Sample Business Contracts

Manufacturing Agreement - MedImmune Inc. and Dr. Karl Thomae GmbH

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                         MANUFACTURING - AGREEMENT
This Agreement is made as of November 27, 1997, by and between

whose registered office is at 35 West Watkins Mill Road, Gaithersburg,
Maryland 20878 U.S.A.
                          (hereinafter referred to as "MEDIMMUNE")


whose registered office is at Birkendorfer Strabe 65, 88397 Biberach an der
Riss, Federal Republic of Germany
                          (hereinafter referred to as "THOMAE").


WHEREAS the parties have - among others - concluded a Contract Research and
Development Agreement regarding the research and development of a method to
produce MEDI-493 in a commercial scale; and

WHEREAS MEDIMMUNE has all rights to the Product and is the owner of the
Process and

WHEREAS MEDIMMUNE wishes THOMAE to act as its agent to manufacture Product
for MEDIMMUNE, and THOMAE accepts, to manufacture  Product as agent for
MEDIMMUNE for commercial use, manufactured in accordance with the Process.

NOW THEREFORE, the parties hereto agree as follows:


In this Agreement the following terms shall have the meanings indicated:

1.1    "MEDIMMUNE" means MedImmune Inc. as laid down first above.

1.2    "Contract Research and Development Agreement" means the agreement
       on MEDI-493 (the humanized IgG 1 monoclonal antibody specifically
       directed against Respiratory Syncytical Virus (RSV)) between the
       parties to this Agreement dated November 27, 1997regarding the
       development of the Process.

                                 (PAGE 1)
1.3    "Product-price" means THOMAE's prices for manufacturing Product,
       Bulk Product, Final Product and/or Finished Product (as the case
       may be) to be calculated on the basis of the assumptions set forth
       in Appendix 1.


1.5    "Product" means any product containing MEDI-493 in Bulk Product or
       as Final Product or as Finished Product its sole or combined active
       ingredient and produced according to the Process.

1.6    "Bulk Product" means Product which has been purified to a
       concentrated form and can be stored in a liquid or frozen form
       under appropriate conditions.

1.7    "Final Product" means unlabelled final container containing
       lyophilized Product.

1.8    "Finished Product" means Final Product and also labelled and

1.9    "Specifications" mean the specifications to be enclosed hereto as
       Appendices 3 for Product, Final Product and Finished Product
       produced and supplied hereunder by THOMAE. These Appendices will be
       agreed upon by the parties after the finalization of the Process.

1.10   "Process" shall be the final Process for manufacturing Product
       developed and agreed by the parties according to the Contract
       Research and Development Agreement.

1.11   All other terms used herein shall have the same meaning as defined
       in the Contract Research and Development Agreement.


2.1        (a) Subject to MEDIMMUNE's right to manufacture set forth in
           Section 2.1 (b), MEDIMMUNE hereby appoints THOMAE as
           MEDIMMUNE's exclusive agent to manufacture Product for
           MEDIMMUNE and THOMAE hereby accepts such agreement

           (b) Subject to MEDIMMUNE's right to manufacture Bulk Product
           and/or Final Product and/or to have a third party to produce
           Final Product and/or Finished Product from Bulk Product
           produced by MEDIMMUNE, THOMAE will manufacture Product for
                exclusively throughout the world during the full term of
           this Agreement and according to the provisions of this
           Agreement (incl. Rolling Forecasts and Minimum quantities) and
                                 (PAGE 2)
                will have and cause its licensees to have Product
           manufactured by THOMAE throughout the world for the period of
           this Agreement.

2.2    Subject to Section 3 below THOMAE undertakes to manufacture for
       MEDIMMUNE the quantities of Product ordered by MEDIMMUNE within its
       Capacity. All manufacture of Product hereunder will be made in
       accordance with the Process and will be delivered in agreed form
       suitably packed as specified in the Specifications.
2.3    All quantities of Product will be produced in a production facility
       designated by THOMAE which is approved by the FDA and all of the
       European Community regulatory authorities for commercial scale
       production and deliveries.
       To the extent that MEDIMMUNE requests that THOMAE secure regulatory
       approval of the manufactured Product in other countries, then
       THOMAE shall seek such regulatory approval of its production
       facility unless such approval would require change in the
       production facility. MEDIMMUNE shall pay any additional costs for
       such approval. If changes are required by the respective authority
       and if THOMAE does not agree to make such changes at MEDIMMUNE's
       expense, then MEDIMMUNE shall have the right to seek a third party
       manufacturer for the respective country(ies).
       THOMAE shall take reasonable efforts to secure approval of THOMAE's
       manufacturing facility by the FDA and the respective European
       regulatory authority and THOMAE's obligations under Section 2.1
       above are subject to such approval as the case may be.

2.4    Rolling Forecasts
       Beginning as of March 10th, 1998 and by the 10th of the last month
       of each quarter MEDIMMUNE will provide THOMAE with a 3 (three)
       years Product forecast planning horizon for Final Product and
       Finished Product or an update thereof . The planning horizon shall
       start the first day of the fourth month after the first forecast
       which shall be July 1st 1998 or an update thereof.
       The rolling forecasts are to be broken down to single months.
       The forecast for the first year (months 1-12) are firm orders and
       cannot be changed.
       The forecast for the second year (months 13-24) is a partly binding
       forecast which means that the forecast can fully be changed within
       this period as follows:
       the forecast be increased within the Capacity, but is limited to
       the following restrictions when decreased:

       months 13-15 the forecast can be reduced by
       months 16-18 the forecast can be reduced by
                                 (PAGE 3)
       months 19-21 the forecast can be reduced by
       months 21-24 the forecast can be reduced by

       The forecast for the third year (months 25-36) is a non-binding
       The rolling forecasts (including firm orders) for Final Product and
       Finished Product are laid down in Appendix 2.

2.5    THOMAE shall use reasonable efforts to manufacture and deliver to
       MEDIMMUNE all quantities of the Product beyond the binding
       forecasts at MEDIMMUNE's request within its Capacity.

2.6    THOMAE shall make deliveries by the 10th day of the month for which
       a firm order is made.

2.7    Minimum quantities
       Provided that the Product is approved in the USA, beginning January
       1st 1999, the minimum quantity of Product to be ordered for
       manufacture on behalf of MEDIMMUNE each calendar year is

       If the quantity falls below the minimum quantity of (CONFIDENTIAL
       TREATMENT HAS BEEN REQUESTED) annually, THOMAE will charge
       MEDIMMUNE an annual surcharge according to Article 5.2.

2.8    Exclusivity/Competition
       During the term of this Agreement, THOMAE agrees that it will not
       manufacture Product for a third party nor shall THOMAE assist any
       third party with respect to development or manufacture of a
       monoclonal antibody against RSV, except where THOMAE is granted
       marketing rights to such a monoclonal antibody.


3.1    Warranty/Limitation
       THOMAE warrants that the Product to be manufactured by THOMAE here
       under corresponds to the Specifications and shall be produced
       according to current GMP standard and in accordance with all
       applicable laws, rules and regulations in the country where
       The Product shall be delivered free and clear of liens and claims
       which affect title.
       THOMAE makes no other warranty of any kind, express or implied.

                                 (PAGE 4)
3.2    Tests of the Product and agreed upon Audits
       MEDIMMUNE shall have the right to carry out agreed upon customary
       tests of the Product and agreed upon audits at reasonable times, of
       the premises and facilities where THOMAE performs work under this
       Agreement, and of the premises where it stores raw materials,
       auxiliary materials, intermediates, packing materials for the
       Product and the Product itself. The agreed upon tests of the
       Product shall be included in Appendix 3 hereto.

3.3    Defective Product (including loss and inaccurate quantity)
       Claims on account of quantity, quality, loss or damages to the
       Product shall be made by MEDIMMUNE in writing within 90 (ninety)
       days following receipt thereof, and THOMAE's liability for damages
       for such claims shall in no event exceed the manufacturing price or
       replacement of goods for the particular shipment with respect to
       which such claims are made. No Product will be returned to THOMAE
       without THOMAE's written permission.

3.4    Indemnification by MEDIMMUNE
       In accordance with all applicable law MEDIMMUNE shall be
       responsible for, and hold THOMAE harmless from any damage, loss,
       cost or expense relating to third party claims or suits arising
       from the packaging, use, marketing or sale of the Product by
       MEDIMMUNE, or its licensees or other authorized persons or
       entities, other than those which arise out of a breach of warranty
       by THOMAE and those which arise out of gross negligence or willful
       misconduct of THOMAE or its officers, employees or agents, and
       provided that upon receipt of notice by THOMAE of any claims or
       suits relating to such use or sale of the Product, THOMAE shall
       notify MEDIMMUNE thereof without delay and shall permit MEDIMMUNE
       to handle such claims or suits at the cost and discretion of
       MEDIMMUNE including but not limited to defense, settlement and
       compromise thereof.

3.5    Infringement of intellectual property rights
       With respect to the Process MEDIMMUNE shall be responsible for and
       hold THOMAE harmless from any third party claim of infringement of
       its intellectual property rights from a third party based upon
       THOMAE's contractual activities hereunder.

3.6    Limitation of Warranty / Liability
       Except as provided in Article 3.1 above THOMAE makes no warranty of
       any kind, express or implied.
       Except for willful misconduct THOMAE shall not be liable for any
       lost profits or any special, incidental or consequential damages.

                                 (PAGE 5)
3.7    Delivery/Risk of Loss
       THOMAE shall deliver or arrange for the delivery of the Product
       manufactured for MEDIMMUNE to a carrier designated by MEDIMMUNE on
       the basis of EXW THOMAE's plant in Biberach, in accordance with
       Incoterms 1990 as published by the International Chamber of

       Title to Product manufactured hereunder shall remain with
       MEDIMMUNE and risk of loss of Product shall remain with THOMAE
       until delivery to the carrier as set forth in the next sentence.
       THOMAE's liability as to risk of loss or damage during
       transportation thereof shall cease upon delivery of the Product in
       good condition to the carrier at THOMAE's plant in Biberach
       designated by MEDIMMUNE.

3.8    Indemnification by THOMAE
       THOMAE shall indemnify, defend and hold MEDIMMUNE and its officers,
       employees and agents harmless from and against all third party
       losses, damages, costs and expenses (including, without limitation,
       reasonable attorneys` fees), including injury to persons or damage
       to property, resulting from any breach of the warranties made by
       THOMAE under this Agreement or which arise out of and are proved to
       be directly associated with the gross negligence or willful
       misconduct of THOMAE or its officers, employees or agents in
       carrying the obligations under this Agreement and provided that
       upon receipt of notice by MEDIMMUNE of any claims or suits relating
       to such use or sale of the Product, MEDIMMUNE shall notify THOMAE
       thereof without delay and shall permit THOMAE to handle such claims
       or suits at the cost and discretion of THOMAE including but not
       limited to defense, settlement and compromise thereof.
3.9    Superiority
      No provision which may purport to impose different conditions upon
       MEDIMMUNE or THOMAE, nor any other modification of this Agreement,
      will be of any force and effect, unless in writing and signed by
       both parties claimed to be bound thereby. In the event of any
       inconsistencies the terms of this Agreement shall govern.


       THOMAE is willing to support MEDIMMUNE with regard to post
       licensing issues (e. g. possible registration-issues in the various
       countries) on commercial conditions to be agreed upon.


                                 (PAGE 6)
5.1    Product-price
       The Product-price for manufacturing the Product shall be calculated
       according to the scheme laid down in Appendix 1. The basic
       assumptions of that scheme as titer, yield, and production scale
       will be reassessed after scale-up of the Process to the commercial
       scale and then be valid for this Agreement.


5.3    Payment Conditions
       The Product-price for Product delivered to MEDIMMUNE or according
       to MEDIMMUNE's instructions shall be payable by MEDIMMUNE within
       30 (thirty) days after receipt of Product by the respective party
       in DEM (Deutsche Mark) by wire transfer to an account to be
       nominated by THOMAE.

5.4    Currency
       "Deutsche Mark" or "DEM" means the lawful currency for the time
       being of Germany or, in case of the implementation of the European
       Monetary Union, the Euro on the basis of the official conversion

5.5    Prices Adjustments
       (a)The Product-price mentioned in Article 5.1 above (basis
           01.09.1997) may be increased by THOMAE effective at the
           beginning of a calendar year (for the first time effective
           January 1st 2000) by (CONFIDENTIAL TREATMENT HAS BEEN
           REQUESTED) per year for increasing costs of labour and raw
       (b) In case any cost (in terms of cost of labour, material and/or
           regulatory requirements for producing Bulk Product, Final
           Product and/or Finished Product increases by more than
           (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) in a given calendar
           year, which THOMAE must demonstrate, the parties shall agree
           upon the direct amount of     such increase based on good faith
           negotiations to be effective on January 1st of the calendar
           following the more than (CONFIDENTIAL TREATMENT HAS BEEN
           REQUESTED) increase and the price for Product in such calendar
           year shall be increased for such amount, provided that      the
           price increase taken by THOMAE under Article 5.5 (a) shall be
           credited toward any corresponding increase under this Article
           5.5 (b).
       (c)In case of a change of the Process which influences the basic
           assumptions the price shall be recalculated according to
           Appendix 1.
                                 (PAGE 7)


6.1    THOMAE shall not disclose MEDIMMUNE Confidential Information to any
       person other than its employees or employees of affiliated
       companies of the Boehringer Ingelheim group who have a need to know
       such information in order to perform their duties in carrying out
       the work hereunder and who have an obligation to maintain the
       confidentiality thereof as provided herein.

6.2    MEDIMMUNE shall not disclose any THOMAE Confidential Information to
       any person other than

       (a)its employees or consultants who are bound by similar
           obligations of confidentiality and who have a need to know such
           information in order to provide direction to THOMAE or evaluate
           the results of the work, or
       (b)regulatory authorities, for example, the FDA, that require such
           information in order to review an IND, BLA or other regulatory
           filing. THOMAE will be informed and must agree prior to filing
           of any THOMAE Confidential Information to regulatory
           authorities. In these cases where THOMAE restricts MEDIMMUNE's
           ability to file THOMAE Confidential Information, THOMAE agrees
           to provide the Confidential Information directly to the
           regulatory authorities and will provide a letter of
           authorization for cross-reference to MEDIMMUNE.
       (c)persons or entities that manufacture Product for MEDIMMUNE
           after termination of this Agreement or during this Agreement as
           permitted herein.
6.3    The obligations of confidentiality applicable to MEDIMMUNE
       Confidential Information and THOMAE Confidential lnformation shall
       not apply to any information that is:
       (a)known publicly or becomes known publicly through no fault of
           the recipient;
       (b) learned by the recipient from a third party entitled to
       disclose it;
       (c)developed by the recipient independently of information
           obtained from the disclosing party;
       (d)already known to the recipient before receipt from the
           disclosing party, as shown by its prior written records;
                                 (PAGE 8)
       (e)required to be disclosed by law, regulation or the order of a
           judicial or administrative authority; or
       (f)released with the prior written consent of the disclosing

7.     LICENSE

7.1    Use of MEDIMMUNE Cell Line and Intellectual Property

       (a) MEDIMMUNE and THOMAE hereby acknowledge and agree that
           MEDIMMUNE is providing Cell Line, Process and MEDIMMUNE
           Confidential Information to THOMAE for use by THOMAE on behalf
           of and for the benefit of MEDIMMUNE for the purposes of this
           Agreement, that THOMAE will make use therof solely for such
           purposes and that MEDIMMUNE hereby consents to such use.
       (b) MEDIMMUNE hereby delegates to THOMAE as agent for MEDIMMUNE the
           authority to manufacture Product solely on behalf of and for
          the benefit of MEDIMMUNE.
7.2    Except as granted under this Agreement, no right or license, either
       express or implied, under any patent or proprietary right is
       granted hereunder by virtue of the disclosure of MEDIMMUNE
       Confidential Information or THOMAE Confidential Information.



8.2    To the extent permitted by law, if either party shall become
       insolvent or shall make assignment for the benefit of creditors, or
       proceedings in voluntary bankruptcy shall be instituted on behalf
       of or against a party or a receiver or trustee of all, or
       substantially all of the property of a party shall be appointed,
       the other party shall be entitled to terminate this Agreement by
       giving written notice to this effect to the first party whereupon
       this Agreement shall so terminate, unless such situation is
       rectified within a period of 60 (sixty) days.

8.3    Either party may terminate this Agreement for any material breach
       of this Agreement, if such breach is not cured within 90 (ninety)
       days following receipt by the party committing the breach of
       written notice of the intent to terminate. Such termination shall
       become effective immediately upon further notice to the defaulting

                                 (PAGE 9)
8.4    Premature Termination

8.4.1  This Agreement may be terminated by MEDIMMUNE at any time if
       MEDIMMUNE shall withdraw the Product from all relevant markets.

8.4.2  In this case MEDIMMUNE will pay to THOMAE the Product-price for the
       firm ordered quantities (see Article 2.4 above) of the Product.


8.4.4  These payments shall be due within 1 (one) month after receipt by
       THOMAE of the notice of premature termination from MEDIMMUNE and
       receipt by MEDIMMUNE of the respective invoice of THOMAE.

8.5    Introduction of the Euro
       The introduction of the Euro as the legal currency or legal tender
       in Germany (see Article 5.4 above) shall in no way affect the
       validity of this Agreement and shall not entitle any party hereto
       to terminate, or to require any amendment to, this Agreement.


9.1    Force Majeure.
       Neither party shall be in breach of this Agreement if there is any
       failure of performance under this Agreement (except for payment of
       any amounts due hereunder) occasioned by any act of God, fire, act
       of government or state, war, civil commotion, insurrection,
       embargo, prevention from or hindrance in obtaining energy or other
       utilities, labor disputes of whatever nature or any other reason
       beyond the control of either party; provided, however, that if a
       party is not able to perform becomes of a force majeure pursuant to
       this Article 8.1 for a period of 6 (six) months, the other party
       may terminate this Agreement with immediate effect.

9.2    Publicity.
       No press release or other form of publicity regarding the work
       performed hereunder or this Agreement shall be permitted by either
       party to be published unless both parties have indicated their
       consent to the form of the release in writing.
       Nothing in this Article 9.2 shall prevent the parties from
       disclosing this Agreement as required by applicable laws, rules or

                                 (PAGE 10)
9.3    Notices.
       Any notice required or permitted to be given hereunder by either
       party shall be in writing and shall be (i) delivered personally,
       (ii) sent by registered mail, return receipt requested, postage
       prepaid or (iii) delivered by facsimile with immediate telephonic
       confirmation of receipt, to the addresses or facsimile numbers set
       forth below:

<S>                                   <C>
If to THOMAE:                         Dr. Karl THOMAE GmbH
                                      Birkendorfer Strabe 65
                                      88397 Biberach an der Riss
                                      Federal Republic of Germany
                                      Attention: Prof. Dr. Rolf G. Werner
                                      Fax:             0 73 51/54-51 31
                                      Phone:           0 73 51/54-48 00
If to MEDIMMUNE:                      MEDIMMUNE Inc.
                                      35 West Watkins Mill Road
                                      Gaithersburg, Maryland 20878
                                      Attention: President
                                      Fax:                    301/527-4201
                                      Phone:                  301/417-0770
       Each notice shall be deemed given (i) on the date it is received if
       it is delivered personally, (ii) 3 days after the date it is sent
       by Federal Express, UPS,DHL, MSAS, World Courier or similar service
       if receipt is immediately confirmed in writing (iii) on the date it
       is received if it is sent by facsimile with immediate telephonic
       confirmation of receipt.

9.4    Applicable Law/Jurisdiction.
       This Agreement shall be governed by and construed in accordance
       with the laws of Germany without regard to its choice of law
       principles. The courts of the place of domicile of THOMAE shall
       have exclusive jurisdiction over all legal matters and proceedings

9.5                                                           Compliance
       with Laws.
                                                              THOMAE shall
       perform the work hereunder in conformance with current GMP, as
       applicable, and all German and/or EEC laws, ordinances and
       governmental rules or regulations pertaining thereto.

                                 (PAGE 11)
9.6    Relationship
       THOMAE shall not incur any liabilities on behalf of MEDIMMUNE nor
       pledge the credit of MEDIMMUNE nor make any representations or
       warranties on behalf of MEDIMMUNE nor hold itself out to third
       parties as having any such rights.
       MEDIMMUNE shall not incur any liabilities on behalf of THOMAE nor
       pledge the credit of THOMAE nor make any representations, or
       warranties on behalf of THOMAE nor hold itself out to third parties
       as having any such rights.

9.7    Waiver.
       No waiver of any term, provision or condition of this Agreement
       whether by conduct or otherwise in any one or more instances shall
       be deemed to be or construed as a further or continuing waiver of
       any such term, provision or condition or of any other term,
       provision or condition of this Agreement.
9.8    Severability.
       If any provision of this Agreement is held to be invalid or
       unenforceable by a court of competent jurisdiction all other
       provisions shall continue in full force and effect. The parties
       hereby agree to attempt to substitute for any invalid or
       unenforceable provision a valid or enforceable provision which
       achieves to the greatest extent possible the economic legal and
       commercial objectives of the invalid or unenforceable provision.

9.9    Entirety.
       This Agreement, including any exhibits and appendices attached
       hereto and referenced herein , constitutes the full understanding
       of the parties and a complete and exclusive statement of the terms
       of their agreement, and no terms, conditions, understandings or
       agreements purporting to modify or vary the terms thereof shall be
       binding unless they are hereafter made in writing and signed by
       both parties.

9.10   Assignment.
       This Agreement shall be binding upon the successors and assigns of
       the parties and the name of a party appearing herein shall be
       deemed to include the names of its successors and assigns provided
       always that nothing herein shall permit any assignment by either
       party. However, THOMAE may assign this Agreement to an affiliated
       company taking over the operative biotech business of THOMAE and
       MEDIMMUNE may assign this Agreement in the case of a merger or
       acqusition or transfer of its assets related to this Agreement to a
       third party without the prior written consent of THOMAE.

                                 (PAGE 12)

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed by their duly authorized representatives on the day and year first
above written.
<S>                      <C>                     <C>
Gaithersburg,            Biberach,              
/s/David M. Mott         /s/Dr. Jacob            /s/Dr. H. Michelberger
   David M. Mott            Dr. Jacob               Dr. H. Michelberger
                         (Member of Board)       (Head of Legal Department)
Appendix 1:
Appendix 2:
Appendix 3:

                                 (PAGE 13)