Speaker 1  0:00  
So good afternoon and welcome to today's webinar material transfer agreements presented by Autumn. My name is Sammy Spiegel, one of autumns professional development managers and I will be your staff host for today. This is the third of our five webinar series on agreements and disclosures. We look forward to having you join us each week. 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. Should you need closed captioning during today's session, the Zoom 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, Marcia kirsteen, IP and the Michelson Institute for intellectual property. We appreciate your ongoing support. I now have the pleasure of introducing you to today's distinguished speakers. Robert Brown currently serves as Associate Director in the LSU Office of Innovation and Technology Commercialization, and is primarily responsible for the day to day oversight of the office. Prior to his current position, Robert served as the director of technology transfer at Cleveland State University, and Assistant Attorney General for the state of Ohio. He is a registered patent attorney licensed to practice law in the states of Ohio and Florida. Dr. Schmidt soltana is the Assistant Director of licensing in Rutgers University's Technology Transfer Office Innovation Ventures. In her role, she is responsible for the management of intellectual property licensing and related commercialization programs. Prior to joining Innovation Ventures, she was a postdoctoral fellow in the Department of Biochemistry and Molecular Biology at Rutgers, Robert Wood Johnson medical school, she now holds a Master's in biotechnology and a PhD in biochemistry. Please join me in welcoming Robert and smile. We're so excited to learn from you both today. And Robert, I will pass it over to you to get us kicked off.

Speaker 2  1:58  
Thank you, Sammy. And thank you, everybody, for getting on the webinar today. I hope it's helpful for you, and you're all having a good week. So today, we are going to talk about material transfer agreements. And just as a Next slide, please. Just as a little disclaimer beginning, before we get started, you know, these are the our personal views and they do not reflect the opinions of our respective institutions or a bottom and it's not intended as legal advice, even though we will be talking a lot about legal. So anyways, just be cognizant of that. Next slide. So this is what we're gonna go over. In this webinar. We're basically going to go over why and TAs are important things to consider specifically for academic mgas. We'll go over some of the commonly negotiated terms, and then some tactics of how to address some of the thornier issues with material transfer agreements. And then we'll finish up with some special issues, specifically with regulated and proprietary materials and labor licenses. And then finally, with human materials. Next slide. So, before Well, before we get into that, I guess we'll start off with what is a material transfer agreement. They are basically legally binding contracts that where one party, the recipient requests materials from another party, another researcher or organization, the provider for use in the recipient zone research. The recipient is basically granted a temporary custody over the material they don't they don't own the material, the provider maintains ownership. And that's an important thing. The the MTA defines the rights of the provider and the rights of the obligations of the recipient with respect to the materials, who can use the materials and under what circumstances who owns the material and has rights to any resulting materials such as progeny, derivatives or modifications. There are a variety of materials that may be transferred and under an MTA biological materials are usually the most common things such as reagents, cell lines, mouse models, plasmids vectors, these are the most frequently transferred materials but in TAS may also be used for other things such as chemicals, software sometimes. So devices of all sorts. So it really covers the gamut. And depending on what the material is, so, so for instance, if it's human material or animals, there are regulatory considerations that you're going to have to think about and consider, which we'll go over later.

Unknown Speaker  5:33  
Thanks, Robert. So good afternoon, everyone. This is Shamala. And first of all, I would like to thank you all for joining our today's webinar. So why MKS are important. As Robert mentioned, they are important contractual document that basically defines the terms and facilitate the exchange of material in estimated data between the researchers, they may not directly, you know, generate revenue for the institution, other than, you know, possible cost reimbursement, but they do enable the researcher to acquire material, they need to move their research forward, that could result in publications, collaborations, inventions, and in turn, can even lead to some commercialization activity and can bring dollars to the you know, institution, MTA also puts a limit on the use of material, their physical handling, distribution to third parties, for example, mostly in, you know, academics, the MTA are limited to non commercial use, they can also limit, you know, to particular field. So, in a nutshell, you can say that, MTA provides a mechanism to basically protect the interest of the owner or provider at the same time to facilitate the transfer of material, you know, to the Research Committee to work to generate more data to make new inventions. MPs also are very important and helps in defining the ownership of any research results that are generated with the use of the material. But this is a very important and it's important to be addressed upfront, rather than later. In general, the party who transfer the material or the provider retains the ownership on the material, but the results generated with the use of material or in generally, under the standard terms are owned by the recipient. Many times we see MTA, with the kind of language that asked the recipient to assign all rights to the inventions results, everything to the provider, and in such kind of language in the academic setting is mostly not acceptable. But again, it's very important to go back to the PII to understand what is the scope of work that you're talking here about? Is there any IP potential, and let's say if the provider is not willing to, you know, change such kind of language, it is also important to ask a question, is there any other source for the same material from where you can, you know, the recipient can request the material. So, again, from researchers perspective, many times, you know, their goal, or what they would like to get is to get access to this material to move their research forward. But at the same time, I personally feel like you know, being a part of a tech transfer office, it's very important that we educate the researcher, what could be you know, downstream actions, because if you're agreeing to such language before we move forward. Another thing that is important here is empty is also protect any proprietary material. So IP rights of the provider provider can be protected by including special provisions, for example, that can limit the disclosures, limit the usage or transfer to any third party. Very important. MTA facilitates researchers rights to publish. I think this is the most important factors in the academic research. And MTA MTA should enable the recipient of the material or to publish and present without restriction in the ideal world receiving should not require approval from the provider to publish the results that they have generated with the use of the material. But you see a many times language in the MTA that requires recipient to go to the provider to get their approval before they publish any manuscript and then sometimes provide a need to review the manuscript. And if that's the situation, it's always important that you put a timeline there, that the provider is needed to respond to the recipient within let's say, in general, the standard is somewhere between 15 to 45 days they should get back to the recipient, if they would like any confidential information to be removed from the manuscript, and if there is no response recipient should be free to publish. Again MTS are also important because me We are in same form the recipient when the material being transferred may be infectious, hazardous are subject to special regulation, because in such a situation they may require additional approvals, or emptier, also address any potential issues like liability, indemnification. This is very important because MTA generally spells out that, you know, recipient, that recipient of the material assumes all liability for damages that may arise from their use is storage of disposal of the material. But many times you see some kind of indemnification languages in the MTA. That is inappropriate us from one party to the another that can lead to long negotiations. Last but not the least, to transfer humans samples. And MTA is required to ensure the compliance with laws and regulations. I'll be discussing it in much more detail in the later part of the webinar. Next slide, please. So, when handling an MTA, it is good to consider some, especially the academy MTS, it's good to consider some of the points that I have listed here. For example, what is the material being transferred? As Robert mentioned, the material that is being transferred could be a whole array, it could be a biological material, it could be, for example, if it's a biological material, it could be a cell line, it could be a vector, it could be a mouse model, or it could be a chemical or chemical composition that is being transferred, or it could be even a prototype. So again, depending on the MTA, you can decide what is the right template to use, for example, if it's a biological material, maybe the UB MTA is the best, you know, to facilitate the transfer of the material. Also, it is important to consider whether material being transferred, is hazardous, or, you know, is this proprietary? Or is it export controlled? Again, if if the material falls in any of these category, it requires additional provisions in the MTA. And Robert is going to touch upon these provisions in more details in you know, second half of of this presentation, rights to publish. As mentioned earlier, this is one of the I think most important point for academic researchers to publish, publish their data and you know, they should, there should be no restriction on publishing the research research results, or the results that are generated by the use of material by by the recipient. So, if the review is required by the provider, make sure there's a timeline for that review, it should not be open ended, you know, so that you notice the recipient is like like waiting for indefinite amount of time for provider to respond. Sometimes provider might request additional timeframe, maybe third, if they have to file any patent application that might delay sometimes delays the public a submission of the manuscript, but another 30 to 45 days. Again, it's always good to spell things out in the MTA. So that at a later time, we are not again, struggling back and forth, you know, there's no time defined and now you're waiting for from provided response. In general in general, university typically avoid terms that restrict orgasmic freedom, such as restriction on publications, very important point who will own the IP or intellectual property. IP language is perhaps the most challenging and most negotiated term of the MTA may contain sometime may contain like overreaching language, you know, that reach out to PII institutions, past inventions, future inventions, that something might not have anything to do with the material itself. So it's a it's important to consider when when you're negotiating MTA, that will how much there's how much this IP language reaches out into your future inventions. I think I missed a part about authorship matter, I'm going to touch discuss it now. So another factor to be considered by the in the academy, MTA is authorship. Usually, usually Academy researchers are usually very good in giving, you know, referencing the source of the material, and even giving acknowledgments from where they received the material. But if this is something important to your researcher, make sure you spell it out in the MTA. You write it down that you know, the recipient of the material will acknowledge the source from where it is received or give reference to XYZ. Sometimes some of the provider also request authorship. If they're providing the material, sometimes it's okay but sometime based on the journal where you're submitting, they have you know, kind of criteria of how to kind of list anybody as an author. So in those situations, it might get slightly tricky if the provider is just contributing to the material and nothing else.

Unknown Speaker  15:15  
Another important point, does MTA grant any ownership rights or royalty free license to the provider for university invention created with the use of material, this is a very problematic provision. And this is more common when there's MTA between commercial partner, and institution because again, most of the commercial entity would like to protect themselves from blocking, blocking IP. So in general, the middle ground that I feel, you know, could be, we don't want that as a recipient, you can say to the potential commercial partner, we don't want any rights to your material and, or any rights to the improvement. But let's say we are using your material to test any of our technology, then it's not fair to give rights to that technology to you, for example, I can give an example for example, you have organoids, and you want to test whether it could be used to screen certain drugs, and now you're receiving these drugs from a commercial entity. So it wouldn't be appropriate to give the IP rights to that organoids to this company, who is providing you these molecules just to test whether your organoids you know, actually are able to screen the drugs or not. So in those kinds of situations, you know, definitely a one should push back. And if, if you're working in the same, you know, kind of domain, where the IP is for this company, sometimes you can offer them an option two option to negotiate a license, but again, make sure you put a good timeline there, you know, after what is Option B here, and after which the recipient should be free to do whatever they want with their IP. Another point is, is material, export control. This is also very important, because by law, certain, there are limits, you know, by the government on transfer of certain materials. Because of, you know, variety of reasons, such material needs to be, you know, clearly spelled out kind of these export control restrictions. And Robert is going to go into more details, I believe, after one or two slides, Robert?

Speaker 2  17:34  
Yeah. Next slide, please. Okay, so this is just kind of a high level overview of probably the more significant provisions yet, you'll see over and over again, and MPAs, like Somalia mentioned, while there may not be a lot of money, or no money attached to these agreements, we process a lot of them. And it is critical to get these tools to our researchers to conduct their research. So it's a very important activity that we do on behalf of our researchers, even though it doesn't necessarily bring in money for us. So, like Shamala mentioned, ownership of IP is one of the more significant ones, obviously, the provider from the providers position, they have this very special proprietary material, and they have an incentive to not, you know, share it with others other than the person that they purchase from them or whatever. You know, from our side, as researchers, they want to be able to freely use the material as much as possible. And then when it comes to new material develop from from using the provider materials. We as universities have, you know, major limitations to that, I think, you know, from the provider, it makes sense that they would want to own their materials. And as universities, we understand that it's just when they try to grab too much. And so when they have language that is very broad that can cover anything develop related to the material or not, it's not even that you just have to incorporate the material that if it's just related to using the material, they will try to claim that they own this is not keep in mind, like they're not funding the research, we actually in many cases may be paying them to use the material. And so it's not like they're a sponsor of research where they should be expect some sort of rights to the resulting IP. And on top of that, there's very likely the opportunity, the chance that this material will be used in a federally funded award because most you know, research at universities is funded by the federal government and then state and nonprofits and this industry. But under federal law, universities retain title under vital, but the vital act to any inventions developed under federal award. And so we have issues giving away ownership and to these providers in those circumstances. publication and confidentiality actually together kind of go hand in hand. So obviously, the providers position is they don't want to limit publication, they want to maintain the secrecy of the details of their material they provided maybe, you know, it's not, you know, for whatever strategic reasons. And then obviously, as a, excuse me, as a, as universities, we have a mission to publish. And so we can't accept terms that would interfere with our researchers ability to do that. And so we are, as Shamala mentioned, you know, we looked for things like limiting their review time and only allowing review and not final approval, those are ways that we handle that. And also, we have to publish to rely on other regulations that apply to university research. In particular export control. We rely universities rely on the fundamental research exemption to export control laws, which are the laws developed by the federal government to kind of control the access to sensitive materials that can use for nefarious means, like weapons of mass destruction, or, you know, hazardous chemicals like anthrax, things like that. So that's what publication on some confidentiality, again, the provider probably wants to maintain confidentiality, but depending on how, how it's written, they may impact publication and then our researchers ability to disseminate results. So you know, clearly identifying confidential information, allowing them the provider to review proposed publication and either redact or de anonymize the information, if possible. Those are just ways that you can handle that. You know, so the other part is, they are allowing you to use the materials under very limited circumstances. So usually, it'll be for only nonprofit purposes, and only the the amount given that you purchased and you can't copy it or make duplicates. There may be issues with the type of material again, so if it's a, if it's listed on, you know, as a control technology under Export laws, there may be limits on who you can share it with or what you could do with it. If it's involved in human subject research, obviously, that has to go through IRB reviews and approvals. And then the last part really is like liability, like what happens if something goes wrong, either in the transfer of the materials or in the use of it? Universities, typically, we're nonprofits, and whether we're state or private, we are nonprofits. And so you know, we always try to limit our liability to our own officers, agents and employees and and it shouldn't be directly attributable to our actions. And so we would not want to indemnify or cover the costs of any third parties. So that's kind of an important stuff to think about with liability. Next slide, please. So yeah, so these are just kind of the hot button type areas where you should probably be a little bit more concerned than the standard MTA. So, you know, if you're dealing with hazardous materials, you know, make sure your researcher has got approval from any biosafety committee to make sure that the materials can be received and handled appropriately depending on what it is. Again, export controlled materials, so they're under the Department of Defense and the Department of Commerce have two regulations. The under the Department of Commerce is the Export Administration Regulations ear and then under the Department of Defense's ITAR, international trafficking and Arms Regulations. The ITAR has a US Munitions List which lists a bunch of categories of types of technologies that are controlled and as far as Who you can share with or use the material. And then under the Department of Commerce, there is this called the Commerce Control List. And they have a similar list of technologies that are depending on certain, you know, what, who, who the transactions with, you know, it prevents the transfer of materials to certain embargoed or sanctioned countries. So this would be places like North Korea, Iran, Cuba, there's a list and it fluctuates over time. And, more importantly, what that is considered a deemed export. So that means it may not be an actual export to that country, but to someone within the United States that is a national that country that so that's another important thing that researchers need to be aware of, depending on who's using the material in the lab, you know, you have to be careful with the export implications of that. How this comes up in mgas. A lot of time, not a lot of time, but there are a fair amount of times where the company wants us to identify export materials. Yeah, even though they don't, it's their material. But they don't know the classification code, whether it is controlled or not, you know, you try to go to your researchers, and they have a hard time fitting in the category. And one of the categories in these two lists I mentioned, and so really kind of push back and have the, the provider, they know more than us what materials they have, and whether whether it's as poor control or not. So try to push back to have them identify if there is export control material being shared, and if they have the appropriate license to share and make sure there's a plan in place to handle.

Speaker 2  27:02  
And then, so proprietary materials, again, especially with for profits, they have a very keen interest in protecting and owning their materials, and then anything resulting from it. And so here, the concern is just trying to stretch themselves too much and try to grab more than they should. And, again, this is not, they're not funding research. So you know, it's it's, they're simply providing materials that are going to be used in experiments or testing. And we are actually paying them sometimes for the material. So their argument that they should get, you know, all the rights to IP that may come out of using their material. However, related to gently or not, that is a little bit too much of a stretch. So try to limit it to their materials, look at the standard definitions, and like the UVM TA and other standard templates, where they define modifications, progeny derivatives, and unmodified derivatives. Those are, those are good ones. And typically in the UVM TA, I believe the recipient is granted rights and modifications, except for modifications that include the original material, again, vary upon principles of fairness, and it's just reasonableness. And then, the last thing is be mindful of language that limits how the materials can be used or transferred. We have a lot of researchers that have collaborations with others, and other universities. And so that could just make it a lot more cumbersome or difficult to engage in the research. If there are limits to you know, only the PII for instance, can can touch the material or you know, you just want to make sure it's it's a little bit it's it's conducive to how the researcher are intending to use the materials. Next slide, please. So these are just some ways to kind of as a standard process, I guess, how to handle and TAs efficiently. I always think it's a good idea to know have a general idea to know what the material is where it's coming from, is it coming from another university or from a for profit, universities to university is so much easier. We all know the headaches of processing these things, we all are under the same, essentially the same rules and regulations and issues and so we have a very pretty good understanding of how to work with each other. There's even been attempts to try to even though it was some universities to send email acknowledgments rather than having to sign full forms depending on what's being transferred if it's not something very sick. nificant and proprietary, let's just make this easy, we have a good faith, you know, relationship with each other, we know we're not going to, you know, sue each other for something, you know over this thing and you just want to memorialize just, you know that their transfer happened. And so those are creative ways to do it. There's also the, you know, the ubnt has like that one page, you know, where you put all the details on the one page, and that helps facilitate the transfers. The I think Dan age has a simple letter agreement thing, too. So just, you know, try to start from those. And, and once you have the understanding what the material is, maybe it's just a benign material, it's not export controlled, it's not human material, you know, that might be a very simple en TA, and you may want to try to prioritize, depending on how many you have in a given week or day. Two folks, you know, get the easy ones out quick. And then you can focus on the more complicated ones. For you, when you're dealing with non standard terms, you know, again, looking at the context of what the material is going to be used for, like, in what's the actual scope of work that they're going to use it that helps, because it can help you flesh out whether an invention will happen, or whether they will actually even come up with something that modifies the original material. I mean, you know, it may be a totally unrealistic thing, that based off the scope of work and not an issue. So, but yeah, but pay attention to definitions. Again, and always revert back to the standard kind of definitions we're all familiar with, again, review the IP potential, and that might help way, so if you're stuck on, and I think Shamala mentioned it earlier, if you're stuck on a language that the provider is just really adamant that they must have, and it's going against your standard practice. Depending on what your university's policies and practices are, there may be a way to get around it wave your general policies, if you have to, if it's something critical, that might be something to do, like, if this is the sole source of this material, and you can't get it anywhere else, and it's super high tech, and super innovative and whatever, and then maybe, you know, you might have to make a concession there, just so that your researcher can get access to it. And, you know, again, that's in a situation where research really wants this material and they can't get it anywhere else. But if you're stuck in a, in a stuck point where you there's no movement on this terms, you know, can you get it somewhere else, I mean, you know, is this the only person you can get it from. So you're just kind of trying to figure out a way to make it work under your university's policies. You know, and, and try to find a middle ground there. Always really rely on other people when you can, you know, so depending on where how you're out your university set up, but you know, whoever is the responsible person for export controls, or your IP Office, IRB, IACUC, biosafety, all those can be very helpful resources. And then, of course, never fully keep your researchers informed, and especially with the terms that you think may may be problematic for their research and may not, you know, sometimes they're not going to publish, they, you know, it's just the nature of what they're doing with the with the material, they don't have intentions to publish. So maybe the restrictions on that aren't that important, or, you know, so, but just making them aware of the impact of accepting these terms, what that could have on their future research and, and the output the results of their research is, is important. Next slide. Alright, so I'm going to go into this limited use label licenses. What are those? They're basically what you find on PrEP product packaging are those, you know, those little eight point font terms and conditions that come in those little booklets when you buy the product, and they're basically limited licenses have limited scope granted to the purchaser of this product and limits what you can do with it. And so from Next slide, please. I just put an example here, you don't necessarily have to read the whole thing. In essence, what this one is doing is it's saying you can only use this for Research Use Only you only you the purchaser and only the amount we gave you and then on the bottom it list a bunch of situations where they would not want you to use it, depending on how they write these down there, it could have an impact on things that universities do. So maybe in this one, you know, a could be providing a service or to, to for financial gain. I mean, we give consulting work, you know, to industry and others outside of the university all the time. That could be a little vague, right there. You know, but production and manufacture product for general sale, that probably doesn't apply to us, you know, so just kind of go through those, the challenge with the label licenses is that finding them, right, because they don't necessarily go through the same set the same channels that our standard MTA does, you know, so, standard mgas, may go through your tech transfer office, or in some cases, your Sponsored Programs Office or even another office. But these label licenses, a lot of times go through procurement. And if there's not a good system in place for spotting these, they can get lost in the shuffle, especially with the little eight point fonts that they put these in. Sometimes. So yeah, that's I think the challenge is being able to have a process in place to make sure that you're having someone identifying these as problematic and either training your procurement people to know how to address these or reminding them to run it by the office that usually handles intellectual property or material transfer agreements.

Speaker 2  36:47  
Next slide. Yeah, so the reason we're worried about these things is they may have terms that conflict with our policies and our rules. Again, if they're asking for ownership of the results of, you know, what you use their, their material with, as I mentioned before, we we don't usually give away ownership to new stuff, we can make exceptions if it's directly related to their material, but you know, we had to be careful how the limits of that. So yeah, look for things where they're where they are broad, and they're saying things like, you know, anything made using our material we own, that would be a lot. It's not just incorporating their abilities just by using their material and you come up with something new, they don't. So that would be too broad. So yeah, and they may have, again, limitations on modifying the materials using components. And then they may limit in quantity or who you can share with and stuff. So it's just a good check to be cognizant of the fact that that these types of label licenses exist. Next line. Yeah, it's just kind of, I didn't realize it was a bed, this was an example of us. I don't know if we can scroll it down, because you can't get the bottom part there. Basically, this was an example of a decent middle ground with this label license in that this company was saying that they would not assert infringement of their patents for the manufacture use sale of a therapeutic clinical diagnostic vaccine or other product developed by the recipient using their products, so long as their product is not cleaned or used in the manufacture of these therapeutics, diagnostics, whatever. And so that is kind of a little bit of middle ground where they, they weren't totally prohibiting it, they just didn't want you to put their stuff into whatever you're making, which is a fair compromise. All right, next slide.

Unknown Speaker  39:20  
So another special issue that we'll be touching in the seminar is transfer of human material. So, any MTA for transfer of human material can translate to research involving human subject matter. So, immediately a lot of privacy issues comes in and most of the time, when you're handling any kind of class of human material, there is strict restrictions, to avoid identification of the subject from from whom these materials are acquired. And these materials could be anything like you know, these could be a tissue these could be cells, these could be cell lines derived from you know, any any particular cell object, these could, human materials could even be a biological waste. So for all of this, like the provider here, and both the recipient, you know, have to make sure that the M MTA and all this transfer is in compliance with all applicable federal regulations. And, and they need to be have protocols reviewed and approved by Institutional Review Board. And it is very important the provider, make sure works with IRB to make sure that the informed consent form allows them to transfer these materials to, you know, another requesting party, not just that. Also, even if the material is a biological waste. In that situation. Also, IRB need to approve the protocols for proper transfer of these materials from the provider to the recipient. And in general, you see the terms, you know, for transfer of human material that it cannot be used in humans for any diagnostics, prognostics, or treatment purposes. Next slide, please. There are a couple of templates that are available online related to transfer of human tissues. And this is a section from Autumn website, that is an empty template for human tissues. And the reason I put it here is just to highlight some language here are not just the recipient need to have IRB protocols approved to work with, you know, the material that they received, but also provide a need to ensure that the original material that is acquired by them, that is human tissues are human sample, they are collected under proper IRB, you know, approved guidelines under informed consent, and they have to follow all these, you know, required, they have to be in compliance with all these, you know, regulations before they transfer the material. And if it's a de identified, sample is still the provider and recipient both have to, you know, follow up PHR, your protection, health information guidelines, and everything is put in place at the end to make sure, you know, in no way the recipient or provider can identify the human subject from whom the original material was obtained, without written approval from the provider. Thank you. I think this was all for today's webinar. Next slide, please, Sammy, and we are now open to any questions.

Speaker 1  42:49  
Hello, again, thank you both so much for all of this insightful information attendees, please feel free to use the chat or the q&a box. And then I think if I see a hand raised, I can also grant some speaking permission for questions. But I can get us started. You mentioned that you can sometimes transfer materials with a simple letter or an email. Can you explain a little bit further how that would work?

Speaker 2  43:13  
Yeah. It's funny, because like, depending on how big your institution is, and the understanding of, or bandwidth to accept, kind of things like that some people are just have a low risk tolerance and prefer to have a formal document. I mean, even with our dire can't, our LSU campuses, sometimes we are the same institution, we are all under the Board of Supervisors. But like, you know, some of our other campus t do they want to have an MTA with us? And so we have to negotiate these whole MTA is where it's not even me who How are you going to sue each other if we if we had to, right? And so really, it's really just trying to memorialize, maybe because one of the researchers wants to make sure the other teachers knows that this is his, his or her stuff. And, you know, they want to be attributed on the paper they're made. And it's usually very specific things like that. But we're not going to sue each other. So you know, it's why don't we just memorialize it somehow, either through an email or some simple form letter and not have to go through the whole hassle of negotiating a full MTA, right? And usually, there's like, a couple key things that they care about. They want to make sure that you know, the material is identified as owned or created by this one researcher and stuff. But even among other universities, I think we all can feel appreciate the pains of having to do these than the amount that we do these four and so because they're usually so standardized, but hopefully they can get more standardized by Uh, we're always gonna have the outliers. But to the extent that we can make this easier on all of us, you know, I'm one of the I'm on that boat. So, you know, it's just also the, the, I guess the risk tolerance level at your institution for doing something like that.

Speaker 1  45:19  
Do you have anything to add on that point? I don't want to not give you the opportunity if you had something more. Okay, perfect. It looks like we have a hand raise from one of our attendees. John. John, I'm gonna open up your mic. So you should be able to speak?

Speaker 1  45:44  
One second, John, you might have to unmute. And if you would prefer to type your question that is fine as well. We can. Yeah, as I say, we can circle back I see another question that got submitted through the chat. Robert, is that where you were going as well? Yeah.

Speaker 2  46:01  
So I see this question, how do you ensure that right, that should be granted with a commercial license, since are being incorporated into an MTA? So I mean, look for it, you know? And, again, what are they? It so it's gonna be a commercial license to the results of using the material, right? And so we again, break that down into does it sit into one of the buffet buckets of a modification that should be owned by the institution or the provider? But yeah, you should, as a matter of practice, I mean, as maybe as a concession, you can, you can give a non exclusive internal, non commercial license, so they, you know, feel like they have some access to whatever results from the work work with the research. But yeah, I mean, I think you should really push hard on not giving commercial licenses in MCH.

Unknown Speaker  47:14  
So I just want to add to that, maybe, you know, sometimes, if the other party is really pushing hard, that you know, this, this MTA cannot move forward unless they have certain rights. And this is the only source with the I can get this material. Sometime you can give certain rights just for, you know, research purposes. But they cannot commercialize and limit your ability to commercialize the invention that you your institution makes.

Speaker 2  47:45  
And the other part too, so and I should have mentioned this earlier, but apart from export controls, there's also this thing called unrelated business income tax, and it's we can't generally licensed technologies prior to development or value technologies prior to development. And so these terms are given prior to research being conducted, and they don't even know what the research is that going to be conducted a lot of times. And so And yet they want rights to whatever redevelop again, again, I think it's a big stretch for them to ask for these things. Again, they're not sponsoring the research, you know. And so really push back on that, but you can use that argument as an as a reason why we can't give them a license. You know, they can always come back later for the license, but they'd have to pay us for that.

Unknown Speaker  48:45  
Oh, gotcha.

Unknown Speaker  48:46  
Just to add to Robert, are we referring here for sale bar? Because sometimes, you know, before the invention is created, if you offer it for sale, recently, there was a layer case laws that can jeopardize the future IP protection. Yeah, the point.

Speaker 1  49:04  
Another question I see is just Can you can you go into a little bit more depth or just re explain rights to publish and authorship matters?

Unknown Speaker  49:14  
Sure. So as I mentioned before, for in general, university typically avoid terms that restrict freedom for any kind of restriction for publication, because as an academy researcher, the key motto of whatever they are doing is to publish their results, right. So make sure when you are negotiating an MTA, you don't put any restriction on the publication. And if the other party is really pushing back on those kinds of terms, you can give them an opportunity to review the MTA and during review, they have opportunity to basically remove if they think there's any confidential information out there. The provider is included. You know, In that particular manuscript. Also, as I mentioned before, it's always important to have a timeline or a timeframe, within which you should ask the provider to respond to the review or with their comment to the manuscript, that you provide them. So that, you know, the recipient is not waiting forever to get a comments back or following up email after email, usually, I like to put a language like, you know, maybe within 15 to 30 days, you can definitely pick one number 30 days, you know, if provided do not respond, then, you know, recipient can publish or something like that, or submit the manuscript. And regarding authorship, again, just to touch base, in general, academic researchers are very good in acknowledging referencing the source of material. But if it's something that you're you know, PII is very particular about make sure to put put that down in the MTA. Because, again, MTA is a contract, anything that is there is legally binding. So make sure it's there. So that, you know, the recipient realizes that this is really important for you know, the provider, and they make sure that they acknowledge them properly. Sometime, the provider can ask also the authorship, again, this is a more of a discussion with the researcher, whether they can, they are okay with granting the authorship or not to the provider of the material, if they're just the provider of the material and not contributing anything to the research. And sometimes that could be an issue with certain journals, because they have a specific requirement, you know, the authors should have contributed in XYZ way to the manuscript.

Speaker 1  51:41  
Great. Thank you, I see a couple more questions that have come through. First, we will go to this one was submitted by Jade asking for a little bit more of an elaboration on the sale bar point that you've mentioned during the presentation.

Unknown Speaker  51:58  
Okay, so, so what happens is, I know there's a recent, you know, case law, where what happened is, if you offer and it's still like, no, it's still like, not a very clear, clear thing, what what kind of into seal bar, but if you cannot offer to sale, if you offer to say sell, before you file patent application, it can, it can be assumed as a prior disclosure. So sometimes, those kinds of things should be considered if you're putting licensed language in the MTA that you're offering it for sale, even before any IP filing.

Unknown Speaker  52:45  
Robin, anything to add on that one?

Speaker 2  52:51  
No, I mean, so yeah, I agree. There's the the on sale bar. And I never really thought about the MTA contracts. But it could have indicated the main thing, I think, and probably where the gray area, I haven't read that case, but it's the details of the invention, have they been disclosed? Like, you know, and so, and some of these situations, they don't even know what the IP is they just want rights to whatever happens, you know, like, there's no, it's not identified with the IP, it's just any IP that comes out of this, we want to we want licensed to it, you know, so I think it would have to be the sale would have to be to the specific IP that the patent got filed on, and not just a broad strokes, any IP that comes out of this. So, but it could be I mean, there could be details about what this you know, scope of work is and what you know, more details about how they're using the materials and stuff like that, and what they expect to get out of the project. Sometimes they're there. So yeah, it's definitely something to think about.

Speaker 1  53:57  
Great. And then our last question, it's a bit of a long one, so I'm going to read it out. But if you Robert and China want to follow along on the q&a box, feel free. So our attendee Julie's asking I'd be interested to hear your thoughts on provisions in academic mth that would request assignment of right and titled modifications of the material to the provider and vital implications are university takes the position that modifications when defined cannot be assigned when there is federal funding? However, I'm specifically asking about a provision referring to modifications undefined a material to find owned by the provider rather than a modification as contemplated by UVM TA for example, with the recipient be able to agree to such a provision without violating rental

Speaker 2  54:50  
so that is a good question. Um, so vinyl, allows universities to elect title If we don't have to if we if we don't elect title to inventions, right, and so it's not necessarily it may not be something you patent right. And so if it's not something you patent and you're not going to like title, it doesn't go through the unbridled stuff, right. So if it's like a standard research tool, and I think NIH has guidance about not patenting research tools. And for, you know, for the specific purposes, we allow for our use of these things, so I would probably, first check to see if, if this is something patentable, that we're working with here, the modifications that you came up with, you know, that might help with that part. And even if it was patentable. So, I mean, if you if you elect Tyler, you, as a university, you own it, right. And as owner, you could do whatever you want with it. Now universities generally tie, you know, because of idle and all these other things that we have a hard time doing that. I guess I would be careful, yeah. Because I want to know, you know, if it's a patentable invention, or just a standard research tool, and the other thing you might want to try is joint ownership. You know, there's nothing advisable says you can't share ownership, and as long as the university retains their ownership. So that has worked a couple times for me, where, you know, there's nothing Bible that says you can't share our game, we share it all the time, based on within mentorship and stuff. So, you know, you can assign your part interests as well as an owner. So that might be one way to do it.

Speaker 1  56:57  
I'm muted. Like, one more just came in, with the mere transfer of material under an MTA be considered a sale of the material? If so, perhaps on the on sale bar would be triggered? I'm just surprised. Not a thought about onsale bar in the context of an MPA, MTA. Sorry, thanks, we'll have to look more into this. So with the near transfer material, the under an MTA be considered sale of the material is the question there.

Speaker 2  57:31  
I think it's only actually would pop up with the results of the stuff, right? Because they already have these materials, we're probably getting it from a provider, or we're providing, so they're already in existence. And so you know, I don't I don't think the patenting questions with existing materials. That's what happens with these existing materials down the road. And so I mean, selling them selling this material. I mean, you have to be for consideration to be a sale, right. So I mean, a lot of times these entities don't, we don't exchange compensation. So that that's one thing. See, I'm trying to think through, I mean, again, it would have to be have licensed commercial license language in this MTA to make it problematic. I think, and I would have to be specific details of what this future new invention might be, so that we know what we're selling, as opposed to just whatever IP you guys, you know, came up with. So I think those are the two things that would in and again, I don't, I don't know this too much in the context of an MTA it's definitely worth looking into more, but my initial take is that, you know, just by having language says, you know, whatever develops from this material, you know, we have rights to not our own or whatever that I think you'd have to identify, you know, specifically and then there'd have to be, if it's a sale, it has to be a legitimate sale, like there's the exchange of money. So, you know.

Speaker 1  59:13  
Oh, okay. Well, it looks like that is all the questions that have been submitted, and we are right at the top of the hour. So, on behalf of autumn, I would just like to thank both of you for such an informative discussion and attendees. Thank you for joining and participating and submitting great questions today.

Transcribed by https://otter.ai