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EX-10.85
SUPPLY AGREEMENT
(Fluocinolone Acetonide and Fluocinonide)
THIS AGREEMENT is made and entered into by and between Medicis
Pharmaceutical Corporation, a Delaware corporation ("Buyer"), and Syntex
Pharmaceuticals International Limited, a Bermuda corporation ("Seller").
WHEREAS, Pharmaceutical Fine Chemicals S.A. ("PFC"), a Luxembourg
corporation, acquired from Seller certain assets relating to Seller's chemical
manufacturing plant at West Sunrise Highway, Freeport, Grand Bahama Island, The
Bahamas (the "PFC Plant"); and
WHEREAS, PFC manufactures and supplies to Seller the Active Ingredients
(as defined herein) upon the terms and conditions set forth in a Supply
Agreement effective February 13, 1996 between Seller and PFC (the "PFC
Agreement"); and
WHEREAS, pursuant to Asset Purchase Agreements dated January 21, 1997
between Buyer and its Affiliates and Seller or its Affiliates (the "Asset
Purchase Agreements"), Buyer and its Affiliates have purchased from Seller and
its Affiliates certain assets relating to the Syntex Dermatological Business;
and
WHEREAS, Buyer wishes to purchase Active Ingredients from Seller that
Manufacturer will be manufacturing for Seller.
NOW THEREFORE, in consideration of the representations, warranties,
covenants and agreements set forth herein, the parties hereto agree as follows:
1. DEFINITIONS
1.1 "Active Ingredient" shall mean the compounds known by the
following generic names fluocinolone acetonide and fluocinonide, in each and all
of the forms set forth on Schedule A attached hereto and incorporated herein.
1.2 "Affiliate" of a party shall mean any individual, corporation
or other business entity (e.g. limited or general partnership, trust or estate,
joint venture or association) controlling, controlled by or under common control
with such party. "Control" (including "controlling", "controlled by" and "under
common control with") shall mean the direct or indirect ownership of more than
fifty percent (50%) of the voting or income interest in such party, corporation
or other business entity respectively. Notwithstanding the foregoing, Genentech,
Inc. ("Genentech") shall not be considered an Affiliate of Seller for the
purpose of this Agreement for so long as there are material restrictions on the
ability of Seller and its Affiliates to control Genentech.
1.3 "Contract Year" shall mean the twelve (12) month period
commencing on the Effective Date and ending on the first anniversary of the
Effective Date and each consecutive twelve (12) month period thereafter during
the term hereof commencing on an anniversary of the Effective Date; provided,
however, that the third Contract Year shall terminate February 13, 1999.
1.4 "DMFs", shall mean the Type 2 Drug Master File filed by Seller
or an Affiliate of Seller with the FDA.
1.5 "Effective Date" shall mean the Closing Date as defined in the
Asset Purchase Agreements.
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1.6 "FDA" shall mean the United States Food and Drug
Administration.
1.7 "Manufacturer" shall mean PFC, or any other manufacturer
designated pursuant to the terms of Article 10.
1.8 "NADA" shall mean New Animal Drug Application.
1.9 "NDA" shall mean New Drug Application.
1.10 "Plant" shall mean the PFC Plant, or, if applicable, the plant
of any other Manufacturer.
1.11 "Quarter" shall mean each of the three (3)-month periods
commencing with the first, fourth, seventh and tenth months of a calendar year.
1.12 "Requirements" means all quantities of the Active Ingredient
required by Buyer and its Affiliates for their own use in manufacturing the
Products or having the Products manufactured by a third party for sale in the
Territory.
1.13 "Safety Stock" shall have the meaning set forth in Section
5.4.
1.14 "Territory" means the United States, Canada and Puerto Rico.
2. SUPPLY AND PURCHASE
Subject to the terms and conditions of this Agreement, during the term
of this Agreement, Manufacturer shall manufacture and Seller shall supply the
Active Ingredient to Buyer in bulk form and Buyer (or an Affiliate of Buyer)
shall purchase Buyer's Requirements of the Active Ingredient exclusively from
Seller; provided that Buyer's obligation to purchase its Requirements from
Seller shall terminate on February 13, 1999. Seller shall use all reasonable
efforts to induce PFC to enter into an agreement with Buyer to manufacture and
sell to Buyer the Active Ingredients following February 13, 1999, on terms not
substantially less favorable than those currently being provided by PFC to
Seller (giving due regard to the volume of Buyer's purchases). Notwithstanding
Buyer's obligations to purchase its requirements of Active Ingredients
exclusively from the Seller, Buyer may purchase the Active Ingredient from
third parties during any time period in which Seller (i) is in material breach
of this agreement and such breach results in Seller's failure to supply Active
Ingredients to Buyer or (ii) contends that its performance is excused pursuant
to the provisions of Section 15.1. Nothing in this Agreement shall prohibit
Buyer from taking such actions as Buyer in its sole and exclusive discretion,
deems necessary and appropriate to qualify with the FDA or other regulatory
agencies one or more additional facilities to manufacture the Active
Ingredients.
3. GOVERNMENTAL AUTHORIZATIONS
Seller shall manufacture or shall cause to be manufactured the Active
Ingredient in accordance with the detailed processes and procedures described
in all currently approved product license applications for the Active Ingredient
in the Territory (including without limitation, as applicable, the DMFs, NDAs
and NADAs pertaining thereto). No changes will be made to the manufacturing
process(es), testing procedures, or packaging and labeling and storage
conditions used to manufacture and store such Active Ingredient, and/or prepare
such Active Ingredient for shipment, that are outside the scope of, and thus not
permitted by, such currently approved product license applications without the
prior written notice to and consent of Buyer, which consent may not be
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unreasonably withheld or delayed.
4. ACCESS TO FACILITIES AND RECORDS
4.1 Plant. Seller shall exercise all rights it has under the PFC
Agreement to procure the same access rights for Buyer to the Plant. On a
periodic basis, but no more frequently than twice per calendar year, Seller
shall endeavor in good faith to procure access, on reasonable notice during
regular business hours, for representatives of Buyer to have access to the
facilities at the Plant utilized in the manufacture, analysis, packaging, and
storage of the Active Ingredients (and any raw materials and intermediates
pertaining thereto). Seller also shall endeavor in good faith to procure access
on such visits to the written records relating to the manufacture, analysis,
packaging, storage, and stability and regulatory compliance procedures for the
Active Ingredients (and any raw materials and intermediates pertaining thereto).
Notwithstanding the foregoing, if additional visits are required because of a
particular problem or concern, Seller shall endeavor to arrange such additional
visits on reasonable notice during regular business hours. Without limiting the
foregoing, Seller shall provide Buyer with copies of, or oral notification of if
not in writing, any notice, communication or other information received by
Seller pursuant to Article 4 of the PFC Agreement and any comparable notice,
communication or other information received by Seller from a Manufacturer other
than PFC. Seller shall endeavor in good faith to have an individual at PFC
appointed with whom Buyer may directly communicate concerning the Active
Ingredient and will inform Buyer in writing upon such appointment.
4.2 Records. Seller will supply to Buyer copies of any documents
(e.g., batch records, stability data) received from Manufacturer relating to
the Good Manufacturing Practice ("GMP") compliance of the Plant and the
manufacture of the Active Ingredients and will, upon the reasonable request of
Buyer, request such documents and information from Manufacturer and forward them
to Buyer. Seller will promptly notify Buyer of any significant changes in
manufacturing, including changes in the manufacturing process, synthesis,
packaging, and test methods (unless compendial) and will provide Buyer with the
necessary DMF and NDA authorization documents. Additionally, Seller will
promptly notify Buyer of and provide Buyer with copies of any correspondence
relating to regulatory actions concerning the DMFs for the Active Ingredients
and any regulatory activities concerning the Plant which materially affect the
Active Ingredients.
5. ORDERING PROCEDURES
5.1 Orders and Forecasts. Buyer shall place orders for the Active
Ingredients in a manner as to allow for the efficient scheduling of production
and, subject to the provisions hereof, Seller shall fill such orders received
in writing from Buyer. At least ninety (90) days prior to the start of each
Quarter, Buyer shall provide Seller in writing with (a) its firm order of the
total amount of the Active Ingredients to be ordered for shipment during such
Quarter and (b) its non-binding estimate of the total amount of the Active
Ingredients that may be ordered for shipment during each of the next three (3)
Quarters (each such estimate after the first estimate containing an updating of
the estimates for the last two (2) Quarters of the preceding estimate and adding
an estimate for the next succeeding Quarter). The first such estimate shall be
made by Buyer concurrently with the execution and delivery of this Agreement and
shall cover the period from the Effective Date through June 30, 1997. In any
event, Buyer shall submit its firm orders for the Active Ingredients at least
ninety (90) days prior to the desired shipment date and Seller shall endeavor
to ship such Active Ingredients in the quantity listed in such firm order by
the specified shipment date. To the extent Buyer's total orders for shipment
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during a Quarter exceed one hundred twenty-five percent (125%) of Buyer's last
estimate for such Quarter, Seller may extend the shipment date for such excess
by such reasonable period as is required for the manufacture thereof.
5.2 Minimum Order Size. During the term hereof, individual orders
for Active Ingredient shall be not less than one (1) kilogram for fluocinolone
acetonide (milled or micronized), one hundred fifty (150) grams for fluocinolone
acetonide dihydrate (micronized), and five hundred (500) grams for fluocinonide
(milled or micronized).
5.3 Shipping. Title and risk of loss to each quantity of each
Active Ingredient supplied by Seller to Buyer hereunder shall pass to Buyer upon
delivery by Seller or its agent to Buyer's designated receiving site. The costs
of freight and insurance for each such shipment shall be borne by Seller.
5.4 Safety Stock. Buyer wishes to maintain quantities of Active
Ingredient equal to one year's supply of the Active Ingredients, in their
various forms, based upon the most recent four (4) quarters of orders and
forecasts provided to Seller pursuant to Section 5.1 of this Agreement ("Safety
Stock"). Seller shall endeavor in good faith to provide the Safety Stock to
Buyer within six (6) months of the Effective Date. The amount of Safety Stock
to be ordered and the timing of delivery of such Safety Stock shall be
determined by the Buyer in accordance with the ordering provisions of this
Article 5.
6. PRICING OF THE ACTIVE INGREDIENTS
6.1 Price. Buyer shall purchase the Active Ingredients from Seller
at the same prices as Seller or its Affiliate is purchasing such Active
Ingredients from PFC (including any discounts taken by Seller under the PFC
Agreement). Seller shall pay for all costs, insurance and freight charges for
the shipment of the Active Ingredients from Seller's point of origin to Buyer's
designated receiving site. Buyer shall be responsible and pay for any and all
customs duties, value added, excise and other taxes (excluding those paid by PFC
with respect to the Products), clearances and/or levies of any type whatsoever
with regard to the supply of the Active Ingredients from Seller hereunder. The
current prices are set forth on Schedule A. The prices for each Active
Ingredient may be changed by Seller at such time as Seller's acquisition cost is
changed pursuant to Article 6.2 of the PFC Agreement; provided that Seller
shall, upon Buyer's request, provide evidence reasonably acceptable to Buyer of
any such change.
6.2 Payment. All prices set forth herein are in United States
Dollars. Each payment due Seller for the Active Ingredients supplied hereunder
shall be made by Buyer to a bank account designated by Seller in United States
Dollars by bank transfer no later than thirty (30) days after the date of
Seller's invoice, unless such Buyer specifically designates a portion of any
shipment as Safety Stock, in which case payment due Seller for such Safety Stock
shall be made by Buyer to a bank account designated by Seller in United States
Dollars by bank transfer no later than one-hundred eighty (180) days after the
date of Seller's invoice. Seller shall invoice Buyer for the Active Ingredients
upon shipment of the Active Ingredients.
7. SPECIFICATIONS, WARRANTIES AND REMEDIES
7.1 Methods and Analysis. The analytical methods to be used in
testing for compliance with the applicable Specifications are attached hereto
as Schedule C ("Methods of Analysis"), as the same may be amended from time to
time by Seller upon the prior written notice to and consent of Buyer, which
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consent may not be unreasonably withheld or delayed.
7.2 Specifications. The specifications for each Active Ingredient
are attached hereto as Schedule B (the "Specifications"), as the same may be
amended from time to time by Seller upon the prior written notice to and consent
of Buyer, which consent may not be unreasonably withheld or delayed.
7.3 Reference Standards. Buyer shall receive from Seller
reasonable amounts of reference standards for the Active Ingredients as well as
for certain known degradation products and foreign related substances. Buyer
shall also receive from Seller as soon as possible after the Effective Date the
safety data sheets for the Active Ingredients. If Seller changes the
Specifications or the Methods of Analysis pursuant to Article 7.1 above, Seller
shall immediately furnish the changed Specifications or Methods of Analysis to
Buyer, so as to enable Buyer to comply with any regulatory requirements as a
result of such change.
7.4 Warranty.
7.4.1 PFC Agreement Warranties. Seller warrants that the
PFC Agreement is valid and in force as of the Effective Date. Seller shall use
all reasonable efforts to maintain the PFC Agreement valid and in force through
February 13, 1999.
7.4.2 Warranty with respect to Active Ingredient. Seller
warrants (i) that all quantities of each Active Ingredient supplied hereunder
shall meet the applicable Specifications at the time such Active Ingredient is
delivered to the manufacturing facility referred to in Section 5.3, or, failing
to meet such Specifications pursuant to Sections 7.5, 7.6, and 7.7 within the
time period set forth in Section 0, shall be replaced by Seller at Seller's sole
expense, and (ii) that such Active Ingredient will be manufactured in accordance
with the applicable DMF (and the process and equipment referred to therein), the
applicable GMPs and the governmental authorization(s) referred to in Section 3
and shall not be adulterated as that term is defined by the United States Food,
Drug and Cosmetic Act and the regulations promulgated pursuant thereto. No
change in the manufacturing process and/or equipment used with respect thereto
shall be made or authorized to be made by Seller unless and until approved by
Buyer in writing, which approval shall not be unreasonably withheld or delayed,
if such change would result in such Active Ingredient not being manufactured by
Seller in accordance with the applicable Drug Master File (and the process and
equipment referred to therein), the applicable GMPs and the governmental
authorization(s) referred to in Section 0.
7.5 Certificate of Analysis. For each shipment of Active
Ingredient supplied hereunder, either Seller or Manufacturer shall forward from
Manufacturer a Certificate of Analysis specifying, inter alia, the results of
each of the determinations required to show conformance of such shipment of
Active Ingredient with the applicable Specifications. The figures set forth in
such Certificate of Analysis shall be accepted as accurate for the purposes of
this Agreement unless Buyer within thirty (30) days after the first receipt of
the Active Ingredient (at Buyer's facility where the Active Ingredient will be
analyzed for compliance with the applicable Specifications) notifies Seller in
writing (facsimile notification will be satisfactory if a confirmation of such
notification is provided by the facsimile machine) that it has analyzed
representative samples from such shipment in accordance with the applicable
Methods of Analysis and has determined that such samples do not conform to such
Specifications.
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7.6 Independent Analysis. If there is a difference of opinion
concerning the conformance of any shipment of an Active Ingredient with the
Specifications for such Active Ingredient, Buyer and Seller agree to consult
with each other in order to explain and resolve the discrepancy between each
other's determinations. If, after good faith attempt by the parties to do so,
such consultation does not resolve the discrepancy, Buyer and Seller agree to
nominate an independent, reputable laboratory, acceptable to both parties, that
shall repeat the applicable Methods of Analysis on representative samples from
such shipment provided by both Buyer and Seller, and the resulting
determinations shall be binding on Buyer and Seller for the purposes hereof.
7.7 Replacement Shipment. Any shipment of Active Ingredient
alleged by Buyer not to meet such applicable Specifications therefor shall be
held without use thereof by Buyer pending the outcome of the analysis referred
to in Section 0. If so requested by Buyer in writing, Seller shall endeavor to
promptly send a new shipment of Active Ingredient (of similar quantity as to the
amount of such Active Ingredient being analyzed pursuant to Section 0) to Buyer
(at the selling price and on such other terms and conditions as set forth
herein) so as to enable Buyer to continue to manufacture the Products.
7.8 Expenses. The costs of the independent laboratory referred to
in Section 0 shall be borne by (i) Buyer if the Active Ingredient is determined
to conform to applicable Specifications, or (ii) Seller if the Active Ingredient
is determined not to conform to the applicable Specifications. Buyer shall not
be obligated to pay for any Active Ingredient that does not conform to the
applicable Specifications (and is returned to Seller after determined to be
non-conforming), but shall be obligated to pay for any new shipment of Active
Ingredient that is sent pursuant to Section 0.
8. OPERATING PROCEDURES
8.1 Seller shall report to Buyer any information or any findings
associated with the use of the Active Ingredients received from Manufacturer
that may suggest significant or unexpected hazards, adverse reactions,
contraindications, side effects or precautions pertinent to the safety of the
Active Ingredients, as soon as any such information is received or findings are
made. If either party learns of any serious adverse event that suggests a
hazard, adverse reaction, contraindication, side effect or precaution
attributable to, or associated with, any Active Ingredient supplied hereunder,
such party shall inform the other immediately. Other information about less
serious events shall be reported promptly by Seller to Buyer upon receipt of
such information from Manufacturer.
8.2 If either party reports any significant or unexpected hazard
concerning any Active Ingredient that has met the applicable Active Ingredient
Specifications, the parties shall meet in good faith to discuss if there have
been any changes in the manufacturing process and/or storage conditions therefor
that could have led to any such hazard and immediately act to take all necessary
remedial measures.
9. RECALL
9.1 Buyer may, in its sole discretion, effect a recall of products
containing any Active Ingredient supplied by Seller hereunder (whether such
recall is voluntarily or governmentally imposed), and, to the extent necessary
or needed, Seller shall cooperate and will use all reasonable efforts to require
Manufacturer to cooperate with Buyer in carrying out any such recall. Upon
either party's request, the other party shall procure for the requesting party
or its representatives access to any information in the non-requesting party's,
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possession or control relating to any Active Ingredient supplied hereunder and
contained in the products recalled as is reasonably necessary to effect such
recall and/or to correct any problems that may be associated with the
manufacture of such Active Ingredient being recalled, and shall allow the
requesting party or its representatives to make copies thereof. If, pursuant
to the preceding sentence, Buyer is the non-requesting party, Seller shall use
all reasonable efforts to procure for Buyer or its representatives access to any
information in the Manufacturer's, possession or control relating to any Active
Ingredient supplied hereunder and contained in the products recalled as is
reasonably necessary to effect such recall and/or to correct any problems that
may be associated with the manufacture of such Active Ingredient being recalled,
and shall allow the requesting party or its representatives to make copies
thereof.
9.2 If a recall is caused as a result of, directly or indirectly,
any act or omission of Buyer, Buyer shall reimburse Seller for the out-of-pocket
costs incurred by Seller as a result of such recall, including without
limitation any costs reasonably expended by Seller at Buyer's request in
assisting with such recall, and shall make any payments required hereby for any
Active Ingredient that has been manufactured or supplied by Seller in
conformance herewith, but cannot be sold due to such recall, and any affected
work-in-process.
9.3 If a recall is caused as a result of, directly or indirectly,
any act or omission of Seller or Manufacturer, Seller shall reimburse Buyer for
the out-of-pocket costs incurred by Buyer as a result of such recall, including
without limitation any out-of-pocket costs reasonably expended by Buyer to
effect the recall and any payment made by Buyer for Active Ingredient previously
purchased from Seller that is subject to the recall and cannot be sold.
10. ALTERNATIVE MANUFACTURING SITE
Buyer and Seller understand that Buyer wishes to purchase Active
Ingredients from Seller that PFC will be manufacturing for Seller. Buyer and
Seller also understand that it may become necessary for a Manufacturer other
than PFC to manufacture the Active Ingredients. In the event that Seller wishes
to designate a Manufacturer other than PFC, Seller shall notify Buyer
immediately and shall appoint with Buyer's consent, not to be unreasonably
withheld, a Manufacturer other than PFC to manufacture all or a portion of the
Active Ingredients. Seller hereby warrants than any Manufacturer other than PFC
selected in accordance with this Article 10, shall be capable of manufacturing
the Active Ingredients in accordance with the provisions of Section 7.4.2.
11. TERM OF AGREEMENT AND TERMINATION
11.1 Term. The term of this Agreement shall commence on the
Effective Date and terminate February 13, 1999.
11.2 Termination for Breach. Either party shall have the right to
terminate this Agreement by written notice to the other in the event that the
other shall commit any material breach of its obligations hereunder and shall
fail to cure such material breach within ninety (90) days after being called
upon in writing to do so, such termination to be effective only upon the
non-breaching party giving written notice of termination to the breaching party
after failure of the breaching party to cure such material breach within such
ninety (90)-day period.
11.3 Termination Due to Insolvency. Either party shall have the
right to terminate this Agreement effective upon written notice to the other
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party in the event: (a) the non-notifying party becomes insolvent or makes an
assignment for the benefit of creditors, (b) a receiver is appointed for the
non-notifying party, or (c) bankruptcy proceedings are instituted against the
non-notifying party or on the non-notifying party's behalf.
11.4 Results of Termination. The proper use by either party hereto
of a termination right provided for under this Agreement shall not give rise to
the payment of damages or any other form of compensation or relief to the other
party with respect thereto. Subject to the foregoing, termination of this
Agreement shall not preclude either party from claiming any other damages,
compensation or relief that it may be entitled to upon such termination.
Termination of this Agreement in whole or in part shall not relieve Buyer of any
amounts owed Seller, nor shall it relieve the parties of their obligations with
respect to the Active Ingredients supplied prior to such termination by Seller
hereunder.
12. INDEMNIFICATION
12.1 Buyer agrees to defend, indemnify and hold Seller and its
Affiliates and their respective directors, officers, agents and employees
harmless from and against any and all losses, damages, liabilities, costs and
expenses (including without limitation reasonable attorneys' fees and other
litigation costs, regardless of outcome) arising out of any and all governmental
or private actions (or their insurers under rights of subrogation or otherwise)
that are related in any way to: (a) the storage, formulation, use, transfer or
sale by Buyer and its Affiliates of the Active Ingredients supplied by Seller
to Buyer hereunder; (b) any claim of failure by Buyer and its Affiliates to
comply with any governmental authorizations relating to the use of such Active
Ingredients by Buyer and its Affiliates; (c) Buyer's negligence (or the
negligence of Buyer's Affiliates) or any acts by Buyer (or its Affiliates) in
violation of this Agreement.
12.2 Seller agrees to defend, indemnify and hold Buyer and its
Affiliates and their respective directors, officers, agents and employees
harmless from and against any and all losses, damages, liabilities, costs and
expenses (including without limitation reasonable attorneys' fees and other
litigation costs, regardless of outcome) arising out of any and all governmental
or private actions (or their insurers under rights of subrogation or otherwise)
that are related in any way to: (a) the manufacture, transfer and handling
(including the quality control testing, packaging and storage) of any Active
Ingredient supplied by Seller to Buyer hereunder; (b) any claim of failure by
Seller to comply with governmental authorizations relating to the manufacture
or handling of such Active Ingredient, including, without limitation, Seller's
obligations under Section 0; (c) any claim of failure to comply with
governmental laws or regulations pertaining to the manufacture or handling of
such Active Ingredient,including, without limitation, any laws or regulations
pertaining to the disposal of waste materials resulting from such manufacture
(including any non-conforming material); or (d) Seller's negligence (or the
negligence of Seller's Affiliates) or any acts by Seller (or its Affiliates)
in violation of this Agreement.
12.3 All claims under this Section 11 shall be asserted and resolved
as follows:
12.3.1 In the event that a third party asserts a claim or
demand for which a party (the "First Party") believes the other party (the
"Second Party") is liable hereunder, the First Party shall promptly notify the
Second Party of the nature and extent of such claim or demand in writing.
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12.3.2 The Second Party shall have the right (but not the
obligation) to defend any claim or demand by appropriate proceedings. The First
Party will cooperate with the Second Party at the Second Party's request in the
defense against such claim or demand. The First Party may participate in, but
not control, any such defense or settlement, but only at its sole cost and
expense.
13. DISCLAIMER
EXCEPT AS OTHERWISE SPECIFICALLY SET FORTH IN THIS AGREEMENT, SELLER
MAKES NO REPRESENTATIONS TO BUYER, DISCLAIMS ANY WARRANTIES, EXPRESS OR IMPLIED,
WITH REGARD TO THE ACTIVE INGREDIENTS SUPPLIED BY SELLER TO BUYER HEREUNDER,
INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND/OR
FITNESS FOR A PARTICULAR PURPOSE, AND SELLER ASSUMES NO RESPONSIBILITIES
WHATSOEVER WITH RESPECT TO THE FORMULATION, USE, SALE OR OTHER DISPOSITION BY
BUYER OR ITS AFFILIATES, CUSTOMERS OR OTHER TRANSFEREES OF ANY ACTIVE INGREDIENT
SUPPLIED BY SELLER HEREUNDER.
14. INDEPENDENT PARTIES
Each party shall act solely as an independent contractor and nothing in
this Agreement shall be construed to give either party the power or authority
to act for, bind or commit the other party in any way. Nothing herein shall be
construed to create the relationship of partnership, principal and agent or
joint venture between the parties. Accordingly, neither party shall use or
refer to the name or logo of the other party or its Affiliates (or use any name
or logo confusingly similar thereto) in any public statements, whether oral or
written, including but not limited to, shareholder reports, communications with
stock market analysts, press releases or other communications with the media, or
prospectuses, without the prior written consent of the other party.
15. FORCE MAJEURE
15.1 Each party shall be excused from the performance of its
obligations hereunder in the event such performance is prevented by force
majeure, and such excuse shall continue as long as the condition constituting
such force majeure continues plus thirty (30) days after the termination of such
condition. For the purposes of this Agreement, force majeure is defined as
follows: causes beyond the reasonable control of Buyer or Seller (as the case
may be), including without limitation, acts of God, acts, regulations, orders,
decrees or laws of any government or agency thereof, war, civil commotion,
damage to or destruction of production facilities or materials, labor
disturbances (whether or not any such labor disturbance is within the power of
the affected party to settle), epidemic, and failure of suppliers (excluding the
inability of Manufacturer to supply to Seller for any reason other than force
majeure), public utilities or common carriers.
15.2 In the event of force majeure lasting more than three (3)
months (or which the parties acknowledge will last more than three (3) months),
the parties agree to meet and discuss how this Agreement can be justly and
fairly implemented under the circumstances provided that, with respect to force
majeure on the part of Buyer, Seller shall not be obligated to supply any Active
Ingredient hereunder if Buyer cannot make prompt payment therefor (consistent
with the terms and conditions hereof) to Seller.
16. GOVERNING LAW AND ARBITRATION
16.1 This Agreement shall be governed by and interpreted in
accordance with the laws of the State of New York U.S.A. (regardless of the
choice of law principles of the State of New York or any other jurisdiction).
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16.2 Any controversy or claim arising out of or relating to this
Agreement, or the breach thereof, shall be settled by final and binding
arbitration in New York, New York in accordance with the Commercial Rules of the
American Arbitration Association in effect on the Effective Date (hereinafter
referred to as the "Rules"), and judgment upon the award rendered by the
arbitrators may be entered in any court having jurisdiction thereof.
16.3 In any arbitration pursuant to this Article 17 the award shall
be rendered by a majority of three arbitrators, one (1) of whom shall be
appointed by each party and the third of whom shall be appointed by mutual
agreement of the two (2) party-appointed arbitrators. In the event of failure
of a party to appoint an arbitrator within thirty (30) days after commencement
of the arbitration proceeding or in the event of failure of the two (2) party-
appointed arbitrators to agree upon the appointment of the third arbitrator
within sixty (60) days after commencement of the arbitration proceeding, such
arbitrator shall be appointed by the American Arbitration Association in
accordance with the Rules. The arbitrators shall apply the governing law set
forth in Section 16.1. In no event shall either party be entitled to an award
of punitive damages pursuant to any arbitration hereunder.
16.4 At Buyer's request, Seller shall join PFC and shall use all
reasonable efforts to require any Manufacturer other than PFC to join any
proceeding under this Article 16. If Seller desires to join Manufacturer in
any proceeding under this Article 16, Buyer shall not object to or in any way
attempt to preclude Seller from joining PFC or any Manufacturer in such
proceeding.
17. SUCCESSORS AND ASSIGNS
This Agreement shall be binding upon and shall inure to the benefit of
the parties and their respective successors and assigns; provided that this
Agreement may not be assigned by any party without the written consent of the
other party; provided, further, either party may assign this Agreement to one
of its Affiliates, whether such Affiliate currently exists or is formed in the
future, without such written consent.
18. NOTICES
Any notice required or permitted to be given hereunder shall be deemed
sufficient if sent by facsimile letter or overnight courier, or delivered by
hand to Seller or Buyer at the respective addresses and facsimile numbers set
forth below or at such other address and facsimile number as either party hereto
may designate. If sent by facsimile letter, notice shall be deemed given when
the transmission is completed if the sender has a confirmed transmission report.
If a confirmed transmission report does not exist, then the notice will be
deemed given when the notice is actually received by the person to whom it is
sent. If delivered by overnight courier, notice shall be deemed given when it
has been signed for. If delivered by hand, notice shall be deemed given when
received.
if to Buyer, to:
Medicis Pharmaceutical Corporation
4383 East Camelback Road
Phoenix, Arizona 85018
Attn: Jonah Shacknai
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with a copy to:
Brown & Bain
2901 North Central Avenue
Phoenix, Arizona 85012-2788
Attn: Frank M. Placenti
if to Seller, to:
Syntex Pharmaceuticals International Limited
Ave. Samuel Lewis
Torre Hongkong Bank, Piso No. 18/P.O. Box 7386
Panama 5, Republic of Panama
Attn: General Manager
with a copy to:
F. Hoffmann-La Roche Ltd.
CH-4070 Basel, Switzerland
Attn: Corporate Law Department
and a copy to
Syntex (U.S.A.) Inc.
3401 Hillview Avenue
Palo Alto, California 94304
Attn: Corporate Law Department
19. SURVIVAL
Section 7.4 and 10.4 and Articles 2, 9, 11, 12, 13 and 15 shall be in
force during the term of this Agreement and shall survive expiration or
termination, as the case may be, of this Agreement.
20. ADDITIONAL TERMS
20.1 Entire Agreement. This Agreement and the exhibits hereto
embody the entire agreement of the parties hereto with respect to the subject
matter hereof and supersede and replace all previous negotiations,
understandings, representations, writings, and contract provisions and rights
relating to the subject matter hereof.
20.2 Amendments; No Waiver. No provision of this Agreement may be
amended, revoked or waived except by a writing signed and delivered by an
authorized officer of each party. No failure or delay on the part of either
party in exercising any right hereunder will operate as a waiver of, or impair,
any such right. No single or partial exercise of any such right will preclude
any other or further exercise thereof or the exercise of any other right. No
waiver of any such right will be deemed a waiver of any other right hereunder.
20.3 Counterparts. This Agreement may be executed in one or more
counterparts all of which shall together constitute one and the same instrument
and shall become effective when a counterpart has been signed by Buyer and
delivered to Seller and a counterpart has been signed by Seller and delivered
to Buyer.
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20.4 Severability. The parties agree that (a) the provisions of
this Agreement shall be severable and (b) in the event that any of the
provisions hereof are held by a court of competent jurisdiction to be invalid,
void or otherwise unenforceable, (i) such invalid, void or otherwise
unenforceable provisions shall be automatically replaced by other provisions
that are as similar as possible in terms to such invalid, void or otherwise
unenforceable provisions but are valid and enforceable and (ii) the remaining
provisions shall remain enforceable to the fullest extent permitted by law,
provided that the rights and interests of the parties hereto shall not be
materially affected.
20.5 Captions. Captions herein are inserted for convenience of
reference only and shall be ignored in the construction or interpretation of
this Agreement. Unless the context requires otherwise, all references herein
to Articles and Sections are to the articles and sections of this Agreement.
IN WITNESS HEREOF, the parties have caused this Agreement to be
executed by their duly authorized representatives to be effective as of the
Effective Date.
SYNTEX PHARMACEUTICALS MEDICIS PHARMACEUTICAL
INTERNATIONAL LIMITED CORPORATION
By /s/ John R. Talbot By /s/ Mark A. Prygocki Sr.
------------------------- -------------------------
Name John R. Talbot Name Mark A. Prygocki Sr.
----------------------- -----------------------
Title: President Title: Secretary
--------------------- ---------------------
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SCHEDULE A
CURRENT PRICES
PER KILOGRAM IN UNITED STATES DOLLARS
Fluocinolone acetonide milled $12,495.21
Fluocinolone acetonide micronized $14,110.92
Fluocinonide milled $12,433.70
Fluocinonide micronized $14,183.03
Fluocinolone Acetonide
dihydrate micronized $15,580.00
All prices CIF, Buyer's Designated Manufacturing Facility
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SCHEDULE B
ACTIVE INGREDIENT SPECIFICATIONS
To be supplied three days prior to Closing
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SCHEDULE C
METHODS OF ANALYSIS FOR THE ACTIVE INGREDIENT
To be supplied three days prior to Closing