Add the following clause, as prescribed in point 25.1101 (c) (1), the following clause is added: (value added). Given that domestic manufacturing, the Court of Justice held that it was not necessary to determine the separate question of whether the tablets were also substantially modified in the United States. The FAR says that both prong are sufficient to make a final product “U.S.-made” and therefore be in compliance with the trade agreements clause. Therefore, under the TAA and its RULES of application in the FAR, the VA incorrectly found that the protester`s entecavir did not comply with the TAA and its regulatory implementation in the FAR. The Court also found that the FAR did not block Acretis entecavir tablets. Under the FAR TAA clause 52.225-5, a contractor must supply “only finished domestically manufactured or designated products in the United States.” And the “final product of the United States” is defined as “an item that is extracted, produced or produced in the United States, or that is deeply processed in the United States.” The Court stated that the origin of the components was not relevant to determining where a product is manufactured. Because Acretis manufactured the tablets in New Jersey, the product was a TAA-compliant “American final product.” According to the Court, “it is not necessary for a product in the United States to be manufactured or substantially redeveloped to be a finished product manufactured in the United States.” Instead, “such products can be . . .

made in the United States from components made from abroad. Where a contracting exceeds the WTO APA threshold and therefore the TAA applies, the United States has imposed a blanket ban on the purchase of goods from “non-eligible” countries where there is an offer of U.S. products or products from an eligible country. The aim of this restriction is to encourage other countries to make international trade commitments on public procurement. In most cases, this restriction prohibits the U.S. government from purchasing products from countries such as China and India that are not members of the GPA. In addition to the FAR clause on trade agreements, the government argued that the tablets were not compliant because they are not “fully” manufactured in the United States, and that the manufacture of the final tablets in New Jersey did not “substantially” transform the Indian active ingredient into a new product. This argument required the government to read the “full” adverb of the country of origin`s legal test, if it exists, in the TERMS agreements clause of the FAR, as long as it does not exist. The adverb “complete” also does not exist in the BAA or its regulatory implementation. The Court found that the “finished product manufactured in the United States” clause is defined as “an item that is extracted, produced or produced in the United States or that is significantly modified in the United States.” FAR 52.225-5 (a) (added).

The Court stated that, regardless of the fact that the manufacture of the tablets essentially converts Indian ingredients into a new product, the definition of a compliant final product of each product “made in the United States” and that the entecavir tablets were indisputable, regardless of the source of their ingredients and other ingredients, it is necessary to amend the provision for 52.204-8. , annual representations and certifications, and the clause at 52.222-19, Child Labor – collaboration with the authorities and corrective measures, with compliant changes to the clause data in 52.212-5, contractual conditions necessary for the implementation of statutes or executive orders – Commercial Objects and 52.213-4, General Conditions – Simplified Acquisitions (other than commercial).