As the demand for the services of toxicology consulting firms continues to grow, it is crucial that these entities find new and innovative ways to create operational efficiencies. This can be done in a number of ways, through maximising existing resources and minimising the use of new external consultancy resources in areas in which expertise already exists within the organisation. Establishing strong synergies with a solid outsourced, third-party laboratory partner can also create efficiencies both financially, and in terms of time management by removing the requirement for training new resources. However, a legal agreement must exist between both entities to set out a clearly defined scope of use for the tools and technologies developed by the third-party lab, and for the intellectual property (IP) which can arise from such technology. A non-exclusive licensing agreement is the ideal legal instrument to support the relationship between the two entities. In this instance, as the third-party lab has full ownership over the technology and the IP, the toxicology firm can be granted a non-exclusive licence for use of the technology in specific fields, allowing them to do what they do best, without infringing on the ownership rights of the partner. The ten below points will outline the role of non-exclusive licence agreements in the toxicology sector, with a specific focus on the larger contract research organisations. These points, pulled from the article Navigating Non-Exclusive License Agreements: A Comprehensive Guide, outline how the strategic allocation of resources in pharmaceutical and drug research can be greatly enhanced by establishing legally binding non-exclusive licence agreements.
- What is a non-exclusive licence agreement? In the context of toxicology and drug development, a non-exclusive licence agreement can be defined as an agreement that allows the toxicology consulting firm to disseminate a technology/IP without precluding the third-party lab from distributing the technology/IP to other labs.
- Type of use for non-exclusive licence agreements in toxicology The use of non-exclusive licence agreements will aid a toxicology firm in expanding its service offerings and specialities into new markets, without the investment of time and money required to develop the technology and IP in-house.
- The role of legal agreements and intellectual property in the strategic allocation of resources in a toxicology consulting firm In order to prevent toxicology consulting firms from paying for the same technology two or more times, it is important that due diligence be completed in the exploration of synergies between organisations. By having a legal agreement in place that establishes the synergies, the services offered by both organisations can be maximised while reducing the threat of infringing on any IP ownership rights.
- Demonstrating the importance of legally binding non-exclusive licence agreements in the form of real-life examples or case studies By establishing a non-exclusive licence agreement between a toxicology consulting firm and a toxicology service partner, both organisations are able to practice the technology/IP freely, without potentially infringing upon each other’s rights.
- Making use of legal agreements to facilitate collaboration with pharma companies The presence of a non-exclusive licence agreement will remove the risk of infringing upon another organisation’s intellectual property rights. This, in turn will reduce the risk of pharma companies, who undertake their own due diligence regarding collaborations, choosing not to enter the agreement provided by the toxicology consulting firm.
- Financial impact and costs savings By forming non-exclusive licence agreements, a toxicology consulting firm can reduce or even eliminate the high costs associated with developing technology and IP. This in turn, lowers the ultimate cost to the client, and leaves the unit price unaffected.
- The role of legal agreements in improving regulatory navigation and compliance during a toxicology study By establishing a legally binding non-exclusive licence agreement, findings can be accurately reported and remedial measures properly implemented within the toxicology project.
- Use of non-exclusive licence agreements to maximise synergies in the pharmaceutical industry and drug research By combining services between two organisations and documenting the process or results in the form of a legally binding non-exclusive licence agreement, the outputs of drug development can be maximised.
- Establishing a legal agreement to avoid challenges in a toxicology consulting firm Subsequent to the completion of a toxicology project, the client may wish to expand the scope of the project, but the project may exceed the capabilities or experience of the original toxicology consulting firm. If a non-exclusive licence agreement is in place between the toxicology consulting firm and a third-party toxicology lab, the work can be sourced externally and the capacity of the toxicology consulting firm can be retained.
- Educating toxicology clients on the importance of using non-exclusive licence agreements By outlining the benefits of establishing a non-exclusive licence agreement to clients who may not be aware of the importance of a legally binding legal instrument during a project, a toxicology consulting firm can demonstrate the real value of a strategic approach to the project, and promote the possibility of collaboration in the future.