EX-10.9 18 file010.htm MANUFACTURING AND SUPPLY AGREEMENT


                                                                    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 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 Mark") 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.
                                 330 Mallory Station, Suite A-1
                                 Franklin, TN 37067
                                 Attention: President and CEO
                                 FAX: 615-844-1281

          With a copy to:        Harwell Howard Hyne Gabbert & Manner, P.C.
                                 315 Deaderick Street, Suite 1800
                                 Nashville, TN 37238
                                 Attention: Mark Manner
                                 FAX: 615-251-1059

          If to Luitpold:        Luitpold Pharmaceuticals, Inc.
                                 One Luitpold Drive
                                 Shirley, NY 11967
                                 Attention: President and CEO
                                 FAX: 631-924-8650

          With a copy to:        Sonnenschein Nath & Rosenthal LLP
                                 1301 K Street, N.W.
                                 Suite 600 East Tower
                                 Washington, DC 20005
                                 Attention: Peter S. Reichertz
                                 FAX: 202-408-6399


                                       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/ Samuel Lynch                         By: /s/ Mary Jane Helenek
    ----------------------------                 -------------------------------
Name: Samuel Lynch                           Name: Mary Jane Helenek
Title: President                             Title: President, CEO


                                             By: /s/ Jean M Bellin
                                                 -------------------------------
                                             Name: JEAN M BELLIN
                                             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


**


                                        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.




**

                                       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

James Monsor
Senior Director, Operations
BioMimetic Pharmaceuticals, Inc.
330 Mallory Station Rd
Suite A
Franklin, TN 37067

                                FAX: 615-844-1281


                                       21



                                    EXHIBIT F

                          PRODUCT STORAGE INSTRUCTIONS

Store product according to label storage conditions printed on kits.


                                       22



                                    EXHIBIT G

**

**   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.