This issue is used for provisions related to the transfer of technology and/or materials between organizations. “Materials” can include a number of tangible items such as biological samples, cell lines and antibodies, and requirements for the transfer of materials are often related to use for research and development purposes. “Technology transfer” generally refers to the provision of a broader set of data, materials, documentation, know-how and other assistance needed to manufacture a product. The details of the ‘technology’ to be transferred must be carefully defined in order to ensure that it is sufficient and appropriate for the purpose of the agreement.

Technology transfer provisions may be a key objective of an agreement (e.g. the licensing of manufacturing rights to enable the production and sale of a finished product), or the parties may only intend to exercise the provision in certain circumstances (e.g. if one party is not fulfilling its obligations). The conditions under which optional technology transfer rights may be exercised are discussed under the Ensuring Continuity, Preparedness & Response and Effects of Termination issues.

Questions to consider when developing provisions for ensuring continuity

• What is included in the technology and/or materials to be transferred?
• What are the responsibilities of each party to in relation to the transfer of materials and/or technology?

Example approaches found in the MAPGuide

• What is included in the technology and/or materials to be transferred?
  • Some of the more detailed technology transfer provisions in the MAPGuide specify the transfer of information such as:
    • Materials required for preclinical and clinical development;
    • Preclinical and clinical data;
    • Stability data;
    • Know-how;
    • Manufacturing methods;
    • Regulatory documents; and
    • Third party agreements required to manufacture the licensed product.
  • Some agreements also include a general statement that the information transferred must be sufficient to enable the conduct of development, clinical trials and manufacture of the product.

• What are the obligations of each party to ensure successful transfer of the technology?
  • Several agreements in the MAPGuide include a requirement for a technology transfer plan detailing timelines, the type and duration of support from the transferring party, and success criteria. In contrast to these agreements, there are also some technology transfer provisions in the MAPGuide which specify a one-time transfer of specific information, with no ongoing obligations on the part of the transferring party.
  • Some MAPGuide agreements also place specific obligations on the technology recipient to be operationally and technically capable of receiving the technology.