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EXHIBIT 10.1
EXECUTION COPY
GENERIC DISTRIBUTION AGREEMENT
This
Generic Distribution Agreement (this "Agreement") is entered into
as
of February 12, 2006 (the "Effective Date") by and between King
Pharmaceuticals,
Inc., a Tennessee corporation with a principal place of business at
501 Fifth
Street, Bristol, TN 37620, USA ("King"), and Cobalt
Pharmaceuticals, Inc., a
Canadian company with a principal place of business at 6500 Kitimat
Road,
Mississauga, Ontario LN5 2Bb, Canada ("Cobalt"). King and Cobalt
are
collectively referred to herein as the "Parties" and individually
as a "Party."
RECITALS
WHEREAS, King sells the Branded Product (as hereinafter defined)
branded
under the name Altace(R) in a capsule form in the Territory (as
hereinafter
defined);
WHEREAS, Cobalt desires to distribute a Generic Product (as
hereinafter
defined) in capsule form in the Territory; and
WHEREAS, Cobalt seeks to have King manufacture and supply, and King
seeks
to manufacture and supply to Cobalt, a Generic Product for
distribution in the
Territory;
NOW,
THEREFORE, in accordance with the foregoing recitals, and in
consideration of the mutual covenants contained herein, the Parties
agree as
follows:
AGREEMENT
1.
DEFINITIONS
1.1
"Act" means the United States Federal Food, Drug and Cosmetic Act,
as
amended.
1.2
"Action" has the meaning set forth in Section 3.12(a).
1.3
"Affiliate" means any corporation, firm, partnership, or other
entity
that directly or indirectly controls or is controlled by or is
under common
control with a party. For purposes of this definition, "control"
means
ownership, directly or through one or more Affiliates of (a) fifty
percent (50%)
or more of the shares or voting rights in case of corporation or
limited
company, (b) fifty percent (50%) or more of the shares of stock
entitled to vote
for the election of directors, in the case of a corporation, (c)
fifty percent
(50%) or more of the equity or controlling interests in the case of
any other
type of legal entity (including, without limitation, joint
ventures) or status
as a general partner in any partnership, or (d) any other
arrangement whereby a
party controls or has the right to control the Board of Directors
or equivalent
governing body of an entity.
1.4
"Agreement" has the meaning set forth in the preamble.
1.5
"API" means active pharmaceutical ingredient.
PORTIONS OF THIS
EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE
COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.
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1.6
"Applicable Law" means applicable United States and foreign
laws,
rules, regulations, guidelines and standards, including, but not
limited to,
those of the FDA and comparable foreign Regulatory Authorities,
including
without limitation the Act.
1.7
"Aventis" means Sanofi Aventis or any of its Affiliates.
1.8
"Branded Product" means the capsule formulation pharmaceutical
product
containing the active ingredient Ramipril as approved by the FDA
under New Drug
Application Number 19-901 and marketed by King under the name
Altace.
1.9
"Bulk Product" means Ramipril in a form intended for further
processing
into a pharmaceutical formulation and which is not in final
formulation intended
for use by consumers.
1.10
"Calendar Quarter" means the period of three (3) consecutive
calendar
months ending on each March 31, June 30, September 30 or December
31, as the
case may be, of a year; provided that the first Calendar Quarter of
an agreement
will begin on the Effective Date and end on the last day of the
calendar quarter
within which the Effective Date falls.
1.11
"Capsule Supply Agreement" has the meaning set forth in Section
3.13.
1.12
"cGMP" means the minimum standards for methods to be used in, and
the
facilities or controls to be used for, the manufacture, processing,
packing or
holding of a drug to assure that such drug meets the requirements
of the Act as
to safety, and has the identity and strength and meets the quality
and purity
characteristics that it purports or is represented to possess, as
established
through FDA regulations (including, but not limited to, 21 C.F.R.
Parts
210-211), FDA guidance and FDA current review and inspection
standards and
current industry standards.
1.13
"Cobalt" has the meaning set forth in the preamble.
1.14
"Confidential Information" means the existence and contents of
this
Agreement and any information, in whatever form, disclosed by a
Party or its
Affiliates (the "Disclosing Party"), to the other Party or its
Affiliates (the
"Receiving Party"), in connection with the performance or
implementation of this
Agreement including, but not limited to, the Specification, the
Branded Product,
the Ramipril drug master file, including without limitation any
pending patent
applications, patent office correspondence, FDA applications and
submissions,
FDA correspondence, technical or clinical data, trade secrets, and
know-how,
including, but not limited to research, product plans, products,
services,
suppliers, customer lists and customers, prices and costs, markets,
software,
developments, ideas, techniques, business methods, photographs,
sound-recordings, algorithms, inventions, laboratory notebooks,
processes,
formulas, technology, specifications, test results, designs,
drawings,
engineering, hardware configuration information, marketing,
licenses, finances,
budgets and other actual or anticipated business, research or
development
information or any information provided pursuant to Sections 3.7
and 3.9 through
3.11 of this Agreement which is disclosed by the Disclosing Party
to the
Receiving Party, whether or not specifically designated as
confidential.
Confidential Information will not include:
PORTIONS OF THIS
EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE
COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.
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(a) information which at the time of disclosure is publicly
known;
(b) information which, after the time of disclosure, becomes part
of
the public domain, except by breach of an agreement between the
Disclosing Party
or any Affiliate thereof and the Receiving Party or any Affiliate
thereof;
(c) information which is or was in the possession of the
Receiving
Party or any Affiliate thereof at the time of disclosure by the
Disclosing Party
and was not acquired directly or indirectly from the Disclosing
Party or any
Affiliate thereof or from any other party under an agreement of
confidentiality
to the Disclosing Party or any Affiliate thereof; and
(d) information which the Receiving Party can show through
written
documentation is or was developed by the Receiving Party or its
Affiliates
independently of receipt hereunder.
1.15
"Dispute" has the meaning set forth in Section 7.6.
1.16
"Effective Date" has the meaning set forth in the preamble.
1.17
"FDA" means the United States Food and Drug Administration or
any
successor organization and all agencies under their direct
control.
1.18
"Generic Product" means an unbranded version of the Branded
Product,
with trade dress, including, without limitation, product intaglio
that differs
from the Branded Product.
1.19
"Indemnitee" has the meaning set forth in Section 4.4(c).
1.20
"Indemnitor" has the meaning set forth in Section 4.4(c).
1.21
"Initial Forecast" has the meaning set forth in Section 3.2(a).
1.22
"Initial Term" has the meaning set forth in Section 6.1.
1.23
"King" has the meaning set forth in the preamble.
1.24
"Launch Date" has the meaning set forth in Section 2.5(a).
1.25
"Launch Quantity" has the meaning set forth in Section 3.2(a).
1.26
"Party" or "Parties" has the meaning set forth in the preamble.
1.27
"Ramipril" means the compound
(2S,3aS,6aS)-1[(S)-N-[(S)-1-Carboxy-
3-phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole-2-carboxylic
acid, 1-ethyl
ester.
1.28
"Regulatory Authority" means the FDA or any counterpart of the
FDA
outside the United States, or other national, supra-national,
regional, state or
local regulatory agency, department, bureau, commission, council or
other
governmental entity with authority over the distribution,
importation,
exportation, manufacture, production, use, storage, transport,
clinical
PORTIONS OF THIS
EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE
COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.
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testing, pricing and/or sale of the Generic Product, including any
device
incorporating the Generic Product.
1.29
"Renewal Term" has the meaning set forth in Section 6.1.
1.30
"Specifications" means the specifications provided by King with
respect to the Branded Product, as approved by applicable
Regulatory Authorities
and mandated by Applicable Law, as amended from time to time in
accordance with
such standards.
1.31
"Term" has the meaning set forth in Section 6.1.
1.32
"Territory" means the United States.
1.33
"Third Party" means any person other than a Party or an Affiliate
of a
Party.
2. DISTRIBUTION;
LAUNCH
2.1
Generic Product. King hereby grants to Cobalt the
non-exclusive,
personal, non-transferable (provided that Cobalt will have the
right to transfer
the right set forth in this Section 2.1 to Cobalt Laboratories,
Inc.), and
non-assignable right to distribute the Generic Product in the
Territory during
the Term in accordance with the terms hereof. The foregoing right
will not
include any right whatsoever to (a) any intellectual property owned
or licensed
by King or Aventis, including, without limitation, any right to use
the
trademark Altace or (b) the New Drug Application Number 19-901, nor
will it
include the right to distribute the Generic Product outside the
Territory or
manufacture the Generic Product or have the Generic Product
manufactured at any
time.
2.2
Distribution of the Generic Product. Cobalt may distribute the
Generic
Product in the Territory through distributors and wholesalers in a
manner
customary for the sale and distribution of generic pharmaceutical
products,
including, without limitation, communicating and interacting with,
and making
information available to, distributors and wholesalers concerning
the Generic
Product; provided, however, that Cobalt will not promote the
Generic Product in
the Territory in any manner; and provided further that (a) any such
distributor
will be required to enter into a written agreement with Cobalt
agreeing to
comply with the terms of this Agreement, and (b) Cobalt has
obtained King's
prior approval of such distributor and the terms of the relevant
written
agreement, which approval will not be unreasonably withheld or
delayed.
2.3
King's Rights to Branded Product. Nothing contained in this
Agreement
will prevent King from marketing, distributing, selling and
promoting the
Branded Product in the Territory during the Term.
2.4
Cobalt Obligations. Cobalt will use commercially reasonable efforts
to
launch and distribute the Generic Product as of the Launch Date,
such efforts to
be no less than the efforts made by Cobalt in connection with other
generic
products distributed by Cobalt.
2.5
Launch Timing.
PORTIONS OF THIS
EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE
COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.
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(a) King and Cobalt agree that the Generic Product may only be
commercially launched by Cobalt upon the earlier of (1) [***], the
"Launch
Date").
(b) Prior to the Launch Date, King will supply Cobalt with an
agreed
upon Launch Quantity; provided that neither Cobalt nor any of its
Affiliates may
distribute such Launch Quantity prior to the Launch Date, and all
wholesalers
and distributors will hold the Launch Quantity in quarantine until
the Launch
Date and may not distribute it until they receive written
authorization from
Cobalt. If this Agreement is terminated prior to the Launch Date,
then Cobalt
will return the Launch Quantity to King.
3. SUPPLY
3.1
Purchase of Generic Product. During the Term, subject to Section
3.13,
Cobalt will purchase [***] the Generic Product in finished form
from King, and
King or a designee of King, will manufacture, sell and deliver to
Cobalt such
quantities of Generic Product [***], in accordance with the terms
and conditions
set forth in this Article 3 and this Agreement.
3.2
Forecasts; Purchase Orders.
(a) At
least [***] prior to the anticipated Launch Date, or as soon as
practicable after Cobalt provides notice to King of the anticipated
Launch Date,
Cobalt will deliver to King a [***] forecast for its purchases of
Generic
Product beginning on the date of such forecast (the "Initial
Forecast"), which
will include an initial launch quantity agreed upon by the Parties
(the "Launch
Quantity"). The first [***] included in such Initial Forecast will
constitute a
binding order for Generic Product from King. Thereafter, Cobalt
will provide
King with rolling [***] forecasts for the Generic Product on a
quarterly basis
within [***] prior to the start of each Calendar Quarter covering
Cobalt's
expected purchases of Generic Product during the [***] commencing
at the
beginning of such upcoming Calendar Quarter. The forecast for the
first [***]
included in each rolling forecast (except for the Initial Forecast)
will
constitute a binding order from Cobalt for [***] the Generic
Product included in
such forecast, and the forecast for the subsequent [***] included
in each
rolling forecast (except for the Initial Forecast) will constitute
a binding
order from Cobalt for [***] the Generic Product included in such
forecast.
(b) Cobalt will place purchase orders for Generic Product in
accordance with its binding forecasts by delivering a purchase
order in writing
to King no later than the 25th day of each calendar month. Each
purchase order
will contain the information set forth in Appendix 1 to this
Agreement. Each
purchase order will be for at least the minimum quantities
consistent with
King's then current minimum batch sizes for the Branded Product or
multiples
thereof. In the event of a conflict between the terms and
conditions of this
Agreement and a purchase order, the terms and conditions of this
Agreement will
control.
(c) No purchase order will be binding on King unless accepted
in
writing by King, with confirmation of the expected delivery date
for the Generic
Product included in the purchase order. King will use commercially
reasonable
efforts to accept the purchase order as presented and confirm date
of shipment
within [***] of receipt thereof; provided that King will not be
required to
accept purchase orders (i) for quantities of Generic Product in
excess of the
PORTIONS OF THIS
EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE
COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.
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amount specified in the forecast for the relevant month, (ii) if
the delivery
lead time for the purchase order is less than [***], or (iii) if it
otherwise
fails to comply with the terms and conditions of this
Agreement.
3.3
Delivery.
(a) King will deliver the Generic Product to Cobalt or Cobalt's
US
designee FOB King's or King's designee's manufacturing or packaging
site or
warehouse. Title and risk of loss as to the Generic Product
purchased by Cobalt
will pass to Cobalt upon the earlier of (i) a common carrier
accepting
possession or control of such Generic Product and (ii) the passage
of such
Generic Product from the loading dock of King's or King's
designee's site or
warehouse to any employee, agent or contractor of Cobalt or such
common carrier.
(b) Each delivery will be accompanied by a certificate of
analysis
containing such information as may be agreed upon by King and
Cobalt from time
to.
(c) At [***] expense, King will ship the Generic Product on a
carrier
or carriers specified by Cobalt under the designated procedures
provided by
Cobalt for transportation of the Generic Product. The [***]
freight, insurance,
handling, fees, taxes and other costs associated with the shipment
of the
Generic Product will be borne by [***]. King and Cobalt agree to
cooperate to
prepare, obtain, and maintain all necessary export and import
registrations
relating to the Generic Product. The [***] export licenses, import
licenses and
customs formalities for the import and export of goods will be
[***].
3.4
Capacity. If King, upon receiving a forecast or purchase order
in
accordance with Section 3.2, believes that it will be unable to
meet such
forecast or purchase order, King will give written notice of such
inability to
Cobalt. King will use commercially reasonable efforts to deliver
Generic Product
to Cobalt in accordance with any purchase order accepted by King as
set forth in
Section 3.2. King will not be liable to Cobalt for any late
delivery of Generic
Product if King has satisfied its obligation set forth in the
preceding
sentence.
3.5
King's Source. King will have the right, in its sole discretion,
to
purchase from any Third Party, including Aventis, the Generic
Product or Bulk
Product used to manufacture the Generic Product sold to Cobalt
during the Term.
3.6
Price and Payments. Cobalt will pay to King a price per unit for
the
Generic Product fixed at a gross margin acceptable to King in its
sole
discretion, but such price will not exceed [***] of the wholesale
acquisition
cost per unit of the Branded Product at time of purchase of the
Generic Product.
King will submit invoices to Cobalt for Generic Product delivered
to Cobalt from
time to time. Cobalt will make all payments to King in United
States Dollars
within [***] after the date of each invoice. Interest will be
payable upon all
amounts not paid on the due date at the rate of [***] over the base
rate of
interest reported in the Wall Street Journal, New York edition on
the date of
payment by Cobalt to King and will accrue from the due date until
such sum is
paid, whether before or after judgment.
3.7
Shortcomings and Defects.
PORTIONS OF THIS
EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE
COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.
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(a) Within [***] after the delivery of Generic Product to
Cobalt,
Cobalt will notify King in writing of any complaint regarding
obvious
qualitative faults and/or quantitative shortcomings in the Generic
Product, and
Cobalt will simultaneously send samples of faulty Generic Product
to King. If
Cobalt fails to notify King of any such defect within such [***]
period, Cobalt
will be deemed to have accepted the delivered Generic Product with
respect to
such obvious faults or shortcomings. Cobalt will notify King in
writing within
[***] after becoming aware of any defects in the Generic Product
that may not or
would not have been obvious at delivery by visual inspection of
such Generic
Product made with reasonable care, and Cobalt will simultaneously
send samples
of faulty Generic Product to King.
(b) If King agrees that such Generic Product is defective or
the
Generic Product has been confirmed to be defective by an
independent party
pursuant to this Section 3.7, King will replace any defective
Generic Product
with respect to which Cobalt has notified King as set forth in this
Section 3.7
[***] at the next practicable delivery date.
(c) If King disagrees that the Generic Product is defective,
the
Parties will endeavor to settle such disagreement amicably and
constructively
between themselves. If they fail to agree within [***] after
receipt of the
notice of defect, the Parties agree to nominate an independent,
reputable
laboratory within the Territory, acceptable to both Parties, which
will examine
representative samples taken from such consignment using the
methods of analysis
provided by the Parties, and the result will be binding upon the
Parties. The
charges for such examination will be borne by the Party found to be
in error
with respect to whether or not the Generic Product is
defective.
(d) King's [***] liability or responsibility for defective
Generic
Product will be limited to right of replacement set forth in this
Section 3.7.
Cobalt will make arrangements with King for the return or disposal
of any
Generic Product rejected in accordance with this Section 3.7; the
costs of such
return or disposal will be paid by King.
3.8
Labeling. King will use, or cause its manufacturer to use, the
appropriate packaging art, packaging, and labeling provided by
Cobalt for the
Generic Product; provided that King has approved in writing all
packaging art,
labeling, and all packaging provided by Cobalt; and provided
further that such
art, packaging, and labeling comply with Applicable Law. Cobalt
will provide
King with camera-ready proofs of all packaging materials and
labeling. All
packaging and trade dress of the Generic Product, including,
without limitation,
product intaglio must differ from the Branded Product.
3.9
Recalls.
(a) Cobalt will comply, and assist King as appropriate in
complying,
with recall policies regarding the Branded Product or Generic
Product issued
from time to time by King or any applicable Regulatory Authority
and
communicated to King. King will have [***] authority to communicate
with any
Regulatory Authorities regarding any recall of the Generic Product,
as King
believes necessary [***].
(b) Cobalt will bear the expense of any recall resulting from
(1)
damages to or defects in the Generic Product occurring after
delivery of such
Generic Product, (2) packaging or
PORTIONS OF THIS
EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE
COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.
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labeling of the Generic Product, including any infringement claims
regarding any
trademarks, trade names or