A drug development project can be abandoned even if it has been successful so far. Suppose your Pharma Company client is the first licensee of a Baby Biotech compound. Your client carried out the program by filing an IND and has spent a total of $50 million to date. Let`s also assume that your client, although the results have been promising so far, decides to abandon the project because he has other more promising projects on his plate and he does not have enough resources to follow them all. Pharma Company reluctantly decides that it must terminate the licensing agreement with Baby Biotech. In this scenario, Baby Biotech will likely attempt to license a connection to third parties or follow the project itself. The basic drug file is the collection of information and data resulting from the development process of a potential pharmaceutical product, such as toxicological studies and clinical trial results. The drug development process is highly regulated and structured in that certain types of testing and procedures must be performed for all potential products, although the details of these tests and procedures may vary from potential product to product. The cost of drug development is prohibitive (current estimates are $400 million to $800 million over an average of up to 10 years), so the basic drug file has an intrinsic value represented by these costs.

An important issue that must be taken into account when granting biotechnographic licences is the provision of the drug management file in the event of early termination of the licence agreement. From your client`s point of view, for all the above reasons, he wants an exclusive worldwide license for and among all patents related to the technical peptide. After paying for the discovery of the versatile link, her position is that she is entitled to all the potential value of the discovery. Although it does not have the resources to develop simultaneously for possible different indications, it wants the right to monitor and benefit from this process through a sub-licensing programme. As John LaMattina explains in Forbes, at the time of the agreement, there were still many questions about Eliquis` success. The commercial drug is competitive and there was no guarantee that this drug would prove more effective than comparable products, including in development. In addition, Phase 3 studies are expensive, and Bristol-Myers Squibb has struggled with a tight research and development budget. In addition, multinational pharmaceutical companies Merck (NYSE:MRK) and Hanmi Pharmaceutical, headquartered in Korea (KRX:008930).