Hi, I’m Michael H Cohen, founding attorney of Cohen Healthcare Law Group.  Today, we’re going to address a very specialized topic, and that is what legal protections do you need in a Contract Manufacturing Agreement for Dietary Supplements?

We’re talking about when you hire somebody and they’re going to make the dietary supplements and label them for you.

First of all, the Manufacturer, the one actually making the supplements, they have to take legal responsibility for making sure that those supplements comply with applicable laws and regulations. They have the factory; they’re doing the batch production. So, you want them to take legal responsibility. They have to have a whole slew of quality control measures and those are things that we specify in the contract. They have to follow Good Manufacturing Practices, it’s very detailed.

As the Client, the one contracting for the supplements, you want to provide the specs. So, you want to say what goes in the supplements.

The second really important point is confidentiality.  Your contract manufacturing agreement has to protect your information, your proprietary information about what goes in the supplements.

And third, more broadly, intellectual property.  So, who owns what at the end of the day? Let’s say these supplements become really popular, how do the profits get distributed?

Ideally, you just pay the manufacturer to do what it does, and you get the profits. But what if something unusual happens, say that they discover that they have a meeting together and one or the other comes up with idea to make the supplements more effective, tastier, or more bio-available?

So, then, who has the right to that innovation? That’s the level of detail you want to specify because when you’re drafting this agreement, it’s a sentence or a phrase that your lawyer puts in, that could someday be worth millions of dollars. And you don’t want to be in a lawsuit fighting over that sentence that you thought was there, but maybe wasn’t there.

So, you want the intelligence in beforehand and it’s worth it to get yourself the right agreement.

If you enjoy today’s video and would like to dive deeper into any of the topics, contact us and we’ll arrange for your Legal Strategy Session. In the Legal Strategy Session, we’ll address your specific healthcare legal needs, review your business, and give you concrete recommendations to help you move forward. To get started, click below. We’d love to talk to you.