’s carrier at ANIKA’s Facility (the “Shipping
Point”).  Shipping terms will be Ex
Works (EXW) per INCOTERMS 2000.  ANIKA
will pack all Licensed Product ordered hereunder in a manner suitable for
shipment and sufficient to enable the Licensed Product to withstand the normal
effects of shipping, including handling during loading and unloading.  GALDERMA shall be responsible for designating
the carrier(s) and negotiating terms for shipment of Licensed Product with ANIKA’s
insights and recommendations, and shall be responsible for payment of all
transportation charges, shipping insurance, handling, storage, taxes, custom
duties and fees and all other charges incident to the storage and movement of
the Licensed Products in commerce subsequent to delivery by ANIKA to the
Shipping Point.  ANIKA agrees not to
direct the shipment of any Licensed Product to GALDERMA or any other location
other than as directed by GALDERMA.  In
the event any of said charges are paid by ANIKA, with the approval of GALDERMA,
ANIKA shall invoice GALDERMA therefor, and GALDERMA shall remit said amount(s)
to ANIKA not later than thirty (30) days after the date of invoice.


9.2.          Certificates of
Analysis.  At the time of delivery, ANIKA
shall provide GALDERMA with a certificate of analysis for each batch of the
Licensed Product delivered confirming that each batch of Licensed Product
complies with the applicable Specifications, and containing a statement of
conformance confirming that each batch of product complies with the cGMP.


ARTICLE X - MANUFACTURING
INSPECTIONS


10.1.        Inspection by
GALDERMA.  During the Term, GALDERMA
retains the right to perform independent quality assurance audits of the
Facility where the Licensed Products are manufactured and of the procedures and
capabilities relating to the manufacture of the Licensed Product.  Such audits shall include, without
limitation, inspection of manufacturing, laboratory and storage facilities, any
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all records
relating to such manufacturing.  Such
audits shall not unreasonably disrupt the normal operations of ANIKA.  Such audits shall be conducted during normal
business hours upon at least twenty (20) Business Days prior written notice and
shall be limited to not more than one(1)  visit per year, except in the
event of a Recall of the Licensed Product not caused by GALDERMA or
governmental action involving the Licensed Product, in which case GALDERMA
shall have the right to one (1) additional audit visit per such Recall or
governmental action.  Observations and
conclusions of such audits will be issued by GALDERMA and discussed with ANIKA,
and the Parties may agree upon what, if any, corrective actions will be
implemented by ANIKA in response to such observations and conclusions.  ANIKA shall implement any such agreed-to
corrective actions as soon as practicable at its expense.  The cost of all such audits shall be borne by
GALDERMA.


10.2.        Inspection by ANIKA.  ANIKA shall have the right to visit GALDERMA’s
or GALDERMA’s Sellers’ facilities where the Licensed Product is stored or
delivered from time to time during the Term to perform a quality audit of
GALDERMA’s records concerning storage and distribution (including shipping and
handling) of the Licensed Products.  Such
audits shall include, without limitation, inspection of distribution and
storage facilities, all equipment and machinery and all records relating to such
storage and distribution.  Such audits
shall not unreasonably disrupt the normal operations of GALDERMA.  Such audits shall be conducted during normal
business hours upon at least twenty (20) Business Days prior written notice and
shall be limited to not more than one (1) visit per year, except in the event
of a Recall of the Licensed Product not caused by ANIKA or governmental action
involving the Licensed Product, in which case ANIKA shall have the right to one
(1) additional audit visit per such Recall. 
Observations and conclusions of such audits will be issued by ANIKA and
discussed with GALDERMA, and the Parties may agree upon what, if any,
corrective actions will be implemented by GALDERMA in response to such
observations and conclusions.  GALDERMA shall
implement any such agreed-to corrective actions as soon as practicable at its
expense.  The cost of all such audits
shall be borne by ANIKA.


10.3.        Governmental
Inspection.  ANIKA hereby agrees to
notify GALDERMA promptly of any inspection of the Facility where the Licensed
Products are manufactured or any manufacturing process or procedures relating
to the Licensed Product by any relevant governmental authority to the extent
that such inspection pertains to the Licensed Products and ANIKA has sufficient
advance notice thereof.  ANIKA shall promptly,
and in any event within ten (10) Business Days, provide GALDERMA with a copy of
any correspondence or documents issued by the relevant governmental authority
relating to the inspection promptly after such correspondence or documents have
been received by ANIKA.  ANIKA agrees to
implement reasonable compliance requests pertaining to the Licensed Products as
directed by any governmental authority.



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ARTICLE XI - PRODUCT
INSPECTION; NON-CONFORMING PRODUCT


11.1.        Licensed Product
Inspection.


(a)           GALDERMA shall promptly upon receipt
inspect all shipments of the Licensed Product.


(b)           In the event that GALDERMA reasonably
believes that any portion of the Licensed Product delivered to GALDERMA by
ANIKA fails to conform with any Specification, GALDERMA may reject all or a
portion of the same by giving written notice to ANIKA within thirty (30) days
of GALDERMA’s receipt of the Licensed Product and may not so reject after
thirty (30) days from GALDERMA’s receipt of the Licensed Product.  Such notice shall evidence GALDERMA’s claims
of nonconformity of the Licensed Product with an analysis of the allegedly
nonconforming Licensed Product that shall have been prepared by GALDERMA or its
agent.  Such report shall be accompanied
with a copy of the records pertaining to such testing and a sample of the
Licensed Product from the batch analyzed. 
If the non-conformity is due to damage to the Licensed Product caused
subsequent to ANIKA’s delivery to a common carrier at ANIKA’s Shipping Point,
ANIKA shall have no liability to GALDERMA with respect thereto.


(c)           If, after its own analysis of a
sample stored by ANIKA from such lot of the Licensed Product (which such sample
ANIKA is required to retain) (the “Retained Sample”), ANIKA confirms such
nonconformity, ANIKA shall, at GALDERMA’s election (which election shall be
communicated in writing to ANIKA no later than ten (10) Business Days after
GALDERMA’s rejection of such Licensed Product pursuant to Section 11.1(b)),
either replace the nonconforming Licensed Product with a conforming Licensed
Product as soon as reasonably practicable at ANIKA’s expense or refund to
GALDERMA the entire Per Unit Price therefor; provided, however,
that, if GALDERMA elects to have ANIKA replace such nonconforming Licensed
Products, then upon all such occurrences ANIKA shall be obligated to use no
more than commercially reasonable efforts to replace such nonconforming
Licensed Products.  Except as set forth
in Section 13.2(a) of the License Agreement, the foregoing, and the rights
under this Article XI, shall be GALDERMA’s sole and exclusive remedy with
respect to such nonconformity, unless this Agreement and the License Agreement
are terminated pursuant to Section 13.2(a), in which case GALDERMA shall be
entitled to all available remedies in respect of any breach of this Agreement
or the License Agreement.  The
nonconforming Licensed Product shall either be returned to ANIKA, at ANIKA’s
request, or destroyed by GALDERMA, in each case at ANIKA’s expense.


(d)           If, after ANIKA’s own analysis, ANIKA
does not confirm such non-conformance to the Specifications or whether the
Retained Sample of the Licensed Product has such a defect, either Party may
deliver the Licensed Product to an independent Third-Party laboratory, mutually
and reasonably acceptable to both Parties, for analytical testing to confirm
the Retained Sample of the Licensed Product’s conformance to the Specifications
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associated with such Third-Party testing
shall be at GALDERMA’s expense unless the tested Retained Sample of the
Licensed Product is deemed by such Third-Party to be materially defective or
not in compliance with the Specifications, in which case all such costs, including
reimbursement of freight and disposition costs, shall be paid by ANIKA.


(e)           Except as provided in Section
11.1(b), no inspection or testing of or payment for Licensed Product by
GALDERMA or any Third-Party agent of GALDERMA shall constitute acceptance by
GALDERMA thereof, nor shall any such inspection or testing be in lieu or
substitution of any obligation of ANIKA for testing, inspection and quality
control as provided in the Specifications or under applicable local, state, or
federal laws, rules, regulations, standards, codes or statutes.  In the event that any such shipment or batch
thereof is ultimately agreed or found to meet the Specifications, GALDERMA
shall retain such shipment or batch, and all the terms and conditions of this
Agreement and the License Agreement shall continue to apply to such Licensed
Product.


ARTICLE XII - CORRECTIVE
ACTION


12.1.        Reportable Events.  ANIKA shall be responsible for notifying all
applicable regulatory authorities of reportable events (including without
limitation complaints) involving the Licensed Product for which ANIKA receives
written notification, as required by Applicable Law.  GALDERMA shall notify ANIKA of potentially
reportable events promptly but in no event later than twenty-four (24) hours
after it receives notice of such event. 
In addition, all such notices shall be consistent with the requirements
of law in the applicable jurisdictions.


12.2.        Licensed Product
Complaints.  The Parties shall
determine which Party shall be responsible for complaint investigation by
reference to their respective responsibilities under Applicable Law.  Each Party shall promptly communicate to the
other Party by facsimile, telephone or email (and confirm any such telephone
communication as instructed at the time) any complaint received in respect of
the Licensed Product in the configuration supplied by the other Party.  To the extent applicable or known by the
notifying Party, each notification of a complaint shall contain, but not be limited
to, the lot number, dosage size, expiration date, indication for actual use,
description of circumstances involved in the failure of the Unit(s) in
question, and any other pertinent information available at that time to the
Party that receives such complaint.  The
Parties shall reasonably cooperate to address the complaint, including
providing access to employees with knowledge of facts pertinent to such
complaint and making available all relevant documentation.  For avoidance of doubt and notwithstanding
the foregoing, nothing in this Section 12.2 is intended to shift between the
Parties responsibilities under Applicable Law concerning complaints related to
Licensed Products.


12.3.        Safety or Efficacy
Concerns.  Each Party agrees to
notify the other Party as soon as practicable of any information of which it
becomes aware which relates to the safety or efficacy claims of the Licensed
Product.  Upon receipt of any such
information, the Parties shall consult with each other in an effort to arrive
at a mutually agreeable course of action that is consistent with the
obligations of the Parties under this Agreement and consistent with Applicable
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12.4.        Licensed Product
Recalls.


(a)           If (x) the Licensed Product is
subjected to a recall by any governmental agency or (y) either Party, after
notification to, and good faith consultation in an emergency meeting of the
Steering Committee with, the other Party (including, if requested by either
Party, in one or more face-to-face meetings), elects to make a Licensed Product
recall, withdrawal or corrective action (collectively, the “Recall”),
the expense of such Recall shall be borne as follows:


(i)            If (i) it is established that the
Licensed Product was nonconforming pursuant to Article XI upon delivery by
ANIKA to a common carrier at ANIKA’s Shipping Point, or (ii) such Recall arises
from any breach by ANIKA of the provisions of this Agreement, then ANIKA,
subject to Article XIV of the License Agreement, shall hold GALDERMA harmless
and shall bear all expenses related to the Recall, including the replacement of
the recalled or withdrawn Licensed Product, which shall be replaced as soon as
reasonably practicable.


(ii)           If such Recall arises as a result of
actions or omissions on the part of GALDERMA Sellers, or from any breach by
GALDERMA Sellers of the provisions of this Agreement, then GALDERMA, subject to
Article XIV of the License Agreement, shall hold ANIKA harmless and shall bear
all costs and expenses in connection with such Recall.


(b)           If either Party elects to make a
Licensed Product Recall, the other Party shall reasonably cooperate in good
faith with the electing Party to effect such Recall.  Upon any Recall due to safety concerns
(unless such Recall arises under the circumstances described in Section
12.4(a)(ii)), GALDERMA shall be relieved of its obligations under Section
12.1(j) of the License Agreement and Article V hereof during the continuation
of such Recall solely for the country in which such Recall was effected, provided
such Recall materially interferes with GALDERMA’s ability to sell the Licensed
Products in such country.  If such safety
concern, which (for the avoidance of doubt) excludes concerns arising under the
circumstances described in Section 12.4(a)(ii), has a material adverse effect
on aggregate Net Sales of the Licensed Products in any Sales Territory (taken
as a whole), GALDERMA shall have the further right to terminate all of its
rights and obligations under this Agreement and the Supply Agreement with
respect to such Sales Territory so that thereafter the definition of Territory
shall not include such Sales Territory for all purposes under this Agreement
and the Supply Agreement.


ARTICLE XIII - INSURANCE


13.1.        Each Party agrees to
procure and maintain in full force and effect during the Term valid and
collectible insurance policies in connection with its activities as
contemplated hereby, which policies shall be in compliance with Exhibit B
attached hereto, provided that GALDERMA 
shall procure such insurance with respect to the United States as
promptly as practicable (and in any event within two (2) months following the
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other Party’s
request, each Party shall provide the other with a certificate of coverage or
other written evidence reasonably satisfactory to the requesting Party of such
insurance coverage.


ARTICLE XIV -
COORDINATION WITH LICENSE AGREEMENT


14.1.        Article VII
(Publication; Transfer of Data; Confidentiality; Cooperation), Article X
(Representations and Warranties), Article XIII (Term and Termination), Article
XIV (Indemnification), Article XVI (Dispute Resolution) and Article XVII
(Miscellaneous) of the License Agreement are incorporated into this Agreement
by reference to such articles.  For
avoidance of doubt, the incorporation of Article XIII (Term and Termination) of
the License Agreement into this Agreement by reference means that this
Agreement is coterminous with the License Agreement.


ARTICLE XV - GUARANTY


15.1.        PARENT irrevocably guarantees the full and timely
performance by GALDERMA, and each of its successors and assigns that are
Affiliates of PARENT, of all its obligations under this Agreement, as now or
hereafter amended, restated, supplemented or otherwise modified from time to
time, in favor of ANIKA and each of its successors and assigns, and hereby
undertakes that if GALDERMA, or its successors or assigns, shall in any respect
fail to perform and observe all of the terms, provisions, conditions and
stipulations of this Agreement (the “Obligations”), PARENT shall perform
or have performed all such Obligations as required by this Agreement without
any requirement that ANIKA first proceed against GALDERMA or resort to any
other means to collect or receive the benefit of the Obligations.  Claims hereunder may be made on one or more
occasion.  The obligations of PARENT
under this Article XV shall be primary, absolute and unconditional obligations
of PARENT and shall not be subject to any counterclaim, set-off, deduction, diminution,
abatement, recoupment, suspension, deferment, reduction or defense based upon
any claim PARENT may have against GALDERMA.


 


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1.1.          IN WITNESS WHEREOF,
the undersigned have duly executed and delivered this Agreement as a sealed
instrument effective as of the date first above written.


	
  

  	
   

  	
   

  
	
  GALDERMA S.A.

  	
   

  	
  ANIKA THERAPEUTICS, INC.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
  /s/ Humberto C. Antunes

  	
   

  	
  By:

  	
   

  	
  Charles H. Sherwood

  
	
   

  	
   

  	
  Name: Humberto C. Antunes

  	
   

  	
   

  	
   

  	
  Name: Charles H. Sherwood, Ph.D

  
	
   

  	
   

  	
  Title: President and CEO

  	
   

  	
   

  	
   

  	
  Title: President and CEO

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  GALDERMA PHARMA S.A.

  	
   

  	
   

  	
   

  	
   

  
	
  (with respect to Article 15 only)

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
   

  	
  /s/ Humberto C. Antunes

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Name: Humberto C. Antunes

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Title: President and CEO

  	
   

  	
   

  	
   

  	
   

  



 















 


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EXHIBIT A


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EXHIBIT B


Insurance
Requirements


Each Party shall procure and maintain, at all times,
and at its own expense, until final completion of the work covered by this
Agreement, and during the time period following termination if either Party is
required to return or perform additional work, for any reason whatsoever, the
types of insurance(s) specified below.


A.            Commercial General Liability


Coverage on a Commercial General Liability Occurrence
Coverage Form (or equivalent) with limits of not less than $1,000,000 for each
occurrence, $5,000,000 products/completed operations aggregate, $1,000,000
personal injury/advertising injury aggregate and $2,000,000 general
aggregate.  Each Party will endeavor to
inform the other Party of any exclusions or amendments to the policy form which
would result in direct impact to such other Party.  Each Party’s policy shall be specifically
endorsed to include the other Party, its subsidiaries, and its directors,
officers and employees, as an Additional Insured, as respects negligence caused
by the first Party as a result of this Agreement.  Each Party shall supply the other Party with
proof of the above insurance and a copy of the policy(ies) as promptly as practicable
after the signing of this Agreement, but a Party’s failure to demand such proof
or forms shall not waive such Party’s rights to such coverage as specified
herein.


B.            Excess Liability


Umbrella Liability coverage with a limit of liability
no less than $5,000,000 each occurrence, $5,000,000 aggregate.



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