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EXHIBIT
10.1
SUPPLY AND DISTRIBUTION
AGREEMENT
THIS SUPPLY AND
DISTRIBUTION AGREEMENT (this “Agreement”),
dated as of May 13, 2008 (the “Effective
Date”), is entered into by and between Biopure
Corporation, having offices located at 11 Hurley Street, Cambridge
MA 02141 (“Biopure”) and Dechra Veterinary
Products, having offices located at 7015 College Blvd., Suite 525,
Overland Park, KS 66211 C Dechra”), (each, a
“Party” and collectively, the
“Parties ”).
RECITALS
A. Biopure currently
manufactures, sells and distributes the Product (as such term is
defined below).
B. Biopure desires to
manufacture and sell the Product to Dechra for Dechra’s
exclusive distribution and resale within the Territory, and Dechra
desires to purchase the Product under this Agreement for
Dechra’s exclusive distribution and resale within the
Territory, pursuant to the terms and subject to the conditions of
this Agreement.
NOW, THEREFORE, in
consideration of the mutual agreements and covenants set forth
herein and other good and valuable consideration, the receipt and
sufficiency of which the Parties hereby acknowledge, the Parties,
intending to be legally bound hereby, agree as follows:
As used in this Agreement,
the following terms shall have the meanings set forth in this
Section 1 unless the context dictates otherwise:
1.1
“Affiliate” with respect to any Party, shall
mean any entity controlling, controlled by, or under common control
with, such Party, for only so long as such control exists. For
these purposes, “control” shall refer to: (a) the
possession, directly or indirectly, of the power to direct the
management or policies of an entity, whether through the ownership
of voting securities, by contract or otherwise, or (b) the
ownership, directly or indirectly, of more than fifty percent
(50%) of the voting securities or other ownership interest of
an entity.
1.2
“Agreement” shall have the meaning assigned to
such term in the Preamble.
1.3 “Applicable
Laws” shall mean all applicable laws, statutes, rules,
regulations and guidelines that apply to the sale of the Product in
the Territory or the manufacturing, promotion, marketing,
packaging, labeling, importation, exportation, warehousing or
distribution of the Product that is to be sold in the Territory or
the performance of either Party’s obligations under this
Agreement, including, without limitation, all applicable standards
or guidelines (including the latest FDA guidance documents)
promulgated by the appropriate Regulatory Authority in effect from
time to time.
1.4 “Binding
Quantity” shall have the meaning assigned to such term in
Section 3.3.
1.5
“Biopure” shall have the meaning assigned in the
Preamble.
1.6 “Breaching
Party” shall have the meaning assigned to such term in
Section 11.2.
1.7 “Contract
Quarter” means the respective periods of three
(3) consecutive calendar months during the Contract Year
commencing on the first day of the first Contract Year.
1.8 “cGMP”
shall mean current Good Manufacturing Practice as defined in Parts
210 and 211 of Title 21 of the Code of Federal
Regulations.
1.9 “Confidential
Information” shall have the meaning assigned to such term
in Section 9.1.
1.10 “Contract
Year” shall mean each twelve (12) month period
commencing on the Effective Date, but if the Effective Date is not
the first day of a calendar month, then on the first day of the
first month that begins after the Effective Date. If any Contract
Year is less than twelve (12) months, the rights and
obligations under this Agreement that are calculated on a Contract
Year basis will be proportionately adjusted for such shorter
period.
1
[**] = Portions of this agreement have
been omitted pursuant to a confidential treatment request. An
unredacted version of this agreement has been filed separately with
the Commission.
1.11
“Customer” means any Third Party that purchases
Product from Dechra.
1.12
“Dechra” shall have the meaning assigned in the
Preamble.
1.13 “Effective
Date” shall have the meaning assigned to such term in the
Preamble.
1.14 “ FDA
” shall mean the United States Food and Drug Administration
and any successor agency or entity that may be established
hereafter.
1.15
“Field” means the veterinary market.
1.16 “Firm
Order” shall have the meaning assigned to such term in
Section 3.4(a).
1.17
“Forecast” shall have the meaning assigned to
such term in Section 3.3.
1.18
“GAAP” shall mean generally accepted accounting
principles in the United States.
1.19 “Governmental
Authority” means any national, state, provincial or local
or any foreign or supranational government, governmental,
regulatory or administrative authority, agency or commission or any
court, tribunal or judicial or arbitral body.
1.20
“Indemnitee” shall have the meaning assigned to
such term in Section 10.3.
1.21 “Initial
Term” shall have the meaning assigned to such term in
Section 11.1.
1.22 “Manufacturing
Standards” shall have the meaning assigned to such term
in Section 3.2(a).
1.23 “Net
Sales” means the amounts invoiced to Customers for
Product which shall be equal to the selling price of the Product
multiplied by the number of units of Product and shall exclude any
taxes associated with the sale of such Product.
1.24 “Long-Term
Inability to Supply” shall have the meaning assigned to
such term in Section 3.6(b).
1.25 “Material
Safety Data Sheet” shall mean the material safety data
sheet used to comply with the Occupational Safety and Health
Administration’s Hazard Communication Standard, 29 CFR
1910.1200.
1.26 “Minimum
Purchase Amounts” shall have the meaning assigned to such
term in Section 2.2.
1.27 “Non-Breaching
Party” shall have the meaning assigned to such term in
Section 11.2.
1.28 “Non-Conforming
Product” shall have the meaning assigned to such term in
Section 3.7.
1.29
“Party” and “Parties” shall
have the meaning assigned in the Preamble.
1.30
“Process” shall mean the process by which
Biopure shall manufacture the Product, as determined by Biopure
from time to time.
1.31
“Product” shall mean the product identified on
Schedule 1.31 attached hereto.
1.32 “Product
Specifications” shall mean the packaging information and
specifications regarding the Product attached hereto as Schedule
1.32.
1.33 “Purchase
Price” shall have the meaning assigned to such term in
Section 5.1.
1.34 “Regulatory
Approval” with respect to the Product shall mean all
Regulatory Approvals and Filings required for the marketing and
sale of the Product in the Territory that have been granted, or
otherwise permitted, by all appropriate Governmental
Authorities.
2
[**] = Portions of this agreement have
been omitted pursuant to a confidential treatment request. An
unredacted version of this agreement has been filed separately with
the Commission.
1.35 “Regulatory
Approvals and Filings” means any and all applicable
approvals (including pricing and reimbursement approvals),
licenses, registrations or authorizations of any Regulatory
Authority (as well as any filings, data rights, rights to
cross-reference and correspondence relating thereto) necessary or
useful for the sale, marketing, use and distribution of the Product
in the Territory, including, without limitation, any:
(a) premarket approval or premarket notification of the
Product, including any supplements and amendments thereto;
(b) postapproval marketing authorizations (including any
prerequisite manufacturing approval or authorization related
thereto); (c) labeling approval; and (d) technical,
medical, and scientific licenses.
1.36 “Regulatory
Authority” shall mean, the Government Authority(ies) in a
jurisdiction responsible for granting Regulatory Approval for the
manufacture, use and sale of the Product in such
jurisdiction.
1.37 “Renewal
Term” shall have the meaning assigned to such term in
Section 11.1
1.38 “Royalty
Fee” shall have the meaning assigned to such term in
Section 5.2.
1.39 “Short-Term
Inability to Supply” shall have the meaning assigned to
such term in Section 3.6(b).
1.40
“Term” shall have the meaning assigned to such
term in Section 11.1.
1.41
“Territory” shall mean the United States and its
territories and possessions.
1.42 “Testing
Specifications” shall mean the testing procedures and
specifications with respect to the manufacturing of the
Product.
1.43 “Third
Party” shall mean any person who or which is not a
Party.
| 2. |
APPOINTMENTS; DECHRA OBLIGATIONS |
2.1 Appointment of
Distributor for Products. Subject to Section 2.2, Biopure
hereby appoints Dechra as its sole and exclusive distributor (even
as to Biopure and its Affiliates) of the Product to promote, sell
and distribute the Product throughout the Territory consistent with
Regulatory Approvals.
2.2 Purchase
Obligations. For each Contract Year during the Term, the
purchase of Product from Biopure by Dechra shall meet or exceed the
aggregate minimum purchase amounts set forth on Schedule 2.2
(“Minimum Purchase Amounts”). Dechra may use any
purchase amounts in excess of the Minimum Purchase Amounts from the
immediately prior Contract Year to satisfy a deficiency in the
Minimum Purchase Amounts in a current Contract Year to remain in
compliance with the Minimum Purchase Amounts requirement in this
Section. In the event Dechra fails to achieve the Minimum Purchase
Amounts for any Contract Year, Biopure will have the option to
(i) convert the exclusive distribution rights granted in this
Agreement with respect to the Product to nonexclusive rights,
(ii) terminate this Agreement or (iii) waive the
requirement of this Section 2.2 for such Contract
Year.
2.3 Marketing and Sales
Obligations.
(a) Dechra shall use its
commercially reasonable efforts to actively distribute, sell and
promote the sale of Product throughout the Territory. Dechra shall
undertake such activities at its own expense in a manner consistent
with industry practices where such activities may include utilizing
subdistributors. Dechra will be responsible for distributing,
selling and promoting the Product to emergency and critical care
specialists, as well as general practitioners in the Field and in
the Territory. Dechra will undertake, at its expense, full
responsibility for all marketing and sales activities, including
direct promotion and facilitation of sales to veterinarians,
promotion at trade shows, development and implementation of
promotional and educational programs, preparation and distribution
of sales literature and other materials and all other activities
customarily associated with the commercial marketing and
distribution of such Product.
(b) On a quarterly basis,
Dechra shall provide a summary to Biopure of all Product sold by
Dechra to each end-use Customer during such Calendar Quarter and
shall use commercially reasonable efforts to require its
subdistributors to provide the same.
(c) Dechra shall furnish to
Biopure copies of all marketing, promotional and advertising
material in advance of publication.
3
[**] = Portions of this agreement have
been omitted pursuant to a confidential treatment request. An
unredacted version of this agreement has been filed separately with
the Commission.
(d) Dechra will present a
marketing plan within thirty (30) days following the Effective
Date and annually thereafter, with updates not less frequently than
every three months, which may be telephonic or as the parties deem
appropriate.
(e) Dechra shall store,
handle, ship, promote, sell and market the Product in conformity
with Applicable Law and with all Material Safety Data Sheets and
any information and updates provided by Biopure \ pursuant to
Section 3.2.
(f) Dechra shall not solicit
or accept orders for the Product other than from Customers within
the Territory and shall immediately forward to Biopure inquiries
relating to the Product received by Dechra from outside the
Territory,
(g) Dechra shall deliver all
Customer orders as soon as practicable following the receipt of the
order.
(h) Dechra shall conduct its
business in the purchase and resale of Product as a principal for
its own account and at its own expense and risk. Each Party
covenants and warrants that it will not act or represent itself
directly or by implication as agent for the other Party and will
not attempt to create any obligation, or make any representation,
on behalf of or in the name of the other Party.
(i) Neither Dechra nor an
Affiliate of Dechra shall during the Term, engage directly or
indirectly, whether as principal or agent or otherwise whatsoever,
in the manufacture, marketing or sale of any product directly
competitive with the Product in the Territory and in the Field
without the express written consent of Biopure.
| 3. |
MANUFACTURING AND SUPPLY. |
3.1 Biopure Sales and
Marketing Materials. Upon Dechra’s request and at no cost
to Dechra, subject to Section 8.4, Biopure shall transfer to
Dechra sales and marketing materials relating to the Product that
Biopure has readily available in its possession.
3.2 Manufacturing and
Supply.
(a) Biopure shall manufacture
the Product in conformity with the Process, Product Specifications,
cGMP, Testing Specifications and Applicable Laws as may apply from
time to time (collectively, the “Manufacturing
Standards”). The Manufacturing Standards may be modified,
or in any other manner changed or affected, only as provided by
Section 6.3.
(b) Biopure shall store and
handle the Product in accordance with the Product Specifications
and Applicable Law.
(c) Biopure shall provide
Dechra in written form all information and any updates thereto
regarding handling precautions, toxicity and hazards associated
with the Product. Biopure shall provide Dechra with the appropriate
Material Safety Data Sheets and any updates thereto for the
Product.
3.3 Forecasts. Dechra
shall submit to Biopure, at least thirty (30) days prior to
the first day of each month during the Term hereof (or for the
first month only, as soon as practicable after commencement of the
Contract Year but no later than ten (10) days after the
commencement of the Contract Year), a twelve (12) month
rolling forecast (“Forecast”) of the quantities
by package size of Product Dechra expects to order during such
period. Each Forecast shall be non-binding, with the exception of
the first three (3) months reflected therein, which shall be
considered a binding quantity (“Binding
Quantity”).
3.4 Orders.
(a) Biopure shall use its
commercially reasonable efforts to deliver to Dechra the Product
that Dechra has ordered pursuant to a written firm order by the
requested delivery date (each such order, a “Firm
Order”). Each Firm Order for Binding Quantity shall be
submitted by Dechra prior to the end of each applicable calendar
month for which the applicable Forecast was delivered.
4
[**] = Portions of this agreement have
been omitted pursuant to a confidential treatment request. An
unredacted version of this agreement has been filed separately with
the Commission.
(b) Each Firm Order shall
specify the Product, the quantity of the Product, the destination
to which the Product is to be delivered and the time and manner of
delivery (including the carrier to be used) in accordance with
Section 3.5.
(c) As soon as practicable
after the Effective Date but no later than ten (10) days after
the Effective Date, Dechra shall issue a written Firm Order for
Available Inventory in existence at Paragon Logistics’s
Memphis, Tennessee facility in an amount not to exceed a total
purchase amount of [**]. As used herein, “Available
Inventory” means Product with a remaining shelf life
equal to or greater than [**].
3.5 Delivery;
Invoicing.
(a) Biopure shall package and
label all Product as instructed by Dechra. Dechra shall be
responsible for all labeling and artwork costs relating to the
development of new labels, change over to Dechra’s label from
Biopure’s label and any changes made to the labeling or
artwork of the Product; otherwise, expense for labeling of Product
on an ongoing basis shall be Biopure’s responsibility and is
included within the Purchase Price of the Product. Product shall be
appropriately labeled in accordance with the Product
Specifications, Applicable Law, Regulatory Authority requests and
Dechra’s written instructions with a traceable batch number
and date of manufacture. Biopure shall ship each shipment as
instructed by Dechra, F.O.B. Biopure’s facility. All freight
expense and costs of insurance shall be borne by Dechra and are not
included within the Purchase Price of the Product. Title to and
risk of loss of Product shall pass to Dechra upon shipment of such
Product in accordance with the terms of this Section.
(b) Biopure shall invoice
Dechra at the time of shipment for the applicable Purchase Price
for the Product then shipped. Each such invoice shall state the
quantity of the Product contained in the shipment.
(c) Dechra or its designee
shall confirm the quantity of the Product contained in any shipment
and confirm that the Product contained in the shipment matches the
lots and expiry dates contained in the certificate furnished
pursuant to Section 6.1 (a). In the event the quantity of the
Product shipped is greater or less than the quantity reflected in
Biopure’s invoice for such shipment or there is a discrepancy
between the Product and the accompanying certificate, then within
ten (10) days after Dechra’s or its designee’s
receipt of such shipment, Dechra shall notify Biopure concerning
such overage or shortage and the amount of any invoice
automatically shall be increased or reduced, as the case may be, to
reflect the actual quantity of the Product contained in such
shipment. The Parties will cooperate to resolve any other
discrepancy described in this item (c).
3.6 Inability to
Supply.
(a) Biopure shall notify
Dechra: (i) as promptly as possible, but in no event more than
fifteen (15) days after Biopure’s receipt of a Firm
Order from Dechra or (ii) immediately upon becoming aware of
an event of force majeure under Section 12 or any other
cause that would render Biopure unable to supply the quantity of
the Product to Dechra that Biopure is required to supply under such
Firm Order. In the event of any Short-Term Inability to Supply,
Dechra shall be entitled to a reduction in Minimum Purchase Amounts
and Consulting Hours in proportion to the supply shortfall until
such Short-Term Inability to Supply ends. In the event of any
Long-Term Inability to Supply, Dechra shall not be required to
purchase the Minimum Purchase Amounts set forth in Section 2.2
or the Consulting Hours set forth in Section 4.2 for the
duration of the Term. In no event shall Dechra relinquish its
exclusivity rights as set forth in Section 2.1 due to a
Short-Term or Long-Term Inability to Supply.
(b) An “Inability to
Supply” shall mean, with respect to the supply of any
Product, Biopure’s failure for any reason, including without
limitation force majeure reasons or otherwise, to supply
Dechra with quantities of such Product equal to at least eight-five
percent (85%) of the Binding Quantity of such Product for the
applicable time period. A “Short-Term Inability to
Supply” is an Inability to Supply Product which is
reasonably expected to continue for no more than a three-month
period of time. A “Long-Term Inability to
Supply” is any Inability to Supply Product that is
reasonably expected to exceed or actually exceeds a three-month
period of time.
(c) In the event Dechra
believes that any Short-Term Inability or Long-Term Inability to
Supply exists, Dechra shall provide Biopure with written notice
thereof, and Biopure shall make use of the internal capacity of
Biopure to fill the Product supply shortfall as soon as
practicable.
3.7 Returns. In the
event that the Product does not conform with the applicable
Manufacturing Standards and Product Specifications (as may be in
effect from time to time), where such non-conformance is due
to
5
[**] = Portions of this agreement have
been omitted pursuant to a confidential treatment request. An
unredacted version of this agreement has been filed separately with
the Commission.
Biopure’s acts or omissions
(“Nonconforming Product”), Biopure will arrange
at its sole cost and expense, for all such Non-Conforming Product
to be picked up and destroyed in accordance with Applicable Law and
shall deliver to Dechra a certificate of destruction signed by an
authorized representative of Biopure. In addition, Biopure shall
promptly replace such Product at its expense.
3.8 Status Meetings.
Not less frequently than once every three (3) months,
representatives of the Parties shall meet, at such times and in
such places or telephonically as the Parties shall deem
appropriate, to discuss manufacturing matters, work-in-progress and
the Product.
4.1 Consulting
Services. Upon Dechra’s request, Biopure shall provide
certain consulting and technical services that shall be mutually
agreed upon by the parties in writing (“Consulting
Services”) . Notwithstanding any Consulting Services
Dechra shall remain responsible for following its own standard
operating procedures and Applicable Law.
4.2 Provider of Consulting
Services; Fees. The Consulting Services shall be provided by
Biopure’s employee, [**] successor (each a
“Consultant”) or if no successor exists, then
this Section 4 shall not apply, and neither party shall have
any obligations pursuant to this Section 4. The Consulting
Services shall be provided at a rate of [**] and Dechra shall pay
for a minimum of (a) [**] of the Term and (b) [**] of the
Term (where (a) and (b) are collectively,
“Consulting Hours”). In addition, Dechra shall
reimburse Biopure for reasonable, documented
“out-of-pocket” business and travel expenses that are
incurred by Consultant and are necessary for Consultant’s
performance of the Consulting Services so long as Dechra provides
its prior written approval to travel by Consultant.
| 5. |
PURCHASE PRICE; FEES; PAYMENTS. |
5.1 Purchase Price for the
Product. For purposes of this Agreement, the “Purchase
Price” applicable to all orders invoiced by Biopure shall
be the price as set forth on Schedule 5.1. Dechra alone
shall establish its resale pricing of the Products sold to it by
Biopure hereunder. Dechra shall pay all invoices duly issued by
Biopure under this Agreement within thirty (30) days after the
date of the applicable invoice. All invoices and payments required
to be paid hereunder shall be in U.S. Dollars, and all such
payments shall be made by wire transfer in immediately available
funds to an account designated by Biopure, unless the Parties agree
to settle such payments through other means.
5.2 Royalties payable to
Biopure. Dechra shall pay to Biopure a royalty fee as set forth
in Schedule 5.2 (the “Royalty Fee”).
Royalty Fees shall be paid within fifteen (15) days following
the end of a month on Net Sales in the preceding month.
| 6. |
QUALITY CONTROL; RECALL. |
6.1 Records; Batch
Certificates.
(a) Biopure shall provide
Dechra with a certificate of analysis and/or certificate of
conformance for each batch of Product delivered to
Dechra.
(b) Biopure shall keep
records related to the handling, manufacture, packa
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