Speaker 1  0:08  
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Speaker 1  1:16  
All right, good afternoon and welcome to today's webinar, building your institution revenue stream by research tool licensing presented by Autumn. My name is Sammy Spiegel, autumns 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 for the panelists, we encourage you to use the q&a feature on your zoom toolbar. If you have a technical question or comment, please feel free to use the chat. You may also use the raise hand feature to ask a question aloud throughout the presentation. Should you need closed captioning during today's session, the Zoom closed captioning feature is turned on and available on your toolbar. Before we begin, I would like to take a moment to acknowledge and thank autumns online professional development sponsors, Marshall Gerstein, IP and the Michelson Institute for intellectual property. We appreciate your ongoing support. I now have the pleasure of introducing you to today's presenters. Jamie Hallberg is responsible for identifying and licensing new technologies in the life sciences area for milliporesigma. Previously, he was a Business Development Associate at the Harvard Harvard office of technology development, where he worked with university faculty and commercializing their innovations. Jamie also worked at Quest Diagnostics and their Athena division as a business development director. He earned his PhD in biochemistry from the University of Virginia Nidhi Sabol manages a variety of agreements to support research and commercialization activities at Rockefeller University in her role as the assistant director of business development and licensing. She's also an active member of the autumn community, and always passionate to share her experiences with autumn members and learn from theirs. Welcome, Jamie, unity. We're so excited to have you both with us here this afternoon. And I will now turn it over to you to introduce today's session and begin the presentation.

Speaker 2  3:12  
Awesome. Thank you so much, Sammy, for kind introduction. I'm thrilled to be here with Jamie, a longtime colleague and friend, as we are now going to be navigated a lot of research through licensing. Our main goal here is to help you understand what we are doing, and how we are doing the research with licensing bringing a revenue stream for organizations here at Rockefeller, how we are building our relationship with the companies as GE savvy said please feel free to interrupt, ask questions as we move forward or your word of wisdom, your experiences. That's what item community is. So with that, I'll pass it to Jamie.

Unknown Speaker  4:03  
Great. Thank you, Mary. And hello, everybody. Very nice to

Unknown Speaker  4:09  
speak with you today and have this presentation. I look forward to the questions look forward to the feedback and sharing our experiences with with research tool licensing. So this first slide here is the agenda. But we'll talk about we'll talk about the type of research tools how to build your inventory examples around that managing background IP he see practices or if any, if there is sometimes that can be a complicating factor when licensing research tools and so we will we will touch on that nitty we'll talk in detail about licensing structures, different types of licensing structures and then also the post deal compliance. So look forward to again speaking to you When, again, don't hesitate to ask any questions.

Unknown Speaker  5:04  
Next slide, please. So, you know, you might

Unknown Speaker  5:08  
ask yourself, you know, what are the research tool licensing benefits, you can see this, this slide has two parts the university side and the company side, since I represent the company side of the research tool, I'll start with that. And then I'll pass it over to, to nity. For her perspective on the benefits to the to the university, but from the company perspective, you know, why we work with academic institutions in licensing reagents is first and foremost are validated, they're already made, they have a high quality to them. Usually they're in in publications, most often they're, they're in publication. So by virtue of that, that has a high amount of value for our company, it saves time and money. So if there's an important reagent that's been made, and published on, we don't have to spend the resources internally and trying to duplicate that we can go directly to the source. Most often the case, these reagents that were these research tool, reagents license that we're licensing from universities are best in class, in many cases, they're our highest selling products that we have in our portfolio, they're their best in class, they're, you know, one of a kind, very, very unique, they add diversity in our catalog, you know, having reagents that are published, and again, from an academic source, not just the ones that we might get from another commercial supplier, or remake internally, you know, adds diversity to our to our catalog. And then lastly, as I already sort of touched on, they, the publications just add significant value for our products. You know, just to put things in perspective, we sell over 200,000 products in our in our catalog. So, because of that we don't have a dedicated, you know, sales force that's, you know, talking law specific, you know, reagents, we can add that publication on our website in which that reagents been used, and that just a significant amount of value to us. So often a university perspective, I'll pass it over to committee.

Speaker 2  7:20  
Yeah, so universities as academic institution or goal is to facilitate the research and development we want others to build upon the research our university or our scientists have done. And this is a big opportunities for university to put their validated tools validated research reagents out in public. It reduces the burden of dissemination. So whenever our scientists publish a manuscript, they often sign up a clause in their submission is they'll make those reagents available for others to build upon. Now, just think about a lab who is busy working on their own project and start getting hundreds of requests to supply materials, they will happily do it, but that will add burden to them, and take time away from their desk. So what we want them to is focus on their signs. To make more of these reagents are more inventions and groundbreaking research doing groundbreaking research. We want to take that burden away. And that is research, shoe licensing actually helps us do that. Ask a pain. Ask your colleagues doing MTA as I used to do it a long time ago, when I made a transition to tech transfer. There are hundreds and hundreds and hundreds and sometimes it's just becomes overwhelming. So that boredom can be reduced that administrative burden from the organization, not just from your tech transfer office can be taken away. If you partner it with another organization and people are usually happy. If there is less workload and the research reagents are available. Worldwide or more broadly, there is usually no patent cost. So you're not writing off. It's no investment acid. Most of our organizations have and universities are rich and building these research tools. There's a lot of papers that are always antibody is getting created mouse model cell lines that can be widely available through this mechanism. Everybody likes revenues, and it does bring revenues back to university that can feed institution own research and development engine, as well as benefit contributors, the scientists who made those regions you can build and we'll dive into details. How you can build a continuous stream rather than just a short term. So there is more than just licensing it and getting done with it. Usually, the increments are simpler than patents, you can do multiple licenses, because most of the reagents get non exclusively licensed, we will also touch upon that how you can structure it, it's simple, you can have X number per tool, you can have different mechanisms set up with different partners, based on your experience with them based on what works, what not to have a simple sale to process, you know, okay, we have something, Company X, Y, and Zed we have worked with them in past. So it's an easy flow. What makes scientists or investigators proud as the more it gets used to in research and development, there'll be more publication, and it's a pride or investigators take as like, Hey, I have X number of citations, and it keeps growing. Not that you're sharing the materials. It's they're using it as Jamie mentioned, there are papers that add value to to their catalogue, but that also adds value to scientific citations, it goes back people will go back and cite where that material was developed. So it increases and we proudly participate in adding to that pride as an institution to the institution and the investigators.

Unknown Speaker  11:42  
So after you team making it.

Unknown Speaker  11:45  
So what are the types of research tools, while this is just a short list, there's many, many others that could be could be added here. But these are these from, from our perspective, you know, the most common type of research tools. The first is antibodies. And that's actually the one that we do the most type of licensing for is antibody, this could be hybridoma cell line, this could be a polyclonal antibody, it could be recombinant version of the of the antibody, mouse lines, mice were very well of places like Jackson, Jackson labs and others where you can house those. But again, those are usually not patented. But they can also be part of part of this list cell lines much like much like antibodies, you know, very ubiquitous, this could be any type of cell line from human to miles to rags to safiullah yeast, it doesn't really matter what type of sound right? It is, plasmids, again, there's a lot of these these types of materials, but plasmids are a part of that recombinant proteins, as well can be the plasmid to make the recombinant protein or the recombinant protein itself. Most often the case like in with antibodies, and recombinant proteins, or even, you know, plasma cell lines, we take on the responsibility of manufacturing knees. So in many ways, it's a simple transfer of the material to us, and then we take on responsibility of manufacturing those, there are cases, however, where a lab might be willing to manufacture for us, and we're not opposed to that, that's certainly a possibility. It's not, it's not common, but it's certainly done. So if the lab wants to make, you know, large batches of antibody, recombinant protein, for us, that's that something that we can work with the most often the case, you know, it's really just the starting point for us to, to, to make the reagent ourselves. But also, I can also mention here as we're talking about tangible material here, but along a lot of times alongside with many of these, these examples here there is some know how that we get with use of the of the reagent, maybe there's a protocol on how to culture a cell line or to purify that as well. So we are getting, you know, some tangible material, but also getting some, some some know how from the lab as well about how to how to use the region.

Unknown Speaker  14:32  
So next slide. So how can you

Unknown Speaker  14:38  
build your inventory in making a more proactive approach and you know, identifying what types of reagents at your universities that you could potentially outracing this to a company. So the first and foremost, you know, is is literature sourcing. So as I said before, one of the things that we look at in order to either identified a new opportunity or as a consideration about whether or not we want to license something is literature. So you might be a case manager for certain faculty, you can either reach out to them directly, obviously, or you can see when they published, maybe they're not telling you about everything they have, you can look at their their current or past publications. And you can actually go through the materials and methods and see where they sourced that reagent from a lot of times, it will state, the company that they might have made the antibody or the reagent for, or they state that they actually made it themselves. And so for us as a company that helps us learn to learn as well about how a particular new reagent is made, you know, novel targets, maybe there's a Kol is the second bullet point there. Thought Leaders, there's a Kol, who is notorious for, you know, publishing and you know, very high profile journals, and they identify new targets, where they're trying to characterize them. Those would be examples, conferences, you go to conferences, you can see, labs, they often before they publish, they might describe New reagent that they made at a conference, looking at market size, like things like requests. You know, if your office managers and TAs and there's a lot of requests for a particular material, you might want to consider reaching out to a company to see whether or not they would be they would consider in licensing it looking at the competition, in terms of, you know, what, you know, the, what's out there that people are currently using? How does it compare to that? literature references as well. Numbers of publications associated with the target? That's one of the things that we'd look at as well, as you know, if we're talking about an antibody or even a cell line, you can look at how many publications there were associated with, with that particular target or that particular area and see, are the publications going up? Or are they going down depositories, you might have a local one there at your university where there are core lab where these things are stored, you might want to make inquiries there. And then also understanding about, you know, the applications associated with it. And I just sort of does go back to sort of the competition as well. Maybe there's, you know, again, these as an antibody as an example, maybe there's, you know, anybody that works in a special application, like say, chromatin immunoprecipitation, or chip but all the other antibodies in the marketplace, only work by Western Blot, that is something that would be very unique, and from a company perspective that we would definitely want to be able to see and try to utilize in terms of our marketing efforts.

Speaker 2  18:00  
And I'll just add one little thing here for depositories, as Jamie touched upon, there might be some core facility in your organization, where that's helping the scientist at your institution, make the antibodies, you know, there might be a mouse facility. So those are very good place to source these tangible materials. Also, the depositories like Jackson lab, and MMRC are gene ATCC. So if you are seeing some deposition agreements that your office assigning, that could be also, you know, help you identify what's going there. It also helps us as a university to store you know, the scientists move from one place to another, you own the materials, where are those materials available, so that if you end up licensing it to a company, you can guide them and say, Hey, once license is done, you can get it from depository acts. So that also helped us a lot of our our materials are deposited either to the internal facility or the external depository. So I just wanted to make that note.

Unknown Speaker  19:23  
Great. Actually, I see a couple of questions I'll address partially right now. So one is from from Mica. So do companies license reagents that were firmly patented after the patent has expired? And I will touch a little bit about patents. And actually, I could give a whole presentation about, you know, the the lack of a need for patents as it relates to in licensing reagents. And so the answer that is yes. You know, is apps. Absolutely, I mean, again, I'll talk a little bit about it in a later Live, but a patent is not required, whether or not and so the the second part of the question is, you know whether or not, you know, the method for making is out there. Yes, that's absolutely true. 100% true, they might have the antigen sequence. But But honestly, having worked 15 years in this in this industry of working with academics and licensing reagents, that reagent from that lab that has been in multiple publications has more value than if we just decided, you know, in most cases to make it ourselves based on based on that public information. It's that unique reagent that that lab has that's been published on maybe if it's a monoclonal antibody has a very, very unique ID associated with that. That's the clone that people want, because it's been requested and been used in many, many publications. So it's a great question. It's a very common question that I that I get when we make inquiries about licensing, research tools. And another perspective,

Speaker 2  21:05  
I would just want to add one simple thing here is oftentimes you might get cushion hay, why there is a fee associated to it, is there any pattern and you need to basically tell them, It's not the pattern, your licensing, it's that tangible, the material, your licensing, same as you own a house, and you've rented that house, or sublease that house. So that material and the validity and the data supporting that validation from follow up publication just add more value to it. It's just verifying and re validating every time someone publish with that read. And so the, as Jamie mentioned, yes, you can make new, but they it will be a time lag. And there will be an expense from a company's perspective, to put the similar material or the similar reagent on the catalog because you have to make it you might not be able to match all the characteristics, especially good ones. So you have to fix it. So it's time and money that a company also saves.

Unknown Speaker  22:21  
Yeah, well said, well, so

Unknown Speaker  22:22  
now the question here is, is are a set of questions, one once license? Is the tool available, unavailable to use in collaborative projects? And the answer that is that? No, it's not unavailable. And nobody will talk about this later on. Most often, their licenses are non exclusive. So you know, that by itself, just, you know, gives the the lab and university ability to share that with other labs or even license it to other other companies, which we don't want. But of course, they they can, they can do that. Does NHF guidelines and licensing reagents developed using federal funding? You know, I don't know the chapter and verse, but I do know that, you know, in general, you know, by doll and all the other legislation, they do highly encourage that it's available, you know, as to many people as possible. And that's also a reason why it's, it's, most of the licenses are not exclusive, but I wonder if anybody has some other color to provide to that?

Speaker 2  23:29  
Yeah, so even I'll go out of the tangible material license for a second. So even if you're exclusively licensing an asset, which is not a research tool, most of the universities put in the language, which is called reservation of rights. And that's basically Yes, under Badal of US government can hack in use or marching. And the second thing is we at least at Rockefeller always reserve the right to give our materials to other not for profit and academic institutions. So we try to address it, the dissemination is a very big thing, which NIH wants everybody and other other supporting organization if you're getting funding from and this could this is one really good mechanism that you make it more widely available than just doing MTS because now it's everywhere you do a Google search, the catalogs from different companies will show up who's selling it and all the territories it's available, but we'll touch upon this, as Jamie said, a little later. Thank you.

Unknown Speaker  24:47  
So in terms of marketing, the antibody and there's two there's two perspectives here. There's university perspective and how they market to companies and then once we license And the the reagent, how we how we market our products. So I'll start with myself with the company perspective, and then maybe we'll do the university. But as you heard from me before, you know, the publication is the best marketing tool for a reagent opportunity for us to, to commercialize. As I said before, using the example of hybridoma cell as unique clone ID or even just the name of a cell line. You know, that's something, you know, that laboratory laboratories and researchers are when they're trying to plan their next experiment, they're most likely going to use a publication to help guide that and so they could use, you know, Google or others to, to, to try to find that next opportunity. So publications, you know, and again, we could put that publication on our website next to our product. So just an awesome marketing tool, we're basically telling our customer that it's the same antibody as used in that paper or papers that people are familiar with, or that lab that's associated with, with those publications, conferences, you know, we do market our products at conferences, or platforms that are associated with it, Google search optimization. So this is a technique that's, that's used by marketing, our marketing team in terms of, you know, trying to make sure that when a customer Google something that that product shows up. And it's just something that's common that that's used in industry newsletters, to customers, email blasts, you know, landing pages, and not every case, but Well, every product has its own page, in terms of the product. But if it's a very, very creative, we can create our own, you know, landing page about not just that particular reagent, or even set of regions or that particular area in which that region is used in say, for example, like post translational modifications as a, as an example, maybe from a university perspective.

Speaker 2  27:17  
Yeah. So as Jamie said, publications, I categorize them auto marketing material. So people, a lot of time, even Jamie and other friends in research region feel, they'll often come and say, Hey, we found this paper is this clone available. So that's for antibody for mice, you know, is the same thing, hey, we, we found this on Jack's lab, we are interested in this specific strain, and we found your contact, can you tell us more about how to in license or bring it on board for research use and whatnot. So that publication aspect where there will be a unique ID where there will be a Jackson catalog number, those are all auto marketing tools. You're not even doing as a tech transfer person or a licensing person, it's, it's already out there for the researcher agents. There are two main categories where I say, okay, passive marketing, you know, some universities do send out the newsletter about what their technologies are. Sound do mix up both one time, they'll have the patent technologies and the other time it's too. So there is a wide variety, it depends upon how much time and resources you have. A newsletter could be you on website, you on your website or office page, you can have as fancy as you want to go up picture of a mouse and experiment. Or you can have a simple table say, these are the antibody clones that's available for licensing, they target this and here are the references. Same for mice, these are the mice, this is the basic nomenclature, what's not getting knocked out. And there is the reference. So that also works with just a wide range how much you want to put in flyers and back old days when we used to go for in person meetings, used to carry fliers and it's like, hey, just pass it on to your team if somebody's working on now, if the QR code, you know, you can make a QR code with your web link. And that's good enough. Actor marketing as I first mentioned, the number of MTA is your offices getting or doing or you know, you bump into a scientist in the hallway or they pick up the phone and say I'm getting tired of shipping these materials day in day out? What are my choices? You know, the relationship building no question is a bad question as I pick up the phone and you can call me anytime, is when you see that uptake. It's time to talk to your scientists or your scientists need to talk to you to find an alternative path licensing Oh, when that usually happen, and I get an email or a phone call, I say, can you send me the paper, I'll go through the paper, like write a blurb, you know, in an email, and I'll just circle it, send that email to all the people I know are working in the field. It just helps that's like active, reach out, we're doing visualise from companies, you know, once you build a contact, are you meeting someone say, Hey, can you send us your wish list? What area of interest you have? What antibodies? Are you looking for? Is it anything under the sun versus? No, we are only looking for flow cytometry your reagents, and if you have any, so that once you have that list, it's basically something new, you see, you know where to go. So all that helps all that work. So and it's just, you know, never hesitate to try even something new. And keep adding to this list, because there's always something that's missing, or new that you can step in.

Unknown Speaker  31:11  
Yeah, so the next, you know, topic is, you know, background IP is, as I mentioned, no introduction, this, this could be, you know, some some complications that come up with regards to, you know, out licensing your, your tangible property, you know, but one thing you might want to look at is, you know, the label licenses for, you know, companies that they might have got some of the materials for to create the new IP, like, an example would be like, like, a plasmid where they're oftentimes using different sequences from different other constructs to build a new construct. And that, in many ways can be, you know, problematic in terms of licensing, Uri agents, mice, when they're using one mouse with another mouse to create a new mouse. Well, those, you know, mice that they started with the beginning, you know, we're often are have IP or, you know, rights around around them. So, you know, there could be could be issues there, you know, cell lines that are expressing a specific, you know, biomarkers, say, for example, that could be an issue. So, I mean, there's a lot of ways in which you would attack that, you can obviously ask, you know, the lab where they got the materials that are to make their new invention, and then you can go back to the company's labor licenses and see, you know, is there a, any prohibitions around that, so, it's just probably part of your diligence checklist for for determining whether or not you know, something that you guys can, can mark it to, to accompany MTA is I mean, you know, if it's, if you got a material from another academic lab, and there was an MTA associated with it, you know, there could be restrictions on you know, creation of new new property, or there might be co ownership rights, with the other university or company, in which you got the material under under an MTA again, that's just part of the due diligence, you know, background sponsored research agreements, right. So a new tangible property is created via a sponsor research, most often the case the company that funded is going to have some rights around that, that could be, you know, issues and all this is just, you know, freedom to operate restrictions, with, say, other patents, et cetera. But I can say, just based on my own experience, and types of, you know, reagent licensing, that we do that, you know, it, it, it's not uncommon, but it's not frequent, though a lot has happened. It's nonetheless, you don't want to be in a situation where you don't do these diligence, background, checklists, things and then then the licenses of the company and then they start marketing. And then someone comes back to you and says, Hey, what's going on there? Please explain. So I've done this for 15 years, I believe, believe me, it's happened. It's not frequent, but it happens. And so doing these early diligence, checklist things is, is very, very important. Yeah,

Speaker 2  34:34  
and something that worked for me, I'll just throw it out there. So we whenever we are licensing something out, and it's a tool, we what we call, it's a tool disclosure agreement, where a scientist will fill in if any of these applies, and sometimes there is a paper you can read and you will see oh, okay, for building this specific plasmid date, to three other from three different sources. And then you go to their website and it's somewhere there. And nobody in the lab was aware of any labor license. So now you're basically wearing your detective hat and kind of finding out what happened. Some time those labor licenses are in the packaging box. The head of the lab or those scientists doesn't know about it, because it came through purchasing, somebody opened the box threw everything out and reagents went on shelf. So a lot of times and I have seen that it's, there is a link on the invoice somewhere, and the purchasing paid the invoice from lab account, but neither tech transfer nor the receiving scientists actually was aware of those. So those things happen. And what I personally do is, as Jamie said, as those cushions if you have a paper, you can go back and see is there any you smell anything. And if it passes your smell test or not, it's you can fix them, it's just a matter of knowing them, you cannot fix a problem unless you know what the issue is. And my fifth 1015 years of doing this, something things just come as a surprise, you know, you'll get an email saying, Hey, we found this somewhere, and you never had permission from us, you have to go back and redo it and things get more complicated than fixing it and moving on. So doesn't seem like a big issue, but it's better to make sure that it passes your smell test. And you're all good to go. For institutions like if there is MTA is you can do inter institutional agreements, if they co own something, who was going to take a lead how it can be made available labor licenses, you can go back to the supplying company or the depository and you can say hey, this is what we need, this is what we are licensing for, do we have permission or try to as an institution, I tried to get a broader okay or approval. And if there are some defined terms that needs to be cleared out are just do it beforehand, it will be much easier than dealing with it later and in the lifecycle of your license. Still, all with knowing what you have, how you can source more materials, how you can source and build your inventory. Now the next step is and you found a your partner who really like it, it comes how we make it happen, how we make it happen. As for our licensing, it's, it's a two way street, you have something to sell and you have a buyer. So make sure you understand the position or licensee or the buyer is coming from. And then there are ways you can make. So for the grant for the research region tools, the research brand is usually non exclusive. It gives you opportunity as an institution to license at multiple times and have multiple streams coming back to the organization. It gives you freedom to license it or give it to any anybody you want for profit or not for profit. These non exclusive licenses don't limit any FTAs you know, if there is an antibody in the catalog, and you don't want your collaborators to go buy from that company and you want to supply a chair or there is no problem there is no restriction on it. Companies definitely wants to have some exclusivity and might come and say hey, can we have it exclusively? It happens very, very rarely in research reagent or to feel and you can say, we have the burden to disseminate that as broadly as possible. If push come to shove and you are okay and you're scientist Okay, there is a medium, you know, mid path forward where you can say, for this specific clone, we will do a code exclusive license. What that means is there is number of parties or there was a limit, you can only limit it to five companies, three companies, 10 companies, whatever makes sense for your organization. Field of use, as I would say is one of the crucial components when you're structuring or you're doing research show licensing, because just showing or giving the same license template to everybody rd might put you at a disadvantage. So knowing what licensee wants to use the material for is really important are they only going to use to run some nice experiments, or you give them a fixed amount of antibody and they use it for staining, that sort of search use, they don't need a commercial license for that. Some people want clinical use, hey, I want to use it for research. But I might want to also go for clinical trials in some way. So you have to define your field of use, Research and Development Development here can be defined in different ways from different people. So I'll try to use that as a definition will the development captures the clinical use or not? Okay, so Research Use Only regions, it's a new license, it's a commercial license to a company where they can sell the research grade reagents, are they going to go beyond that? Maybe if this is it for diagnostic use, you specify what a licensee needs for, and you have to do your customization, I put the manufacturing use year because we have a tool which is not going to be the end product, but is really crucial for the manufacturing of that product. So in that case, you really want to make sure that you capture what you want to in terms of revenue. So you cannot sell our material because it's for manufacturing use, what you can sell is the product manufactured through the use of the material, the duration, or the term of these licenses vary from case to case, internal research could be one year it could be annual renewal basis to 10 years or 15 years or as long as it makes sense for your organization. I would always like to have an endpoint sometimes people want for perpetuity. And you need to know where your technology is. And that just give you some some vision to where your staff is currently are later in life. So, Jamie and I were brainstorming about this and thought, you know, putting some sample language showing you some samples might be helpful about what we are talking. So this is just a sample and not Millipore. Urraca fuller says hey, this is what we always use for we have seen this floating around and we thought it will be good for everybody on this webinar. So this is when you're licensing, a miser plasmid or cell line or anything for internal research purposes. So as you see, I kind of highlighted some components licensor is granting a license for the term of the agreement, a non exclusive most of the time, it's non exclusive, to make have made and use materials for internal research purposes only. So that's what we are granting standard could be at its facility, you can be flexible and allow CRO if a licensee wants to use a CRO

Speaker 2  43:19  
no other rights are license granted, right. So this is what we are permitting a licensee there is no harm if you see additional use for that material to put additional language is what's not allowed, let's be clear what's allowed what's not allowed. And in this case, it's just an example saying for avoidance of doubt licensee may not manufacture or sell a commercial product utilizing the material or its derivative so you cannot sell the materials and it's for internal research use so you cannot make a product and say by the way, we can sell the product right we put a GFP in your material and now it's a derivative. So just just try to explain as clear as possible what is allowed what is not another another interesting language is commercial license, you'll see different flavors of it. Again, non exclusive worldwide right and license to make have made use and now there is a sell, sell product in the field of use always important without the right to sublicense. You need to be flexible there, why you want why the preferences not to sublicense because you want the sub licensee to come to the institution and take a direct sub license, direct license. But things can be different, what your licensee is envisioning. They might be pulling together different technologies. And now want to have right to sublicense that bundle product you know which has different components which you cannot it just simplify their life they do their potential sub licensee don't need to go to 10 different licensers to sell to a non end user and you're not granting them right to sell to non end user. So, like Millipore will sell it to scientists and labs, right. But a lot of time you need to be flexible. If a company doesn't have presence somewhere in the world and using distributor, they'll come back and struct us out. And we'll talk about how you can address that when you're structuring your agreement. Financial Terms always important because that's where the money is flowing from. These are, this is a list which might not be applicable on each and every type of tangible material or to license. But there's usually an upfront which ranges it could be low, hundreds to 1000s 10s of 1000s. So based on you need to know value of your tool value of your mind value of your antibody, there is annual. And for research region, business annual becomes the royalty component, and you need to be mindful, if nobody wants to pay a higher annual than they can make money on. Right. So if the royalty rate, whatever you have decided, the lower threshold is $3,000. And you ask for $50,000 annual, the chances are dealer's gonna die. Right. So be realistic. For research reagents, there are for internal research use, there is usually an animal, you supply the material, they use it for a year, 12 months cycle, they pay for another year, which is pretty standard. royalties, internal research use, hard one to argue. But again, if you, you have a super cool model that will tell you, Hey, this is the molecule that's going to pass phase one, phase two, phase three and will be product, if you have something magical like that. Maybe you can if not royalty, you can think about how some other creative way of getting compensated if there is a success. royalties, or we talked about to sales to non end user. That's where the distributors come from, also called as OEM. When a company OEMs the materials they sell it to non end user for further resale at a lower price, which is pretty standard and research reagent business kit, if there are multiple components are going to come into one product. And there are payments that could be made. Stacking, if you need to have if a licensee needs to in license some other technologies. And that needs to be adjusted. So the four things here are the adjustments outside your standard royalty rate. It's good if you can just get one. But lies if licensee has plans for making combination product and there are plans to use distributors to increase their coverage globally. It's worth considering and hearing them out and make adjustments milestone payments. Again, if it's diagnostic, if it's therapeutics, it's the scums and success fees. There are, it's on a case by case basis, not all the licenses license types we talk about will have milestone payment component, some might. And then again, you need to know what your reagent is doing and how it's adding value to the whole lifecycle. Credit, I put it there, it's not usually there. But sometimes lab will say, Geez, it will be it would be good if I can get some supply of antibody for my own lab for my own research. A lot of time, most of the time, I never had issues working with the companies. But this might impact some component of upfront, you know, if companies spending money for manufacturing and it's a bulk, it's a big request, it needs to be adjusted and we work it out. OEM language is here, it's again when it's the sales is to non end user. So think about if there is while 400 box and now if a company is selling to a distributor for $70 What will be considered as net sales and You can come up by with your discussions is like what is the threshold? What is the normal range you accompany offers, you don't want them to offer 90% discount. And now you get X percentage royalty on just $10 of net sales. So this is just an example that if discount goes beyond a threshold, you can put a step up royalties, basically saying, building a control so that you go don't get diluted to a very small amount. Other things that impact the royalties, and you'll see this in some flavors or not, but good to understand what the stacking is, when your licensee is obligated to pay royalties to third party, you'll say, Well, you should have done your research, you know, and this is what it is. Or you can say, I understand we understand. But you know, for a product up to 25% royalty, we think is fine. But if it goes beyond beyond 25%, we'll take a step down. I would like to say if everybody else who are getting royalties, take a step down, we will take a step down, it needs to be fair and equitable to everyone. We can agree to appropriate a reduction, but at the same time, how much lower you want to go. So let's say going back to an example of 10% Are you willing to go back to point one might not be so what is how can you build on it, you can build a floor that no matter what it is, or royalty should not go below 2%. You know, do your math, do your judgement about your staff. And you should have a floor so that you don't get diluted to zero, I'm not saying you usually do. But there is a possibility and it's better to address that and contract. A similar trajectory is the combination product and with multiplex things of their companies are mixing, you know, there are a lot of things that's coming together to form a product, you should care what your stuff value is. And so net sales gets multiplied by what people call in the field adjustment factor. It's basically value of net sales of the product in a given country divided by total value, right and it should not impact one product that's combination the other which is not you know, one multiplex can have 50 components and other product has 10. So, it needs to be on a product by product basis. So be clear when you use it. Again, floor is important, I love to put the floor so that I know. In the extreme situation, this is the royalty rate or organization is going to get

Speaker 2  53:12  
we added another sample language where people like to define active components. What does it helps is to avoid the deductions on buffer, if you're putting us aligned to mix all antibodies that should not be considered as part of our denominator be as a total component. So be mindful. I kind of like acting components, you know what deductions can be made or what can go in a denominator. Again, having a floor is important or good to have, there will be cases where you will have both combination product and stacking. So it's good to have say in either cases separately or combination of a and b, this is the floor. It works. You just have to talk it out if there is any problem. There are additional terms that vary by the agreement, indemnification insurance depends upon field of use, and maybe your university counsel or general counsel will have comments on it. Change of control is good to capture what happens if a company gets acquired by or there's a change or choice of law. I understand there are some university that are very, very particular about the choice of law and won't go silent. So make sure you get all that okayed by your counsel. So with that, I know it took longer and so we have only two slides left. So after you JB if you can walk us through the preferences or your preferred ways of these license.

Unknown Speaker  54:51  
Absolutely. So thank you. And he so yeah, in terms of you know, how we like to work with universities in licensing reagents, if there can be a master agreement, you know, it's really a golden opportunity. There's a lot of work sometimes in the upfront, but the back end, especially if you're gonna be doing, you know, more than one agreement per year, or just one agreement per year, you just do a simple amendment to the master agreement. And we have one with with Rockefeller, and it works beautifully, the nitty Nike agreement done, literally within a day or days, I mean, a couple of days, it's done, because all we really have to focus on is just the licensing terms, the financial terms associated with it. So really love master agreements, they're, they're wonderful, you know, access to the investigator, you know, nothing better than, you know, I, as was mentioned, in beginning, I worked at a licensing office and so before joining milliporesigma, so I do know that you have a lot of cases on your on your plate, and he might not be an expert on all the topics that you manage the cases, cases, but So access the investigators, or have a conversation about their agent, you know, and just really 10 or 15 minutes, is just as perfect, you know, we they get to speak and ask questions, they can answer them and, you know, getting at, you know, information directly from them is always always preferred, you know, validation clauses. So this essentially, is a grace period built within the license agreement itself, where we will get a certain amount of time to validate the antibody before we pay the licensing fee, or, in some cases, you know, some of the licensing fee paid upfront, some of it paid later after after validation. So that's our, our preference in terms of working with the IRS, rather than doing an MTA. And then a license agreement, you sort of knock out, you know, two birds with one stone. I mentioned this, at the beginning, you know, hybridomas, preferred, but not, but not required, he said, we'd like to take on the responsibility of manufacturing, and I'll have to, but the downside of when we don't get the hybridoma, we get the the finished goods, or the, the, the antibody directly from the labs where they manufacture is that if it becomes really a high performing product, guess what, we're going to be coming back to the lab to ask them for more and lead times and you know, uncertainty for the customer, you know, not preferred. So that's why we like to take on as much as we can all the manufacturing, so we can control that with the customer, you wouldn't want to disappoint a customer or not having you know, the product available. And you know, in the case of licensing polyclonal antibodies, the volumes matter in what form it's in, obviously, the more the better. But, you know, we take on those as they come. And then lastly, and most importantly, no patent is required for our needs. And I'll just give you a very simplified example. Again, using a hybridoma cell line. Let's say that investigator, you know, XYZ makes a extremely valuable one of a kind. hybridoma recognizes a target no one's ever to make an antibody to, and it's the only one in the world that can do what it does. And at the same time we go through the patent prosecution process of patenting it fantastic. You spend 1000s of dollars patenting it, and then one day, the freezer breaks down in the lab, and the hybridoma is lost forever. So you have issued patents or patents, but no hybridoma what's the value to us as a company? Well, I think it's pretty obvious, right? We want the hybridoma we want to tangible material means more than anything. So if I could highlight one thing, you know, from the company perspective, you know, does not need a patent, you know that the know how and the tangible materials, the most important thing,

Speaker 2  59:13  
and I'll just add one, one thing here is no pattern. You can use that to educate your scientists, when they come to you with a disclosure on an antibody or a mouse and say, Hey, we let's file a patent. You can you can say that's not what's required here. We want you to publish, we can license this and bring revenues back to you and university without a pattern. That's basically helping you save your patent budget because most of us are on a fixed pattern budget, but also save investigators time and reviewing those patent application even if you decide to and you might not eat and get a you should pattern it has been very complicated these days. So no pattern is, I think I use it and my interaction is like the real values in that hybridoma. So make sure you don't lose that. And you just don't give it without any paperwork even to Academy collaborators because the last thing you want is you gave it with no obligation so they can do whatever they want to and pass it along. And that's where you start losing your rally. No pattern is saving cost for the organization and actual values in the material you're going to license

Unknown Speaker  1:00:47  
concerns from commercial partners and do these types of licensing deal deal strategies exclusive versus non exclusive there are cases where we do like exclusive not for antibodies necessarily, but for other types of materials we like exclusive and we also like to be creative, sometimes the types of deals that we do in, in, in in licensing reagents, you know, acid ownership, multiple contributors, labs involved, the generator deals we touched on early could be sometimes the most most complicated, you know, factor obviously, that needs to be settled before any license can can take place, you know, storage of materials, you know, depositories, PII, bad centralize facilities, you know, if you know, just having backup for those types of materials is, is is is very, very important. But it's really just access to the materials that that matters most most to us. So, and that is the final slide. So questions. I saw

Speaker 2  1:02:01  
some questions. Yeah. There are a lot of questions. So I think if we can go from top, it's for you, Jamie. Can you give us color on how companies view distributors, resellers and sub licensing? Should tech transfer office restrict any transfer of rights or materials? Any thoughts on definitions? So I think we added some language sample language. But Jamie, I'll pass it on to you.

Unknown Speaker  1:02:28  
This is something that does come up in a lot of agreements that we manage, and restrictions now. I mean, the engine of how the the reagent world works is through distributors and resellers. I mean, there's some countries in the world, that's the only way you can sell your products, period. So it's not coming from a site in the United States where we were offering our product. So, you know, restrictions is, is is a big deal to us. I mean, and then, if you think about it from from the 1000 foot point of view is if if University restricts a company selling through distributors and resellers, etc, that's going to automatically mean last royalty stream coming coming to your institution, as I said, in many countries outside United States, that's the only way you can do business period. So it just automatically means you're reducing your market opportunity.

Speaker 2  1:03:35  
Yeah, and you can have different mechanism to address so that you don't get diluted to zero. But again, being mindful of what our licensee is doing and how they envision or making our prod presence is through distributors and it's quite standard in research reagent feel. Things are differently sublicensing. Again, I touched upon it because it's a non exclusive license. Unless there there is a scenario where the product has different components. You can have sub licensing restricted or limited to sale of that combination or that product which have different components. So you don't sub license, the materials you sub license the right to sell that complicated product. Next question is is it better to not give the diagnostic use field to companies to ensure a further opportunities? My answer is yes. Give away what your licensee wants. If they're not developing diagnostic, why do they need a license? I usually this is my favorite question and it helps me understand the licensee what they're doing. If they don't have any need to have diagnostic use or Keep it to our institution and wait for more opportunities. Is it better to give more market reach to companies are reserved the opportunities for tech transfer office to work directly with a diagnostic company? If if it's a research region company and not making a diagnostic, I don't see there's any use by that. It's just you're going abroad, right? Not going to add value to their portfolio, and you won't be seeing any product. That's my, but if there is any diligent business plan, or you know, that there is diagnostic on the horizon, I would do that. And I also tried to keep these two field of use separate in a different licenses, just so that if one field of use gets dropped down or gets terminated, you can still keep going with the other rather than coming back to the table. And renegotiating the whole thing. On TV, in case you want to add something to that.

Unknown Speaker  1:06:08  
Yeah, that's not really other than to say that, yes, of course, you know, if we were, if we were offered the opportunity to license a reagent that includes diagnostics, you know, at a very reduced price for the same price, then then yeah, absolutely, we would, it's just a lot of it comes down to price, sometimes diagnostic opportunities, the price can increase. And so And thus, you know, we might want to because it's not really a specialty, at least a business that I support. And and then so, you know, but if the opportunity presents itself, yeah, we would certainly

Unknown Speaker  1:06:43  
consider it. Oh,

Speaker 2  1:06:44  
so this is what I would just add, I think from company perspective, the broader the license grant, the cheaper prices could from university perspective, it's if there is a need, and there is a development of products in all fields of use good. If not, I would reserve that for tech transfer to build more opportunities. Would it make sense to license exclusively for internal Research Use Only? any downsides? I would never do that. And the reason is internal research use. You're basically cutting the whole world outside that licensee not to use your Material not to use your tool for research and the whole engine of research. I should not say never, but that's my preference, you just need to do internal researches, why exclusivity? Right, if you have a mouse, you that has magic, you want others to use it to create more magic to the world, right? To make more drugs for the world. So, internal research use and exclusivity doesn't go hand in hand for me, unless there is a very strong reason that I am not seeing it. So those requests my answer usually as we not exclusively license it. And there needs to be a very solid reason why.

Speaker 2  1:08:25  
Yep, anything Yeah. So next. Yeah, in in your example, it does allow, sublicense, right to sell to a non end user for resale resell the product, okay, not the sub licensing of the asset. So there are two different things. Sub licensing is when a company can have sub licensing rights to your materials. Here, they are taking a clone making a purified antibody and now selling that purified antibody to a distributor for further resale. There is no shipping of the hybridoma. So this is OEM where they're selling the purified antibody, we are allowing that and we kind of talk about licensed product, the licensed product is getting to the distributor, not the licensed materials, if that makes sense.

Speaker 2  1:09:30  
Awesome um, I know we are little over time, but I think this was wonderful. If anybody has any word of wisdom. Feel free to share in chat or or by other mechanism. And if there are any unanswered cautions Jamie and I'm happy to pick it offline. These are our email addresses. Always happy to chat about fun stuff. and research to licensing

Unknown Speaker  1:10:03  
as this is our passion. Yeah. And any new opportunities, please. There's my email address.

Speaker 1  1:10:12  
Excellent. Well, Nidhi and Jamie, thank you so much on behalf of autumn and all of our attendees for such an informative class discussion today and taking the time to answer all of our questions, attendees, thank you all so much for joining us, and spending a bit of your time with us today. As a reminder, a recording of the webinar will be available within a few days on the autumn Learning Center. That is also where your certificate can be downloaded for participating in today's event, as well as access a PDF copy of the slides as a handout. So you'll see Jamie and knitties contact information in that handout in case you didn't catch it just a moment ago. And then please don't forget to complete the webinar evaluation which will open when you close out of this zoom session. Your feedback helps us to continue planning great webinars for you in the future. And we appreciate your insight on that. So with that, I will say thank you again so much for joining us, Jamie and Eddie, thank you again for sharing all this information. And we look forward to seeing you all soon.

Unknown Speaker  1:11:15  
Have a great day. Bye awesome afternoon.

Transcribed by https://otter.ai