Sample Business Contracts

Manufacturing and Supply Agreement - Novoste Corp. and BEBIG Isotopen- und Medizintechnik GmbH d/b/a BEBIG Isotopentechnik und Umweltdiagnostik GmbH

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                              Novoste Corporation
                         3890 Steve Reynolds Boulevard
                               Norcross, GA 30093
         represented by its Vice President of Manufacturing Don Webber

                     - hereinafter referred to as NOVOSTE -


                    BEBIG Isotopen- und Medizintechnik GmbH
        d/b/a so far as BEBIG Isotopentechnik und Umweltdiagnostik GmbH
                             Robert-Rossle-Str. 10
                                 D-13125 Berlin

     represented by its General Managers Dr. Andre Heb and Dr. Gunnar Mann

                      - hereinafter referred to as BEBIG -


1.  NOVOSTE produces medical devices and has developed a catheter based device
    for the delivery of radiation seeds to the site of restenotic lesions in
    coronary arteries for the inhibition and prevention of restenosis
    (hereinafter referred to as "Restenosis Device").

2.  BEBIG manufactures radioactive sealed Strontium-90 Seed sources (BEBIG
    Product Code SrO.SO3) in units called seed-trains usable in the Restenosis
    Device (hereinafter referred to as "Product" or "Seed-Trains").

3.  The parties hereto concluded an Agreement under the term RESTENOSIS THERAPY
    PROJECT DEVELOPMENT AND SUPPLY AGREEMENT dated November 14, 1994, amended by
    (hereinafter referred to as the "Framework Agreement"), dated November 15,
    1996, dealing et. al. with the supply of the Product to NOVOSTE.

4.  Additionally BEBIG granted an option to purchase all of BEBIG's tangible and
    intangible assets required for the production of the Product under an
    agreement called the OPTION TO PURCHASE ASSETS AGREEMENT dated August 22,
    1995 (hereinafter referred to as the "Purchase Option Agreement").

5.  Both the Framework Agreement and the Purchase Option Agreement were amended
    referred to as "Amendment 1") dated July 23, 1998, dealing inter alia with
    the transfer of certain assets required for the manufacturing of the Product
    as security collateral to NOVOSTE.

6.  Finally the parties hereto concluded a 2. AMENDMENT TO THE FRAMEWORK
    AGREEMENT AND SECURITY AGREEMENT dated February 11, 2000.

7.  Both parties intend to continue their cooperation on the basis of the
    considerations described hereinafter.

8.  THEREFORE, in the light of the above, both parties agree to the following
    MANUFACTURING AND SUPPLY AGREEMENT (hereinafter referred to as the

(S)1 Previous Agreements

1.   Validity of Previous Agreements: The parties mutually agree that this
     Agreement supersedes all agreements mentioned above (collectively referred
     to as "Previous Agreements"). These Previous Agreements shall no longer be
     valid after the Effective Date of this Agreement and all rights and claims,
     whether existing or contingent, whether known or unknown, shall finally and
     fully be released and settled. All payments that have been made by


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     NOVOSTE to BEBIG under this Previous Agreements shall be and remain the
     sole property of BEBIG and NOVOSTE shall not be entitled to reclaim these

2.   Waiver of the Option: NOVOSTE waives in particular its option to acquire
     the assets as specified in section 1 of the Purchase Option Agreement. In
     this regard the option fee of one hundred thousand dollars (US$100,000) as
     specified in section 2 of the Purchase Option Agreement that has been paid
     by NOVOSTE to BEBIG shall be and remain the sole property of BEBIG and
     NOVOSTE shall not be entitled to reclaim this payment.

3.   Retransfer of Security Collateral: Additionally with the execution of this
     Agreement NOVOSTE retransfers the title in the Security Collateral A and B
     as defined in par. 2 of section B of Amendment 1 to BEBIG. The parties
     mutually agree that the investment contribution of an aggregate sum of DM
     2,500,000 paid by NOVOSTE in respect to the Framework Agreement and the
     Amendment 1 shall be and remain the sole property of BEBIG and NOVOSTE
     shall not be entitled to reclaim this payment. In respect to the retransfer
     of the title in the Security Collateral NOVOSTE promises to hold BEBIG
     harmless from any debts, liabilities or obligations incurred in connection
     with the transfer of the Security Collateral.

4.   Offset License Fee Payments: Two prepaid offset license fee payments for
     the year 2000 for a total of 354.670 USD have been made by NOVOSTE to
     BEBIG. These prepayments are not subject to refund or return to NOVOSTE by

(S)2 Manufacturing and Supply of the Product

1.   Manufacture and Sale of Product: During the Term, BEBIG shall manufacture
     and sell the Product to NOVOSTE, in accordance with the terms and
     conditions of this Agreement as specified below and in quantities specified
     in NOVOSTE's purchase orders. The obligation to supply NOVOSTE is limited
     to a production capacity of ***** Seed-Trains per year with a maximum of
     ***** individual Seed sources unless otherwise agreed in writing. In 2001
     the production capacity is limited to ***** Seed sources per week. BEBIG
     will exert a maximum and best effort to meet NOVOSTE's actual purchase
     requirements above the foregoing commitments.

2.   Forecast: NOVOSTE shall provide to BEBIG a rolling forecast for Seed-Train
     delivery requirements for 12-month periods, the first such forecast to be
     delivered to BEBIG within 30 days of the date of execution of this
     Agreement and subsequent rolling and updated forecasts to be delivered to
     BEBIG each 90 days thereafter during the term of this Agreement and any
     extensions thereof.

3.   Purchase Orders: NOVOSTE shall submit firm purchase orders to BEBIG from
     time to time, but not later than three (3) months before the established
     Date of Delivery of Seed-Trains. NOVOSTE may exceed the forecast
     requirements set forth in the 12-month rolling forecasts, in which case
     BEBIG will do its best effort to fulfil NOVOSTE's orders.

4.   Quality Assurance: BEBIG warrants and represents that the Product supplied
     by BEBIG under this Agreement will be manufactured in accordance with all
     applicable ISO 9000 and EN46000 regulations. BEBIG shall notify NOVOSTE of
     any proposed or planned changes in the manufacturing processes or
     components of the Product, and shall not implement such changes until such
     time as NOVOSTE approves the proposed or planned changes, in writing. In
     addition, BEBIG agrees to have implemented a quality control system and
     procedures as shall be appropriate to assure compliance with the
     requirements of International Standards. NOVOSTE has the right to supervise
     the agreed upon quality and shall be entitled to inspect the facility in
     which any part of the Product is been manufactured upon one (1) week's
     prior notice.

5.   Terms of Use of the Trains: NOVOSTE agrees not to have a Seed-Train in
     clinical use after a period of 18 months from the Date of Manufacturing of
     any such Seed-Train, as evidenced by the manufacturer's certificate. BEBIG
     will deliver the Seed-Trains to NOVOSTE within 30 days after the Date of
     Manufacturing. The time for Use of the Seed-Trains in the clinic shall not
     exceed a period of 12 months.

6.   Use of existing manufacturing line: BEBIG agrees not to sell directly or
     indirectly radioactive sources produced on the manufacturing line on which
     the Product for NOVOSTE is manufactured.

7.   Insurance. BEGBIG is obliged to maintain a reasonale damage insurance for
     the Product manufacturing line insuring against damages covering the risks
     of fire, water damage, storm


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     and hail and theft with breaking and entering. BEBIG also maintains all
     necessary insurance coverage under the German Atomic Law for the
     manufacturing facility.

(S)3 Remuneration and Payment Terms

1.   Price: NOVOSTE agrees to pay the prices (collectively referred to as the
     "Price or Prices") according to the following price schedule:

                        in 30 mm    in 40 mm    in 60 mm
                        packaging   packaging   packaging
                        ---------   ---------   ---------


     In the event of an increase in material costs, BEBIG may add to the Prices
     increases in material cost, after such cost increases exceed 5 % during any
     one year period of the Agreement . BEBIG shall provide NOVOSTE with
     evidence for such price increase.

     Prices are ex works BEBIG's manufacturing facility Berlin (INCOTERMS),
     including packaging and ensuring product is cleared for export but
     excluding taxes if any. NOVOSTE agrees to pay for reasonable shipping costs
     for such deliveries.

2.   Payment Guarantee: NOVOSTE guarantees the following minimum annual payments
     (collectively referred to as "Annual Guaranteed Payment"), for all
     purchases of Products of NOVOSTE to BEBIG during the term of this

            Year    Annual Guaranteed payment
            ----    -------------------------

            2002             *****

      During the respective calendar year payments of the invoiced Price shall
      be credited against the Annual Guaranteed Payment commitment until the
      remaining balance equals zero. In case NOVOSTE may order less Seed-Trains
      than prepaid by the Annual Guaranteed Payment commitment the remaining
      balance of the respective Annual Guaranteed Payment shall be due and
      payable, in full, by NOVOSTE to BEBIG, 30 days after the end of the one-
      year contract period.

      In the event that the three month purchase orders are less than the
      prorated Guaranteed Payment, NOVOSTE and BEBIG shall in good faith
      negotiate an appropriate prepayment or mutually acceptable alternative.

      All Seed-train revenues resulting from deliveries in 2001 which are in
      excess of the Annual Guaranteed Payment for 2001 can be credited against
      the Guaranteed Payment of the year 2002.

      In the event both parties have entered into a new development and
      manufacturing agreement for a new source by the end of year 2002 the
      Annual Guaranteed Payment commitments for the years 2003 and 2004 under
      this Agreement shall be the payment commitments for the new agreement.

3.    Surcharge: BEBIG will make a substantial investment in the Sr-90 seed
      production line upon the execution of this Agreement to ensure continuous
      production for a period of four (4) years. NOVOSTE agrees to pay a
      surcharge of ***** for the first ***** seeds (total: *****) delivered
      after the execution of this Agreement to cover a part of BEBIG's
      investment costs. This surcharge will not be credited against the Annual
      Guaranteed Payments and will be charged separately.

4.    Payment terms: Payment shall be due within 30 days after receiving an
      invoice from BEBIG. The payment shall be made free of charge to account
      no. ***** at the Commerzbank Berlin, code no.   *****.


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(S)4  Warranty

1.   Warranties: BEBIG warrants and represents that the Product when delivered
     to NOVOSTE will meet all Product specifications and be free from defects
     and unreasonable hazards in material and workmanship and conform to
     applicable specifications and to contract requirements.

2.   Warranty Period: During a period of twelve (12) month following the Date of
     Delivery (referred to as the "Warranty Period") BEBIG agrees to replace at
     its own expenses any defective Product which has been returned to BEBIG by
     NOVOSTE. This provision does not apply to any defective Product that will
     be returned after expiration of the Warranty Period.

3.   Occurrence of any Defective Product: NOVOSTE is obliged to immediately
     notify BEBIG in writing upon becoming aware of any potentially defective
     source train. In such case the two companies agree to mutually determine
     the cause of defect and work in good faith to identify the root cause.

4.   Exclusions of Warranty: Any warranty is excluded with respect to defects
     caused in BEBIG's reasonable opinion by (i) accident, abuse, alteration,
     misuse or neglect, (ii) failure to use Products under normal operating
     conditions or environment, , (iii) (iv) failure to use or take any proper
     precautions under the circumstances, (v) user modification of any Product.

(S)5 Terms of Disposal

1.   Disposal Obligation: BEBIG will, on NOVOSTE's request, take back Seed-
     Trains for final disposal at a flat rate of ***** per seed. The flat rate
     shall be valid for disposal of a total of ***** seeds, however, BEBIG
     shall not be required, at the ***** rate, to dispose of more than 6000
     seeds per year. For any additional seeds disposed by BEBIG, the flat rate
     will be *****. However, NOVOSTE is not obliged to send Seed-Trains back to
     BEBIG for disposal. BEBIG agrees not to reuse Seed-Trains returned for

2.   Duration: The disposal obligation by BEBIG as stated above, shall be in
     effect for a period of 18 months after termination of this Agreement.

(S)6 Force Majeure

1.   Force Majeure: The performance of a Party, required by this Agreement,
     shall be extended by a reasonable period of time if such performance of the
     respective Party is impeded by an unforeseeable event beyond such Party's
     control, which shall include but not be limited to acts of God, industrial
     actions, riots, wars, embargo or requisition (acts of government).

2.   Notification: In case of Force Majeure, each Party shall promptly notify
     and furnish the other Party in writing with all relevant information
     thereto and the Parties shall negotiate in good faith appropriate

(S)7 Term and Termination

1.   Term of the Agreement: The Agreement shall be valid for a period of four
     (4) years (referring to as the "Initial Term") beginning from the date of
     Execution of this Agreement (referred to as "Effective Date"). The
     Agreement will automatically be extended for a period of one (1) year
     (referred to as "Extended Term") unless written cancellation is given by
     either party six (6) month before the end of the Initial Term or any
     Extended Term (collectively referred to as "Term"). During the Extended
     Term the terms and conditions as of the last year of the Initial Term shall

2.   Line Decontamination and Disposal: After termination of this Agreement and
     provided that both parties will not enter into an Agreement to continue the
     production of the Product, then NOVOSTE agrees to pay BEBIG the costs to
     decontaminate the strontium 90 line assets, up to a maximum of US$250,000.

3.   At the time of termination of this agreement, BEBIG will grant to NOVOSTE a
     fully paid, non-exclusive and non-transferable license to all its know-how
     and intellectual property used in the design and manufacture of the Seed
     trains. NOVOSTE will not assign these rights to any third party, however,
     NOVOSTE may permit a third party manufacturer to utilize the said know-how
     and intellectual property for the sole purpose of manufacturing product for


4.   In case of material breach of this agreement caused by BEBIG, NOVOSTE will
     give written notice to BEBIG within 30 days. If such breach is not cured by
     reasonable measures by BEBIG within 90 days from the date of notice, then
     NOVOSTE may permit a third party manufacturer to utilize the said know-how
     and intellectual property for the sole purpose of manufacturing product for

(S)8 Confidential Information

     Each party promises to hold in confidence any confidential information
     disclosed by the other party in the execution of this Agreement and the
     Previous Agreements and not provide such information to third parties,
     during this Agreement and for a period of two (2) years after its
     termination. Neither party shall have the right to use the confidential
     information given to the other party for any purposes other than those of
     this Agreement. The confidential information and all copies or part or all
     thereof, shall be and remain the exclusive property of the disclosing

(S)9 Miscellaneous

1.   Amendments: This Agreement may only be amended or modified at any time and
     in all respects by an instrument in writing executed by NOVOSTE and BEBIG.

2.   Notices: Any notices or other communications required or permitted
     hereunder shall be sufficiently given if delivered personally or sent by
     registered or certified mail, postage prepaid, addressed to:

          To NOVOSTE:    NOVOSTE Corporation
                         3890 Steve Reynolds Boulevard
                         Norcross, GA 30093
                         Attn: Don Webber

          To BEBIG:      BEBIG Isotopen- und Medizintechnik GmbH
                         Robert-Rossle-Str. 10
                         D-13125 Berlin
                         Attn: Dr. Andre Heb

     or to such other address as shall be furnished in writing by a party to the
     other and shall be deemed to have been given as of the date so personally
     delivered or three (3) days after being deposited in the United States
     mail, postage pre-paid, as the case may be.

3.   Governing Law: It is the intention of the parties the laws of the Federal
     Republic of Germany, both substantive and remedial, should govern the
     validity of this Agreement, the construction of its terms and the
     interpretation of its rights and duties of the parties.

4.   Execution of Counterparts: This Agreement may be executed in counterparts,
     each of which shall be deemed an original, but both of which together shall
     constitute one and the same instrument.

5.   Succession: All the terms and provisions of this Agreement shall be binding
     upon and inure to the benefit of, and be enforceable by, BEBIG and NOVOSTE
     and their successors and valid assigns.

6.   Entire Understanding: This Agreement constitutes the entire agreement
     between the parties hereto, and there are no agreements, understandings,
     restrictions, warranties or representations between the parties other than
     those set forth herein.

7.   Severability: Should any provision of this Agreement be or become invalid
     or void, the remaining provisions will continue to be in effect. Invalid or
     void provisions are to be replaced by such provisions that will fulfil the
     intent of the parties and the economic purpose of this Agreement in a
     legally binding form.

8.   Adverse Regulatory Events: Bebig agrees to inform Novoste immediately in
     writing upon receipt of any information regarding any adverse regulatory
     event that holds any potential to interfere with production schedules or
     specification changes


     NOVOSTE:                               BEBIG:

     Date: 14 June 2001                     Date: 20 June 2001
           -------------------------              --------------------

     /s/ Donald J. Webber                   /s/ Dr. Andre Heb
     -------------------------------        -----------------
     Donald J. Webber                       Dr. Andre Heb
     Vice President of Manufacturing        General Manager

                                            /s/ Dr. Gunnar Mann
                                            Dr. Gunnar Mann
                                            General Manager