"Remember, I'm proposing a one off (of purchasing financing). Basically the buyer pre-pays or should I say loans money against the order (as opposed to a 3rd party finance company.)"
OPC, I'm once again confused. I thought we were talking about a third party lender, making a loan against the security of the purchase contract, which I don't believe is commercially feasible.
But you're talking about a purchase and sale agreement, where MNKD is the seller, and the user of the product is the buyer, but also the lender. If it's just those two parties, then why not do the deal now, what is there to wait for? But if MNKD and the buyer make a deal and say they are going to wait for approval to ship the product, then that's contingent and I can't see the buyer making a meaningful down payment, or advance, under that sort of deal, and certainly not a loan. The buyer is surely not going to prepay for that order, unless the buyer is getting some commercial advantage by doing so. Would MNKD promise to only sell and/or license to that buyer, perhaps for a set time frame (2 years) and/or for certain geographic areas?