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Supply and Data Access Agreement for a Biological Product

Subject matter

Biological product and related data.

Summary of use(s)

Supply of and access to a biological product and related confidential data and information; royalty-free non-exclusive license for patents to related formulations.

Purpose or background

A supply and data access agreement as well as a patent licensing agreement within a collaboration.

Contact details

Dr. Riemer
Fortbildung und Seminare
D-79540 Lörrach
Germany

SUPPLY and DATA ACCESS AGREEMENT

between

A, a company incorporated under the laws of […]     (“ A“)

and

D, a company organized under the laws […] ("D")  

a "Party" and collectively the "Parties"

 

OPERATIONAL PROVISIONS

1. Definitions:

Affiliates

 

shall mean any business entity which controls, is controlled by or is under common control with either Party; for the purpose of this definition, a business entity shall be deemed to "control" another business entity if it owns, directly or indirectly, in excess of 50% of the outstanding voting securities or capital stock of such business entity or any other comparable equity or ownership interest with respect to a business entity other than a corporation.

Agreement 

shall mean this […] Supply and Data Access Agreement including the Annexes to it.

Country/Countries

shall mean the European Union 27 countries
Defect
shall mean any non-conformity of the Product with the Specifications.
Defective Product  
shall mean any Product that does not conform to the Specifications.
Effective Date                    
shall mean the date of the last signature of this Agreement by both Parties.
Party
shall mean either party to this Agreement.
Year 
shall mean the period from 1st January through 31st December.
    1. Supply, Ordering
      • D shall supply, and A shall purchase, such quantities of the Product as A may order in accordance with the terms and conditions of this Agreement.
      • Within five (5) calendar days of receipt of D’s confirmation, A shall provide to D a firm written purchase order (including authorized purchase order number), shipping instructions, requested delivery dates, and pack sizes, all in relation to each of the products so ordered.
    2. Delivery, Supply Prices, Payment
      • All deliveries shall be accompanied by all transportation documents required by law and freight handlers (carrier).
      • The risk of damage to or loss of each consignment of the Product shall pass to A on delivery.

    3.3        A shall pay within […] days of the invoice date.

    3.4       For the avoidance of doubt each Party is free to set the prices for its end-use products in each Country.

    1. Duration, Termination
      • This Agreement shall enter into force on Effective Date.

    It shall expire upon the fifth anniversary of the Supply Date. The Parties will then negotiate whether to sign a new agreement for supply and data access

    • Either Party may terminate this Agreement with immediate effect by giving written notice of termination to the other Party upon the occurrence of:
    1. any material breach of this Agreement by the other Party which remains uncured after 60 days’ written notice thereof from the non-breaching Party; or
    2. the other Party suffering a change in ultimate control or being taken over by or merging with another company or entity or its legal form, or one of its parents companies being taken over by or merging with another company not belonging to the same group of companies; or
    3. the other Party becoming bankrupt or insolvent, having a receiver appointed over the whole or part of its assets, ceasing or threatening to cease to carry out the whole or part of its business, or the whole or part of its business and assets being sequestrated, nationalised or in any other way transferred into state ownership.
    1. Warranty and Liability
      • D warrants that the Product conforms to the Specifications and the Packaging Instructions as per the respective delivery date. Conformity with the Specifications shall be determined by reference to the method of analysis set forth in the Specifications.

                Neither party shall be liable to pay consequential, indirect, special, punitive or exemplary             damages to the other party arising out of the performance or non-performance of this     Agreement.

    1. Force Majeure
      • In the event that either Party is affected by any circumstances which prevent the performance by such Party of its obligations hereunder in whole or in part, then such Party shall notify the other Party of the nature and extent of such circumstances.
      • Neither Party shall be deemed to be in breach of this Agreement, or otherwise be liable to the other Party, by reason of any delay in the performance, or non-performance, of any of its obligations hereunder to the extent that such delay or non-performance is due to any unforeseeable circumstance beyond its control and which a Party cannot avoid in spite of taking all reasonable care in accordance with the particular circumstances and of which the other Party has been notified of in accordance with Article 7.1 (“Force Majeure”), including but not limited to acts of god, strikes, riots, wars, fire, flood and cancellation of registrations. The time for the performance of such obligation shall be extended accordingly. The Party so affected shall take all reasonable steps to minimise the loss caused to the other Party and the Parties shall as soon as practicable enter into bona fide discussions with a view to alleviating the effects of said circumstance or to agreeing upon such alternative arrangements as may be fair and reasonable.

     

    1. Secrecy
      • Both Parties shall maintain and preserve during the term of this Agreement the confidentiality of all information relating to the Product or Data which is disclosed to the other Party pursuant to or in connection with this Agreement (whether orally, electronically or in writing and whether or not such information is expressly stated to be confidential or marked as such) (“Confidential Information”). Each Party shall disclose Confidential Information only to those of its employees who need them for the manufacture of the Product and who shall be under the same commitment of confidentiality. Each Party shall be responsible for these employees and for their strict compliance to the above.
      • Except from this obligation will be:

    (a)        information known to the receiving Party prior to disclosure;

    (b)        information which is or becomes public knowledge through no fault of the           receiving Party;

    (c)        information which is disclosed by a third party with legal right to do so;

    (d)        information a Party is required to file with any governmental regulatory authority under compulsion of law.

     

    1. Access to Patents
      • During the term of this Agreement D grants A a royalty-free, non-exclusive license to its patents related to A Formulations to make, have made by third parties, use, import, sell and/or offer for sale of A Formulations in the Territory without granting the right to sub-licence. In any case this license is limited solely for the duration of this Agreement and to those activities that are required for A to perform under this Agreement.
      • In case of expiry or termination of this Agreement the Parties will negotiate the terms and conditions for this license including an appropriate royalty fee in a license agreement.
    2. Miscellaneous
      • Assignment: Any assignment of this Agreement, in whole or in part, by a Party shall require the written prior consent of the other Party; provided, however, either party may        assign its rights and delegate its duties under this Agreement to one or more of its     
      • Variation: No variation to this Agreement shall be effective unless it is in writing and signed on behalf of both Parties by their duly authorised representatives.
      • Severability: In the event any provision of this Agreement is deemed to be void or unenforceable under any applicable law, the remaining provisions shall not be affected           and       the void provision shall be deemed to have been replaced by such valid and enforceable           provision which most closely reflects the original intention of the Parties.
      • Notices: All notices provided under this Agreement shall be in the English language and in          writing and shall be given by registered letter or facsimile to the addresses set forth        below,

    11.5      Governing Law: This Agreement shall be governed and construed by the Laws of […], excluding the principles of conflict of laws and the United Nations Convention on the International Sale of Goods.

       

    […]

     

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