Speaker 1  0:00  
Welcome to today's webinar, understanding the academic and industrial collaboration agreements presented by Autumn. My name is Sammy Spiegel, autumns professional development manager and I will be your staff host for today. This is the first of our five webinars series on agreements and disclosures. We look forward to having you join 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 our 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 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 distinguished speakers. Brian Dragon is an intellectual property attorney with 10 years of experience in technology transfer. He has spent the last six years at Howard Hughes Medical Institute of Science, philanthropy, advancing basic biomedical research and science education, primarily negotiating material transfer agreements and patent licenses, while providing support on collaboration agreements and sponsored research agreements. Before his time at HHMI. Brian was with Mass General Graham, a collection of hospitals in the Boston area, negotiating a variety of agreements including material transfers, confidentiality related agreements, collaborations and clinical trial trial agreements. MIDI sobre wall is a Senior Associate Director of Business Development and licensing at the Rockefeller University, and manages a wide variety of agreements to support research and commercialization activities. Knitting is also an active member of the autumn community and always passionate to share her experiences with autumn members and learn from Maris. Please join me in welcoming Brian and maybe we are so excited to learn from you both today. And midea, think I'm going to pass it over to you first, and you should be able to screenshare.

Speaker 2  2:08  
Thank you so much, Sammy, for giving us the opportunity to be here and kick off this webinar series. Brian and myself are thrilled to be here and introduce and share our knowledge of collaboration agreements with the whole group here. Sammy, could you please confirm that? You could see the presentation not see your slides just yet?

Speaker 2  2:45  
There we go. Okay, awesome. So as I said, we are happy to share our information, or knowledge of what we have learned over the years, Brian and I worked together on these sorts of agreements for a long time. So it's my pleasure to be a co speaker with Brian. During the webinar, we also encourage you all to ask questions and comments and share your experiences as your you dealt with the collaboration agreements. To make it more interactive, there'll be definitely a q&a session at the end. But please chime in as we walk through these lights. So what is the agenda for today, are we going to talk about different types of collaboration agreements, as we see between universities, and universities are not for profit institutions, and with the industry or for profit organizations are going to take our time in general terms in a collaboration agreement. And a further deeper dive in TP terms of the collaboration agreements will give you a summary at the end. There'll be sample languages we came across and talk will be very useful for the audience here. Brian was putting a lot of effort putting that together. So thank you, Brian, and the q&a to make it more interactive. So before we launch in, there is a poll question for all of you. I'm happy to read it and Sammy will bring it up. It is it's your office responsible for reviewing the collaboration research agreements with not for profit institutes that is universities other other not for profit organizations and for profit for profit organizations. So here we go.

Unknown Speaker  5:10  
Okay, so it looks like everyone at least negotiates both types or touches on touches on both, not for profit and for profit.

Speaker 2  5:21  
Yes, and I also see that some of us in the audience only review IP terms, which is also quite usual, based on the university. You know, sometimes it's related all the collaboration agreement goes to what we call sponsor research department, and only the IP related terms flow through so that that gives us a fair picture of where we are all coming from, we will move on to the next. So, types of collaboration agreements are usually two as I initially mentioned, academic collaborator when we are talking about the research collaboration between academic and academic parties, entities. And the other category or the bucket is industrially sponsored collaborative research agreement, there is a rare chance that there is an industrial partner involved and no funding involved. So in our experience, 99.9% There is some sort of funding and recategorize them as a sponsored research agreements are sponsored collaborative research agreements. As we all experience, we are working towards the same goal, whether it's a university partner, or collaborator, or industry collaborator, that both parties have the agreement to work together on a common scientific goal to force foster innovation and help people in need. So that's the reason the collaboration agreements normally come together. Because of that commonality. However, I thought it will be really helpful for us to go back to the drawing board and understand what are the conflicting values when we are dealing or working with an industrial partner than a university as and what brings us closer to Me and do are a common interest to do a collaboration. So universities have public mission. And it's all the whole research or the programs are usually driven by a public mission. However, the industry works on the shareholder value, they have to report what they have done, and how they are proceeding with the project. Back to their short shareholders. In universities, most of the projects are initiated by investigators, and we work on investigator needs, what they want to achieve. Industry on the other side, works on what is the market, so are they decision factor. And so we call it the projects are driven by market needs. If there is no market for a product, it's hard to believe it will be a primary our primary project for an industry, university scientist, highly believed in publication, that's what they're there for. They want to create knowledge and disclose knowledge and share knowledge. However, for industry, their belief is more focused on revenue generation to launch a product because they invested money. It's a result driven. They want to share the knowledge that's already there. Right? So University believes in creating knowledge and interest to users that knowledge will their own knowledge and make the products public disclosure is we want to publish we never say RPIs Hey, hey, wait, you cannot publish. That's not how universities work. We encourage that publication. However, industry will ultimately publish but there will be always that confidentiality period. They want to keep it to themselves to be first on the market. We are there for education. We want to provide education to researchers, postdocs, graduate student, undergrads, you name it. Universities have measurable objectives, how many products and move forward from one category to another. So it's knowledge for knowledge sake is what universities are focused on, and management of knowledge for profit is what interest rate is coming from. However, there are still some commonalities there are some common interest that is very encouraging. Both universities and interest rates focus on the development and commercialization of new and useful technologies, creating societal value Everything in collaboration, they are science driven. They want to put their project based on the science, believe in collaborative innovation. And we have seen so many examples in recent past. Ultimately, sharing of knowledge is what we are here for. And both universities and industry research is driven by patient needs to find cures for next generation. So, with that in mind, understanding being in other person shoe where they're coming from is always very crucial when you're talking about the contract. But before we start, before we put our pen on paper, before we start drafting, or redlining or reviewing and negotiating, it's really important to know few things before we start. What are those? Understanding the research project? Making sure that it's like through collaboration? Have a discussion with your PI, what they envision, who came up with the project? Was it a true collaboration? Or was it hey, I already had this plan, I went to a company or a collaborator, they had this mouse model or a small molecule. And they said, Sure, we'll give it to you under collaboration agreement. Is it true? I don't think so. So you get or maybe, and then you went through a list of questions to make sure that it's a true collaboration? Can it be addressed by some other agreement? Can it be just an MTA and I know, there are webinars scheduled for that, so I won't comment much about it. But sometimes, in both Brian and my experience, we have ended up in a situation where we have 20 pages contract. And when we started with research project, it was actually not a true collaboration. So don't waste your time. Just be upfront and understand what the project is. What's the timeline? Right? Is it a one year project? Is it a two year project, or it is a never ending project, and never ending project is a red flag and you need to be cautious. Because as we go through the slide deck, there are obligations, there are grant bags you will be talking, they'll be seeing that you don't want to just have never ending, you know, you want to have a relationship and for that healthy, productive relationship, you want to define things properly. The third one is overlapping projects in the lab. And this becomes really important when you are working on a project, which is overlapping. And you have already entered another contract with another party. And now how do they talk to each other? Are you creating conflicts internally in the lab? It's good to know upfront because then when you are reviewing the contract or drafting the contract, you can be very precise or specific about what is one project and compasses and how it's different than others so that you avoid any conflicts down the road. Are there any third party obligations? And a lot of times you'll get a research project, it will list

Speaker 2  13:30  
things that are obtained from others. So have a discussion, Hey, are you planning to use any mice you obtain from others? And then are we allowed to use that mice for a collaboration agreement? Most of the time, if it's up emptier Yes, but it's better to check upfront, rather than after things happen. And now you're trying to undo what it's done. And walk out researcher and collaborator expectations. A lot of times, you might have ended up in a situation where a researcher from your end says, Hey, we're going to do this collaboration, no strings attached. Right? That's what my collaborator told me. It's a true collaboration, we'll work together but no strings attached. For me, it's like no strings attached. Makes me go back in detail and say it's not reflected in the contract. So so understanding those expectations, and making sure that you not only know your researcher expectation, but a collaborator expectations as well. makes life a little easier on that end. So with that, we'll move into general terms in a collaborative research agreement. There are lot of terms you will go through but once you're going to hang off, you will see okay, this makes sense. Is this is a red flag or we have to tweak it. So research project, the whole collaborative research program, is that price a collaborative agreement? So what are people going to do in collaboration with each other? IP, very, very, very important things can get ugly if it's not properly defined. It's pay super, a lot of attention there transfer of materials among parties. It also goes back to third party application if you're transferring something outside the project and whatnot. And we'll jump into details confidentiality, because remember, there was the conflicting value about conflict confidentiality, which also comes through in the contracts and the publication sometime, you know, confidentiality and publications, two different things, can we find a medium solution or path forward, human subject language, it's only needed if you're using if either of the collaborator is using human materials, blood plasma, cell line tissues. So it's important to now and get through that compliance with laws and regulations. We all believe, or when we get an agreement, we believe that both parties follow the laws and regulations. But there's always that section to make sure that your assumption is true. Use of name assignment is use of name, how we can use each other names, if we want to assignments, what if a PII moves from one institution to another, which is very common in academic world? Can he take a project with him, and how your institution responsibilities pass along most of the time, it's like, if that happens, we'll get back to the table and talk the right path forward. But there will be always a clause defining that. And if a company goes through acquisition or merger, or some sort of event, and they assign everything to third party governing law, we'll get into that. And so everything is important. But with the time we have, we pulled some of the key terms, and thought I won't go into the details. That doesn't mean that we don't like to talk about others, we are happy to answer any questions there. So we'll start with a research project statement of work very, very, very important. A whole try to work with your PII to make it specific, rather than leave it very open ended. Because you don't want to poison other projects. For example, modulating a target x could be our project, and modulating or target x, or indication y could be another project. But if you think it through, the second one is more specific, and can be narrowed down. So try to be specific what parties are thinking because if the indication is open ended, and company is working only in, let's say, infectious disease area, and you come up with something related with erode and degenerative, there might not be the right match, but you have already promised something. So state of statement of work very, very important aims, how the project is going to run through what will be the first step and second and third, who will do which of those aims. And so the responsibilities, what would be transferred between two entities to make to make this happen, the research project happened compounds, mice, tissues and whatnot. Well, there'll be an in go, no go decision. So party a is doing a one and party B will to aim to but if you don't succeed and the results of a Do you want to have guidance post there and say it's a no go decision versus it's a good decision. So that sometimes comes handy and helpful. duration of the project, as we talk about how long this project is going to last are usually one to three years up. I would say I'm usually okay. Beyond that. I would say, Hey, how about after three years, we can put an amendment if you still want to go on because privacy changes, people move on to the For a project, so you don't want that hanging somewhere there in your labs and reporting obligations. So reporting, which is how frequently there'll be exchange of reports and how formal and academic work sometimes is just picking up the phone. And walking through talking about the results, hey, the mice died versus nicer, right. And this is what we did, versus how formal record needs to be transferred between the parties is there any specific format that needs to be followed, it will all go in the reporting budget. So the budget is, it's different when you're talking about academic collaborations versus industrial collaborations, because a lot of time in academic collaboration, each party spend their own money unless it's a southern border or a sub grant. Versus for industry, as I mentioned, sponsored research is where you need to have full on full blown budget personnel supplies, indirect, and you have to make sure that everything is right in order. So this is a sample language or a snapshot of the research project. So this is what it should look like. from an administrative perspective, it can be as detailed as a pie wants to put in, what is the title so that you can appropriately file it background? Who's the investigator in at party a versus party B? What are the project timeline, materials provided between two parties, it can also add on to third party obligations, because if under our MTS sponsored research project is allowed, then you can just put it out there so that commercial partner or the partner knows about it, study design aims and responsibilities as we spoke, payment schedule only for the contracts where money is involved. So another poll question up here. It's based on if there is a collaborator, a whole profit collaborator who sponsored the money sponsored the project under a collaboration agreement, what grants will you feel comfortable granting.

Unknown Speaker  22:28  
Also, just to mention, we will be making the slides available so so please don't feel like you have to copy down all the all the template language.

Unknown Speaker  23:16  
moster are comfortable with a nerf?

Speaker 2  23:21  
Yes, that's what it looks like. But it's interesting to note also that some of us are okay granting an exclusive license for all field of use, or a non exclusive license for all field of use. So we'll just go over this is a good check for us. And maybe we can, after we discuss IP, we can go back to these results and why we should think twice before we make our grant. So intellectual property that we are talking about a project. In a collaborative research agreement, there could be a two big buckets and then there are some pockets of you have just called as background IP, IP that falls outside the research project, we're going to collaborate it could be materials, some know how anything which is not created during the research project before the effective date, or during the effective date. So basically, this is a collaborative research program. So anything outside in the lab is background IP. And sometime it's important to transfer those materials are now how far the research project to be successful. So we'll talk about the background IP and specifically transfer of materials. What will be permitted use and what will be the restriction allow what's allowed versus what's not allowed. But for a minute, let's go back Add to the project IP because the whole collaborative research program is going to get is going to give birth to some research project IP, inventions, copyrights data, know how results. So when we talk about the patents, we talk about the inventor ship, I should say it's fairly easy to a very complex process. But in mentorship is a legal determination, right? You don't want to have a wrong inventorship because that can lead to null and void patent application. But you can have lawyers go sit down with all the potential inventors and make that decision or help you make that decision and why that makes them and inventorship. So we usually have language is inventions in mentorship will be determined by US patent law or other national applicable law, if there are differences. So once that's sorted, it's basically those inventors are going to be part of that patterns. Us was first to invent and now we are first to file with rest of the world. So legal determination, inventorship filing that all needs to be taken good care of when we are talking about a commercial project or a project that can give birth to a product with commercial value. However, the tricky part becomes ownership. Right? One thing is simple. When we're talking about a project IP, there will be an IP that will be sold. So if it's made by parties, a employees it's parties is sole invention, party B, so we'll employ party B Solon mentioned. And then there will be this mix, which is a joint IP. But sometimes you see language around co ownership, or where it's like, no matter if it's soul or join, irrespective of InVenture inventorship, we will call on everything, and you need to be cautious whether it is okay for the project to allow co ownership to other party. The fair language that works for us globally is inventorship reflects ownership. If you are an inventor, you are an owner. It's a sole invention, and only one party is has inventors on it, it's the sole invention. You need to pay attention to your policies, if you can assign the ownership to a third party. That that's that's also that needs to be addressed. So that's why I keep going back if for academic and industrial partners and try to say, hey, you cannot assign our ownership to a third party or because we accepted this funding or some other funding source. However, we appreciate that you invested money, time and resources, we can talk about what is called licensing, we can talk about option that I'll jump onto it in a bit. And what can we do? What is permitted? Because we both parties work together, we can permit some use it for ourselves for party a and party B it is not. It's mostly mutual. It's what we call as internal research use. Right? So a couple of things to pay attention here internal research use if the output or the resultant IP you can envision is a screening method, right? internal research uses what you need. A company would say, Okay, I'll screen compounds using your screening method and develop a product. But I did all that under internal research use, right. So you have to pay attention and see that hey, if it's that process can be built in some sort of increments down the road if that happens. If it's a cell and gene therapy, how can you grant a clinical use? Oh, can they treat patients without coming back to you so permitted use of internal research use needs to be defined quite in detail rather than my internal research use, interpretation could be different from other party just as I would not assume a lot of thing there. So I wouldn't base my language preference on assumptions. IP strategy in expenses, most of us know that it costs a lot of money when we talk about patterns and patterns going globally. So how will we come up with the strategies with universities we usually say hey, we'll talk about where we want to go what we want to bracket protect. One party usually takes a lead In IP prosecution with input from other jointly pay the expenses and when it's time to get the revenues, one party license it out are typically the licensing. When money comes in, how will that go back to the other institutions, so that's addressed under IIA inter institutional agreements. However, with companies, again, now we are talking for with a for profit entities there, you might want a for profit to pay the expenses, for some grand to that IP, normally an option to take a commercial license. And definitely it's worth having their inputs, because they are putting the money or putting the money in the prosecution. I have seen a variety where the normal preferences, university will lead the prosecution with input from the company because you don't want a company or a collaborator to kill the program. And now they don't need to take any license from you. So it's basically a trust or an open conversation you need to have with your collaborator, how you see it. And then commercialization and licensing. We know universities usually don't have mechanism or capabilities to launch a product. However industry is so industry will be, as we said, Prof they were they considered the revenues as one of the values. So that needs to be tied and and we'll show you some language about how you can reflect and pay attention in a collaborative research agreement. So this is about the transfer of material. I won't go word by word, but I highlighted some of the key concepts here. So we're talking about transfer of materials developed outside the course of research project, either by collaborator or institution, okay. And we also talk about the project the materials developed during the research project. So as I said, internal research use or for the use of that research project is all fine internal research is fine, as far as it's defined for the project materials, not you might not want to give right to the material developed outside the research project outside the collaborative research project. So depending upon what the materials are, you may be you may not be pay attention, what are you granting, and what the other party can use it for? Pretty standard. Everything that goes out is goes with no warranties. And the legal title remains unchanged. So if it's our institution material, the ownership or the legal title will stay with the institution. If it's collaborator, it will stay with a collaborator.

Speaker 2  32:55  
Again, these are just sample languages, but give you a fair good idea about how things work and what we have seen pretty standard in the process. So the most crucial and important factor or definition, which I tried to review from all the angles and interpret, okay, am I missing out on something is the definition of invention. There's one example for the purpose of this agreement and invention is any invention or discovery, whether patentable or not patentable. So now we're talking about materials and whatnot, are copyrightable or non copyrightable, that is concede oddities to practice in the course of the research project, right? So we try to limit it very narrowly. And this is how we'll base all the grant back to our collaborator or a sponsor based on this. However, things to keep in mind, if you have two competing projects in the lab. One is using compound a from company a compound B for Company B, for the same indication, you might want to narrow it down to that compound. And the language which works for me is claiming your compound, you know, claiming companies a compound or claiming companies be compound. So although you're having the same project, but you can subdivide or subgroup them based on where the materials or collaboration agreements are coming down to that one way that works fairly well for me, I don't know Ryan, if you have any other suggestions here.

Unknown Speaker  34:39  
Sorry, I just got distracted by a question that came in.

Speaker 2  34:43  
Indications could be another one, which is like indication by indication which we talked about. And it's really important that you as at least for university, like for me, it's really important that my researcher have rights to use all the results without limit Dacians for internal research purposes, we're not going to launch a product or commercialize our project product out of collaboration agreement. This is a sample language about the IRA we talked about. If there is a potential commercial value in an invention, we enter into an IRA talking about the responsibility of commercialization, as well as patent prosecution and sharing revenues and cost are also usually captured under IIA. I know there is an IRA webinar also coming up. So that will give you more details on that industrial collaboration of that I we think is really you have to pay attention. Is party HL grand party be a non exclusive paid up worldwide royalty free license to any invention? It's right, in any joint invention for internal use purposes only. And that goes back to the poll question where 65% of us said non exclusive internal research use license, I'll give it away. Right. So that's pretty standard in the field. And pretty acceptable. However, the commercial license is, we try to avoid however, in some instances, we have to grant a non exclusive license fully paid up non exclusive license upfront. Otherwise, I, my preference is given tunnel research, choose purpose only license and then grant an option an exclusive option to enter into a commercial license. So the language example here is party a agrees that party B shall have the right to negotiate an exclusive royalty bearing worldwide license to acquire the rights to any such invention by recipient, which is basically company gets an option. It's time limited, they cannot have never ending option. Two it says party B may exercise its option in 90 days, it could be 60 days, but pretty standard term here. And once they exercise, they have 120 days, which we call negotiation period to enter into a license if they decide now we don't need it. Everybody goes their own way. If they don't, if both parties don't end up negotiating a contract, they go their own way unless they put an extension and it's mutual or decision. So I know we had some q questions, Brian Yoder or me?

Unknown Speaker  37:48  
Sure. So the the first one that came in was back under the MTA terms. And the question was do the presenters suggest building MTA terms into the research agreement, or enter into a separate standalone MTA and tie it back to the sponsored research agreement. I personally feel it's better to build the MTA terms into the collaboration agreement, especially when so many of the terms will likely overlap. Like publication, restricted uses. I'm also a big proponent of keeping everything where it can easily be found and tracked. So you don't have to dig through three agreements, in order to understand what's going on. Maybe I don't know if you if you feel differently.

Speaker 2  38:36  
I agree with Brock. But you Brian. And the third thing is, you know, sometimes you just look at one agreement, and you say there is no MTA or no material obligations. You can actually limit the material sharing for the research project better under a collaborative research agreement, when you're talking about two separate agreements, you are basically giving some more room of interpretation that, hey, it's project independent. And so if the desire is to make it dependent on a collaboration agreement, definitely for administrative purposes, for clarity purpose, it's better to have one contract or one collaborative agreement addressing the material sharing as well.

Unknown Speaker  39:22  
So I have seen arrangements where there was basically a proof of concept in order to determine if the collaboration would work moving forward. And in that case, it was a standalone MTA with a collaboration to follow. But the MTA was was reviewed under MTA policies. So there was there were the publication, the standalone publication, standalone confidentiality, and then if there was a thumbs up for the project to move forward, then a separate collaboration is going to be entered into. But I think that's different than what the question is So the second question is why define inventions as conceived or reduced to practice? Why not restrict the definition of inventions to only those conceived during the research project? That's a great question. And you certainly could define it that way. This is just sample language that has been used in the past have also seen, conceived and reduced the practice in the course of the research project, in order to tighten it up and potentially avoid any headaches with tracking when the date of when something was exactly invented or not.

Speaker 2  40:37  
Yeah, and conceived or reduced to practice during the research project. And I mentioned and claiming the collaborator materials or compounds. So yes, it's, as Brian said, it is just a sample language you can tighten up as you proceed. And based on project, you know, Oh, great question. So with that, I think we'll move to the next poll question. And I'll hand it over to Brian for more fun things.

Unknown Speaker  41:19  
So the third question is whether or not you believe that the statement is acceptable or unacceptable, where the university shall not publish any results or data without written approval of the collaborator?

Speaker 2  41:50  
And it seems like everybody agrees that it's an unacceptable term, because approval is stronger than written consent. You know, it's, you should not be waiting for approval forever. So with that, Brian, it's all yours. All right,

Unknown Speaker  42:11  
thank you. Next slide, please. Not too much trouble. So this is sample language of a confidentiality provision. It's just a sample, your institution may have different preferred language, but it is highly likely that the parties will be disclosing confidential information to each other during the collaboration. For example, as needing mentioned earlier, the background intellectual property may need to be kept confidential. Each party may be bringing partially completed results to the table in order to in order to make a whole result. You may not need anything robust for academic collaborations. But it might be a good idea to include a confidentiality provision just in case. It's rarely a large negotiation points between academics. But it's almost always a large point. When dealing with for profits companies. Companies will often try to keep information confidential indefinitely. And I know that's unacceptable by a number of academics. Companies may also try to keep tangible research materials confidential, which is difficult to track and difficult to maintain. If someone from another lab enters the lab space, does your PII have to cover a test tube with a blanket. There's also potential publication issues if the material itself is considered confidential. You may need to specify you may have to agree to it in the confidentiality provision, but include a separate carve out in the publication provision stating that information relating to the material may be published in accordance with the terms of the agreed upon publication provision. So things to consider and Next slide, please. Speaking of publication, so going back, it's important to again, consider the balance that we discussed, namely the academic missions of knowledge dissemination against the industry need to utilize that knowledge for products and services. In my experience, there must must must be a pathway to publish. Your collaborator cannot and should not be able to deny your scientists ability to publish in in any manner. And it's very important to abide by academic customs scientific standards as well as complying with obligations of scientific journals. And part of that is also a potential obligation to share published materials, and including those that are rising from the collaboration. So on this next slide, we have sample publication language. This is primarily directed towards industry, or a detailed academic collaboration. Academic collaborations can range from a simple statement of its disagreement is not intended to delay any publication to something much more robust, like the language described here. In collaborations with companies, this is usually a heavily negotiated provision. But it's, it may be important to explicitly spell out the ability to publish, it is common to include standard delays for the other party to review. For example, there's a 30 day review period included here. It's also common for there to be a further delay to allow for patenting. But rarely is it longer than 90 days total. But it's it's important to check with your organization to see if, if you can accept something of a different length, especially if say a company is providing unpublished compounds are unpublished materials as part of a collaboration and may need a longer time period. It's possible that organizations may have more leeway when unpublished materials are being sent.

Speaker 2  47:21  
The other thing I would just add here is the poster presentation that also counts for the public disclosure. But usually, you don't have that lead time to provide a poster presentation for review. So your PI must come and say, Hey, for poster, I just want a week or two. And you just have to make sure that you are committed for that.

Unknown Speaker  47:47  
Yes, it's great point. Thank you. So this is just sample language about sharing published compounds. The top two are the first one is from I believe the NIH has simple letter agreements. The second one, I think is from autumns MTA to for biological materials. And the last one for the industrial collaboration is one that HHMI includes in its collaborations. It's very robust. But HHMI feels strongly about making materials that are integral to publish a publication available to the research community. There is a carve out for materials that can be generated without restriction, for example, something that may not be patented, as well as providing for the compliance with this provision by putting research materials into it into repositories, for example, Jax, or we're adding. Next is just to touch on human subjects research, because this is an extra level of very important scrutiny. It is incredibly important that the investigator has informed consents that there would be no HIPAA violations by sending materials as well as indemnification if need be. But it's very important to make sure that your investigator has coordinated with

Unknown Speaker  49:37  
with your IRB in order to get either an approval or an exemption.

Unknown Speaker  49:45  
Exemption being if your IRB has determined it's actually non human subject research. Oftentimes, it's good to get that ahead of time before you start, because it can provide it's definitely an area that can cause issues, if you find out towards the end after all this negotiation that your PI actually didn't have any IRB approval or exemption. So this is just a sample language. It is actually Rockefellers were essentially, Rockefeller would require an affirmative statement that's for de identified materials that basically the providers IRB has approved the transfer. But your organization may have different standard language, but it's it's important to coordinate. Yeah, very

Speaker 2  50:45  
important to coordinate, I would say, because, especially if you're working with a sponsor or industry, then you have to make sure that you have that right to share those human materials. And that's appropriately consented. So,

Unknown Speaker  50:59  
yep. Lastly, we've got a couple of terms that are usually not heavily negotiated. compliance with laws and regulations, is usually boilerplate. But it may be a good idea to limit it just to what may be applicable to the Define research project. Your organization most likely has a preferred use of name, language, but it's it's it's less, less of a concern with academics and more of a concern with commercial partners, since they want to advertise the great research that your scientist is helping me to, to bring to light. The assignment is also usually boilerplate. It's a question of whether the project is unique to the entity needing mentioned. If the PII moves organizations, can they pick up the project of new organization, the materials or intellectual property that they were bringing to the collaboration were most likely owned by the original organization. So there's usually a no assignment clause and then maybe a background and TA to transfer IP or materials to the new organization. So that the PII can pick up the project, their governing law can sometimes be sticky. It's it's usually straightforward, especially with academics, but there are some quirks. For example, if the other academic is a state entity, they may have legal obligations and can't agree to certain jurisdictions. Foreign academics also may require that you agree to foreign law. It's very common for academics to accept silence. There's also the option of what's considered a swing gate where the parties agree to the jurisdiction and venue of whoever the defendant is. But it's usually not that big a sticking point, even if you have issues, it's very frequently, very frequently, everyone can make an exception to to it.

Speaker 2  53:24  
And with that, we just put together a comparison chart about how things look different when we are dealing with universities and with for profits of the search budget. We did talk about usually there's no research budget, within university or I can make collaborative research agreements and everybody bears their own expense. exception to that is sub award or or some sort of sub awards are coming from either hosted one university or from NIH, with for profit. Usually there is full support including indirect cost, which sometimes is different when it's academic institution versus when the partnering or collaborative institution organization as for profit, IP ownership, the preferred languages in mentorship reflect ownership for both for profit or not for profit entities, IP prosecution and expenses. With the university is usually it's a sharing mechanism share costs, share revenues, with for profit, supported by funder or sponsor of the project, and in return for licensing and commercialization. funder receives a time limited option right to background IP we talked about. Usually we do, there is no obligation to give away the rights outside the collaborative research project. For me, it's usually the same, though I would say there's more flexibility within the universities you always share, and there's no license as per se, needed. You do MTS for materials and know how it gets out by publication or common discussions, publications within universities. CO publication is pretty standard, or if one entity wants to publish independently, usually it's like, you know, we'll send you 30 days before for prior approval, but it is time limited.

Unknown Speaker  55:34  
But maybe we should have said prior review.

Unknown Speaker  55:40  
We can fix that. Oh, yeah. Yeah.

Unknown Speaker  55:44  
16 times. Yeah. Sorry about that.

Speaker 2  55:48  
Yeah. So you know, you get a chance to review and everyone's component can only be applied for confidential information, other party confidential information if they are okay, with a delay and let us put their CI. And with that, we can go back to Q and A's. Thank you, everyone. Happy to if someone wants to chime in for anything in specific, I think you have a mechanism for person to speak as well.

Unknown Speaker  56:21  
Yep. So there's one one question that we didn't answer yet as well. And there's a question about a concern that by granting a non exclusive license to an invention that it'll create an obligation to create an obligation to file for patent protection for such invention. And whether or not it's common or useful to make an affirmative statement in the contract that the university is under no obligation to pursue patent protection in any territory unless the company acts exercises Its Option, or otherwise covers the expenses of filing.

Speaker 2  56:56  
So the language so I think there are two questions, is it granting a non exclusive license to invention creates an obligation to file for patent protection? I don't think so. Because you're just grinding and internal researches? Which, if you end up there is always confidentiality, that they'll keep it to themselves, if unpublished. Are we agreeing to file No, because if it's a mice, you transfer, give a non exclusive license, nobody finds minimize or sell mine. And also, sometimes we have language that if company or a sponsor decides not to support the patent expenses, they don't get the option, or rights to that invention and university or institution can make any decision whether to file or not to file independently of the sponsor. So they'll have 60 days to comment and say yes, we like it, please file will pay and access. And we exercise our options. So we have 30 days to work on it and think over it. But if say, hey, we don't want it. We don't want you to file on it. Universities can still file independently, and the company won't get any right because they didn't support it. So you can build that in the language about patent prosecution. And if you can email one of us, we are happy to share some sample language around that. What worked for us?

Speaker 1  58:43  
All right. I think that mostly covered we can give folks up here one just came through. Thank you. I was gonna say we can give folks a second to submit any new questions. It looks like we have someone asking background rights seems to be becoming a bigger issue. If the sponsor insists on some background, what are the normal limitations or restrictions that you would recommend including thank you for your question.

Speaker 2  59:06  
So yes, I completely agree that sometimes everybody wants background right, you can make it a freedom to operate license, if it is required. We will grant a license FTO for a company to exercise or to practice the invention may during the research project that could be one or you can say we can talk outside this collaborative research program and we will enter into an internal research use license or whatever is needed. So you can have independent license for that background IP.

Unknown Speaker  59:51  
You know, just yeah, just to emphasize, I was just about to say that maybe sorry. Just to re emphasize let me Adding it to use of the invention developed in the research project is very key and important.

Speaker 1  1:00:09  
And it looks like we actually have one attendee Jade who would like to ask a question out loud. So Jade, I'm going to unmute you right now. And we can get that answered.

Unknown Speaker  1:00:19  
Thank you. Oh, can you hear me? Okay? Yes, yes. Fantastic. Really great presentation. Thank you so much. I think I got into the space when I started working with universities. So in the past, I only worked with for profit organizations. And after collaborating with universities, I think your presentation really highlight the differences and the conflicts approach that different organizations take. So fantastic presentation. My question or comments is, is with respect to inventorship. And I should preface this by saying I am an IP lawyer. So I think your point is super violent, when it comes to inventorship is a legal question. And it can be really complicated, depending on where we are and which country we're facing. So the two concepts, conception and reduction to practice, I think the law is quite consistent, but when the devil is always in the details, so my understanding is conception is the key question, especially in the United States. And I should also say I am in Canada. So in Canada, both questions are relevant when it comes to mentorship. So that is all to say, the question of mentorship is quite tricky. And often I tell my clients, perhaps when it comes to ownership, we don't tie it to mentorship, just because it was just we're just treading water, we may not have the certainty we want when it comes to ownership if we tie ownership with inventorship. And I would love to hear your perspective on that point. The second issue is with respect to ownership, especially joined to recall ownership. Again, the law is quite different between Canada and the United States. For example, in Canada, it is a situation where a patent is owned by two owners, one owner cannot even grant a non exclusive license to anyone without consent from the other co owner. And I understand that in the United States, the law is different we're by you can grant an exclusive license to another person without consent from the co owner. So I would love to hear your perspective on CO ownership and how to deal with that issue.

Speaker 2  1:02:44  
Thank you. Sure. No. Wonderful question, Jay, then, thank you so much for liking the presentation. So I I completely understand that there are different territory, when we get to the territorial details, it gets more complex than how it looks from one country perspective. But if we think about, and it depends on the technology, frankly speaking, where is the major markets are? So if even if in US, you have a joint owner, and you agreed on CO ownership and they launch a product, you're still poisoning the wealth right? In use, you can easily do that. But when it comes to international territories, yes, you have some some, I would say that gives you comfort that, hey, even if you agree on CO ownership, you won't be able to do a license deal without having other one on board. So that's, that puts us also in mentorship, because if the inventors in some of the countries, the owner, ownership stays with the inventor and not with the institution. So I have instances where we do you can call it an inter institutional agreement, but you're dealing doing an agreement with a Pio or a scientist who owned that invention in order to commercialize it further. So I know it's not a straightforward answer to your question. But yes, it's it's different. And it does impose some restrictions how you can not commercialize and that gives you comfort in some territories, but not in others.

Unknown Speaker  1:04:37  
Yeah, I think it's important, it's most most important for everyone to be on the same page. So even if the, the way that you agree on inventorship or ownership is I can't think of the word non orthodox as As long as everyone understands, can anticipate who the inventors will be and is comfortable with it, then that I think that's important. One thing I will note, though, is that divorcing ownership from inventorship may be problematic for us based academics. Because some of them have an inability to assign rights in something that they create. And that may go back to their tax status or the certain tax laws or whether or not they the university was built with tax free bonds. So it may, in certain instances, entities may not be able to agree to a separate ownership arrangement outside of following inventorship.

Unknown Speaker  1:05:58  
Hopefully that answered your question.

Speaker 1  1:06:02  
I think that that just about covers all of the questions that have come through, I don't see any additional ones. So on behalf of autumn, I would like to thank you, Brian, and Nidhi for the informative discussion and attendees. Thank you so much for joining and participating today. As a reminder, a recording of the webinar will be available in the autumn Learning Center within a couple of days. And slide handouts will be included there. So if you can download these resources that were shared with you today

Transcribed by https://otter.ai