The Licensing Agreement In Pharmaceutical Business Development

More and more biotech and pharmaceutical companies are taking active steps to avoid (1) conflicts of cooperation and licensing; and (2) to resolve disputes that arise without resorting to litigation. There are a large number of non-procedural strategies to help companies overcome the uncertainties associated with cooperation and licensing agreements, including: DEFINE MILESTONES IN CLEAR TERMS The parties should ensure that the boundaries are defined under clear and objective conditions in the agreement in order to avoid ambiguity and subsequent disputes over when a step has been taken or when payment is due to be completed. The development of common objectives and regulatory milestones could include the first submission of a human subject, the submission of a first NOA (new drug application) or the obtaining of the first regulatory approval. Other frequently used steps, such as. B «progress to phase 3» should be defined to provide a clear trigger event at the payment deadline. In fact, licensing agreements today could be the pharmaceutical industry`s preferred business development – perhaps even more than mergers and acquisitions . These agreements can be very successful for companies and their share prices. AMAG has a down payment of $30 million and can receive up to $260 million to reach certain regulatory and sales stones, in addition to royalties and the opportunity to expand its product pipeline. As AMAG CEO Scott Myers said at the time of the agreement: «Unlock (the value) of the feast day … will strengthen our company`s ability to continue to invest in innovative therapies that meet unmet medical needs. As pharmaceutical manufacturers move more towards licensing, they tend to reduce their massive research and development budgets. This can disrupt investors accustomed to the traditional model of pharmaceutical growth: drug discovery leads to products, which generates profits. 6.16 The transfer, sub-licensing and change of ownership of in-licensing agreements can also cause confusion by complicating the conclusion.

«They are not generally counted as assets on the balance sheet,» Jeff Margolis, vice president of RespireRx (OTCQB:RSPI), told the news information network. 7. Competition law and the development of pharmaceutical companies When conflicts of cooperation and licensing arise, the consequences can be costly. In the event of a dispute, companies should think very carefully about whether litigation is the best way to resolve disputes. Drug discovery and development is an incredibly long, costly and uncertain process – but also litigation. And unlike clinical development, which is subject to at least (partial) the rules of science, the results of disputes often depend on factors beyond the control of the parties. Recent jury judgments show that the failure of a single development program can result in licensing disputes worth hundreds of millions of dollars. It is easy to see what drives this process. On the one hand, there are a number of ideas, technologies and products from medical research organizations and small and medium-sized biopharmaceutical companies around the world. On the other hand, there is a pharmaceutical industry with global drug development and marketing infrastructure that is constantly looking for other high-performing revenue suppliers to meet their growth needs.