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Burger King (BK) is an American multinational chain of hamburger fast food restaurants. Headquartered in Miami-Dade County, Florida, the company was founded in 1953 as Insta-Burger King, a Jacksonville, Florida–based restaurant chain. After Insta-Burger King ran into financial difficulties in 1954, its two Miami-based franchisees David Edgerton and James McLamore purchased the company and renamed it "Burger King". Over the next half-century, the company changed hands four times, with its third set of owners, a partnership of TPG Capital, Bain Capital, and Goldman Sachs Capital Partners, taking it public in 2002. In late 2010, 3G Capital of Brazil acquired a majority stake in the company, in a deal valued at US$3.26 billion. The new owners promptly initiated a restructuring of the company to reverse its fortunes. 3G, along with partner Berkshire Hathaway, eventually merged the company with the Canadian-based doughnut chain Tim Hortons, under the auspices of a new Canadian-based parent company named Restaurant Brands International.

The 1970s were the "Golden Age" of the company's advertising, but beginning in the early 1980s Burger King advertising began losing focus. A series of less successful advertising campaigns created by a procession of advertising agencies continued for the next two decades. In 2003, Burger King hired the Miami-based advertising agency Crispin Porter + Bogusky (CP+B), which completely reorganized its advertising with a series of new campaigns centered on a redesigned Burger King character nicknamed "The King", accompanied by a new online presence. While highly successful, some of CP+B's commercials were derided for perceived sexism or cultural insensitivity. Burger King's new owner, 3G Capital, later terminated the relationship with CP+B in 2011 and moved its advertising to McGarryBowen, to begin a new product-oriented campaign with expanded demographic targeting.

Burger King's menu has expanded from a basic offering of burgers, French fries, sodas, and milkshakes to a larger and more diverse set of products. In 1957, the "Whopper" became the first major addition to the menu, and it has become Burger King's signature product since. Conversely, Burger King has introduced many products which failed to catch hold in the marketplace. Some of these failures in the United States have seen success in foreign markets, where Burger King has also tailored its menu for regional tastes. From 2002 to 2010, Burger King aggressively targeted the 18–34 male demographic with larger products that often carried correspondingly large amounts of unhealthy fats and trans-fats. This tactic would eventually damage the company's financial underpinnings, and cast a negative pall on its earnings. Beginning in 2011, the company began to move away from its previous male-oriented menu and introduce new menu items, product reformulations and packaging, as part of its current owner 3G Capital's restructuring plans of the company.

As of December 31, 2018, Burger King reported it had 17,796 outlets in 100 countries. Of these, nearly half are located in the United States, and 99.7% are privately owned and operated, with its new owners moving to an almost entirely franchised model in 2013. Burger King has historically used several variations of franchising to expand its operations. The manner in which the company licenses its franchisees varies depending on the region, with some regional franchises, known as master franchises, responsible for selling franchise sub-licenses on the company's behalf. Burger King's relationship with its franchises has not always been harmonious. Occasional spats between the two have caused numerous issues, and in several instances, the company's and its licensees' relations have degenerated into precedent-setting court cases. Burger King's Australian franchise Hungry Jack's is the only franchise to operate under a different name, due to a trademark dispute and a series of legal cases between the two.

The Bank of New York Mellon Corporation, commonly known as BNY Mellon, is an American investment banking services holding company headquartered in New York City. BNY Mellon was formed from the merger of The Bank of New York and the Mellon Financial Corporation in 2007. It is the world's largest custodian bank and asset servicing company, with $2.2 trillion in assets under management and $41.7 trillion in assets under custody as of the second quarter of 2021. It is considered a systemically important bank by the Financial Stability Board. BNY Mellon is incorporated in Delaware.

Through its Bank of New York predecessor, it is one of the three oldest banking corporations in the United States, and among the oldest banks in the world, having been established in June 1784 by a group that included American Founding Fathers Alexander Hamilton and Aaron Burr. T. Mellon and Sons Bank, was founded in Pittsburgh in 1869 by Thomas Mellon and his sons Richard and Andrew. Andrew W. Mellon later became Secretary of the Treasury.

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The American Optical Company, also known as AO Eyewear, is an American company, it designs, manufactures and markets eyewear, primarily sunglasses. Founded in 1869 as a merger of spectacle makers in Southbridge, Massachusetts it has been in existence and operating for over 150 years. Spectacle-making had been established in the town in 1826 when William Beecher had set up a jewelry business there with an apprentice, Robert H. Cole. Cole subsequently bought the business and became the largest shareholder and first president of the American Optical Company. When he retired in 1891 and Beecher died in 1892, the volume of production in the town was about two million frames and a million pairs of lenses per year.

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A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows:

The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards. Form 356h specifies the requirements for a BLA. This includes:

Some biological products are regulated by the Center for Drug Evaluation and Research (CDER) while others are regulated by Center for Biologics Evaluation and Research (CBER).

A BLA is submitted after an investigational new drug has been approved. If the Form 356h is missing information, the FDA will reply within 74 days. A BLA asserts that the product is "safe, pure, and potent", the manufacturing facilities are inspectable, and each package of the product bears the license number.

After approval, annual reports, reports on adverse events, manufacturing changes, and labeling changes must be submitted.

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