Speaker 1  0:00  
Good afternoon, everyone. Welcome to the basics of cooperative research and development agreements with federal labs presented by Otto. My name is Holly lun Lundgren. autumns online professional development manager and I will be your staff host for today. All lines have been muted to ensure high quality audio, and today's session is being recorded. If you have a question, you can enter it at any time using the q&a feature. I'd like to take a brief moment to acknowledge and thank autumns 2020, online professional development sponsors. We really appreciate the ongoing support. And now I will introduce our speaker, Bob Charles joined the office of I'm sorry, Bob Charles joined the office of the staff judge advocate US Army Medical Research and Materiel Command at Fort Detrick, Maryland in September 2001. After a 20 year active duty career as a Judge Advocate with the US Army. Most of his tours were served at Army Medical Department assignments. He was the initial editor and contributed numerous articles over the years to army's medical legal Deskbook Bob was awarded seven meritorious service medals during his active duty military career. At USA Mr. MC Bob is primarily responsible for legal issues involving technology transfer, assistance agreements and patent licensing. He has served on the FLC Executive Board as chair of the legal issues committee from 2002 to 2010. In 2017, he was awarded the Department of Defense medal for distinguished civilian service. After earning his undergraduate degree from UC Berkeley, Bob attended law school at the University of Utah. Well in the military, he graduated from the army jag resident basic and advanced courses. Bob was also selected by the army for advanced civilian schooling being sent for a master's in public health in the program in health and law for lawyers at Harvard University School of Public Health. Bob is also a member of the Texas State Bar. At this time, I'll turn it over to our distinguished presenter. Welcome, Bob.

Speaker 2  2:12  
Thank you so much, Holly, and thank you to all of you out there. I hope you can see me, I hope that this is educational for you. I'm hearing this handsome dress shirt and wearing my very manly Capri shorts. And so I hope you're equally well dressed for the occasion up you're doing the best you can during these very rough days. As Holly indicated, I'm at the Army's medical research, it's now called the medical research and development command at Fort Detrick, Maryland. We do hundreds of cooperative research and development agreements each year with non federal entities including many research universities who those of you out there represent as well as with biotech with foreign governments with private organizations. Back right before I got here, I was looking at a credo that one of our labs is going to enter into with one of the big pharma companies under Operation warp speed to develop the COVID-19 vaccine and we are doing a lot of work both contracting and and undertake transfer with pharma. With the device companies with everyone imaginable. This time, the pace is really picked up. Well, why don't we move on on the slides? Ollie, where'd you go move us up on the slides? Here we go. There we go. We're gonna we're gonna start with a video put out by the Federal lab Consortium for technology transfer, which gives an overview of federal tech transfer go ahead Ali.

Unknown Speaker  4:19  
GPS navigation is everywhere these days, our cars, our phones, and even our watches. But did you know that GPS was originally developed by our nation's top defense laboratories for use in military operations? Thanks to a process called technology transfer. GPS has been made accessible for businesses for the last 20 years. Every day our federal laboratories conduct exciting research, create new materials and devices invent technologies that lead to life saving medicines, and produce the latest and greatest in science and technology. Savvy entrepreneurs and business people like you have benefited from federal resources by commercializing these technologies which helped grow their business and our economy. At the federal laboratories are eager to make their ideas and adventures even their facilities available to all American businesses from startups to large corporations. Imagine being able to license and sell the latest technologies from NASA or the Department of Energy or the National Institutes of Health, or gain access to state of the art federal labs for your own projects. For example, you can access Brookhaven National Laboratory to conduct testing on everything from hydrogen storage materials to metallurgical reactions. You could even partner with government scientists already conducting advanced work in your field as a launching point for your totally new concepts. Some of the most groundbreaking technologies have come out of lab partnerships and lead to more spin offs than a technology may have originally been developed for. Memory Foam. Originally developed by NASA to absorb shock impact during Space Shuttle launches, has been commercialized into products ranging from mattresses to sports equipment, and even prosthetics. A program instituted by the Department of Defense to help military commanders manage information overload has now become part of the Apple iOS, we all know as Siri.

Unknown Speaker  6:06  
Okay, I set up your meeting for today at 4pm. Start

Unknown Speaker  6:09  
by reaching out to a federal laboratory or agency representative to see what resources they may have available. And this is where we, the Federal laboratory Consortium for technology transfer the FLC, come in, and visit our website at WWW dot federal labs.org To find out how technology transfer can help your business succeed and ensure our continued competitiveness in the global economy.

Speaker 2  6:44  
Super, to the message for all of you who are tech transfer personnel at your universities that your companies that you're biotechs that wherever you happen to be state and local government. The message for you is that the federal labs also participate in technology transfer. In fact, we are mandated to do so by federal statute. Go ahead, go next.

Speaker 2  7:20  
Next slide, Holly. There we go. So let's get down to precisely what a crate is, which is our topic for today. Next. Well, maybe we won't maybe we'll start off with a success story. And how, and we can learn from a success story what a crate a is great, and Holly showed this great new YouTube flick.

Unknown Speaker  7:54  
Flying in was a great shock. What I saw out the window of the airplane, were matchsticks scattered across the hills and valleys.

Unknown Speaker  8:05  
No hunters part, no have lotteries cleaning and preparing the meal. That's the harder part. There was a time that we're desperate because there's no water

Unknown Speaker  8:26  
we drove up the hill, and the gentleman began to shout. In Spanish pure water. The people poured out of the town and gathered some 5070 100 people behind our truck. It was the only safe water they'd had like a

Unknown Speaker  8:45  
small mini water treatment plant.

Unknown Speaker  8:59  
He's really great. My impressed with that system is simple and very useful.

Unknown Speaker  9:06  
The Creator began to help us at water step, define and hone better what we wanted to accomplish

Unknown Speaker  9:15  
create as a cooperative research and development agreement. And that allows for the federal government EPA to work directly with private companies. And so there's intellectual property on both sides. We can take each other's ideas, and we can develop something new. I felt like we could work with them, add technology and capabilities. And then we would have something that could be taken to the field. This is what we need. We need water in the communities.

Unknown Speaker  9:41  
What EPA has done is let us say that this is the right tool in your toolkit and your family can be safe and worry about other things to get you through this crisis.

Speaker 2  9:56  
Okay, let's let's peel back The onion on what we just saw, there's a small company named water step, they have a small mini water treatment plant. In this country, if somebody has a municipal water system, if they're going to be providing water out to the public, they need to get certified and approved by the Environmental Protection Agency of federal lab. The EPA also has experts in that field, as you saw on there. And so what happened then the small company went and worked under a Creative with a creative agreement with EPA, to better define, and as the owner of the company said, hone their technology. They what they essentially wanted was some kind of system so that in times of emergency, when the normal water system is cut off, they can take these kids, put them out in the field where they're needed, set them up with their own people, and provide water, their business, they want to sell these, they're a commercial entity, but they're also doing something as you can see vitally important for the public health stricken communities. So they work together, they, you know, the company at IP, they had ideas, the EPA had some IP, they had some testing facilities that they could verify. Validate the system that that water step had, and they worked together under a credo. Well, that's a, that's a, in a nutshell, those kinds of activities are the part the whole the nub of what traders are, why don't we go to the next slide. So in the big picture, a crate is a kind of government contract, which is allows r&d collaborations between our federal labs, and non federal parties, including, of course, universities, and all the entities that you folks out there might represent. One thing nice about craters is they allow the labs great flexibility and discretion, for those of you who are at all familiar with working with, oh, let's say federal grants, or federal contracting, craters are much easier, much less complicated, they're almost always fewer rules that the agencies apply. And it enables the transfer of resources to and from the federal government. In the video, we just saw the expertise where the resources, use of the resources of EPA, their expertise, and, and EPA could also allow this person to come into their plants and into their labs and work with them. So it allows that kind of flexibility there, each one's a one off next. For the lawyers in the crowd, this is the the legal definition out of the statute of what a credo is. And if if you can get your arms around this legal definition, you have about 90% of what you need to know in working with federal labs, I'm going to read it and then we're going to quickly go through the parts of it so that you have an understanding of its flexibility and broadness. And I'm hoping that while I'm going through this a US tech managers that whatever entities you represent, the lights start to go off because it's inevitable that whatever your entity specializes in, if it's a university with many different departments, and medical school, etc, if you're a small biotech, if your work for a foreign government, as you think about this and your role as a tech manager that IP you have that you want further developed. It's a it is almost 100% sure that the US government as a federal lab that fits in your technology space, and they could help you in moving along the development of a technology or coming up with a new technology or spinning out one that's been developed in a federal lab that you've read about or in the professional literature. So here we are. credo is any agreement between one or more federal labs and one or more non federal parties under which the government through its lab, or through his labs provides personnel, the government can provide services, facilities, equipment, intellectual property or other resources. So pretty much anything with or without reimbursement. However, not funds to the non federal parties. So I know if you represent universities are often looking for grants or cooperative agreements, from federal entities, well, you're not going to get money from federal labs under a Creative but you often will get things that are even more valuable. And that's the expertise and access to the unique facilities that are there in the federal labs. And so those are the the various things that a federal lab can provide the non federal parties that you guys can provide funds about that you can provide money to a government lab, assuming you've got and you can provide personnel services, facilities, intellect, equipment, IP, or other resources, so you can provide anything. So this is agreement and agreement toward the conduct of specified r&d efforts, which are consistent with the missions of the various laboratories or the laboratory you're going to work on. Next, please. So here's some examples of of what that definition, the government through its labs can provide personnel. And I'm going to use the experience I've had I've, I am the attorney for at least eight different federal labs for Army hospitals, I, I consult for the defense health agency, which runs the rest of the military, hospitals and labs. So we can provide personnel we can put those folks on temporary duty and send them off to your place to train your people if that's what's necessary for the r&d effort to test to do research, we so we can provide personnel next. We can provide any of the services that are available in those labs and in the labs I represent which represent a broad range of medic medical specialty areas of interest, to the warfighter, and to in but also public health. We can provide any of the services that we have we run everything from bench work at our labs to we have FDA experts, we have we run clinical trials and everything in between any of those services, go ahead. Facilities, so we can bring your folks into our facilities. We if we have a facility that's open, we could lease that facility, we could allow your your group to work inside of it. We there's probably not it hasn't been in time for years when there hasn't been a creative partner who didn't have an employee doing some kind of collaboration with us, inside our facilities using our equipment, working together with our folks on a collaboration. Next, in equipment, there's been a few times where and near the end of a crate, a project. The nonfederal party reached out and said, Hey, we've you were kind enough to loan us this equipment for the last X number of years while we carried out this collaboration together. Would you be willing to just give us that equipment? Well, we can actually federal labs have are authorized to when it says provide equipment, we can give the group we can give up ownership of the equipment, we can also just learn it or lease it. Whatever the parties wish to work out next.

Speaker 2  19:36  
For IP and like your entities out there, we develop intellectual property, we protect it, we license it. So have one of your entities are working with desert. There's a third party that you want to work with but also with a federal lab. And we have a piece of the IP we could certainly give a real Search license, we can give a non exclusive license for a period of time we exclusively license we we can do all of those things and we take in money for Thank you Next. And all of those activities I just described with all of those resources, be they people a quipment services we can provide with or without reimbursement. So as it says in the slide, this is standalone discretionary to the laboratory statutory authority to negotiate and receive reimbursement from nothing, or zero to fair market value for whatever the lab provides. Whether or not we charge in a particular case may depend on how central the collaboration is the mission of the laboratory, and I'm speaking just for my labs, and whether there's there are other funds available, that the labs have if they're going to incur additional costs. So again, as we'll find out a little later in this presentation, all the different federal labs, they operate a little bit differently in this creative space. And, you know, we can charge and sometimes we do charge we charge that only drags but are indirect. So but again, that depends on the situation, we're confronting, whether this is something that is of such importance to us that we need it or whether it's something that that is it's part of our mission, but perhaps central to it, and we don't have the funding available to allow not to be reimbursed. Next. Okay, so we can provide all of those resources, but we can't give funds to non federal parties. So what we will often do if, if we're dealing with a small entity that needs funds, we can point those collaborating or potential collaborating party to other sources of funds such as grants, and we were we are normal our normal budgets each year is about $3 billion, because of COVID 19. We're currently handling billions and billions of dollars. But normally our our grants are our object couple of billion a year, their state funds in Maryland and in other places SBIR, which most of you are would be familiar with, for example, go ahead. Next slide. Because most of you represent universities, and I appreciate the fact that many of these universities depend heavily on federal grants, I want to explain and so that it's very clear to you that although the laboratory itself cannot give funds to the non federal entity, that doesn't mean that the non federal entity, let's say a university can't get funding from the federal agency and still work with that federal lab. We've seen it hundreds of times for federal agencies, excuse me, where non federal entities have gotten contracts or grants, and sometimes cooperative agreements through my command. And as part of their proposal, they are proposing to work with one of our laboratories, and that's allowed the labs we will, in most instances get paid directly by Our command by the program that sponsoring and in occasion, it's a little bit complicated, but on occasion, we allow money to go directly to the non federal parties, who will then turn around through a crater and provide the needed funding for the Federal lab. So all of those are allowed. This is the authority. This is something that we've been doing for quite some time. Thank you next. Okay, so a credit is any agreement between one or more federal labs and one or more non federal parties under which all of you out there that are non federal parties. You can provide anything you can provide funds, personnel, services, facilities, equipment, intellectual property or resources. The parties work out In the statement of work, what resources are going to be provided by each party next? And all those resources are next. negotiable. So we we work out and and part of my job is the kind of this working on the standard boilerplate, where non federal parties want to make changes for various reasons. And we negotiate those. And it's pretty simple, pretty quick. Most of it is handled by email, sending documents back and forth with proposed changes. Occasionally, we get on the phone with our non federal partners to be and we talk it out, what can we give, what can't we give? How can we change the wording and the boilerplate so that both parties are okay. And that's part of a credo. And again, we do this day in day out just like you do in licensing the technologies, marketing the technologies that your entities create. Next, that's fine, we're gonna look at another YouTube. Another situation that provides a good example of what's possible for a crate. Go ahead, let it roll.

Unknown Speaker  26:50  
About three years ago, Mayor Walsh committed the city of Boston to Vision Zero, which is a worldwide movement to end traffic fatalities and serious injuries. For the city of Boston. Our goal is to do that by the year 2030, the sidecar issue actually arose as sort of a precursor to our interest in Vision Zero. And looking at some of the crashes that were happening, especially for people who were riding bikes and walking in the city. A lot of them were in conflicts with trucks and looking into research and working with the Volpe center. You know, we learned about side guards Volpe is

Unknown Speaker  27:23  
a federal r&d lab within the Department of Transportation whose mission is to advance Transportation Innovation for the public good. Truck guard is, is a device it's like a physical barrier on the side of a truck or other vehicle that rides high off the ground that in a collision with a pedestrian or cyclist is intended to help sweep that person out of the way, instead of allowing that person to fall under the wheels and be crushed. So it is really a way to mitigate certain types of crashes involving the sides of trucks and pedestrians or cyclists,

Unknown Speaker  27:51  
bicycles and trucks do not go well together. The roads just they're not meant for both. So this will keep a little bit of an area where they can't fall in between the wheels. We

Unknown Speaker  28:00  
came up with an internal proposal for pursuing this path of research on side guards. That led to a pretty interesting set of findings that we presented externally and professional society meeting where the city of Boston happened to be in attendance. City of Boston in 2012, had a very bad year with respect to fatalities. The city was very interested in what they could do to address that challenge that precipitated the discussion between Volpe and the city of Boston led to a partnership in 2013, where we helped provide some best practice research to them, they launched the pilot on 18 vehicles at the city of Boston with safeguards as a means to protect bicycles to pedestrians and collisions.

Unknown Speaker  28:41  
We liked it, we want to demo it like singing on putting it on my trucks. The accessibility is amazing. The whole design, it's simple, but it's very, very well thought out. And that's why we use it.

Unknown Speaker  28:52  
As federal if we don't have a truck fleet. We don't have the means to deploy this. On the other hand, a city with its own truck fleet with many contractors, many avenues to implement an onboard technology like a side guard is in position to deploy but not necessarily in position to develop the practices and the specifications, and know how to do that. I think it was a very complementary set of skills that came together in the partnership. We have

Unknown Speaker  29:18  
put it on our water trucks. We have put it on flatbeds few box trucks, but pretty much that's it the trash trucks are the most popular because they are on all the city streets and the contractors are all over the ordinance states that anyone doing business with the city must have them.

Unknown Speaker  29:33  
The cost of an installation on a truck runs between 800 and $1,000 per truck. But you compare that to the safety benefit that it offers. We've seen unfortunately a number of instances where had side guards been on trucks there would have been a better outcome of the situation. So I would hope that you know, as time goes on, this becomes the standard on trucks as opposed to something that's added after the fact.

Unknown Speaker  29:55  
Volpe was an important partner and continues to be an important partner to us and thinking through what Side gardens should look like what are the most effective tools? How do they fit on different sizes of trucks? You know, we could start with our own fleet here, but also applying it to all the contractors who do business with the city. There are a lot of other types of vehicles when they have been invaluable in being able to provide that research support that is needed to enact best practices.

Speaker 2  30:29  
Okay, that was pretty cool went by fast. But there's lots to learn from one of the things that I think is so interesting about it having lived back there for a year is that here's the Department of Transportation Volpe lab. They're an r&d lab. And some of you may know this, they're in Cambridge, Massachusetts, right across the Charles River. No, no relation to me, from Boston, Massachusetts, so their next door neighbors. Boston has been having a problem with, you know, accidents between their truck fleet and bicyclists. And if any of you've been back there a million students on bicycles. And where do they meet? They? They don't they don't just call up each other and symbol, anything we can do they meet at a professional meeting, who knows where it was, is probably out in California. And they start talking, it's likely that that the Volpe folks who developed this, the side guards, gave a presentation in the city of Boston said, Bobby, dang, you know, whoever the representative was, maybe we ought to talk about this. So they start talking, and what do they come up with is why don't we run a pilot program? You know, we don't want to, we don't want to put all these things on our fleet, they probably have hundreds of trucks. So they decided to do some research, let's do a pilot program, let's do it for a year or two, and see what happens because it's inevitable that that they're going to crash into somebody, because that's what charts do. And they like it, it works. Well. Yeah, that was it's a wonderful example of ways the creators can come about and what they're what they're useful for. And again, as as the representative from Volpe said, they didn't have the tracks, City of Boston had the tracks, but Volpe had the ideas. So they worked out how they would do it. So I'm going to go another step on this. Let's see that it worked. And they published a paper together. Sylvia Volpe probably has some IP on the side guides on how to design them, they may or may not have IP, if they don't, they at least want to let people know about it, what they look like what the designs are like this, you know, this simple technology could go on the site of 10s of 1000s of trucks that are running around and in our communities, it could save lives, he could create hundreds of jobs. For those who in small metal sheet shops that could design these for the particular size trucks that the municipality or the whoever owned the truck fleet was interested in. They might be able to do them themselves, but it's going to create a lot of jobs and it's going to save lots of lives. Pretty neat. Next please. Okay, we're going to talk for a few minutes about credo authority and IP Next please. Quickly that that one thing different. Again, for those of you who have worked with federal government, most of the time you're working with that. A grant officer contract officer. With Credo as you're working with the director of the lab, they're the ones who can sign so it's, it's not going through a contract shop. It's working directly with the lab. But we also in the same authority that allows these labs to do creators. They're also given authority to negotiate license agreements for inventions made it the lab, or other intellectual property developed in the lab for inventions that sometimes get voluntarily assigned to the law. And these this authority to license covers both the Krita subject inventions that is inventions made under the creator or just inventions that the lab was doing in its day to day work. Next So, labs can grant or agree to grant an advance to a creative partner and this is under the statute, patent licenses. They can agree to assign rights over to a greater authority, excuse me, a creative collaborator, or they can give options to either a license or an assignment in these creative subject inventions, and that can be sold inventions that just made it by lab personnel or a joint invention made between that the lab employee and the non federal entity next. And it's all negotiable. There you go. Thank you. So under, under our credo, as the lab is required to ensure that the partner the non federal entity has an option to choose an exclusive license for a pre negotiated field of views, and taking I'm going to take a couple steps back here. The principal purpose of credos is to encourage give a tool to the labs to work with non federal entities to help these technologies that the lab is working on or the company is working on, to get them further developed, and commercialize. So what we don't want to have happen is that great ideas come out of our federal labs, or come are invented in our labs. And then they are put to practical use, that doesn't do anybody any good. It's a waste of our taxpayer dollars. So the idea behind these, this licensing authority is to find ways to move these technologies into the commercial sector in the business, I'm in medical technologies of various kinds that includes getting the technologies were needed through the FDA. And so that they can be commercialized and sold both in the United States and then to any other regulatory authority around the world. That if it's if it's one of those kinds of technologies like a vaccine next. So the the lab can grant its partner an exclusive license, and there are certain rules. And unlike, well, I've seen universities do this. And I know businesses will do this. When when we license a technology, we fully expect that the licensee is going to put resources and effort into developing and commercializing it, we do not license technologies, so that some big company can put that technology on the shelf. So it won't compete with an existing technology. So we do require as part of our licensing documents that the potential licensee show that it has the resources and the means and it is thought out. It's both its development and marketing strategy. So we can license an invention that we made that's already existing, as property of the laboratory if the patent is within the scope of the creative collaboration, and for reasonable compensation when appropriate. So with our royalties, there's under federal statute, our federal employees can get at least 20% of the royalties that the labs bring in and the lab gets to keep the rest. So that's a an incentive for us to go through all the hard work of working, dealing with patent counsel, and perfecting our rights, improving the technology, etc. Go ahead. And all of that, of course, is negotiable. Nice. And the labs can waive and advance any government ownership rights to joint creative subject inventions. But in any of these cases where we as either sign or license out our technology, one of the non negotiable aspects of it is the government always get a non exclusive non commercial non exclusive license to you Use the technology for government purposes. So that it's in the statute. There's no getting around. That happens every time but again, it's not for the purpose of compete competing in the commercial marketplace is so it's just so that the government can continue to use it for its own purposes. Next. And again, commercial. All right last YouTube, that it's a good one is from the Army Research Lab. Thank you Holly.

Unknown Speaker  40:49  
You may be familiar with cooperative research and development agreements or credos and pen license agreements, or PLA as separate mechanisms to enable partnership between the Army Research Laboratory and industry or academia. But have you considered how these mechanisms can work together to support technology commercialization? Typically, patent license agreements are used to access aerial drone technology for commercial purposes. While cooperative research and development agreements are used to access and share personnel, facilities, equipment, or data, however, these mechanisms are not mutually exclusive. We therefore encourage Army Research Laboratory researchers and partners to think creatively when leveraging these mechanisms. A common use might be the following example you licensed them on a URL patent is interested in accessing either the inventor or another researcher to serve as a subject matter expert or technical adviser for further development of the license technology. In addition to the patent licensing agreement, a cooperative research and development agreement can also be negotiated in order for the licensee to access the subject matter experts to personnel exchange. Please contact us through the technology average portal to learn more about how multiple mechanisms can be leveraged for your research and commercialization goals.

Speaker 2  42:19  
I really like that. That example from where that video from ARL because we do this quite frequently, we'll find a licensee who wants to work with us afterwards was saying keep working with the laboratory and with the inventors to help the development or marketing of the technology to improve the technology. So we do that all the time. And it's a it's a great combining of authorities, as set out in that Clever YouTube Next.

Speaker 2  43:06  
So lab directors have a couple of responsibilities they supposed to give, quote, special consideration to small businesses and small business Consortium. We do like working with small businesses and small biotech. But we've also you know, we've we work with whoever has the ability and capacity to do the collaboration. So while we often work with small businesses, we've worked with the biggest pharmaceutical companies in the world. We've done craters with, for example, the NCAA and the NFL on traumatic brain injury activities. And we've worked with foreign governments, because in many countries, particularly third world countries, those are the organizations, the only organizations that have that expertise. They it's not like the United States has a wide variety of public and private universities and resources from the government that helps fuel all that. So we do it with we have craters with absolutely everybody imaginable, except perhaps the government of Iran or companies in Iran or Syria or North Korea, for example. Right now, we we do have a preference for US businesses that agree that they would substantially manufacture in the US but that's often a problem also, for example, that some of the biggest pharmaceutical companies have their manufacturing plants in Europe, for example, in Belgium, and although we would love them to create the jobs and manufacture Here's some of the vaccines that we work with them. In the US, those plants can cost up to half a billion dollars. And so it would be a bit too much for us to mandate that they build a brand new plant in the United States simply to accommodate the US government's preferences. So we have to negotiate that stuff, but we have to negotiate it internally within the US government. Next. Okay, there's a series of miscellaneous issues we're going to deal with quickly. And then what I want to do is open it up to your questions. A very interesting aspect about creators. And as compared to like government grants and contracts, is no competition is required. In I've been at my command for about 19 years. And I can think of only two instances where the lab decided they wanted to publicize their desire to find a creative partner, which they did, and they set up a series of steps to down select who they would work with. The law does not require competition, we can dance with who we want to dance. For those of you who have dealt with the National Institute of Health, they often don't do that they often require that this goes out there, craters be competed. But that's not how we operate and DOD General. Next. One thing that you need to realize is agencies, practice tech transfer very differently, one from another. Now, I'm going to spend a little time because I know most of you are from universities, and can get confusing they find out that were you've worked with Department of Energy, and they had a cookbook set of terms that they weren't very flexible about or some other agency, which had a much longer template. And they were much slower moving things than we are why that is why Why can't the federal government all operate on the same set of rules? Well, first of all, there's no government wide regulations that exist or there are actually some, but they, they they're very few that exist about how we about craters, how we operate. So each agency issues its own regulations. lab directors maintain a great discretion on whether to collaborate and the terms. And the mission of the federal labs is different, for example, the Department of Agriculture. Everything they do all the research they do is for the purpose of spinning out newer technologies into the marketplace. On the other hand, with Department of Defense, much of what we're trying to do is spin in technologies, not for commercial purposes, or commercial purposes, we only look at if we think well, these technologies will be too expensive. Otherwise, unless there was a commercial application. And even within the Department of Defense is different. For example, if you're at a navy lab that's finding technologies dealing with submarines, or with the radar, or cyber issues. There, they are looking specifically for technologies just for them. On the other hand, where I work because it's the medical field, almost everything we do, has some public health, Apple, excuse me public health applications. So and we just can't, we aren't going to buy enough of them to sustain a business. We really need our creative partners or collaborating partners to be able to find a commercial application so that if something gets manufactured and the in the government or the military buys it for the service member, that it's going to be around for long enough that they can be replaced. We can buy parts etc, etc. Next. More about this a big factors personality of legal staff. Many lawyers, government lawyers are very risk averse. A conservative. Some of you at universities have run into this. You find lawyers are always trying to say no, instead of yeah, we can do that. Or we can do it how you're thinking. But here's another way that we can do. So the personality of legal staff makes a huge difference at the various labs. And while the law authorizes a broad range of, of cooperative arrangements, some federal labs are so concerned about uniformity in what they do, that they just don't want to change their template much to accommodate businesses or universities that need to operate a little differently. But a big part of my job, were at the Army's material and medical and develop development command is to actually negotiate changes in our template necessitated by you know, who we're dealing with or their and their requirements. Next. Okay, here's some examples of that, that you might run into some agencies mandate that their their template their format be use, we don't others do.

Speaker 2  51:25  
Some require a license a government use license, if the collaborator solely invents something in for us that depends on the circumstances, and why we're collaborating. And if our aim is really principally, to just assist some existing technology, like a vaccine are therapeutic that the collaborator has already spent 10s of millions of dollars on it, you know, we don't, we don't really need to have a government use that anything we invent, what we're really there for is to move that technology along so that we can buy it from off the commercial market or through government procurement. Okay. Other examples allowing a collaborator to just provide funds, that's something we do, we've seen that a number of times, and especially with big, big philanthropic groups that are interested in helping us in areas like infectious disease, or like diarrheal diseases, or malaria, Third World, Cetera, the collaborative mostly has a lot of money because there are not for profit, whose mission is to try and improve health care in the third world. So under our laws, or undermine interpretation, our material transfer agreements and non disclosure agreements are created. But that's not true everywhere. We allow for Master agreements where there's one set of legal templates and different sets of statements of work for projects, whether the greater authority can be delegated down, it can't be within the millet Terry services, that it can be, as I understand it, NIH. As I mentioned before, whether creators could be competed whether they the agency allows for creators with foreign governmental entities. Ours does, but some have decided no. And that's just their own interpretation. It certainly is not the law. And there's some others, again, there. That's a variety that you can look at the change are different between the different agencies. Olli, go ahead, please. All right, your turn. Do you have any questions? I'm Hope you've stayed awake. I hope you're caffeinated out there. You're fascinated by creators. Do we have any questions?

Speaker 1  54:06  
Cool. We do have one, Bob so far. If you have any questions, everyone, please enter them in the q&a, and we will answer them as for April. The first question, Bob is what are some creative ways that companies can receive funding from a federal partner from a credo? For example, could the government pay the partner for use of a research service or tool and then collaborate on the subsequent analysis? If not, would this be acceptable is two agreements a contract and a Creta?

Speaker 2  54:36  
Your that's a wonderful question. And actually, we've done that a few times where, let's say a small company, or even a large company, what they do for a living is sell certain services access to certain kinds of instruments that they have or testing that they have. And so there's a government contract with that entity to do that testing, but then we, the laboratory wants to do a collaboration separate and apart once they get the information they want to do collaborate with the experts at that business on some particular research, question or technology. So we've done that a number of times, where, again, they've had both a creative for the, excuse me a contract for some particular services. And alongside it, the Krita. And what we do in the crate is we always just say, you know, this is what's happened the government by separate contract, and we enumerate the contract number, and all that is bought the services. But now, the part the parties wish to collaborate on X issue, and then we do it create it. So that's one way to do it. It's pretty cool. Oh, come on, guys. Anything else you want to know? I see somebody wanted to chat. Okay, that's just from Holly.

Speaker 1  56:26  
You must have answered every question already. They don't have any more.

Speaker 2  56:31  
Yeah. Hi. Recognize these are difficult there. It's more fun when we can all look at each other's face when we can go to a national meeting. Appreciate that. This doesn't have the same feel as when I can interact nose to nose with you. So listen, my email was did you give my email somewhere? Is that the last slide? I can't remember? Let me see. Okay, I see another question. It says at the army, do you have any criteria for issuing non exclusive royalty free licenses to create a partner's? Okay, I'm gonna take two steps on that. One is that there are federal regulations on licensing? They them. They most of them don't apply when it's a non exclusive license. And I think they would, whether my command or the labs, they come to me for that kind of advice. We don't have any set criteria, we're just looking at, well, what do you want to do with it? What what do you want to use it for? And what's the end? Does it especially if it's going to interfere with our later ability to give an exclusive license we'd really have to consider that if it was, you know, narrowly enough drawn and it was for a purpose that fit within our mission. We'd love to do that. So and how other army labs work? I don't know because I just worked with various medical labs. I saw some more questions I thought let's see that go okay, I guess I'm gonna mispronounce his Xia wants to download the slides. Holly, can you tell them how they can get the slides? Yes, absolutely. There

Speaker 1  59:05  
is a link to download the slides that was sent in the email that we sent all of you with the login links. If you didn't get that or have trouble downloading it for some reason, you can just contact me directly at h lundgren@autumn.net. And I'll make sure to get that to you. Looks like we did get another question. In the meantime,

Speaker 2  59:28  
I want to tell you that I think my email was on the first slide. If it isn't it's Robert dot L. That Charles for the number for dot Civ short for civilian mail m a i l.mil. Once again, Robert dot L dot Charles the number four.ci V mail M ei l.mil. And I'd be happy to answer your questions. I really delight in helping people. I'm very passionate about tech transfer, and I love helping people. Okay, Rene asked, how long does the creative partner get to negotiate an exclusive license to the IP? If that's available? Where's that negotiable? Well, that's negotiable. Also, and, of course, it's gonna depend a lot on on, let's say it's a lab invents something, that partner wants to negotiate a license, we inform the partner, hey, we've come up with this invention. Sometimes the the language in the cradle will give them six months from the time they're informed. But a lot of these technologies are very early stage. And so I would really, you know, for further, if you're in a business, it would be easier and make more sense often, to say, Well, can we work with you to see, you know, to try and develop this technology a bit more? And can we get it in the meantime, can we get an option to a an exclusive license in this field, or at least an option to exclusively negotiate with you? Because we want to work with you to help improve that. So we're very flexible in that way, then then, we have an anonymous attendee, or they're regulated requirements, around the handling of joint IP developed a new credo, are the parties treated as joint owners with equal rights in the whole of the joint IP? Why, again, that if I understand that the US still handles IP joint A jointly owned IP differently than our friends in Europe, there's no requirement, if an IP is jointly invented, there is no requirement that we collaborate together that nav one of our one of the two of us handle that as an exclusive. So if the party says, well, thank you so much for this, we're going to take our half ownership, we're gonna go over and use this IP elsewhere. Well, they're welcome to do that there is no requirement that they work with the lab or with the agency and trying to you know, put put all ownership in one plays are negotiated together. I hope that anonymous attendee I hope that answers your question. Anything else

Speaker 1  1:02:56  
didn't have one sneaking in the chat, which federal agencies have an easier process to work with on the credo?

Speaker 2  1:03:05  
Well, it and all lack of humility. Nobody is easier than army's medical research and development command. So as a as an entity within the federal laboratory system, nobody's easier to work with and we are or were I think quicker that we are Department of Agriculture's my, my understanding is they're pretty easy to work with. I've known some of the people there. Those are the ones that I know that are easy. And then there are there are some that are have been historically more rigid. And the Navy historically has been more rigid, but I know that their medical folks have become a lot less. So. In recent years, Department of Energy has been more rigid and kind of as a cookbook of how it works and doesn't have the flexibility that some of the others have. Okay, anything else?

Speaker 1  1:04:22  
Looks like that's all the questions we have. Okay. Do you have any parting thoughts before I close it

Speaker 2  1:04:28  
down? Well, I'm, I hope some lights have gone off as you've thought about working with federal labs and that they have a huge variety of federal labs. They really do like working with outside parties. It is is great for these experts to get access to the smart minds out in industry and academia. And creators are such an easy and wonderful tool at at any given time. My organization has about 900 Open craters. So it's something that we do, it's just a regular part of our business, we're pretty easy to work with maybe the in one thing, pass along is that if you want to know more generally about federal technology transfer, and to get a list of points of contact with the various labs, you might want to go to the federal laboratory consortium website, the it's federal labs.org. Or you can Google, you know, federal laboratory consortium. And they have a lot of resources there to help. They have a lot of templates that the agencies use for creators and other kinds of agreements. They have education programs, and they have resources that are accessible and very cheap or free to find out, you know, about federal technologies that are available, and, and who to work with who to contact at the labs. Well, that's it. Thank you, Holly.

Speaker 1  1:06:24  
Thanks, Bob. On behalf of autumn I want to thank Bob for this discussion. And we want to thank all of you for attending today. We hope you found this webinar informational. I just want to remind everyone that a recording of this webinar will be available for viewing within just a few days of today's date. Access to that recording is included in your registration. You can visit the autumn website to view the recording or purchase of this webinar you might have missed. When you close out today and evaluation will pop up. Please go ahead and fill that out so that we can serve your needs in the future. That will conclude our program for today. Thanks for joining us, and have a wonderful afternoon.

Unknown Speaker  1:07:06  
Thank you all

Transcribed by https://otter.ai