8.01 Duration. This agreement enters into force on the effective date of the supply contract and, unless it is denounced earlier under Article VIII or is not extended on the basis of a written agreement of the parties, it is continued until the third anniversary of the entry into force of the supply contract (the „duration“). At the end of the initial term, the contract is automatically extended to other (1) exercise periods, which cannot exceed three extensions (each of an „extension period“). Contracting parties may terminate the contract by announcing to the other party at least (1) one year of contract before the current period expires. The customer wishes to purchase from Pfizer API in bulk, and Pfizer agrees to provide the same in accordance with the terms of this contract. For a description of the API delivery agreement, see item 3.6Ai. As part of the tesamoreline manufacturing process, the company has entered into an agreement to manufacture and supply the tesamoreline drug with Draxis Pharma, a division of Draxis Specialty Pharmaceuticals, Inc. FDA Coronavirus Statement (COVID-19): THE FDA continues to monitor the supply chain. The CDER Drug Shortage Staff asked manufacturers to evaluate their entire supply chain, including pharmaceutical active ingredients, final dose forms and all components likely to be affected in China or other parts of the coronavirus supply chain (COVID-19). The FDA`s latest information on coronavirus (COVID-19) is available at new coronavirus (COVID-19). 9.07 Integration. This agreement constitutes the whole agreement between the parties with respect to the purpose of this agreement and replaces all previous written or oral agreements. This agreement can only be amended in writing, signed by duly accredited representatives of each of the parties.
March 10: The FDA has updated the status of FDA inspections outside the United States in response to the COVID-19 outbreak. The FDA puts most foreign inspections with immediate effect to April. Inspections outside the United States, considered critical to business, will continue to be reviewed on a case-by-case basis. The FDA based this decision on The State Department`s Level 4 travel guidelines prohibiting travel for U.S. government employees, CDC and prevention recommendations, restrictions on access to foreign visitors by certain countries, and instructions from the Office of Personnel Management.