DISTRIBUTION AND SUPPLY
AGREEMENT
THIS
DISTRIBUTION AND SUPPLY AGREEMENT dated as of October 22,
2006, is by and between STIEFEL LABORATORIES, INC., organized and
existing under the laws of the State of Delaware with a place of
business at 255 Alhambra Circle, Coral Gables, Florida 33134
(“STIEFEL”) and CONNETICS CORPORATION, organized and
existing under the laws of the State of Delaware, with a place of
business at 3160 Porter Drive, Palo Alto, California 94304
(“CONNETICS”).
WHEREAS, CONNETICS
sells, inter alia , the pharmaceutical product
SORIATANE ® in the Territory (as defined below);
and
WHEREAS, CONNETICS
specializes in promoting and selling brand-name drug products for
dermatological uses and does not directly engage in promoting and
selling generic drug products for dermatological uses;
and
WHEREAS, STIEFEL
specializes in promoting and selling generic drug products for
dermatological uses; and
WHEREAS, STIEFEL
wishes to obtain an exclusive (even as to CONNETICS and its
Affiliates, as defined in Section 1.1) right and license to
market, distribute and sell a generic version of SORIATANE
® in and for the United States of America,
including its territories (the “Territory”), subject to
the terms and conditions set forth herein; and
WHEREAS, CONNETICS
is willing to grant such an exclusive right and license to STIEFEL,
subject to the terms and conditions set forth herein;
and
NOW, THEREFORE, in
consideration of the mutual covenants and promises contained
in
Page 1
this Agreement
and other good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, the Parties agree as
follows:
As used in this
Agreement, the following terms, whether used in the singular or
plural, shall have the following meanings:
1.1 “
Affiliate ” means any corporation, company,
partnership, joint venture and/or firm which controls, is
controlled by or is under common control with a Party. For purposes
of this Section 1.1, “control” shall mean
(a) in the case of corporate entities, direct or indirect
ownership of at least fifty percent (50%) of the stock or shares
entitled to vote for the election of directors; and (b) in the
case of non-corporate entities, direct or indirect ownership of at
least fifty percent (50%) of the equity interest or the power to
substantially direct the management and policies of such
non-corporate entities.
1.2 “
ANDA ” means Abbreviated New Drug Application, as
filed with the FDA.
1.3 “
cGMPs ” mean current Good Manufacturing Practices
applicable to the Product, as established by the FDA.
1.4 “
Commercial Launch ” means the announcement of the
availability of the Product for sale or sale of the Product to an
unrelated third party.
1.5 “
Commercially Reasonable Efforts ” means efforts
commensurate with the efforts a Party would extend or has extended
to a product of similar commercial potential.
1.6 “
Confidential Information ” means any communications
between the Parties in furtherance of the purposes of this
Agreement, including but not limited to documents,
electronic
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transmissions
and the contents of the NDA not subject to public disclosure
pursuant to statute or regulation.
1.7 “
Effective Date ” means the date of the signature of
the second (2 nd )
Party signing this Agreement.
1.8
“Equivalent Product” means any oral dosage form of the
product containing acitretin as the active ingredient, which is
manufactured pursuant to an ANDA, 505(b)(2) application or other
regulatory filing which was approved by the FDA and which filing
was filed on the basis of CONNETIC’s NDA for Soriatane
® (other than any product in any strength or
dosage under the trademark or trade name Soriatane
®
).
1.9 “
FDA ” means the United States Food and Drug
Administration.
1.10 “
Generic Entry Date ” means the date of the first bona
fide, arm’s length commercial sale of an Equivalent Product
in the Territory by a Non-Party. ..
1.11 “
NDA ” means the approved New Drug Applications for the
Product, including all supplements and amendments
thereto.
1.12 “
Net Profits ” means Net Sales less the aggregate
Transfer Price of the units of Product included in calculating such
Net Sales.
1.13 “
Net Sales ” mean the aggregate gross revenues derived
by or payable to STIEFEL and its Affiliates from or on account of
the sale of Products in the Territory, less (a) credits or
allowances actually granted, if any, for price adjustments,
retroactive price adjustments, freight and product liability
insurance premiums , recalls, penalties for backorder, rejection or
return of items previously sold, (b) rebates and cash
discounts actually granted, (c) freight, postage and insurance
charges and additional special packaging charges (not to exceed 2%
of gross revenues), (d) excise taxes, sales taxes, duties or
other taxes imposed upon and paid with respect to such sales
(excluding
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income or
franchise taxes of any kind), and (e) costs associated with
any dedicated marketing programs for the Products, all determined
on a basis consistent with United States generally accepted
accounting principles. Sales between or among STIEFEL and its
Affiliates shall not be included in Net Sales unless STIEFEL or its
Affiliates are the end user of Products.
1.14 “
Party ” means CONNETICS or STIEFEL; “
Parties ” means CONNETICS and STIEFEL. “
Non-Party ” means any person other than CONNETICS,
STIEFEL and their respective Affiliates.
1.15 “
Product ” means a generic equivalent of
Soriatane ® (Acitretin) 10 mg and 25 mg capsules that are
purchased by STIEFEL from CONNETICS.
1.16 “
Specifications ” has the meaning given in
Section 4.6(a).
1.17 “
Territory ” has the meaning given to it in the
Recitals, above.
1.18 “
Transfer Price ” means the price charged by CONNETICS
to STIEFEL for Products sold during the relevant reporting and
payment quarter as established pursuant to
Section 5.2.
2.1 License
Grant . Subject to STIEFEL’S timely payment of
CONNETICS’ profit share as provided in Article IV,
CONNETICS hereby grants to STIEFEL an exclusive (even as to
CONNETICS and its affiliated companies) right and license to
promote and sell the Product in the Territory following Commercial
Launch. Such grant includes the right to grant further sublicenses
to STIEFEL’S Affiliates, only.
2.2 Launch
STIEFEL and CONNETICS shall confer to reach agreement upon the
timing of the Commercial Launch of any Product, taking into account
the actions required to be
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undertaken by
STIEFEL and CONNETICS pursuant to this Agreement and current and
anticipated market conditions; provided that Commercial Launch
occur on the Generic Entry Date or such earlier date as the Parties
may agree in writing. From and after the Commercial Launch, STIEFEL
shall use Commercially Reasonable Efforts to market and promote
sales of the Product in the Territory. CONNETICS shall not be
required to accept any orders of any Product from STIEFEL until it
elects to do so, provided that once CONNETICS accepts an initial
order for a Product from STIEFEL, CONNETICS shall accept subsequent
orders for such Product from STIEFEL for as long as this Agreement
remains in effect.
ARTICLE III. RESPONSIBILITIES OF
THE PARTIES
3.1 The NDA
. Subject to Section 3.6, CONNETICS shall be solely
responsible for, and shall, maintain the NDA throughout the term of
this Agreement.
3.2
Production . STIEFEL shall purchase its requirements of the
Products for the Territory exclusively from CONNETICS, on the terms
and conditions set forth in Article IV. CONNETICS agrees that
during the term of this Agreement, all of the Products made by or
for it shall be sold (respectively) only to STIEFEL. CONNETICS
shall only be obligated to supply STIEFEL with its requirements of
the Products from CONNETICS’ existing supplies of Products
held by it on the date of this Agreement.
3.3 Other
Generic Products . Nothing in this letter shall be construed as
to require CONNETICS to prevent the approval of ANDAs claiming
equivalence to the Products; provided that CONNETICS agrees that
neither it nor any of its Affiliates may (a) prepare, file or
present any such ANDA, or (b) assist any non-Party in
preparing or presenting such an ANDA.
3.4 STIEFEL
ANDAs . STIEFEL hereby confirms to CONNETICS that prior to the
execution and delivery of this Agreement, no ANDA has been
submitted to the FDA by or on behalf of STIEFEL or any of its
Affiliates with respect to any such product.
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3.5
Marketing . The Products shall be sold by STIEFEL’s
Affiliate, Glades Pharmaceuticals, LLC (“Glades”),
without a trademark; provided that STIEFEL and Glades may inform
customers that the Products are purchased from CONNETICS pursuant
to this Agreement and refer to CONNETICS in such capacity in
advertisements and packaging.
3.6 Pricing to
STIEFEL’S Customers . STIEFEL shall have sole discretion
to set the prices and terms pursuant to which it or its Affiliates
sells the Product.
3.7 Branded
Products . STIEFEL acknowledges that CONNETICS manufactures and
sells Product under the brand name SORIATANE
®
and, except as otherwise provided
herein, CONNETICS shall not be restricted from such sales
activities by virtue of this Agreement.
3.8 Sales
Outside of the Territory . STIEFEL agrees that it shall not
sell any Product supplied by Supplier to STIEFEL hereunder outside
the Territory, or to any Person that STIEFEL has reasonable grounds
to believe is likely to sell or distribute the Product outside of
the Territory. If STIEFEL becomes aware that any of its customers
have sold Product outside of the Territory, STIEFEL will
(i) direct such customers in writing to cease making such
sales of Product outside the Territory, (ii) take all
necessary legal action at STIEFEL’s sole cost and expense to
stop such Product sales, (iii) advise CONNETICS of such sales,
(iv) provide a copy of the written direction and legal
proceedings to CONNETICS and (v) be liable to CONNETICS for
any lost sales of the Product in whole or in part caused by such
sales outside of the Territory.
ARTICLE IV. SUPPLY OF
PRODUCTS
4.1 Prices.
STIEFEL shall purchase the Products from CONNETICS at the Transfer
Prices. The Transfer Prices will be subject to adjustment in order
to be equal to 107.5% of CONNETICS’ fully allocated freight,
duty, insurance, shipping, stability, raw materials, laboratory
testing, manufacturing, and other directly attributable costs,
including the cost of purchasing the Product from third parties
(the Parties understand and agree that unused capacity is not a
directly attributable cost) including costs billed to CONNETICS at
a later date
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related to the
Products, with no further allowance for profit to CONNETICS or
CONNETICS’ Affiliates. The Parties acknowledge that they have
confirmed the initial transfer price by email.
4.2 Payment
. Terms of payment shall be net thirty (30) days from date of
on which title of Product passes to STIEFEL as set forth in
Section 4.3.
4.3
Delivery . Delivery shall be FOB STIEFEL’S address as
set forth in Section 10.4. CONNETICS shall, at its cost,
ensure that adequate insurance coverage exists on the Product in
transit to such delivery point in the event that such Product is
damaged, destroyed, or lost, and shall bear all costs of such
insurance. Title to Product shall pass to STIEFEL when STIEFEL
shall label such Product for sale, and until such time, STIEFEL
shall hold such Product on consignment, as bailee for and on behalf
of CONNETICS, and title to such Product shall remain with
CONNETICS. STIEFEL shall keep CONNETICS’ title to all Product
consigned to STIEFEL free and clear of all liens and encumbrances
arising through STIEFEL. STIEFEL’s storage facilities used to
store the Product shall comply with all applicable federal, state
and local laws, rules and regulations in the Territory, including,
without limitation, all cGMPs, STIEFEL shall hold all consigned
Products in compliance with cGMP, and shall provide documentation
thereof upon request by CONNETICS. STIEFEL shall bear the risk of
loss of consigned Products, and shall be responsible for insuring
consigned Products against loss. Product held on consignment by
STIEFEL will at all times remain under the control of CONNETICS and
be held for and on behalf of CONNETICS by STIEFEL as bailee until
such time as title to the Product is transferred to
STIEFEL.
4.4
Forecasts . Prior to the date of execution of this
Agreement, STIEFEL has provided to CONNETICS an initial twelve
(12) month forecast that estimates the quantity of the
Products to be purchased by STIEFEL, including strengths and
packaging sizes, during the initial twelve (12) months of this
Agreement. Within thirty (30) days following the execution of
this Agreement and thereafter on the first business day of each
month during the term of this Agreement, STIEFEL shall provide to
CONNETICS a rolling forecast that estimates the quantity of the
Products to be purchased by STIEFEL, including strengths and
packaging sizes, during the
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upcoming twelve
(12) months. With respect to such rolling forecasts, the first
three (3) months of such forecast shall constitute a firm purchase
order for the Products for such calendar period. Except for the
first three (3) months of such rolling forecast that
constitutes a purchase order as provided herein, such forecast
shall constitute an estimate of STIEFEL’S requirements for
the Products that is supplied for CONNETICS’ convenience
only, is non-binding on STIEFEL and shall not itself be deemed an
order of Products.
4.5
Warranties . CONNETICS represents and warrants to STIEFEL
that (a) each Product STIEFEL purchases from CONNETICS shall
meet all specifications for the Product as set forth in the
respective NDA, in all respects other than labeling (as will be
updated by CONNETICS from time to time, the
“Specifications”) through its marked expiration date;
(b) each Product, when manufactured, packaged and sold to
STIEFEL, shall comply with all applicable federal, state and local
laws, rules and regulations in the Territory, including without
limitation cGMPs; and (c) CONNETICS and CONNETICS’
supplier’s manufacturing and storage facilities used to
produce or store the Product shall comply with all applicable
federal, state and local laws, rules and regulations in the
Territory, including, without limitation, all cGMPs. Within thirty
(30) days of written notice from STIEFEL that any Product
delivered to STIEFEL fails to meet any Specifications, CONNETICS
shall replace such defective Product with an equal amount of
Product conforming to all Specifications, at no charge to STIEFEL.
In that event, STIEFEL will have the option to return or hold such
non-conforming Product, at CONNETICS’ expense, pending final
disposition of the non-conforming product. If a non-Party
laboratory that does not otherwise provide goods or services to
CONNETICS or STIEFEL, and is mutually acceptable to both parties,
subsequently establishes that such Product indeed conformed with
all Specifications at the time CONNETICS delivered it to STIEFEL,
STIEFEL shall pay the full price of the quantity of Product it
returned, plus the costs of such testing, plus ten percent (10%) of
the full price of the quantity of Product it returned, and
CONNETICS will, upon STIEFEL’S request, have such Product
shipped to STIEFEL, at STIEFEL’S expense. If such laboratory
establishes that such Product did not conform with all
Specifications at the time CONNETICS delivered it to STIEFEL,
CONNETICS will be solely responsible for the costs of such testing
and all shipping costs.
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(a) CONNETICS
shall deliver to STIEFEL the NDA approval letter and other
documentation required to import and to distribute the Products
with its acceptance of STIEFEL’S first order for the
Products. Prior to each shipment of Product hereunder, CONNETICS
shall provide STIEFEL with a (i) Certificates of Analysis for
each finished Product packaging lot present in such shipment, and
(ii) a Certification of Conformance, containing a statement
that each such batch present in such shipment was prepared in
accordance with provisions of the NDA, any other applicable health
registrations, and applicable cGMPs.
(b) CONNETICS
shall be responsible for conducting (i) an ong
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