We can help with both in-licensing and out-licensing. Our consultants can begin with a search for licensing opportunities, perform due diligence, assist with negotiations and then handle the transfer of ownership and technology.
Most companies at some stage enter into licensing negotiations with partners, whether for in- or out-licensing or for local manufacture, distribution or marketing. In these situations it is often convenient to contract out the ‘leg work' required to locate opportunities and judge the suitability of potential partners and/or products. In this way, clients are relieved of the task of ploughing through leads of which many may ultimately prove worthless, concentrating instead on the more positive opportunities that can be screened and short-listed by Wainwright Associates.
Wainwright Associates have the skills and knowledge of the market not only to find partner companies but also to provide full technical assessments of product dossiers for suitability for registration and marketing.
Wainwright Associates can locate products for in-licensing by clients, according to their exactly specified requirements.
Searches are initiated, maintaining client anonymity, using various techniques:
- Review of patents and literature
- Direct approach to companies
Regular, detailed reports are issued, specifying work done, leads identified and recommendations for further negotiations. Positive leads are pursued in detail according to the client's prioritisation, until a short-list of opportunities can be presented.
We will obtain as much information as possible on candidate products, first non-confidential details and later, when the client has expressed a positive interest and confidentiality agreements are in place, full technical data packages.
Contacts will be developed anonymously with each potential licensing partner until such time as the client is ready to reveal its identity. Formal introductions are then made to allow the client to enter into detailed negotiations and financial arrangements.
Frequently we already know of suitable opportunities, particularly for generic medicines, so we will be happy to check your requirements against our comprehensive database.
Wainwright Associates will identify potential licensees for clients' own products.
To commence the project, the client provides:
- A summary of the major characteristics of the product(s) to be licensed out, including any unique aspects.
- Particular requirements and responsibilities of a licensing partner, such as R&D, manufacturing, QC or distribution.
- Required geographical location of licensing partner and territories to which the licensing agreement will, and will not, apply.
Wainwright Associates prepares a Marketing Brochure containing the major product details in non-specific language, to maintain confidentiality. This is referred to the client for approval.
Potential licensees are sought by various methods including advertising, using agreed texts, under Wainwright Associates' name to preserve the client's anonymity and direct approaches to companies known to have an interest in the area concerned.
Regular monthly reports are provided, detailing the companies contacted and their responses, and seeking the client's prioritisation of the candidates identified.
Leads are followed up until the client is ready to reveal its identity and provide confidential information on the product. After formal introductions, the negotiation process can then be commenced by the client.
Due diligence of the scientific data package is crucial for products intended for licensing. Wainwright Associates provides independent, unbiased assessment reports on all types of products which are invaluable to both licensors and licensees. Data assessments are carried out by discipline experts to the standards of all the major regulatory authorities, to identify areas of weakness or omission in the data and reveal the extent of any further work that will be required.
This service is provided to potential licensees who wish to be reassured of the quality and suitability for registration of dossiers offered under licence. Very often licensors will allow an independent third party to review the data, under a confidentiality agreement, before they are prepared to release the dossier to a potential partner.
Our assessment report is also useful for companies wishing to out-license their products. Rather than release volumes of commercially sensitive information for review by potential licensees, a non-confidential summary of the data accompanied by our independent report allows licensees a rapid means of assimilating the quality of the data and identify any additional requirements.