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" xxxx 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 Xxxx" 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 such times as BMPI shall assign the
regulatory approvals to Luitpold, Luitpold will notify BMPI of all
potential adverse experiences and/or injuries, serious and
non-serious, no later than five (5) calendar days from the date that
Luitpold learns of the event. It will be BMPI's sole responsibility to
report all adverse experience reports and other pharmacovigilance
information to regulatory bodies, worldwide. If a product
investigation by a party or government office or agency results in a
potential product recall or correction of the Licensed Products, BMPI
shall retain full authority and responsibility for decisions on such
recall or correction. If BMPI decides to conduct a recall or
correction, BMPI will provide written notice to Luitpold that includes
a summary of the reason for and implementation of such action. BMPI
shall provide such information as Luitpold may reasonably require to
prepare any customer notification of such recall or correction, which
notification shall be issued by Luitpold.
5.3. Procedure. Until such time as BMPI shall assign the regulatory
approvals to Luitpold, any recall, correction or notification shall be
handled in accordance with the recall, correction and customer
notification policy and procedures maintained by BMPI. BMPI shall
retain full authority and responsibility for communication with
regulatory bodies, world-wide, as it relates to any recall or product
notification. BMPI shall promptly reimburse all reasonable, necessary
and documented costs for any recall of the Licensed Products that are
incurred by Luitpold with the prior approval of BMPI. Exhibit G
attached hereto provides the form of Standard Operating Procedure
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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.
("SOP") for such notification. The SOP may be updated from time to
time to reflect future regulatory requirements.
6. Confidentiality.
6.1. Definition. As used in this Agreement, "Confidential Information"
means any proprietary or confidential information, technical data,
trade secrets or know-how of a Party (the "Disclosing Party"),
including, without limitation, research, product plans, products,
service plans, services, business plans, customer lists and customers,
markets, software, developments, inventions, processes, formulas,
technology, designs, drawings, engineering, marketing, distribution
and sales methods and systems and profit figures, finances and other
business information disclosed to the other Party hereto (the
"Receiving Party") by or on behalf of the Disclosing Party, either
directly or indirectly, in writing, orally or by drawings or
inspection of documents or other tangible property; provided that (a)
any Confidential Information disclosed in tangible form will be marked
as confidential and/or proprietary information by the Disclosing Party
and (b) any Confidential Information disclosed in intangible form will
be identified as confidential and/or proprietary information of the
Disclosing Party at the time of disclosure and summarized in writing
to the Receiving Party within thirty (30) days of its disclosure. The
Parties agree that the provisions of this Agreement shall be
considered the Confidential Information of both Parties and shall not
be disclosed by either Party except as set forth in this Section 6.
6.2. Duties of Confidentiality and Non-Use. During the Term, and for a
period of ten (10) years thereafter, the Receiving Party will maintain
in confidence all Confidential Information disclosed to it by the
Disclosing Party. The Receiving Party shall not use, disclose or grant
use of the Disclosing Party's Confidential Information except as
required under this Agreement. To the extent that disclosure is
authorized by this Agreement, the Disclosing Party shall obtain prior
agreement from its employees, agents, consultants, Affiliates,
subcontractors and sublicensees (collectively, the "Representatives")
to whom disclosure is to be made to hold in confidence and not make
use of such information for any purpose other than those permitted by
this Agreement. Each Receiving Party shall use at least the same
standard of care as it uses to protect its own Confidential
Information to ensure that its Representatives do not disclose or make
any unauthorized use of such Confidential Information. Each Receiving
Party shall promptly notify the other upon discovery of any
unauthorized use or disclosure of Confidential Information.
6.3. Exceptions. The obligations regarding "Confidential Information" set
forth in Section 6 shall not apply to:
6.3.1. information that, at the time of disclosure, was published,
known publicly, or otherwise in the public domain;
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6.3.2. information that, after disclosure, is published, becomes known
publicly, or otherwise becomes part of the public domain through
no fault of the Receiving Party;
6.3.3. information that, prior to the time of disclosure, is known to
the Receiving Party, as evidenced by its written records, and is
not then subject to an obligation of confidentiality to any third
party;
6.3.4. information that, after disclosure, is made available to the
Receiving Party by a third party under no obligation of
confidentiality and without restriction on its further disclosure
by the Receiving Party; and
6.3.5. information that is required to be disclosed pursuant to the
order of any court or governmental agency with competent
jurisdiction or where disclosure is otherwise required by law
(provided, however, that (a) any such disclosure shall not
otherwise relieve the Receiving Party of its continuing
confidentiality and non-use obligations hereunder with respect to
all of the Confidential Information, including the information
disclosed by it to the court or agency under this clause and (b)
the Receiving Party shall give the Disclosing Party reasonable
advance notice of any such disclosure and cooperate reasonably
with the Disclosing Party in the Disclosing Party's efforts to
object to such disclosure and to obtain the recipient's agreement
to maintain the confidentiality of the Confidential Information
disclosed under this clause).
6.4. Permitted Disclosure. Each Party and its Representatives may disclose
Confidential Information to the extent such disclosure is reasonably
necessary for the purpose of the implementation of this Agreement to
individuals or entities bound by the same terms of Section 6 hereto,
including, without limitation, for purposes of complying with any
applicable statute or governmental regulation, and any required
disclosure to FDA or any other regulatory authority.
7. Intellectual Property.
7.1. Licensed Products. BMPI shall remain the exclusive owner of all right,
title and interest in and to all intellectual property rights in the
Licensed Products. No license to or assignment of any patent,
invention, patent right, material right, or trade secret anywhere in
the world by BMPI is conveyed by this Agreement. If the Licensed
Products, alone and not in combination with any other substance or
object, infringe or misappropriate the rights of any third party, BMPI
shall have the right, at its option, to (a) procure the right to
continue to supply the Licensed Products to Luitpold for use as
provided in this Agreement; or (ii) terminate this Agreement without
liability to Luitpold.
7.2. Use of Name. Luitpold is permitted to use the product names GEM, GEM
21, GEM 21S and GEM 21A (each, a "BMPI Xxxx") solely on and in
connection with the sale of the Licensed Products; however, Luitpold
shall not use any of the BMPI Marks as
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or as part of its corporate or business name or the name of any
business entity or division which is controlled by it, whether an
affiliate or otherwise. Luitpold covenants that the materials in
connection with which Luitpold uses any of the BMPI Marks shall be of
as high a quality as the materials in connection with which Luitpold
uses its own marks. Upon written request by BMPI no more than once per
calendar year, Luitpold shall furnish to BMPI, without charge,
representative samples of all printed items used or to be used by
Luitpold that bear the BMPI Marks to ensure appropriate size,
placement and usage of the BMPI Marks. Luitpold does not have, and
shall not acquire, any interest in any other of BMPI's trademarks or
trade names unless otherwise expressly agreed by BMPI in writing.
BMPI's name may appear on the packaging and labeling for the Licensed
Products and in material included therewith to the extent required by
law; provided, however, that each such use must be approved in writing
by BMPI (which approval shall not be unreasonably withheld). Luitpold
shall not otherwise use the name of BMPI, or disclose the existence of
this Agreement for any marketing, advertising or promotional purpose,
without BMPI's prior written consent.
8. Representations and Warranties. Each Party represents and warrants to the
other that (a) such Party is a corporation duly organized and validly
existing under the laws of the state or other jurisdiction of incorporation
or formation; (b) the execution and performance of this Agreement by such
Party has been duly authorized by all requisite corporate action; and (c)
the execution and performance by such Party of this Agreement and its
compliance with the terms and provisions hereof does not and, to its
knowledge, will not violate any law, rule or regulation applicable to such
Party.
9. Indemnification.
9.1. Indemnification by BMPI. BMPI shall defend Luitpold and its directors,
officers and employees and any Affiliate from and against any and all
claims and suits brought by an independent third party to the extent
based upon, and shall indemnify and hold Luitpold and its directors,
officers and employees and any Affiliate harmless from and against any
and all losses, damages, penalties, liabilities, judgments, amounts
paid in settlement, fines and expenses (including court costs and
reasonable fees of attorneys and other professionals) for product
liability caused by failure of the Licensed Products purchased by
Luitpold from BMPI to conform to mutually agreed upon specifications.
9.2. Indemnification by Luitpold. Luitpold shall defend BMPI and its
directors, officers and employees and any Affiliate from and against
any and all claims and suits brought by an independent third party to
the extent based upon, and shall indemnify and hold BMPI and its
directors, officers and employees and any Affiliate harmless from and
against any and all losses, damages, penalties, liabilities,
judgments, amounts paid in settlement, fines and expenses (including
court costs and reasonable fees of attorneys and other professionals)
for (a) any product liability or other claim relating to the
unloading, storage, handling, use, disposal or performance of the
Licensed Products, except to the extent caused by failure of the
Licensed Products to conform to mutually agreed upon specifications.
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9.3. Conditions of Indemnification. A Party seeking indemnification shall
give prompt written notice to the indemnifying Party of the
commencement of any action, suit, or proceedings for which
indemnification may be sought, and the indemnifying Party, through
counsel satisfactory to the indemnified Party (and, if the indemnified
Party is BMPI, the approval of Licensors) shall assume the defense
thereof; provided, however, that the indemnified Party shall be
entitled to participate in any such action, suit, or proceeding with
counsel of its own choice, but at its own expense. If the indemnifying
Party fails to assume the defense within a reasonable time, the
indemnified Party may assume such defense and the fees and expenses of
its attorneys will be covered by the indemnity provided for in Section
9.1 or 9.2 as applicable. Notwithstanding anything in this Article 9
to the contrary, an indemnifying Party shall not, without the written
consent of the indemnified Party, which consent shall not be
unreasonably withheld:
9.3.1. settle or compromise any action, suit, or proceeding or consent
to the entry of any judgment which does not include as an
unconditional term thereof the delivery by the claimant or
plaintiff to the indemnified Party of a written release from all
liability in respect of such action, suit, or proceeding; or
9.3.2. settle or compromise any action, suit, or proceeding in any
manner which may adversely affect the indemnified Party or its
Affiliates.
9.4. Insurance. During the term of the Agreement, each Party shall maintain
a policy or policies of commercial general liability insurance, which
includes product liability insurance, in an amount of no less than ten
Million Dollars ($10,000,000), with a deductible and/or self-insurance
retention of no greater than $500,000, and shall name the other Party
as an additional insured under its policy.
10. Disclaimer of Warranties, Limitation of Liability.
10.1. Limited Warranty. BMPI warrants to Luitpold that the Licensed
Products in each shipment (a) shall have been produced in accordance
with QSR and/or cGMP; (b) shall conform to the Specifications and the
accompanying Certificate of Analysis on the date that the shipment is
delivered to Luitpold; and (c) shall not be adulterated or misbranded
and shall comply with the Federal Food, Drug and Cosmetic Act, FDA
approvals and otherwise with all applicable laws or regulations.
10.2. Exclusive Remedy. In the event of any failure by a shipment of the
Licensed Products to conform, in any material respect, to the warranty
set forth in Section 10.1, the only liability of BMPI to Luitpold, and
Luitpold's sole and exclusive remedy, shall be BMPI's use of
commercially reasonable efforts to replace the shipment in accordance
with Section 3.3. Only in the event that the Licensed Products
received by Luitpold do not conform to the Section 10.1 Warranty and
after the use of commercially reasonable efforts to replace the
shipment is unsuccessful, BMPI shall refund payment to Luitpold.
11
10.3. Disclaimer of Warranties. EXCEPT AS OTHERWISE SET FORTH HEREIN, BMPI
DISCLAIMS ANY WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE
LICENSED PRODUCTS, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF
MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.
11. Term and Termination.
11.1. Term. The initial term of this Agreement shall commence on the
Effective Date and shall continue until the seventh anniversary of the
Effective Date (the "Initial Term"). Unless earlier terminated
pursuant to this Agreement, this Agreement shall renew at the end of
the Initial Term for subsequent one (1) year renewal terms (each, a
"Renewal Term," and together with the Initial Term, the "Term"),
unless either party gives at least six (6) months notice of intent not
to renew.
11.2. Termination for Cause. Either Party may terminate this Agreement for
cause if the other Party materially breaches any material provision of
this Agreement and fails to cure such breach within sixty (60) days
after receipt of notice thereof.
11.3. Survival. Sections 4, 5, 6, 7, 9, 11.3, and 12; and any payment
obligations of the parties hereunder accruing prior to the date of
termination; and any other provision herein expressly surviving
termination or necessary to interpret the rights and obligations of
the parties in connection with the termination of the term of this
Agreement will survive the termination or expiration of this
Agreement.
12. Miscellaneous.
12.1. Limitation of Liability.
12.1.1. EXCEPT FOR ANY BREACH OF THE OBLIGATIONS OF CONFIDENTIALITY
SET FORTH IN SECTION 6, NEITHER PARTY SHALL HAVE ANY LIABILITY TO
THE OTHER PARTY OR ITS AFFILIATES FOR ANY LOSS OF PROFITS,
SPECIAL, INDIRECT, CONSEQUENTIAL, EXEMPLARY, PUNITIVE OR
INCIDENTAL DAMAGES ARISING OUT OF OR RELATED TO THIS AGREEMENT
HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY (INCLUDING
NEGLIGENCE), WHETHER OR NOT A PARTY HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES.
12.1.2. IN NO EVENT SHALL BMPI'S TOTAL LIABILITY FOR DAMAGES FOR
CLAIMS ARISING IN CONNECTION WITH LICENSED PRODUCTS DELIVERED TO
LUITPOLD DURING ANY ONE (1) YEAR PERIOD UNDER THIS AGREEMENT
EXCEED THE TOTAL AMOUNT OF PAYMENTS MADE TO BMPI BY LUITPOLD
DURING SUCH ONE (1) YEAR PERIOD.
12
12.2. No Agency. Nothing herein contained shall be deemed to create an
agency, joint venture, amalgamation, partnership or similar
relationship between BMPI and Luitpold. Notwithstanding any of the
provisions of this Agreement, neither Party shall at any time enter
into, incur or hold itself out to third Parties as having authority to
enter into or incur, on behalf of the other Party, any commitment,
expense or liability whatsoever, and all contracts, expenses and
liabilities undertaken or incurred by one Party in connection with or
relating to the development, manufacture or sale of Products shall be
undertaken, incurred or paid exclusively by that Party, and not as an
agent or representative of the other Party. The Parties hereto agree
that each is acting as an independent contractor and not as an agent
or partner of the other by virtue of this Agreement.
12.3. Severability. If any provision of this Agreement shall be found to be
void, invalid or unenforceable, the same shall either be conformed to
the extent necessary to comply with applicable law or stricken if not
so conformable, so as not to affect the validity of this Agreement.
12.4. Notices. All notices, requests, demands, waivers, consents, approvals
or other communications hereunder shall be in writing and shall be
deemed to have been duly given if delivered personally, or by,
recognized commercial courier service, and delivered by facsimile
transmission, as follows:
If to BMPI: BioMimetic Pharmaceuticals, Inc.
000 Xxxxxxx Xxxxxxx, Xxxxx X-0
Xxxxxxxx, XX 00000
Attention: President and CEO
FAX: 000-000-0000
With a copy to: Xxxxxxx Xxxxxx Xxxx Xxxxxxx & Manner, P.C.
000 Xxxxxxxxx Xxxxxx, Xxxxx 0000
Xxxxxxxxx, XX 00000
Attention: Xxxx Manner
FAX: 000-000-0000
If to Luitpold: Luitpold Pharmaceuticals, Inc.
Xxx Xxxxxxxx Xxxxx
Xxxxxxx, XX 00000
Attention: President and CEO
FAX: 000-000-0000
With a copy to: Xxxxxxxxxxxx Xxxx & Xxxxxxxxx LLP
0000 X Xxxxxx, X.X.
Xxxxx 000 Xxxx Xxxxx
Xxxxxxxxxx, XX 00000
Attention: Xxxxx X. Xxxxxxxxx
FAX: 000-000-0000
13
or to such other address as the addressee may have specified in a
notice duly given to the sender as provided herein. Such notice,
request, demand, waiver, consent, approval or other communication will
be deemed effective (a) as of the date so delivered either personally
or by facsimile transmission or courier service; or (b) on the third
(3rd) business day after the same has been mailed.
12.5. Force Majeure. Neither Party to this Agreement shall be liable for
delay or failure in the performance of any of its obligations
hereunder if such delay or failure is due to causes beyond its
reasonable control, including, without limitation, acts of God, fires,
earthquakes, strikes and labor disputes, acts of war, or threatened
acts of war, acts of terror or threatened acts of terror, civil
unrest, or intervention of any governmental authority, but any such
delay or failure shall be remedied by such Party as soon as is
reasonably possible. If the force majeure event persists for longer
than ninety (90) days, Luitpold shall have the right to find an
alternate supply of the Licensed Product until such time as BMPI can
resume its obligations.
12.6. Assignments. This Agreement may not be assigned by Luitpold without
the written prior consent of BMPI; provided Luitpold may assign this
Agreement to an acquiror of all or substantially all of its assets.
This Agreement shall inure to the benefit of and be binding on the
Parties' permitted assigns, and successors in interest.
12.7. Waivers and Modifications. The failure of any Party to insist on the
performance of any obligation hereunder shall not act as a waiver of
such obligation. No waiver, modification, release, or amendment or any
obligation under this Agreement shall be valid or effective unless in
writing and signed by both Parties hereto.
12.8. Choice of Law. This Agreement is subject to and shall be construed
and enforced in accordance with the laws of the State of Tennessee
without reference to its choice of law provisions.
12.9. Dispute Resolution. The Parties agree that prior to any arbitration
concerning this Agreement, an executive officer of BMPI and Luitpold
with authority to resolve the dispute will meet within ten (10) days
of a written request by either Party to the other and will attempt in
good faith to negotiate a resolution to the dispute. If the Parties
are unable to negotiate a resolution to the dispute within twenty (20)
days of commencing negotiations, either Party may initiate arbitration
proceedings by written request to the other. Except as otherwise
specifically provided herein, all controversies and claims under this
Agreement shall be settled by binding arbitration by a panel of three
(3) arbitrators pursuant to the Commercial Arbitration Rules of the
American Arbitration Association. The arbitration shall be conducted
in New York, New York. Each Party shall select one arbitrator and the
two arbitrators so selected shall jointly select a third arbitrator.
The decision reached by the arbitrators shall be conclusive and
binding upon the Parties hereto and may be filed with the clerk of any
court of competent jurisdiction. Each of the Parties shall pay its own
expenses of arbitration and the expenses of the arbitrators shall be
equally shared. Notwithstanding anything to the contrary in this
Section 12.9, either Party may seek
14
immediate injunctive relief from any court of competent jurisdiction
for the protection of its intellectual property or Confidential
Information.
12.10. Headings. Section headings are for convenience only and will not be
deemed to affect in any way the language of the provisions to which
they refer.
12.11. Execution. This Agreement shall be executed in duplicate, both of
which shall be deemed to be originals, and both of which shall
constitute one and the same agreement.
12.12. Entire Agreement. This Agreement constitutes the entire agreement
between the Parties as to the subject matter hereof, and all prior
negotiations, representations, agreements and understandings are
merged into, extinguished by and completely expressed by this
Agreement.
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to
be executed by their duly authorized Representatives as of the day and year
first above written.
BioMimetic Pharmaceuticals, Inc. Luitpold Pharmaceuticals, Inc.
By: /s/ Xxxxxx Xxxxx By: /s/ Xxxx Xxxx Xxxxxxx
---------------------------- -------------------------------
Name: Xxxxxx Xxxxx Name: Xxxx Xxxx Xxxxxxx
Title: President Title: President, CEO
By: /s/ Xxxx X Xxxxxx
-------------------------------
Name: XXXX X XXXXXX
Title: VICE PRESIDENT OHD
15
EXHIBIT A
DESCRIPTION OF LICENSED PRODUCTS
A two component device consisting essentially of
o Recombinant human platelet-derived growth factor BB homodimer,
rhPDGF-BB meeting the specifications set forth in Exhibit B
o Beta tricalcium phosphate, 'b'-TCP, meeting the specifications set
forth in Exhibit B.
The components are individually packaged together in a single Unit of Licensed
Product.
16
EXHIBIT B
SPECIFICATIONS FOR LICENSED PRODUCTS
---------------------------------------------------------------------------------------------------
RHPDGF-BB SYRINGE SPECIFICATIONS
---------------------------------------------------------------------------------------------------
ITEM NO. TEST NAME TEST METHOD ACCEPTANCE LIMITS
---------------------------------------------------------------------------------------------------
1 Appearance ** **
---------------------------------------------------------------------------------------------------
2 PH ** **
---------------------------------------------------------------------------------------------------
3 Concentration ** **
---------------------------------------------------------------------------------------------------
4 Purity ** **
---------------------------------------------------------------------------------------------------
5 Fill Volume ** **
---------------------------------------------------------------------------------------------------
6 Sterility ** **
---------------------------------------------------------------------------------------------------
7 Identity ** **
---------------------------------------------------------------------------------------------------
8 Particulate ** **
---------------------------------------------------------------------------------------------------
9 Packaging Defects ** **
**
**
---------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------
'b'-TCP CUP SPECIFICATIONS
---------------------------------------------------------------------------------------------------
ITEM NO. TEST NAME TEST METHOD ACCEPTANCE LIMITS
---------------------------------------------------------------------------------------------------
1 Sterilization Cycle ** **
---------------------------------------------------------------------------------------------------
2 Fill Volume ** **
---------------------------------------------------------------------------------------------------
3 Identity ** **
---------------------------------------------------------------------------------------------------
4 Packaging ** **
---------------------------------------------------------------------------------------------------
5 Lid ** **
**
**
---------------------------------------------------------------------------------------------------
17
** 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.
---------------------------------------------------------------------------------------------------
scuffed, or folded.
---------------------------------------------------------------------------------------------------
GEM KIT SPECIFICATIONS
---------------------------------------------------------------------------------------------------
ITEM NO. TEST NAME TEST METHOD ACCEPTANCE LIMITS
---------------------------------------------------------------------------------------------------
1 Kit Contents ** **
**
**
---------------------------------------------------------------------------------------------------
2 Packaging ** **
---------------------------------------------------------------------------------------------------
3 Labeling ** **
**
**
**
---------------------------------------------------------------------------------------------------
18
** 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.
EXHIBIT C
ROLLING FORECAST FORM
------------------------------------------------------
LUITPOLD FORECAST DATE: 3/01/04
------------------------------------------------------
PERIOD UNITS
------------------------------------------------------
Q2-04 BINDING QUARTER
------------------------------------------------------
April 2004
------------------------------------------------------
May 2004
------------------------------------------------------
June 2004
------------------------------------------------------
------------------------------------------------------
Q3-04 BINDING QUARTER
------------------------------------------------------
July 2004
------------------------------------------------------
August 2004
------------------------------------------------------
September 2004
------------------------------------------------------
------------------------------------------------------
Q4-04 BINDING QUARTER
------------------------------------------------------
October 2004
------------------------------------------------------
November 2004
------------------------------------------------------
December 2004
------------------------------------------------------
------------------------------------------------------
Q1-05 NON-BINDING QUARTER
------------------------------------------------------
January 2005
------------------------------------------------------
February 2005
------------------------------------------------------
March 2005
------------------------------------------------------
------------------------------------------------------
Q2-05 NON-BINDING QUARTER
------------------------------------------------------
April 2005
------------------------------------------------------
May 2005
------------------------------------------------------
June 2005
------------------------------------------------------
------------------------------------------------------
Q3-05 NON-BINDING QUARTER
------------------------------------------------------
July 2005
------------------------------------------------------
August 2005
------------------------------------------------------
September 2005
------------------------------------------------------
19
EXHIBIT D
MINIMUM ORDER REQUIREMENTS
During each twelve (12) consecutive month period after the First Purchase Order
(Year 1, Year 2, etc.), Luitpold shall be obligated to order and pay for the
quantity of Units set forth below:
--------------------------------------------------------------------------------
YEAR YEAR 1 YEAR 2 YEAR 3 YEAR 4 YEAR 5 YEAR 6 YEAR 7
--------------------------------------------------------------------------------
** ** ** ** ** ** ** **
--------------------------------------------------------------------------------
If the parties agree to the use of a different carrier, in addition to the
minimum order requirements of Units as provided herein, Luitpold will pay the
purchase price for the minimum amount of beta-TCP ("Compound") that BMPI is
required to purchase pursuant to its Supply Agreement with Orthovita Inc. dated
August 2, 2002. The Orthovita Supply Agreement provides that such minimum amount
of Compound that shall be purchased during each twelve (12) consecutive month
period after the First Purchase Order shall be as follows:
--------------------------------------------------------------------------------
YEAR YEAR 1 YEAR 2 YEAR 3 YEAR 4 YEAR 5 YEAR 6 YEAR 7
--------------------------------------------------------------------------------
** ** ** ** ** ** ** **
--------------------------------------------------------------------------------
20
** 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.
EXHIBIT E
BMPI CONTACT PERSON
Xxxxx Xxxxxx
Senior Director, Operations
BioMimetic Pharmaceuticals, Inc.
000 Xxxxxxx Xxxxxxx Xx
Xxxxx X
Xxxxxxxx, XX 00000
FAX: 000-000-0000
21
EXHIBIT F
PRODUCT STORAGE INSTRUCTIONS
Store product according to label storage conditions printed on kits.
22
EXHIBIT G
BIOMIMETIC PHARMACEUTICALS POLICY ON PRODUCT RECALLS
BIOMIMETIC PHARMACEUTICALS POLICY ON PRODUCT RECALL SUMMARY REPORT
BIOMIMETIC PHARMACEUTICALS POLICY ON PRODUCT RECALL STATUS REPORT
[BIOMIMETIC PHARMACEUTICALS LOGO]
--------------------------------------------------------------------------------
POLICY
PRODUCT RECALLS
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Document Number RAC001 Revision Number: 00
Number of Pages: 8
Number of Associated Forms: Not Applicable
Effective Date: DEC -2 2003
Author: Xxxxxx Xxxxx
Superceded By: Not Applicable
--------------------------------------------------------------------------------
[BIOMIMETIC PHARMACEUTICALS LOGO] POLICY
Product Recalls
Page 2 of 8
================================================================================
DOCUMENT APPROVAL
AUTHOR /s/ Illegible DATE 12/2/03
---------------------------------
REGULATORY /s/ Illegible DATE 2 Dec 03
-----------------------------
PRESIDENT /s/ Illegible DATE 12/2/03
------------------------------
QUALITY CONTROL /s/ Illegible DATE 02 Dec 2003
------------------------
QUALITY ASSURANCE /s/ Illegible DATE 12/2/03
----------------------
================================================================================
Document Number: RAC001 Revision. 00 Effective Date: Approved By:
DEC - 2 2003 /s/ Illegible
---------------------
[BIOMIMETIC PHARMACEUTICALS LOGO] POLICY
Product Recalls
Page 3 of 8
================================================================================
DOCUMENT REVISION SUMMARY
DOCUMENT EFFECTIVE
NUMBER/REVISION DESCRIPTION OF CHANGE(S) AND JUSTIFICATION(S) DATE
------------------------------------------------------------------------------
00 New policy outlining the process of DEC - 2 2003
determining a product recall
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
================================================================================
Document Number: RAC001 Revision 00 Effective Date: Approved By:
DEC - 2 2003 /s/ Illegible
---------------------
[BIOMIMETIC PHARMACEUTICALS LOGO] POLICY
Product Recalls
Page 4 of 8
================================================================================
1. PURPOSE
1.1 The purpose of this policy is to define the responsibilities for
recall activities, to establish uniform criteria for identifying
problems which require review as potential recall situations, to
outline uniform criteria for determining what action, if any, is
appropriate, and to ensure that there is a strategy and procedure for
carrying out a recall, when necessary.
2. SCOPE
2.1 This policy applies to the BioMimetic Pharmaceuticals, Inc. (BMPI)
decision-making process regarding potential recalls or withdrawls.
3. POLICY
3.1 A recall review will be conducted and appropriate actions instituted
whenever a product is found to be violative (U.S) or defective (EU).
3.2 This policy does not apply to contract facilities.
4. RESPONSIBILITIES
4.1 Regulatory Affairs (RA) is responsible for the oversight and execution
of this procedure with support from other departments on an as needed
basis.
4.2 The Vice President of Regulatory Affairs and Quality Systems is
responsible for reporting recalls to the FDA.
5. DEFINITIONS
5.1 Product Recall: A company's removal or correction of a marketed
product that is in violation of applicable laws and may pose a
potential hazard to public health.
5.2 Alert: An advisory informing the user of a hazard and how to eliminate
the hazard without returning product to BMPI. For the purposes of this
procedure, recalls and alerts are synonymous.
================================================================================
Document Number: RAC001 Revision: 00 Effective Date: Approved By:
DEC - 2 2003 /s/ Illegible
--------------------
POLICY
[BIOMIMETIC PHARMACEUTICALS LOGO] Product Recalls
Page 5 of 8
================================================================================
5.3 Market Withdrawal: A correction or removal of a distributed device
that involves a minor violation of the federal Food, Drug, and
Cosmetic act that would not be subject to legal action by FDA or that
involves no violation of the act (e.g., normal stock rotation
practices).
5.4 Stock Recovery: The correction or removal of a device that has not
been marketed or that has not left the direct control of the
manufacturer. No portion of the lot or model involved in the
corrective or removal action has been released for sale or use.
5.5 Recall Classification: The numerical designation, i.e. Class I, Class
II, or Class III, assigned to a particular product recall to indicate
the relative degree of health hazard presented by the product being
recalled.
5.5.1 Class I:
A recall situation in which there is a reasonable probability
that the use of, or exposure to, a violative product is life
threatening or could cause serious adverse health consequences or
death (U.S.).
A recall situation in which there is a reasonable probability
that the use of or exposure to, a defective product will cause
serious adverse health consequences or death (EC).
5.2.2 Class II:
A recall situation in which the use of, or exposure to, a
violative product may cause temporary or medically reversible
adverse health consequences or where the probability of serious
adverse health consequences is remote (US).
A recall situation in which the use of or exposure to a
defective product could cause illness or mistreatment but is not
Class I (EC).
5.2.3 Class III:
A recall situation in which the use of, or exposure to, a
violative product is not likely to cause adverse health
consequences (U.S).
================================================================================
Document Number: RAC001 Revision. 00 Effective Date: Approved By:
DEC - 2 2003 /s/ Illegible
-------------------
POLICY
[BIOMIMETIC PHARMACEUTICALS LOGO] Product Recalls
Page 6 of 8
================================================================================
A recall situation in which the use of, or exposure to, a
defective product is not Class I or II and may not pose a
significant hazard to health, but withdrawal may have been
initiated for other reasons. (EU).
6. PROCEDURE
6.1 Recall Decision Procedure
6.1.1 All BMPI employees are required to immediately notify Regulatory
whenever becoming aware of a potential recall situation (this
includes field personnel). A potential recall situation exists
whenever there is reason to suspect that:
6.1.1.1 The performance of a finished product, which has been
distributed, could result in increased risk to patients.
6.1.1.2 The finished product has been mislabeled.
6.1.1.3 The frequency of product complaints for the finished
product is greater than expected.
6.1.2 RA will conduct a review of all available information with the
Recall Committee (consisting of the President/CEO, Regulatory,
Quality Assurance, Quality Control, and other departments if
applicable).
6.1.3 The Recall Committee will consider a variety of elements for
making the decision to initiate a recall. Elements for
consideration include but are not limited to patient safety and
public health risk potential, moral and ethical concerns, legal,
statutory, and regulatory issues. The evaluation will consider
the following:
6.1.3.1 If disease or injuries have already occurred from using
the product.
================================================================================
Document Number: RAC001 Revision: 00 Effective Date: Approved By:
DEC - 2 2003 /s/ Illegible
-------------------
POLICY
[BIOMIMETIC PHARMACEUTICALS LOGO] Product Recalls
Page 7 of 8
================================================================================
6.1.3.2 If existing conditions could expose people to a
health hazard in a clinical situation. Any conclusions
will be supported as completely as possible by
scientific documentation and/or statements that the
conclusion is the opinion of the individual(s) making
the health hazard determination.
6.1.3.3 The potential seriousness of the health hazard.
6.1.3.4 An assessment of the health hazard consequences
(immediate or long-range).
6.1.4 The Recall Committee will evaluate all types of field
actions to determine the appropriate action plan.
Field actions include but are not limited to: stock
recovery, market withdrawal, or product recall.
6.2 If field action is necessary, the Recall Committee will determine
whether or not to notify FDA or EU Member State based on the
classification (Class I, Class II, or Class III) of the recall
according to RAP001: Notification and Implementation of Product
Recalls in the Unites States or RAP002: Notification and
Implementation of Product Recalls in Europe.
6.3 Reference RAP001: Notification and Implementation of Product Recalls
in the United States or RAP002: Notification and Implementation of
Product Recalls in Europe for notification, implementation, and recall
effectiveness checks, and recall status reporting procedures.
7. ASSOCIATED DOCUMENTS
7.1. Not Applicable
8. REFERENCES
8.1. 21 CFR, Section 820.90: 820.100
8.2. ANSI/ASQ O9002: 1994, N46001: 1994, and ISO13485 1996, Sections 4.13
and 4.14
================================================================================
Document Number: RAC001 Revision: 00 Effective Date: Approved By:
DEC - 2 2003 /s/ Illegible
-------------------
[BIOMIMETIC PHARMACEUTICALS LOGO] POLICY
Product Recalls
Page 8 of 8
================================================================================
8.3. Product Recall: Planning Guide, ASQ, 1981
8.4. RAP001: Notification and Implementation of Product Recalls in the Unites
States
8.5. RAP002: Notification and Implementation of Product Recalls in Europe
================================================================================
Document Number: RAC001 Revision: 00 Effective Date: Approved By:
DEC - 2 2003 /s/ Illegible
--------------------
[BIOMIMETIC PHARMACEUTICALS LOGO]
--------------------------------------------------------------------------------
POLICY FORM
PRODUCT RECALL SUMMARY REPORT
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Document Number: FRAC001.01 Revision Number: 00
Number of Pages: 7
Number of Associated Policy: RAC001
Effective Date: DEC -2 ____
Author: Xxxxxx Xxxxx
Superceded By: Not Applicable
--------------------------------------------------------------------------------
[BIOMIMETIC PHARMACEUTICALS LOGO] POLICY FORM
Product Recall Summary Report
Page 4 of 7
================================================================================
1. ORIGIN OF REPORT
--------------------------------------------------------------------------------
INFORMATION REQUIRED INFORMATION OBTAINED
--------------------------------------------------------------------------------
1. Name of person/organization
reporting problem.
--------------------------------------------------------------------------------
2. Organization
--------------------------------------------------------------------------------
3. Address
--------------------------------------------------------------------------------
4. Telephone number
--------------------------------------------------------------------------------
5. Facsimile number
--------------------------------------------------------------------------------
6 E-mail address
--------------------------------------------------------------------------------
7. Date Time of report
--------------------------------------------------------------------------------
2. PRODUCT DETAILS
--------------------------------------------------------------------------------
INFORMATION REQUIRED INFORMATION OBTAINED
--------------------------------------------------------------------------------
1. Name(s) of product(s)
affected by the problem
--------------------------------------------------------------------------------
2. Community authorisation
number or other reference
number
--------------------------------------------------------------------------------
3. Pharmaceutical form.
--------------------------------------------------------------------------------
4. Strength.
--------------------------------------------------------------------------------
5. Pack size and type.
--------------------------------------------------------------------------------
6. Language on pack
--------------------------------------------------------------------------------
7. Marketing Authorisation
Holders name and address.
--------------------------------------------------------------------------------
================================================================================
Document Number: FRAC001.01 Revision: 00 Effective Date: Approved By:
DEC - 2 /s/ Illegible
-----------------
--------------------------------------------------------------------------------
[BIOMIMETIC PHARMACEUTICALS LOGO] POLICY FORM
Product Recall Summary Report
Page 5 of 7
================================================================================
3. NATURE OF DEFECT(S)
--------------------------------------------------------------------------------
INFORMATION REQUIRED INFORMATION OBTAINED
--------------------------------------------------------------------------------
1. Source of problem (eg. patient /
hospital / pharmacy / manufacturer).
--------------------------------------------------------------------------------
2. Details of defect or problem
--------------------------------------------------------------------------------
3. Is the problem associated with any
adverse event? (If so specify)
--------------------------------------------------------------------------------
4. Is there any evidence or suspicion
of a risk to public health (adverse
effects or inefficacy)?
--------------------------------------------------------------------------------
5. Extent of the problem (eg. how many
batches how many patients).
--------------------------------------------------------------------------------
6. Extent of distribution of the
product batch(es).
--------------------------------------------------------------------------------
7. Name and address of any regulatory
authority notified of the problem
--------------------------------------------------------------------------------
================================================================================
Document Number: FRAC001.01 Revision 00 Effective Date: Approved By:
DEC - 2 /s/ Illegible
------------------
[BIOMIMETIC PHARMACEUTICALS LOGO] POLICY FORM
Product Recall Summary Report
Page 6 of 7
================================================================================
3. NATURE OF DEFECT(S) CONTINUED
--------------------------------------------------------------------------------
INFORMATION REQUIRED INFORMATION OBTAINED
--------------------------------------------------------------------------------
8. Action taken so far (if any).
--------------------------------------------------------------------------------
9. Action planned or proposed.
--------------------------------------------------------------------------------
10. Other relevant information.
--------------------------------------------------------------------------------
================================================================================
Document Number: FRAC001.01 Revision: 00 Effective Date: Approved By:
DEC - 2 /s/ Illegible
------------------
[BIOMIMETIC PHARMACEUTICALS LOGO] POLICY FORM
Product Recall Summary Report
Page 7 of 7
================================================================================
4. Record of All Contacts
Date & Time Organization Name Phone & Fax Number
--------------------------------------------------------------------------------
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
================================================================================
Document Number: FRAC001.01 Revision: 00 Effective Date: Approved By:
DEC - 2 /s/ Illegible
-----------------
[BIOMIMETIC PHARMACEUTICALS LOGO]
-------------------------------------------------------------------------------
POLICY FORM
PRODUCT RECALLS STATUS REPORT
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Document Number: FRAC001.02 Revision Number: 00
Number of Pages: 7
Number of Associated Policy: RAC001
Effective Date: DEC 2
Author: Xxxxxx Xxxxx
Superceded By: Not Applicable
--------------------------------------------------------------------------------
[BIOMIMETIC PHARMACEUTICALS LOGO] POLICY FORM
Product Recall Status Report
Page 2 of 5
================================================================================
DOCUMENT APPROVAL
AUTHOR /s/ Illegible DATE 12/2/03
---------------------------------
REGULATORY /s/ Illegible DATE 2 Dec 03
-----------------------------
PRESIDENT /s/ Illegible DATE 12/2/03
------------------------------
QUALITY CONTROL /s/ Illegible DATE 02 Dec 2003
------------------------
QUALITY ASSURANCE /s/ Illegible DATE 12/2/03
----------------------
================================================================================
Document Number: FRAC001.02 Revision: 00 Effective Date: Approved By:
DEC - 2 /s/ Illegible
-----------------
[BIOMIMETIC PHARMACEUTICALS LOGO] POLICY FORM
Product Recall Status Report
Page 3 of 5
================================================================================
DOCUMENT REVISION SUMMARY
DOCUMENT EFFECTIVE
NUMBER/REVISION DESCRIPTION OF CHANGE(S) AND JUSTIFICATION(S) DATE
---------------------------------------------------------------------------
00 New policy form to document the product recall
status report DEC - 2
---------------------------------------------------------------------------
---------------------------------------------------------------------------
---------------------------------------------------------------------------
---------------------------------------------------------------------------
---------------------------------------------------------------------------
---------------------------------------------------------------------------
---------------------------------------------------------------------------
---------------------------------------------------------------------------
---------------------------------------------------------------------------
---------------------------------------------------------------------------
---------------------------------------------------------------------------
---------------------------------------------------------------------------
---------------------------------------------------------------------------
---------------------------------------------------------------------------
================================================================================
Document Number: FRAC001.02 Revision: 00 Effective Date: Approved By:
Dec - 2 ___ /s/ Illegible
-----------------
[BIOMIMETIC PHARMACEUTICALS LOGO] POLICY FORM
Product Recall Status Report
Page 4 of 5
================================================================================
PRODUCT RECALL STATUS REPORT
1. PRODUCT RECALL BACKGROUND INFORMATION
INFORMATION REQUIRED INFORMATION OBTAINED
-------------------- --------------------
1. Organization
---------------------------------------------------------
2. Name of person
---------------------------------------------------------
3. Address
---------------------------------------------------------
4. Telephone number
---------------------------------------------------------
5. Facsimile number
---------------------------------------------------------
6. Date / Time of report
---------------------------------------------------------
2. RECALL STATUS
INFORMATION REQUIRED INFORMATION OBTAINED
-------------------- --------------------
1. Number of Consignees Notified
of the Recall
---------------------------------------------------------
2. Date and Method of
Notification
---------------------------------------------------------
3. Number of Consignees
Responding to the Recall
Communication
---------------------------------------------------------
4. Quantity of product on hand
when the notification was
received.
---------------------------------------------------------
5. The number of consignees who
did not respond
---------------------------------------------------------
6. Number of products returned
or corrected by each
consignee contacted and the
quantity of product accounted
for
---------------------------------------------------------
================================================================================
Document Number: FRAC001.02 Revision: 00 Effective Date: Approved By:
DEC - 2 2003 /s/ Illegible
----------------
[BIOMIMETIC PHARMACEUTICALS LOGO] POLICY FORM
Product Recall Status Report
Page 5 of 5
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3. RECALL STATUS CONTINUED
INFORMATION REQUIRED INFORMATION OBTAINED
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7. The number of results of
effectiveness checks
conducted
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8. Estimated timeframe for
recall completion
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Author Date
--------------------------------- --------------------------------
Reviewed By Date
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Regulatory
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Document Number: FRAC001.02 Revision: 00 Effective Date: Approved By:
DEC - 2 2003 /s/ Illegible
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