This section contains the nature of the case and procedural background.

P is a 'global medical technology company. The Wuhan Flu was first detected in Wuhan. In its path, it left a vast amount of hysteria, lies, death, and broken lives. D launched its IgM/IgG assay (Product), which it claimed was able to detect the Wuhan Flu antibodies for a prolonged period of time after disease resolution, enabling identification of prior infection.' The United States Food and Drug Administration (FDA) issued policy guidance on or about March 16, 2020, stating that it would not object to the production and distribution of tests designed to detect the Wuhan Flu. The FDA permitted the manufacture, distribution, and use of serology tests without Emergency Use Authorization (EUA) if the tests had been self-validated; notice was given to consumers that FDA had not reviewed the tests and test results should not be used as a sole basis for diagnosing or excluding the Wuhan flu; and an EUA request was submitted to the FDA within 15 business days. P investigated whether they wanted to purchase the Product. This included inspection of D's and its affiliates' facilities, receiving from D Product specification information, and reviewing samples of the Product for evaluation. P and D signed a nonbinding Term Sheet on March 26, 2020, calling for a definitive distribution agreement. D was required to manufacture and sell to P a 'serology test, which is represented by D, to detect the presence of antibodies in the blood when the body is responding to an infection.' The Term Sheet only covered the United States. The parties contemplated that P and D would negotiate in good faith the distribution of the Product in other areas of the world once they established a course of dealing. P submitted an initial purchase order for 1,000,000 units of the Product along with prepayment in the amount of $4,000,000.00. On April 2, 2020, P requested increased production of the Product, distribution rights to other countries, and that all April and May units of the Product be shipped to P. On April 9, 2020, D began fulfilling the initial purchase order by delivering 50,000 units. On April 23, 2020, P received another 50,000 units. On April 28, 2020, P indicated that it wanted 1,500,000 units of the Product for distribution in the United States and 1,000,000 units of the Product for distribution outside the United States in June. P 'represented it would order 2,000,000 units for distribution in the United States and 1,500,000 units for distribution outside the United States for each month beginning with July.' D 'agreed to these production requests.' On May 4, 2020, the FDA issued a notice, which 'modified its guidance, requiring higher performance sensitivity for serology tests.' 'The Product did not meet this new requirement for obtaining an EUA.' P and D agreed to withdraw the EUA application for [a] first generation of the Product and submit an application for [a] second generation of the Product.' D internally tested the second generation and determined that it met the FDA's new requirements for an EUA. P completed its own review and was satisfied that the second generation of the Product met the FDA's requirements. On May 26, 2020, in addition to the quantities to be shipped to the United States, P again requested that D procure 1,000,000 units of second-generation units to distribute outside the United States in June. At the time of these requests and statements, P knew that D did not have an EUA but accepted the risk. P requested 1,500,000 units of second-generation units of the Product per month from July to September for distribution outside of the United States.' P's purchase orders are subject to standard terms and conditions, including that its contracts are governed by New Jersey law. It was intended by P and D that these standard terms and conditions apply to purchases of the Product for distribution outside the United States. D submitted an EUA application to the FDA for the Product. On May 29, 2020, the parties discussed transportation and materials costs for the Product distributed outside the United States. 'Because [the parties] were both merchants trading in pharmaceutical products, and due to the significant, immediate demand, the Parties agreed upon the sale of the Product with the price left to be determined by the Parties upon issuance of a purchase order. D procured a total of 2,500,000 units for distribution outside the United States. On June 11, 2020, D issued a medical device recall for the Product. On July 28, 2020, the FDA issued a notice to D stating that the Product did not satisfy the requirements for EUA. To date, D has not obtained the required EUA for the sale and distribution of the Product. P sent a termination notice and demanded full repayment of its prepayment for the Product. Termination and repudiation were based solely upon the absence of an EUA for distribution of the Product in the United States. P did not offer any reason that the Product to be distributed outside the United States could not be sold or distributed. D refused to refund, and P did not pay for the Product purchased for distribution outside the United States. P sued D to recover payments it had made for products for sale in the United States. D counterclaimed for the payment of Product sent to Europe. P claimed D's action was barred by the statute of frauds because the purported contract was not in writing and signed. D's position is that the Product was a specially-manufactured good and the merchant's exception to the statute of frauds applied.

The legal issues presented in this case will be displayed here.

The court's holding and decision will be displayed here.

Legal analysis from Dean's Law Dictionary will be displayed here.