Exhibit 10.9
MANUFACTURING AND SUPPLY AGREEMENT
This Manufacturing and Supply Agreement (this "Agreement") dated as
of
this 9th day of December, 2003 (the "Effective Date") is entered
into by and
between Luitpold Pharmaceuticals, Inc., a New York corporation
("Luitpold"), and
BioMimetic Pharmaceuticals, Inc., a Delaware corporation ("BMPI")
(each,
individually, a "Party" and, collectively, the "Parties").
WHEREAS, BMPI shall manufacture and supply the Licensed Products
(as
defined below) to Luitpold; and
WHEREAS, Luitpold shall purchase its requirements of the Licensed
Products exclusively from BMPI for mutually agreed upon limited
purposes.
NOW, THEREFORE, in consideration of the mutual promises, covenants
and
agreements hereinafter set forth, the sufficiency of which is
hereby
acknowledged, the Parties to this Agreement, intending to be
legally bound,
mutually agree as follows:
1.
Definitions. For purposes of this Agreement, the initially
capitalized
terms in this Agreement, whether used in the singular or plural,
shall have
the following meanings:
1.1. "Affiliate" means any company, corporation, business or entity
controlled by or under common control with either Luitpold or BMPI.
"Control" means direct or indirect beneficial ownership of at least
fifty percent (50%) interest in the voting stock (or the
equivalent)
of such corporation or other business having the right to direct,
appoint or remove a majority or more of the members of its board of
directors or their equivalent, or having the power to control the
general management of such company, corporation, business or
entity,
by contract, law or otherwise.
1.2. "Approval Date" means the date BMPI obtains approval from the
FDA or
is granted a "CE" mark or another form of marketing authorization
in
the European Union, whichever occurs first, to market and sell the
Licensed Products in the applicable jurisdiction in accordance with
the Exclusive Sublicense Agreement.
1.3. "cGMP" means current Good Manufacturing Practices and includes
the
Medical Device Quality Systems Regulations (QSR) as defined in 1.11
in
the United States existing on the Effective Date, as promulgated by
the FDA.
1.4. "Confidential Information" shall have the meaning set forth in
Section
6.1.
1.5. "BMPI Mark" shall have the meaning set forth in Section 7.2.
1.6. "Defective Licensed Products" means Licensed Products that do
not meet
the Specifications in Exhibit B or the warranties in Section 10.1.
1.7. "Disclosing Party" shall have the meaning set forth in Section
6.1.
1.8. "FDA" means the U.S. Food and Drug Administration and its
Canadian and
European Union counterpart, and any successor agencies thereto.
1.9. "Initial Term" shall have the meaning set forth in Section
11.1.
1.10. "LIBOR" shall have the meaning set forth in Section 4.4.
1.11. "Licensed Products" means any product consisting essentially
of a
combination of recombinant human PDGF-BB and a synthetic or natural
matrix. The Licensed Product shall initially be as described in
Exhibit A, provided such exhibit may be amended by the Parties from
time to time.
1.12. "QSR" means Quality System Regulations in the United States
as
promulgated by the FDA.
1.13. "Receiving Party" shall have the meaning set forth in Section
6.1.
1.14. "Renewal Term" shall have the meaning set forth in Section
11.1.
1.15. "Representatives" shall have the meaning set forth in Section
6.2.
1.16. "Specifications" means the specifications for Licensed
Products
attached hereto as Exhibit B.
1.17. "Sublicense Agreement" shall mean the Exclusive Sublicense
Agreement
by and between BMPI and Luitpold dated December 9, 2003.
1.18. "Term" shall have the meaning set forth in Section 11.1.
1.19. "Unit" shall mean 0.5 ml of rhPDGF-BB and 0.5 cc's of
Beta-TCP at the
concentration set forth in Exhibit B or if another carrier is used,
the appropriate amount of that carrier.
2.
Supply of Product.
2.1. General. During the Term, BMPI shall be the sole and exclusive
supplier of the Licensed Products to Luitpold and Luitpold shall
purchase all of its requirements for the Licensed Products only
from
BMPI and shall offer to sell, sell, and otherwise commercialize the
Licensed Products, directly and through distributors, only in
accordance with the Sublicense Agreement. In the event the Licensed
Product contains a component that Luitpold has the right to market
separately (for sake of illustration only to include Bio-Oss(R)
Bio-Oss Collagen(R) or Bio-Gide(R), and Luitpold provides this
component to BMPI at no cost, the transfer price of the Licensed
Product to Luitpold shall be reduced proportionately to any cost
savings BMPI receives. BMPI will provide Luitpold information on
the
calculation of any such cost savings.
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2.2. Rolling Forecasts. No later than March 1, 2004, Luitpold will
provide
to BMPI a forecast of its requirements for the Licensed Products
during each of the six (6) calendar quarters beginning with the
second
quarter of 2004. On the first day of the third month of each
calendar
quarter during the term of this Agreement, Luitpold shall update
the
forecasted requirements for each of the calendar quarters covered
by
the previous forecast and shall include forecasted requirements for
an
additional calendar quarter. Each forecast provided in accordance
herewith shall specify the number of Units of the Licensed Products
required by Luitpold in each covered calendar quarter in the form
set
forth in Exhibit C. In the first year following Approval, the
requirements for the first two quarters covered by each forecast
are
binding, and in each year thereafter, the requirements for each of
the
first three quarters covered by each forecast are binding, and
Luitpold shall be obligated to purchase and pay for one hundred
percent (100%) of the forecasted requirements for such calendar
quarters, whether or not Luitpold issues purchase orders for the
forecasted amounts of the Licensed Products in accordance with
Section
2.3; provided, however, that a binding order for any period shall
be
reduced on a pro rata basis if the Approval Date occurs during such
period but has not occurred by the beginning of such period.
2.3. Purchase Orders. A minimum of ninety (90) days prior to
Luitpold's
requested shipment date for any order of the Licensed Products,
Luitpold shall submit a purchase order to BMPI specifying the
number
of Units of Licensed Products to which the order relates, the
address
to which the order should be shipped and the requested delivery
date.
BMPI will accept and fill all purchase orders that comply with the
terms of this Agreement so long as the ordered quantities of the
Licensed Products do not exceed the forecasted requirements for the
month in which delivery is requested. BMPI will use commercially
reasonable efforts to fill any purchase order for quantities of the
Licensed Products that exceed the forecasted requirements for the
month in which delivery is requested as promptly as practicable,
but
BMPI cannot guarantee that it will be able to fill any such order
by
the requested delivery date.
2.4. Minimum Order Requirements. Luitpold shall order the minimum
quantities of the Units set forth in Exhibit D during each twelve
(12)
month period after the first purchase order as provided in Section
2.3
(the "First Purchase Order"). If Luitpold does not order the
required
quantity of Units of the Licensed Products during any specified
twelve
(12) month period after the First Purchase Order or the anniversary
date thereof, BMPI shall invoice and ship to Luitpold at the end of
such period, and Luitpold shall pay BMPI within thirty (30) days
after
the date of Luitpold's invoice, for the cost of that quantity of
the
Licensed Products by which Luitpold's orders during the specified
period fall short of the minimum order requirement for such period
at
BMPI's then existing price of Units as set forth in Section 4.1
hereof.
2.5. Addressee of Rolling Forecasts and Firm Orders. All rolling
forecasts
and purchase orders shall be sent by Luitpold to the person at the
address identified on Exhibit E as such exhibit may be amended from
time to time by BMPI.
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2.6. Additional or Different Terms. Any rolling forecasts, purchase
orders,
confirmations, acceptances, advices and similar documents submitted
by
Luitpold in conducting the activities contemplated under this
Agreement are for administrative purposes only and any legal terms
that may be included on such forms shall not add to or modify the
provisions of this Agreement. To the extent there are any conflicts
or
inconsistencies between this Agreement and any such document, the
provisions of this Agreement shall control as to a particular order
unless otherwise agreed to in writing by the Parties.
3.
Delivery and Inspection.
3.1. Terms of Delivery. All shipments of the Licensed Product shall
be on a
first-to-expire, first out basis from BMPI's distribution facility
and will have a shelf life of not less than one (1) year. Title and
risk of loss or damage to any shipment of the Licensed Products
sold
by BMPI to Luitpold hereunder shall pass to Luitpold upon delivery
of
the Licensed Products by BMPI to the carrier for shipment to
Luitpold.
Unless otherwise agreed upon by the parties or instructed by
Luitpold,
BMPI may select a carrier for the account and risk of Luitpold. All
shipments shall be made at the expense of Luitpold.
3.2. Accompanying Documentation. With each shipment of the Licensed
Products, BMPI shall provide Luitpold with (a) commercially
appropriate shipping documentation, including, without limitation,
bills of lading and any additional documentation reasonably
requested
by Luitpold, (b) a Certificate of Analysis for each batch that
shall
record conformance of the shipment with the Specifications in
Exhibit
B, the QSR and/or cGMP and (c) an invoice for the amount of
Licensed
Products delivered in such shipment. Containers shipped with the
Licensed Products shall be properly marked by BMPI as reasonably
requested by Luitpold.
3.3. Inspection of Licensed Product.
3.3.1. Within fifteen (15) business days after Luitpold's receipt
of a
shipment of the Licensed Products, Luitpold shall inspect the
Licensed Products and the documentation accompanying such
shipment. Luitpold shall promptly, and in no event more than
fifteen (15) business days after receipt of such shipment, notify
BMPI of any Defective Licensed Products or error in the
documentation and provide a detailed description of the Defective
Licensed Products or the error. If Luitpold does not notify BMPI
of any Defective Licensed Products or error in the documentation
accompanying any shipment within fifteen (15) business days after
Luitpold's receipt of a shipment of the Licensed Products,
Luitpold shall be deemed to have accepted such shipment.
3.3.2. Should Luitpold reject any Licensed Products as a Defective
Licensed Products or find any discrepancy between the shipping
documents and the Licensed Products received, and subject to
acknowledgement of such Defective Licensed Products or shipment
error by BMPI, BMPI shall provide
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to Luitpold a replacement shipment of the missing or Defective
Licensed Products as promptly as possible, but in no event more
than ninety (90) days after such notice as Luitpold's sole and
exclusive remedy for the Defective Licensed Products or the
shipment error, and Luitpold shall return to BMPI at BMPI's
expense or destroy, at BMPI's option, any Defective Licensed
Products.
3.3.3. Except to the extent Luitpold provides notice to BMPI in
accordance with Section 3.3.1, all Licensed Products delivered to
Luitpold shall be deemed accepted by Luitpold fifteen (15)
business days after Luitpold's receipt thereof. In addition, if
any shipment of the Licensed Products fails to meet the
Specifications as a result of a cause occurring after receipt of
the Licensed Products by Luitpold, including, without limitation,
storage or handling not conforming with BMPI's written storage
and handling instructions as specified in Exhibit F, BMPI shall
not be responsible for such failure.
3.4. Inspection of Manufacturing Records and Facilities.
3.4.1. BMPI shall maintain and retain, and make available to
Luitpold
for audits, not more than once per calendar year (except where a
recall occurs), during regular business hours and upon ten (10)
business days advance written notice to BMPI its facility(ies)
and records including standard operating procedures, quality
assurance manufacturing records, validation records, batch
production records and other records (excluding financial
records) directly related to the supply of the Licensed Products
as required by FDA or other applicable regulations. BMPI may
delay such inspection for a period of up to thirty (30) days if,
in its good faith judgment, such delay is necessary to avoid a
significant disruption to its business. The sole purpose
Luitpold's audit shall be to review the compliance of BMPI with
the terms of this Agreement and applicable regulatory
requirements. All information reviewed by Luitpold shall be
subject to the confidentiality provisions of this Agreement and
the Nondisclosure Agreement between BMPI and Luitpold dated April
28, 2003, and may not be duplicated.
3.4.2. Luitpold shall maintain, retain, and make available to BMPI
for
audits, not more than once per calendar year (except where a
recall occurs) its facilities and records including standard
operating procedures, quality assurance records, customer
service, storage and distribution records and other records
(excluding financial records) directly related to the storage and
distribution of the Licensed Product. Luitpold shall make these
records available at their facilities, during normal business
hours upon ten (10) business days advanced written notice.
Luitpold may delay such audit for a period up to thirty (30) days
if, in its good faith judgment, such delay is necessary to avoid
significant disruption to its business. The sole purpose of
BMPI's audit shall be to review Luitpold's compliance with the
terms of this agreement and applicable regulatory requirements.
All information reviewed by BMPI shall be subject to
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the confidentiality provisions of this Agreement and the
Nondisclosure Agreement between BMPI and Luitpold dated April 28,
2003, and may not be duplicated.
3.4.3. Each party is responsible for its own costs relating to any
audit.
3.4.4. In the event of a Product Notification or Recall, as
described
in Section 5 of this Agreement, the ten (10) business day
advanced notification requirement for audits by either Party will
be waived by the other Party and both Parties will negotiate an
immediate audit date in good faith. The date for such audit shall
not be more than five (5) business days from the date of the
notification.
4.
Payment Obligations.
4.1. Price. The price of the Licensed Products shall equal ** per
Unit,
which price may be increased by BMPI annually, beginning twelve
(12)
months following first shipment of Licensed Products by BMPI to
Luitpold, by the lesser of (a) ** of the price per Unit charged
during
the preceding year and (b) a percentage equal to the percentage
increase, if any, in the Consumer Price Index for the most recent
month for which the Index is available over the Consumer Price
Index
for the corresponding month in the previous year. For purposes of
this
provision, the term "Consumer Price Index" shall mean the "Index
Number" for "All Items" as published in the Revised Consumer Price
Index--Cities (36 mo. avg. 1982-84 = 100) by the Bureau of Labor
Statistics of the U.S. Department of Labor. To the extent that
there
are changes or modifications to the Specifications or the Unit, the
Parties shall negotiate adjustments to the price in good faith.
4.2. Payment Terms. During the two (2) years after the First
Purchase
Order, ** of the applicable price for any order shall be due and
payable at the time of submission of the applicable purchase order,
and the balance shall be due and payable within ** days after the
date
of BMPI's applicable invoice to Luitpold. Thereafter, the invoice
shall be due and payable within ** days of BMPI's applicable
invoice
to Luitpold. BMPI shall issue an invoice for each order on the date
that the order is shipped. All payments to be made hereunder shall
be
payable in United States dollars.
4.3. Changes in Regulatory Requirements or Increased Costs. If,
during the
Term, there are any changes in the QSR or cGMPs or any other law,
rule
or regulation affecting the manufacture and sale of Licensed
Products
or an increase in total production cost of greater than ** of the
total production cost the preceding year such increased costs shall
be
passed on to Luitpold in the form of an increase to the price upon
ninety (90) days written notice. Luitpold shall have the right to
verify increases to the price through an independent third party
auditor acceptable to both Parties. Prior to the effectiveness of
any
such law, rule or regulation or increase in cost of components,
BMPI
shall provide Luitpold with written notice of any such law, rule or
regulation or
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**
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED
WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.
increase that, to its knowledge, is proposed, as well as any
material
updates to such proposal. In the event the production price
increases
by more than ** in two consecutive years, Luitpold may find an
alternative source of the Licensed Products provided Luitpold gives
BMPI thirty (30) days written notice of the alternative source and
the
price per Unit offered by the alternative source. BMPI shall have
thirty (30) days from the date of such notice to agree to provide
the
Licensed Products at the same price quoted by the alternative
source
or to terminate this Agreement.
4.4. Late Payments. Any payments due under this Section 4 that are
not made
on or before the date specified under the provisions of this
Agreement
shall bear interest, to the extent permitted by law, at an annual
rate
of three percentage points above the 30-day London InterBank
Offering
Rate ("LIBOR") as reported in The Financial Times (or any other
publication agreed to by the Parties) on the date such payment is
due,
with interest calculated based on the number of days such payment
is
delinquent.
5.
Product Notifications and Recall.
5.1. Notification by Luitpold. Luitpold will: (a) notify BMPI in
writing of
any claim or proceeding involving the Licensed Products within ten
(10) days after Luitpold learns of such claim or proceeding; and
(b)
report promptly to BMPI all claimed or suspected defects in the
Licensed Products.
5.2. Notification to BMPI. Until su
