CONFIDENTIAL MATERIALS OMITTED AND
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE OMISSIONS.
SAVIENT PHARMACEUTICALS,
INC.
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i
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SECTION 2 SUPPLY AND PURCHASE OF
PRODUCTS
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iii
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vi
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SECTION 4 FORECASTS, ORDERS
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viii
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ix
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xii
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xii
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SECTION 8 DELIVERY; INVENTORY
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xv
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SECTION 9 DEFECTIVE PRODUCTS
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xv
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SECTION 10 REGULATORY MATTERS
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xvi
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xix
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xix
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SECTION 13 CONFIDENTIALITY
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xx
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SECTION 14 PUBLIC ANNOUNCEMENTS
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xx
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SECTION 15 REPRESENTATIONS AND
WARRANTIES
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xxi
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SECTION 16 INDEMNIFICATION
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xxii
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SECTION 17 DISPUTE RESOLUTION
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xxiii
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xxiii
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A. Product, Specifications and
Packaging
B. Initial
Finished Product Prices
C. Adverse
Event Reporting Procedures
D. Initial
Purchase Order Forecast
SUPPLY
AGREEMENT , dated as of June 12, 2006, by and between
Savient Pharmaceuticals, Inc., a Delaware corporation (“
Seller ”), and Watson Pharma, Inc., a Delaware
corporation (“ Purchaser ”).
WHEREAS ,
Seller would like to make and sell the Products (as defined below)
to Purchaser, and Purchaser would like to purchase the Products
from Seller pursuant to the terms of this Agreement;
NOW,
THEREFORE , in consideration of the mutual promises, covenants
and agreements hereinafter set forth, the parties hereto agree as
follows:
As used throughout
this Agreement and any exhibits, schedules or attachments hereto,
each of the following terms shall have the respective meaning set
forth below:
1.1 “
Additional Amount ” shall have the meaning given in
Section 2.2.3.
1.2 “
Affiliate ” of a Party shall mean any entity that,
directly or indirectly, controls, is controlled by, or is under
common control with such entity. For the purposes of this
definition, the term “controls” (including, with
correlative meanings, the terms “controlled by” and
“under common control with”) as used with respect to
any Party, shall mean the possession (directly or indirectly) of
more than 50% of the outstanding voting securities or other equity
or voting interest of an entity.
1.3 “
ANDA ” shall mean an Abbreviated New Drug Application
filed with the FDA.
1.4 “
Bankruptcy Code ” shall have the meaning given in
Section 7.3.
1.5 “
Bankruptcy Law ” shall have the meaning given in
Section 7.3.
1.6 “
Commercially Reasonable Efforts ” shall mean, with
respect to a Party, those commercially reasonable efforts that such
Party is making in similar circumstances relative to other products
in its portfolio with respect to production and/or marketing,
distribution and sales of its own products that are in production
or that are being marketed, distributed and sold at that time, as
applicable. Commercially Reasonable Efforts shall be in accordance
with the efforts and resources that the Party would use for a
product owned by it or to which it has rights, which is of similar
market potential at a similar stage in its product life, taking
into account the competitiveness of the marketplace, the
proprietary position of the applicable active ingredient, the
regulatory structure involved, and the profitability of the
product.
1.7 “
Damages ” shall have the meaning given in
Section 16.1.
1.8
“Delivery Price” shall have the meaning given in
Section 3.1.
1.9 “
Effective Date ” shall mean the date of this
Agreement.
i
1.10 “
Equivalent Product ” shall mean any product, other
than a Product that Seller is obligated to supply to Purchaser
hereunder, which (i) is manufactured by a Party pursuant to an
ANDA which was approved by the FDA, which ANDA was filed on the
basis of the original NDA for the brand equivalent of such Product
or (ii) is otherwise a generic version of the brand equivalent
of such Product.
1.11 “
Existing Inventory ” shall mean all Product
manufactured by Seller into final tableted form prior to [**]
with the following lot numbers: A18061; C400715; C400721; C500173;
C500174; C500175, and; 4A3069.
1.12 “
FDA ” shall mean the U.S. Food and Drug
Administration, and any successor or replacement agency.
1.13 “
Finished Product Price ” shall mean the aggregate cost
to manufacture and/or Label Product, on a batch by batch
basis,
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(i) if
Product is manufactured and/or Labeled by Seller or an Affiliate of
Seller the sum of Seller’s (a) [**], (b) [**] and (c) [**];
or
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(ii) if such
Product is manufactured and/or Labeled by a Third Party
manufacturer, the sum of (a) [**] and (b) [**].
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All costs
included in Manufacturing Costs shall be calculated in accordance
with U.S. generally accepted accounting principles, consistently
applied to the manufacture of all products produced in the facility
or facilities in which such Product is manufactured and/or Labeled.
[**]
1.14 “
Force Majeure Event ” shall have the meaning given in
Section 11.
1.15 “
Gross Margin” shall have the meaning given in
Section 3.1.
1.16 “
Indemnity Claim ” shall have the meaning given in
Section 16.3.
1.17 “
Initial Purchase Order ” shall have the meaning given
in Section 2.2.1.
1.18 “
Label ”, “ Labeled ” or “
Labeling ” shall mean all labels and other written,
printed or graphic matter upon (i) any packaging, container or
wrapper utilized with the Products, or (ii) any written
material accompanying the Products, including package inserts; or
as the context requires, the act of applying and/or using the
same.
1.19 “
Latent Defect ” shall mean any instance where a lot of
a Product fails to conform to the applicable Specifications or is
otherwise defective or fails to conform to the warranties given by
Seller herein, and such failure would not be discoverable upon
reasonable physical inspection or standard testing of such Product
upon receipt by Purchaser in accordance with Purchaser’s
standard operating procedures.
1.20 “
Launch Quantity ” shall have the meaning given in
Section 2.2.1.
1.21 “
Material Change ” shall have the meaning given in
Section 5.2.1
1.22 “
NDA ” shall mean a New Drug Application filed with the
FDA.
1.23 “
Net Sales ” shall mean, with respect to any Product,
the revenues derived from the sale by Purchaser, its Affiliates,
licensees and assignees from the sale of a Product to independent
third parties, less: (i) all normal and customary discounts
(such as cash discounts, volume discounts, chargebacks, allowances
(including shelf stock adjustments and promotional allowances that
are not selling or marketing-related operational expenses),
government mandated rebates and other rebates, credits, and Product
returns), (ii) freight, shipping, insurance costs relating to
the shipment of the Product, duties and taxes; and (iii) bad
debt related to the Product (as such bad debts are
actually
incurred). Net
Sales shall be determined on an accrual basis (except for clause
(iii) above) in accordance with generally accepted accounting
principles in the Territory, applied on a basis consistent with
Purchaser’s annual audited financial statements. Subject to
the foregoing, Purchaser will not deduct any marketing, selling,
advertising or distribution expenses of any kind to determine Net
Sales.
1.24 “
Packaging ” shall mean all primary containers, Labels,
cartons, shipping cases or any other like matter used in packaging
or accompanying the Products; or as the context requires, the act
of applying and/or using the same.
1.25 “
Party ” shall mean Seller or Purchaser and, when used
in the plural, shall mean Seller and Purchaser.
1.26 “
Patent Defect ” shall mean any instance where a lot of
a Product fails to conform to the applicable Specifications or is
otherwise defective or fails to conform to the warranties given by
Seller herein, and such failure is discoverable upon reasonable
physical inspection or standard testing of such Product upon
receipt by Purchaser in accordance with Purchaser’s standard
operating procedures.
1.27 “
Product ” or “ Products ”, as
applicable, shall mean each of oxandrolone 2.5mg tablets (the
“2.5mg Product”) and oxandrolone 10mg tablets (the
“10mg Product”), collectively the Products and, any
other products the parties agree to include herein; Product shall
not include any branded version of oxandrolone either currently
offered for sale or offered for sale in the future by Seller,
whether or not of the same dosage strength or form.
1.28 “
Purchase Price ” shall have the meaning give in
Section 3.1.
1.29 “
Purchaser Trademarks ” shall have the meaning given in
Section 5.4.
1.30 “
Quality Requirements ” shall have the meaning give in
Section 5.3.
1.31 “
Remainder Payment ” shall have the meaning given in
Section 3.1.
1.32 “
Specifications ” shall mean the specifications for the
design, composition, manufacture, packaging, and/or quality control
of each of the Products, as set forth on Exhibit A
attached hereto and made a part hereof, as the same may hereafter
be modified by mutual agreement of the parties in
writing.
1.33 “
Start Date ” shall have the meaning given in
Section 2.2.3.
1.34 “
Territory ” shall mean the United States of America,
including its territories and possessions and military bases and
possessions (including, but not limited to, the Commonwealth of
Puerto Rico).
SUPPLY AND PURCHASE OF
PRODUCTS
2.1 Supply
and Purchase Obligations .
2.1.1
During the Distribution Term, Seller shall manufacture, or have
manufactured by a third party, and exclusively supply Purchaser
with Products for sale and distribution in the
Territory.
Seller shall supply Purchaser with those quantities of Products as
are ordered by Purchaser pursuant to this Agreement. In the event
Seller has any Product manufactured by an unaffiliated third party,
Seller shall (i) notify the Purchaser as to the identity of
the third party manufacturer prior to the commencement of supply,
and (ii) use its best efforts to obtain from such third party
manufacturer rights for the benefit of Purchaser as set forth in
Section 5.3, 5.5, 10.3, 10.4, 10.9 and 10.10 hereto. During
the Distribution Term (subject to the provisions of
Section 4.5) Purchaser shall purchase from Seller 100% of
Purchaser’s requirements for the Products in the
Territory.
2.1.2
During the Distribution Term (and subject to the provisions of
Section 4.5), Purchaser shall purchase from Seller the
Products solely for distribution and sale in the Territory. During
the Term, Seller and its Affiliates shall not, and shall not
directly or indirectly grant to any other person or entity the
right to, sell or distribute the Products and/or Equivalent Product
in the Territory, and Seller shall not directly or indirectly
cooperate with any other person or entity with respect to, or
supply products or services for, the sale or distribution of the
Products and/or Equivalent Product in the Territory. Nothing in
this Agreement shall prevent the Seller from marketing or selling,
or granting third parties the right to market or sell (i) any
formulation, dosage or strength of oxandrolone, utilizing any
method of delivery, under the brand name Oxandrin® or
(ii) any other branded formulations, dosages or strengths of
oxandrolone, in each case, other than those Products identified in
Exhibit A .
2.1.3
During the Term, Purchaser shall not, directly or knowingly and
indirectly, (i) solicit customers for the Product, or make
sales of the Product, or establish or maintain any branch or
distribution depot for the Product, outside of the Territory, or
assist any party in doing so or (ii) solicit customers for an
Equivalent Product, or make sales of an Equivalent Product, or
establish or maintain any branch or distribution depot for an
Equivalent Product, within the Territory, or assist any party in
doing so. If at any time Purchaser, directly or knowingly and
indirectly, markets, sells, or distributes the Product outside the
Territory, Seller may suspend all sales of the Product to Purchaser
until Purchaser takes appropriate actions to cease such sales. At
such time as Purchaser learns that a customer is directly or
indirectly using, marketing, selling or distributing Products
outside of the Territory, or that such customer is assisting any
other party to do so, then Purchaser shall cease making sales of
Products to such customer until such a time as customer ceases
making sales outside of the Territory and Purchaser shall
immediately notify Seller in writing of such occurrence and take
reasonable actions within its legal rights and powers to cause such
third parties to cease making such sales of the Product outside the
Territory.
2.1.4
[ ** ], nothing in this Agreement shall prohibit Purchaser from
undertaking its own development of any Equivalent Product, seeking
regulatory approval of any such Equivalent Product, or undertaking
manufacturing development and qualification, and limited
manufacture (including third party manufacturing) of stability
batches and validation batches of Equivalent Product, in each case
solely for purposes of seeking regulatory approval for such
Equivalent Product; provided , however , that
Purchaser shall not be permitted to sell any Equivalent Product
which it so manufactures during the Term of this Agreement. [ **
]
2.2
Commencement of Supply .
2.2.1
Seller shall be obligated to commence supply of the Products to
Purchaser within ninety (90) days of receipt of a binding
purchase order of Products from Purchaser in accordance with the
terms and conditions of this Agreement (“Initial Purchase
Order”). The quantities in such Initial Purchase Order shall
be discussed in good faith and mutually agreed
between the
parties (“Launch Quantity”). Subject to the immediately
preceding sentence, the nonbinding forecast for the Initial
Purchase Order is attached as Exhibit D to this Agreement. It
is further agreed that Seller shall use best commercial efforts to
supply a total amount of [**] bottles of the 2.5mg Product, [**],
as soon as commercially practicable but in no event later than
ninety (90) days from the date of receipt by Purchaser of the
Launch Quantities. All orders of Product by Purchaser shall be made
in units which comprise whole batch amounts; the delivery of such
Product shall be in amounts that reflect the actual batch yield
where such yield does not deviate from the defined range ([**]
bottles per batch for 2.5mg Product and [**] bottles per batch for
10mg Product).
2.2.2
Upon receipt of the Initial Purchase Order, Seller shall, as
promptly as commercially feasible and using diligent efforts (but
in any event no later than ninety (90) days after receipt of
such Initial Purchase Order or later date as requested in writing
by Purchaser) supply to Purchaser the quantities of the applicable
Product which are indicated on the Initial Purchase Order for such
Product. In addition to any other right or remedy available to
Purchaser, upon any failure by Seller to provide all of the
Products in the Initial Purchase Order within the specified and
mutually agreed upon time schedule, then Purchaser shall have the
right, but not the obligation, to terminate this Agreement, without
penalty to either Party, with respect to any or all of such
Products (at Purchaser’s discretion) on thirty (30) days
prior written notice to Seller.
2.2.3
The parties agree that they shall cooperate to determine when an
Equivalent Product may become available to the marketplace.
However, Seller shall, at its sole discretion, designate on which
date the Products will be distributed in the Territory by Purchaser
(“ Start Date ”) and provide Purchaser with
reasonable written notice thereof. It is specifically contemplated
and agreed that the 2.5mg Product and the 10mg Product may each
have a separate and distinct Start Date based upon the availability
of an Equivalent Product in the respective dosage forms, and that
Purchaser shall only sell that Product for which Seller has
provided explicit approval and for which a designated Start Date
has been specified in writing by Seller.
2.2.4
Prior to the Start Date, Purchaser shall have in place with all
significant wholesalers, chain and other drug supply and pharmacy
outlets, a communication advising such entities of the
Product’s pending availability. Consequently, if any Product
supplied to Purchaser under this Agreement is delivered by
Purchaser to any third party earlier than two (2) business
days prior to the applicable Start Date, then Purchaser shall pay
to Seller, as liquidated damages (the “Additional
Amount”) an amount equal to (X) the number of units of
such Product shipped or distributed by Purchaser to any third party
prior to the applicable Start Date times (Y) Seller’s
average net selling price for Seller’s branded version of
such Product, less (Z) the amounts paid or payable by
Purchaser to Seller for such Product under Section 3
below.
Notwithstanding
the foregoing, with Seller’s prior written approval,
Purchaser may ship Product to third party purchasers earlier than
two (2) business days prior to the Start Date without penalty
if such Product is held by third party purchasers thereof in
isolation and not available for sale, resale or dispensing until
the applicable Start Date; provided, however, that Purchaser shall
obtain from any third party purchasers of Product contemplated
hereunder binding assurances of non-release prior to the Start
Date. To the extent any third party purchaser releases Product for
sale, resale or dispensing prior to the Start Date, then Purchaser
shall be liable to Seller for the Additional Amount with respect to
such Product as calculated above. The Additional Amount shall be
Seller’s sole and exclusive remedy (whether arising in
contract, tort or otherwise) for the sale prior to the applicable
Start Date of any Product by Purchaser and in no event shall such
sale be considered or deemed as a breach hereunder. Purchaser shall
deliver to Seller written notice of its initial shipment of Product
to the retail trade within twenty-four (24) hours of such
shipment.
2.2.5
Seller shall supply to Purchaser, and Purchaser shall accept from
Seller subject to all applicable terms and conditions herein,
Launch Quantities of Product from Seller’s Existing Inventory
provided that such Existing Inventory complies with the terms and
conditions of this Agreement. Anything to the contrary
notwithstanding, to the extent that any Existing Inventory is sold
to Purchaser by Seller and subsequent thereto Purchaser is unable
to sell such Existing
Inventory
because its remaining expiry dating is equal to or less than twelve
(12) months, Purchaser may return such quantities of Existing
Inventory to Seller and Seller shall thereafter, in accordance with
the applicable terms and conditions herein, refund to Purchaser one
hundred percent (100%) of the Delivery Price actually paid for such
quantities as are actually returned to Seller.
3.1 Purchase
Prices . The purchase price (“ Purchase Price
”) paid by Purchaser for each Product delivered by Seller
shall be paid in two installments. The first installment (the
“ Delivery Price ”) shall be a payment equal to
the number of units of such Product delivered by Seller to
Purchaser pursuant to [**] of such Product. The second installment
(the “ Remainder Payment ”) shall be a quarterly
payment equivalent to [**] percent ([**]%) of Purchaser's Gross
Margin (as defined below) on the sale of such Product for each
calendar quarter during the Term hereof. For purposes of this
Agreement “ Gross Margin ” for a particular
calendar quarter shall be equivalent to [**] of Product sold
during the quarter in question. Purchaser shall provide to Seller
within thirty (30) days of the end of each quarter a
reasonably detailed report which sets forth the Gross Margin for
the quarter just completed.
3.2 Delivery
Price Adjustment . The Delivery Price for Product in effect
during any calendar year may be adjusted by Seller upon notice to
Purchaser during such calendar year to reflect any actual increase
in Seller’s Manufacturing Cost for Product.
3.3 Shipping
Terms . The prices charged by Seller to Purchaser shall be
FCA (Incoterms 2000), Seller’s facility in the Territory at
which finished goods are packaged for shipment to Purchaser. All
deliveries must be accompanied by a packing slip that describes the
Products and identifies the purchase order number and the
shipment’s destination.
3.4 Payment
Terms . The Delivery Price for each Product shall be paid
by Purchaser within sixty (60) days from the date of delivery
of such Product. The Remainder Payment shall be paid to Seller
within sixty (60) days after the end of each calendar quarter.
All payments shall be made in United States dollars.
3.5 Negative
Gross Margin .
3.5.1
To the extent the Gross Margin is negative in any particular
quarter or quarters hereunder Seller shall reimburse Purchaser for
[**] percent ([**]%) of the amount of any such negative Gross
Margin within sixty (60) days after the end of (i) such
calendar quarter or (ii) the expiration or termination of this
Agreement, as the case may be.
3.5.2
For any quarter in which Purchaser claims a negative Gross Margin,
Seller shall have the right to have Seller’s independent
public accountants (reasonably acceptable to Purchaser) conduct an
audit of Purchaser’s financial records, as such information
relates to Net Sales and the calculation of Gross Margin with
respect to each Product during the quarter in question, for a
period of twelve (12) months following receipt of
Purchaser’s notice to Seller of such negative Gross Margin;
provided, however , that this right may not be exercised
more than once in any calendar year. Any audit conducted pursuant
to this Section 3.5.2 shall not count against the maximum
number of audits to which Seller is entitled pursuant to
Section 3.6 herein, and may be conducted by the
independent
public accountants upon the provision of not less than thirty
(30) days prior written notice to Purchaser.
3.6 Annual
Audit Rights .
3.6.1
Purchaser shall keep accurate books and records for purposes of
documenting the amount of the Net Sales and the calculation of
Gross Margin with respect to each Product. Said books of account
shall be kept at Purchaser’s principal place of business.
Upon at least thirty (30) days prior written notice given on
or before June 30th of each calendar year, Seller, at its
expense, shall have the right to have Seller’s independent
public accountants (reasonably acceptable to Purchaser) obtain
access to Purchaser’s financial records for the previous
calendar year, during reasonable business hours solely for the
purpose of verifying the amount of Net Sales and the calculation of
Gross Margin with respect to each Product for such previous
calendar year; provided , however , that this right
may not be exercised more than once in any calendar year. Purchaser
agrees to reasonably cooperate with Seller’s independent
public accountants in the conduct of any such audit. Prior to
disclosing the results of any such audit, the auditor shall present
Purchaser with a preliminary report of its findings and provide
Purchaser with an opportunity to respond to any questions raised or
issues identified; provided, however, that Seller shall receive the
audit report as originally submitted by independent public
accountants along with Purchasers responses thereto to the extent
such responses are given pursuant to questions raised in an audit
and to the extent that the responses are material to resolving the
audit. Seller shall solicit or receive only information relating to
the accuracy of such calculations and shall deliver to Purchaser a
detailed written accountants’ report (setting forth, among
other things, the miscalculations, if any, identified by the audit)
within thirty (30) days of completion of the audit. If Seller
does not submit a dispute in regards to the amount of Net Sales or
Gross Margin so audited within forty-five (45) days of
Seller’s receipt of the audit report, then the amount of Net
Sales and Gross Margin as originally reported by Purchaser shall be
deemed to have been accepted and agreed to by Seller and shall be
binding. Seller shall ensure that Seller’s independent public
accountants maintain the confidentiality of Purchaser’s
Confidential Information on terms no less restrictive than those
set forth in Section 13. Such accountants shall report to
Seller only the results of the verification. Except in the event of
a bona fide dispute, any underpayment or overpayment of the
Purchase Price due to a miscalculation of such amount shall be paid
within sixty (60) days after the delivery of the detailed
written accountants’ report to Purchaser. To the extent that
the results of any audit conducted by Seller discloses an
underpayment of the Purchase Price by Purchaser to Seller by an
amount equal to or exceeding ten percent (10%) for the period in
question, then the costs of the audit shall be borne by Purchaser
and Purchaser shall remit such costs within thirty (30) days
of the presentment of an invoice.
3.6.2
Seller shall keep accurate books and records for purposes of
documenting the Delivery Price. Said books of account shall be kept
at Seller’s principal place of business. Upon at least thirty
(30) days prior written notice given on or before
June 30th of each calendar year, Purchaser, at its expense,
shall have the right to have Purchaser’s independent public
accountants (reasonably acceptable to Seller) obtain access to
Seller’s financial records for the previous calendar year,
during reasonable business hours solely for the purpose of
verifying the Delivery Price for such previous calendar year;
provided , however , that this right may not be
exercised more than once in any calendar year. Seller agrees to
reasonably cooperate with Purchaser’s independent public
accountants in the conduct of any such audit. Prior to disclosing
the results of any such audit, the auditor shall present Seller
with a preliminary report of its findings and provide Seller with
an opportunity to respond to any questions raised or issues
identified; provided, however, that Purchaser shall receive the
audit report as originally submitted by independent public
accountants along with Seller responses thereto to the extent such
responses are given pursuant to questions raised in an audit and to
the extent that the responses are material to resolving the audit.
Purchase shall solicit or
receive only
information relating to the accuracy of such calculations and shall
deliver to Seller a detailed written accountants’ report
(setting forth, among other things, the miscalculations, if any,
identified by the audit) within thirty (30) days of completion
of the audit. If Purchaser does not submit a dispute in regards to
Delivery Price so audited within forty-five (45) days of
Purchaser’s receipt of the audit report, then the Delivery
Price as originally reported by Seller shall be deemed to have been
accepted and agreed to by Purchaser and shall be binding. Purchaser
shall ensure that Purchaser’s independent public accountants
maintain the confidentiality of Seller’s Confidential
Information on terms no less restrictive than those set forth in
Section 13. Such accountants shall report to Purchaser only
the results of the verification. Except in the event of a bona
fide dispute, any underpayment or overpayment of the Purchase
Price due to a miscalculation of such amount shall be paid within
sixty (60) days after the delivery of the detailed written
accountants’ report to Seller. To the extent that the results
of any audit conducted by Purchaser discloses an overpayment of the
Delivery Price by Purchaser to Seller by an amount equal to or
exceeding ten percent (10%) for the period in question, then the
costs of the audit shall be borne by Seller and Seller shall remit
such costs within thirty (30) days of the presentment of an
invoice.
4.1
Forecasts and Orders . The initial forecast for the
Products will be a 24-month non-binding forecast of demand for each
Product after the Effective Date for capacity planning purposes,
and is attached as Exhibit D . Purchaser shall submit
to Seller a purchase order for the initial six (6) months of
the initial forecast within five (5) days of the Start Date of
this Agreement. Within five (5) days after the beginning of
each calendar quarter during the Term of this Agreement, Purchaser
shall provide Seller with a written rolling forecast of
Purchaser’s expected requirements for the Products during the
following twelve (12) months. The first six (6) months of each
such forecast shall be binding; and the amounts set forth for each
of the following two (2) calendar quarters shall constitute a
non-binding, good faith estimate of the Product requirements of
Purchaser for such period for planning purposes only. Seller shall
be required to manufacture and deliver to Purchaser such quantities
of Products as Purchaser orders in any calendar quarter up to 125%
of the quantity forecast for such calendar quarter in the
immediately preceding binding forecast. Seller shall use reasonable
commercial efforts to manufacture, or have manufactured, and
deliver to Purchaser any quantities of Product Purchaser orders in
excess of 125% of the quantity forecasted for such calendar
quarter, but shall be under no obligation to provide to Purchaser
any quantities of Product which exceed 125% of the quantity
forecasted for such calendar quarter. If Seller becomes aware of
any circumstances that may cause Seller to default on its
obligation to deliver such quantities of Product as Purchaser
orders or to fail to supply quantities of Product in accordance
with Purchaser’s forecasts for any calendar quarter, Seller
shall give Purchaser prompt written notice describing such
circumstances, together with a proposed course of action to remedy
such failure. In the event of a significant change in market
conditions, significant new competitive factors and/or new key
customer demands, the parties agree to negotiate in good faith on
appropriate changes to such forecasts.
4.2
Orders . Purchaser shall submit binding written or
electronic purchase orders for Product (or by any other means
agreed to in writing by the parties) to Seller, which shall be
placed at least one hundred eighty (180) days prior to the
desired date of delivery, and which binding orders shall comply
with the binding forecasts set out in Section 4.1. Purchaser
shall have no minimum purchase requirements of Products during the
Term of this Agreement. Purchase orders shall be submitted by
Purchaser to Seller in accordance with previously agreed upon
delivery mechanisms.
4.3
Conflicts . 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.
4.4 Capacity
Allocation . In the event that Seller’s inability
(including without limitation any inability as a result of a Force
Majeure Event) to meet firm orders, in whole or in part, is due to
a shortage of production capacity or common raw materials, Seller
shall promptly notify Purchaser in writing of such shortage of
production capacity or common raw materials, and, if possible, the
date such shortage of production capacity or common raw materials
is expected to end. In such event, Seller shall allocate its
available production capacity or raw materials to the production of
the Products in such proportion (expressed as a function of
equipment utilized) as the production equipment capacity or common
raw materials actually utilized to meet orders for the Products
over the previous six (6) month period bears to total
production equipment capacity which is set up to manufacture the
Products in such facility(ies) over that same period.
4.5 Short
Orders; Alternative Sources of Equivalent Products . In the
event that Seller fails (for any or no reason including without
limitation any Force Majeure Event) to deliver all or any portion
of an order of Product to Purchaser in accordance with the terms of
this Agreement, Seller shall promptly notify in writing Purchaser
of such fact. In addition to any other rights and remedies
available to Purchaser, Purchaser shall have the right, but not the
obligation, to modify any outstanding purchase order.
5.1.1
Attached as Exhibit A to this Agreement are the
Specifications for each of the Products. The Specifications for
each Product shall not be changed except as permitted under this
Agreement.
5.1.2
The attached Exhibit A also reflects the current
Packaging for each Product. The parties agree to cooperate in good
faith with respect to any changes to the Packaging of the Product
with the Party requesting any changes to the Packaging bearing the
development costs (e.g. artwork or package design) of such
changes.
5.2.1
From time to time during the Term of this Agreement, either Party
may submit to the other written proposals for the adoption,
implementation or development of any change, improvement or
modification to the Product. If such change is proposed by Seller,
such change may be implemented by Seller after consultation with
Purchaser (but without requiring Purchaser’s consent) so long
as such change does not negatively impact the safety or efficacy of
the Products, or materially increase Purchaser’s liability
with respect to the Products (any such change hereinafter referred
to as a “Material Change”). If such change is a
Material Change, Seller shall not be permitted to make such change
without the prior written consent of Purchaser, such consent not to
be unreasonably withheld or delayed, and subject to the provisions
of Sections 5.2.2 and 5.2.3 below. The Specifications shall be
modified to reflect any such changes. In the event of any change,
Seller shall establish an appropriate qualification protocol, and
Purchaser and Seller shall determine an appropriate inventory level
for the pre-change Product in order to cover on-going
requirements
during the
qualification process. The foregoing shall not preclude Seller from
implementing process changes or other manufacturing related changes
so long as such changes do not materially alter the
Specifications.
5.2.2
In the event that Seller is required to change the Product
Specifications pursuant to applicable law, rule, or regulation or
in response to the order of a governmental authority or regulatory
body, Seller shall promptly advise Purchaser in writing of any such
change, as well as any scheduling adjustments which may result from
such change.
5.2.3
In addition to the changes under Section 5.2.2, Purchaser
shall also have the right to request that a change be made to the
Specifications at its expense and upon prior written notice to
Seller. Seller shall not be required to make any such change but
shall consider Purchaser’s request in good faith.
5.2.4
In order for Purchaser to include in any Product Label or Labeling
Purchaser Trademarks or similar changes indicating Purchaser as the
distributor of such Product, upon Purchaser’s request, Seller
shall provide Purchaser the Label artwork and text in electronic
format. Purchaser shall update such artwork and text to include
Purchaser Trademarks and such other similar changes as desired by
Purchaser to indicate Purchaser as the distributor of such Product;
provided that Seller shall not be required to accept such changes
if such changes do not comply with the NDA under which the Product
is to be sold and distributed and all applicable laws, rules and
regulations. Purchaser shall make all necessary arrangements, at
its expense, to have such changed Labels or Labeling printed and
shall provide to Seller printer’s proofs for Seller’s
review and approval. Except with respect to the use of
Purchaser’s Trademarks and supplied artwork, Seller shall be
responsible for ensuring the accuracy of all information contained
on all Labels and Labeling for the Products and for the compliance
of all such Labels and Labeling with the NDA under which such
Products are to be sold and distributed and applicable law. In
accordance with the foregoing, Seller shall, within ten
(10) business days of receipt of said printer’s proofs,
provide written notice to Purchaser of Seller’s approval of
such proofs in the form submitted by Purchaser or with such
corrections thereto as included in Seller’s
notice.
5.3 Quality
Requirements . The Seller shall, and shall cause any third
party manufacturer to, materially comply with the quality
requirements set forth on Exhibit E attached hereto
(the “Quality Requirements”), with respect to the
manufacture of the Product. To the extent that any inconsistencies
or conflicts exist between Exhibit E and this
Agreement, the stipulations and provisions in this Agreement shall
prevail.
5.4.1
All trademarks, trade names (if needed) and packaging graphics
(collectively, the “Purchaser Trademarks”) used by
Purchaser in connection with the Products shall be chosen by
Purchaser in its discretion. Purchaser shall be responsible for any
and all liabilities which may arise from Purchaser’s use of
the Purchaser Trademarks. Unless required by applicable law or
regulation or unless otherwise agreed to by the parties, Purchaser
shall not use a trademark, trade name, or copyright of Seller in
connection with the distribution, marketing, promotion or sale of
the Products; to the extent that Purchaser believes that it shall
or must use a trademark, trade name or copyright of Seller, Seller
shall be provided with advance notice of Purchaser’s
intention to do so and Seller must consent prior to any such use by
Purchaser, such consent not to be unreasonably withheld; provided,
however, that Purchaser may use Seller’s trademarks, trade
names and copyright as contemplated under Section 14.1 and in
Purchaser’s advertising and promotional materials in order
to, among other things, identify the Products as comparable to
Seller’s brand version product and to identify Seller
as
the owner of
Seller’s trademark used with its brand version product (e.g.,
“Oxandrolone Tablets– Compare to Oxandrin
® . Oxandrin ® is a registered trademark of Savient
Pharmaceuticals, Inc.”). For the purpose of clarity, any use
of Seller’s trademarks, trade names and/or copyright pursuant
hereto shall be made only with the prior written approval of Seller
as to the specific use thereby contemplated.
5.4.2
Use of Purchaser Trademarks by Seller shall be solely for the
purpose of preparing and Packaging the Products for sale to
Purchaser. Purchaser hereby grants a limited license on a
non-exclusive basis to Seller hereunder to use the Purchaser
Trademarks in accordance with the terms of this Agreement. Any and
all Products supplied hereunder are for sale only to Purchaser for
distribution by Purchaser. Seller will not, at any time in any
manner, represent that it has ownership in any Purchaser Trademarks
and acknowledges that it has no ownership interest in any Purchaser
Trademarks nor will Seller grant a sublicense to any third party to
use such Purchaser Trademarks. Upon expiration or earlier
termination of this Agreement, Seller will cease and desist use of
any Purchaser Trademark in any way.
5.5
Certificate of Analysis; Certificate of Compliance .
Each shipment of the Products to Purchaser shall be accompanied by
a certificate of analysis prepared by an authorized representative
of Seller, including where applicable a third party manufacturer,
confirming that the Products in the shipment have been tested and
shown to be in accordance with the Specifications for such
Products. Such certificates of analysis and certificates of
compliance shall be substantially in the form set forth in the
Quality Requirements.
5.6 Expiry
Dating . Except for Products which comprise the Existing
Inventory which are addressed in Section 2.2.4, all Products
shipped to Purchaser, at the time of shipment by Seller, shall have
no less than [ ** ] months expiry dating remaining for the
2.5mg Product and no less than [ ** ] months expiry dating
remaining for the 10mg Product. Purchaser shall notify Seller in
the event a Product has [ ** ] months or less dating
remaining, and within thirty (30) days of receipt of such
notice Purchaser shall deduct from the next quarterly payment owing
to Seller [**] percent ([**]%) of the amount actually paid to
Seller for such Product. For all deliveries consisting of Existing
Inventory, at the time of shipment by Seller, such Products shall
have no less than [ ** ] months expiry dating remaining. At
Seller’s option and sole expense, Purchaser shall
(a) destroy such Product, or (b) return such Product to
Seller.
5.7
Stability Testing . Seller shall maintain a stability
testing program for the Products and provide Purchaser with an
annual product report thereon. In the event that any results from
such program could indicate that Product would not meet its expiry
date, Seller shall promptly notify Purchaser. At least one
(1) batch per year of each Product (or its branded
equivalent), or as otherwise required by the NDA, shall be included
in the stability program.
5.8 Annual
Report . Purchaser will supply distribution information and
other required information to Seller for the purposes of inclusion
into the Annual Report to FDA and shall provide such information in
a timely manner so as to enable Seller to file the Annual Report in
accordance with applicable regulations. To the extent that Seller
requests additional information from Purchaser, Purchaser agrees to
reasonably cooperate with Seller.
6.1
Term . The term of this Agreement shall commence on
the Effective Date and remain in effect for each Product hereunder
for a period of ten (10) years from the Start Date for such
Product (the “Initial Term”), unless sooner terminated
as expressly provided under the terms of this Agreement. This
Agreement will automatically renew for successive two-year periods
following the Initial Term (each, a “Renewal Term”),
unless terminated prior to the expiry of the Initial Term or any
Renewal Term by either Party confirmed in writing and delivered at
least twelve (12) months prior to the expiration of the Initial
Term or the Renewal Term to which it relates (the Initial Term,
together with any Renewal Terms, the “Term”). The
distribution term for Product shall become effective as of the date
upon which Seller supplies and Purchaser actually receives the
Launch Quantities of Product (the “Distribution Term”)
and shall remain in effect until the end of the Term unless sooner
terminated as expressly provided under the terms of this
Agreement.
7.1
Termination for Convenience . Each of Seller or
Purchaser may terminate this Agreement in its sole discretion (and
without any liability to the other for such termination), with
respect to any Product, at any time on or after the fourth (4th)
anniversary of the Start Date of such Product upon no less than one
(1) year prior written notice to the other, which prior
written notice, if any, shall be delivered on or after such fourth
(4th) anniversary of such Start Date.
7.2
Breach . This Agreement may be terminated, on a
Product by Product basis, prior to the expiration of the Term, by
either Party by giving written notice of its intent to terminate
and stating the grounds therefor if the other Party shall
materially breach or materially fail in the observance or
performance of any representation, warranty, guarantee, covenant or
obligation under this Agreement. The Party receiving the default
notice shall have sixty (60) days from the date of receipt
thereof to cure the breach or failure. If a breach is not curable
within such sixty (60) day period (other than a failure to supply
Product in accordance with the terms of this Agreement), then the
non-performing Party shall have an additional sixty (60) days
within which to cure such breach so long as the non-performing
Party is diligently working towards a remedy for such breach. In
the event such breach or failure is cured in accordance with the
provisions of this Section 7.2, the default notice shall be of
no effect. In the event such breach or failure is not cured in
accordance with the provisions of this Section 7.2, then this
Agreement shall terminate without the requirement of the
non-defaulting Party providing any additional notice to the
defaulting Party.
7.3
Insolvency, Etc . This Agreement may be terminated,
prior to the expiration of the Term, upon written notice by either
Party: (i) in the event that the other Party hereto shall (1)
apply for or consent to the appointment of, or the taking of
possession by, a receiver, custodian, trustee or liquidator of
itself or of all or a substantial part of its property,
(2) make a general assignment for the benefit of its
creditors, (3) commence a vol
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