DEFINE MILESTONES IN CLEAR TERMS The parties must ensure that milestones are set under clear and objective conditions in the agreement to avoid confusion and further disputes about when a milestone was taken or when payment is due to complete that specific step. 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. This new Falconbury in-house seminar provides you with a unique opportunity to learn from a specialized faculty to address the key challenges of negotiating and developing these agreements. It will allow you to design effective watertight agreements and lay the foundation for long-term, profitable relationships. MAKE “REASONABLE EFFORTS” CLAUSES REASONABLE FOR THE DEVELOPMENT PROJECT AT HAND The question of how to measure whether a licensee has made the necessary efforts to develop or market a product under the agreement is one of the most important (and most frequently highlighted) issues related to a licensing agreement. Depending on the jurisdiction, whether the taker agrees to make “reasonable business efforts,” “reasonable efforts,” “best efforts” or another standard for the development or marketing of a product may have a real impact on the likelihood of successful litigation. It also determines whether expertise, specific comparisons with other development projects and/or sector comparisons will be required at a later date to determine whether a licensee`s actions meet such a standard in the event of litigation. The parties should be very aware of their choice and strive from the outset to formulate clear directions in each agreement on the efforts needed to avoid future uncertainties. “Quantum Genomics is the leading biopharmaceutical company, which specializes in the development of a new class of active ingredients based on the central mechanism of action of aminopeptidase A inhibition,” said Dr. Binhui (Ben) Ni, Chief Business and Investment Officer, Corporate Vice President of Qilu Pharmaceutical, “The development of firibastat, first-in-class for the treatment of high blood pressure and/or in combination with other antihypertenus treatments. We are convinced that the unique mechanism of action with strong clinical data places the firibastat to have a significant impact on the lives of patients.
THE REPORTING OBLIGATIONS OF VIEW AS OPPORTUNITIES Regular reporting obligations are a common feature in phased cooperation and licensing agreements. It is necessary for the licensee to inform the licensee, the seller and/or former shareholders of the development status of the licensed product and the efforts made so far to develop or market the product.