All of the above. The terms of such an agreement between the parties that all parties can agree with are the variable(s). Myriad alternatives can exist; the contract ideally contains provisions that each party feels comfortable with and provides terms favorable to each—a win for everybody.
The agreement is presented to the court, and entered into the docket file with no input from the judge. Federal judges do not enforce the provisions of such agreements—it is a contract with provisions that each party agrees with. It differs from a consent decree.
Obviously, appropriate actions by the FDA are variables that affect the parties; more important , those actions also affect the health of the country’s citizens. The FDA is not a party to the agreement; no officer of the government will sign the agreement.
More later. I will not respond to messages containing suggestions. Time permitting, I will read such suggestions if addressed to me.
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