Speaker 1 0:00 Good afternoon and welcome to today's webinar confidential disclosures presented by Autumn. My name is Sammy Spiegel, one of autumns professional development managers and I will be your staff host today. This is the final presentation of our five webinar series on agreements and disclosures. 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 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. Julie Kelly joined Augusta University's office of innovation and commercialization in 2007 with an undergrad degree in business administration, and no clue that tech transfer existed much less what it was all about. After 14 years with a US Oh, I see she accepted a position as the intellectual property and contracts administrator at the Translational Genomics Research Institute th n in September 2021. Over the years, Julie has been responsible for managing departmental intellectual properly property related financials, database management and federal reporting as well as negotiating material transfer agreements, confidentiality agreements, data use agreements and inter institutional agreements. She joined autumn in 2011 and currently serves as a member of both the autumn operations and compliance planning committee, as well as the online professional development committee. Janitor Wally is a contracts administrator in the Office of Technology Transfer at the Rockefeller Institute with over 10 years of experience in contract review. In her role as contracts administrator Jen is responsible for the review and negotiation of the university's confidential disclosure, material transfer and data transfer agreements. Prior to joining the Rockefeller University, Jenna was a contract specialist for the Hackensack Meridian health system in New Jersey, where she was responsible for processing of clinical research related agreements, including but not limited to clinical trial, confidential disclosure, data transfer, MPAs and more. Jenna holds a Bachelor of Arts in anthropology from American University and is currently obtaining her Master's of Science in jurisprudence from Seton Hall University. Janet is also a certified clinical research contract professional. Please join me in welcoming both Julie and Jenna. We are so excited to learn from you both today. And Julie, I will pass it over to you first to get us started. Unknown Speaker 2:50 All right, that's all right screen is. Speaker 2 2:56 Thanks so much for taking time out of your day to join us for today's webinar. I want to start by reading a short disclaimer on behalf of myself and Jenna, the following presentation reflects the personal views and thoughts of myself and Jenna, and is not to be construed as representing in any way the views or advice of our institutions, their affiliates, subsidiaries or divisions or the views or advice of the Association of University Technology managers autumn. The content is solely for purposes of discussion and illustration and is not to be considered legal advice. Oh, there we go. All right. Well, I will skip the slides since CME has given you all of this information. So polls, Sammy is going to post some poll questions that is gonna give us the opportunity to learn a little bit about all of you attending this webinar. So if you would please take a couple of seconds to read through these and and provide your answers. Speaker 1 4:55 We'll give it another couple of seconds since there's three questions and then we'll We'll share the results for everyone on the webinar Speaker 1 5:21 Okay, and everyone should be able to see the poll results now and you can scroll through the three questions. Speaker 2 5:29 Okay, that's that's good to know. We're all university, your own profit. And we do have some we have a couple that are dealing with intake and database as well. All right. Okay, so to kick us off, well, if I can make this work, there we go. Just gonna start off by giving us a an overview of of these kinds of agreements. Jenna. Unknown Speaker 6:02 Thank you. So welcome to everyone. Thank you again for taking your taking time out of your day to be with us. So I apologize to some of this is basic, but good to have a quick overview. So what is a confidential disclosure agreement, a confidential disclosure agreement is executed to protect the use and further disclosure of non public confidential proprietary information, such as inventions discoveries, research projects, and results by recipient party. Anyone who has touched a confidentiality agreement is aware that they come titled as many things so you could have your confidential disclosure agreement or your CDA confidentiality agreement or non disclosure agreement. They all essentially mean the same thing. Throughout the presentation, I will refer to confidentiality agreements or CDA. Unknown Speaker 7:02 When our CDA is necessary, they're necessary prior to disclosure of confidential information, confidential proprietary information not yet published or otherwise publicly available. They tend to precede discussions with industry or academic partners that are meant to evaluate collaborative research projects, investigator initiated studies, to evaluate licensing opportunities and to evaluate participation in industry sponsored clinical trials. Although the slide does say, prior to disclosures, I think it's important to note that sometimes a confidentiality agreement comes after an initial discussion. And CTA may need to be backdated. When CTA CTA requests coming from an investigator, I like to just confirm that whether it's the initial discussion, or they've already had some discussions and whether or not they've shared any confidential information already, just so that I can ensure that if they haven't provided any confidential information that we can we can backdate our CDA. Unknown Speaker 8:15 So there are a lot of agreements that relate to confidentiality agreements that contain like provisions. So they are material transfer agreements, data use and transfer agreements, collaborative research agreements, sponsored research agreements, license agreements, and there are a variety of others as well. One thing to note is that depending upon the type of agreement, the confidentiality provision may be longer or shorter. I spend a lot of time working on material transfer agreements as well. And one thing we like to ensure is that, you know, is confidentiality confidential information really being shared. In addition to the materials, sometimes a template will come in, and it will include a confidentiality provision, but it's really not necessary. So making sure that you understand whether or not confidential information is going to be shared so that you don't have unnecessary superfluous obligations in the agreement is important. Unknown Speaker 9:20 Some basic information to include in CDA is the name and address of the other party. It's my own personal preference to have an interest in the agreement, sometimes I'll receive a template that does not have the other party's address. And because not all confidentiality agreements have been noticed this section I think having the address can be beneficial in case you need that information. The name of the researcher or employee that's going to be involved in this in the discussion, a description of the information that's going to be protected by the agreement, if it's applicable, the reference number of the technology or patent that you may be discussing and On the purpose of the discussion, so I should probably back up and point out that CDA can be mutual unilateral or multi party. Depending upon whether or not it's a mutual mutual or a unilateral CDA, you may have two different descriptions of confidential information. It's really important to make sure that the stated purpose within the CDA covers everything that you think you may be disclosing during your discussions simply because if it doesn't, a lot of times cities, they limit the use of the information so. So it's also very important to make sure that a CDA is the right agreement for what's going to be for the for the relationship that's going to be occurring. So a lot of times a CDA is is the initial agreement. They precede you know, material transfer agreement. For instance, I apologize, I am going to talk a lot about NDA just because of my, my experience. So it's important to make sure that the CDA is really what you want to have in place. Because it will not cover it will likely not cover any of the other activities that are going to be taking place after the initial discussions. Like for instance, transfer of materials. And a CDA often does not talk about things like ownership of intellectual property. So making sure that confidentiality agreement is agreement you really want to put in place the important. Unknown Speaker 11:54 So, some general terms to include in CPAs. I think it's important to just practice that what may be industry standard is not necessarily best for your institution. I don't know. You know, in my experience, I have received a lot of comments from third parties. You know, when I make changes to a CDA to today's terms, that, you know, this is industry standard, and why are you requesting that it be removed? Sometimes the, the answer is simply we just, my institution can't, can't comply with it this way. So I think it's important to know what you know, maybe industry standard and what actually works for your institution. So, one very important, I actually think the most important part of the CDA is having a clear definition of what does and does not constitute confidential information because that definition affects pretty much every other term within the CDA. Another important thing to include in the CDA is a permitted uses of confidential information including to whom the information can be shared. This is where your representatives language comes in. I saw that we have a lot of universities and in from both at Rockefeller and other institutions I've worked at, we don't require confidentiality agreements be signed by our employees prior to as requiring me to use me of employment. So a lot of times in a CDA, you will see language that says that anyone any of the representatives you share confidential information with have to be bound by like terms. That's not something that we can agree to simply because not everybody is signed either signing the CDA or has already signed a CDA with the university. So one way to work around that is at Rockefeller we will include language that says that anybody who receives confidant any of their representatives who receive confidential information will sign the CDA as read and acknowledged that works for a lot of our situations simply because we don't typically have a ton of individuals involved in confidentiality come in in the discussions. But that may not necessarily work for for you all, especially if you have 10 employees who are going to be participating in the discussion such as becomes unwieldy but I just wanted to mention that since I see that a lot and it's a constant problem for us. People are always wanting us to have written have our employees and have signed written confidentiality agreements. Speaker 2 14:56 I was like, you we had the same same requirement where we we couldn't use a written that they were bound by a written agreement for the same reasons as you. So I always tried to use the that they were bound as a condition of employment, you know that that type of language usually worked pretty well for me. Unknown Speaker 15:20 And I guess thank you for pointing. I've used that in past as well. One thing that I had been advised on on some time ago, when we, when I was putting language like that into the agreements is understanding exactly how your employees are bound by the policy, you know. So, you know, is it something where every year you go through annual training, and there's an acknowledgement that, you know, each employee clicks, perhaps into an electronic education module that says they are going to agree with all the policies, you know. So I think just understanding you know, how your employees are bound, and exactly what your policy may say, is very important. Speaker 2 16:09 And that annual training that you're talking about, again, most everything that I'm going to say today is going to be from the perspective of a user. That's where I was for so many years, and I'm still really new at teaching. So I looked into the, the annual refresher, where there's just like a one page confidentiality thing that everybody has to read, and so on. And I think it's important to point out that, that everybody needs to look into what specifically that says, because our one page thing in a you said, it was more related to like HIPAA, and FERPA type, you know, human subjects related data and student data and stuff like that. It did not mention in any way confidential information received from third parties, you know, in relation to research collaborations and things of that nature. And I think it's really important thing for institutions to include in that, that annual refresher. So I encourage everyone to look into what is being done in your annual refresher and try to get that included if it isn't already. Unknown Speaker 17:21 So something else to ensure that you've included in your CDA, there's a time period for disclosing information under the agreement, as well as the time limit on the recipient obligations. Often that comes in the form of the term and termination section of the CDA. I've found it best to make sure that there is a clear term for the agreement. So that means you know, the length of time under during which confidential information can be shared, we tend to stick to a one to two year term, depending upon the specifics of the project. And, you know, the anticipated length of the discussion, we could get some some pushback on that. I know, some, for profit companies like to have the term extend longer, especially if they anticipate, you know, perhaps they may be sharing information from a clinical trial, and they know that some of the results are going to be are going to be ready for some time. So they they don't want to have to, you know, amend the agreement. So, you know, that you may get some pushback, but I, I, it's just, it's a personal preference. I think one to two years is sufficient enough to cover, you know, the length of the discussion. And also, it helps to not have agreements out there for too long. It's I mean, you're going to have obligations that extend beyond the the expiration or termination of the agreement already. So, you know, the more things you can make those, I think, the better. So I'm not entirely certain how many of you have experienced have worked with venture capital firms. One thing that I have noted is that because of the nature of their business, and the fact that they like they talk to lots of different organizations, and oftentimes organizations with competing inventions and data, they like to keep the time limit on their their obligations, pretty pretty low. So we often get requests for three years. tidbit of information. I'm not sure if anyone else has experienced that before, but I think that it's a bit different than a pharma company, for instance, to sometimes asking for a five year term or a seven year term or 10 year term. Also Would we often receive requests to keep trade secrets? Confidential indefinitely? Just at Rockefeller specifically, that's something we don't we don't agree to. We actually will say we don't want to receive trade secrets, because my understanding is that the keeping a trade secrets confidential input entails certain things that beyond what you would normally be required for a for other confidential information. So just something to keep in mind if you're being asked to keep trade secrets, confidential indefinitely? And I think we have a question. Great. Speaker 1 20:54 Yeah, so looks like the question asked is do most offices have a set of preferred terms that negotiators utilize? When I began, we had a list of sticking points and specific language with suggested comment language for redlining purposes. Unknown Speaker 21:16 So in my, when I when I, when I joined Rockefeller, there was no formal document, but there was a great deal of knowledge from from other individuals in the office who, you know, told me what was and was not acceptable. And previous institutions I've worked at, I've actually been involved in putting in place some type of guidance document that that includes, you know, preferred terms, and preferred initial responses, at least when someone comes back and says, you know, why have you removed that? I rely a great deal on our, our legal department, if there's something that I need extra rationale for, or something that, you know, well, I, you know, I am not, I'm not an attorney, so I have to defer to them sometimes. And they, you know, I think this looks consistent with what we would normally accept, but I just want you to, I want you to take a look at that. And I understand, you know, Rockefeller is a smaller institution than a lot of probably the others here. So, you know, that ability to go to legal and get a quick response may be different than then at other institutions. But yeah, I, I am a huge fan, a proponent of the having a list of defined of preferred terms, excuse me, and an initial responses, I think it just, it makes the negotiation process move faster. Speaker 2 22:49 And I know that some institutions actually have, they use software, different different types of software, that they can actually click and put things in agreements and different terms like that. I'm kind of in the same boat as Jenna, when I was at AU, I was in the same boat as Jenna. Whereas it was kind of learn as I go. I knew what, what basically we could accept, and if anything was seeing was weird. And outside of that particular thing, and I didn't know how to handle it, I could go to our contact in the legal department. And that's basically what I'm doing here at agency. But it's basically like starting all over some NGOs going from a state institution to this a nonprofit, nonprofit institution now, so but I have my cheat sheet type language, I have a bunch of macros set up in Word, so that I can just click on a little button and it pops the whole paragraph or two paragraphs in for me. And then I can revise as I need to from that. It's much easier than having to go and open a document, a separate document and copy and paste and everything. Everything's in the one, one document. So I strongly encourage you to use macros, if you're using a lot of those, I have them set up for the actual language of the term as well as a separate one set up for justification for the requests that I'm asking for and that type of thing. Unknown Speaker 24:26 That's actually a really, really good idea. It's not something I thought of before, isn't I'm learning something Unknown Speaker 24:35 I guess we'll just move to some of the other terms. So something else that's very important, I think to include in the CDA is a process for the return destruction and continued use of confidential information. So everyone knows you know, we are a a very tech dependent The world these days, and a lot of our I'm sure, every one of our IT departments has a process in place for backups of information. So a lot of you know, in the return to destruction provision, you're often asked to destroy or return all confidential information. A lot of times those provisions don't take into consideration the fact that the organization backs up its data every day, every few days. And that it may not be possible to destroy all records of their confidential information that are that are kept specifically on those, you know, those backup drives. So I've taken to including language in in the CDA that says that we're not required to to destroy that information. I have gotten some pushback here or there. But you know, at least at least of the organizations, I've worked at the process of going and requesting that information, specific information be destroyed off of a backup drive from perhaps maybe, you know, a year ago, would just be completely unruly and unrealistic. So I think that's very important to include. And that's it, of course, in addition to being able to keep one copy of confidential information, so that you can determine any continued obligations beyond the expiration or termination. Something else that that may just be Rockefeller specific. But oftentimes, the the provision will say that the return or destruction of confidential information will occur either upon written notice or when the discussions have concluded? Well, at least, I don't typically get informed when discussions have concluded, especially if they don't go beyond the term of the CDA. So I think if you're going to include language, saying that you will be destroying confidential information or returning it, as the case may be, when the discussion has concluded, you should make sure that there is some process in place for knowing when that occurs. Because, you know, I'll complete a CDA, I'll inform the investigator, and then from there, unless an amendment is needed, it's kind of are we going to notice requiring that confidential information be destroyed? Or returned? I don't really think about it again. So I think just making sure that you you can comply with that obligation. That's one of those. That was one of the things that's you know, what's industry standard versus what your organization can plot can't comply with? It's not that we couldn't comply with the storing confidential information after discussions have concluded. But you just need to make sure that that trigger, is there. Something else? Speaker 2 28:14 Sorry, we have one question that came in? And it's really a good question. I don't know that there's really a good answer for it. I don't have an answer. So maybe you do. But the question is, how can you be sure that you've destroyed every copy of the information that was shared electronically? I mean, I don't really know that you can. And, like, we always include a pair, a term that says that we don't have to destroy or delete anything that's backed up automatically on our network and things of that nature. So I've always just kind of hoped that that, that protects us on that from it. What do you think? Unknown Speaker 28:58 I'm going to agree, perhaps not the best response. But I yeah, that's another reason for including that language because it is perhaps a failsafe in some respect. I'm not one thing that I like to include is saying that we will either return or destroy all tangible copies of confidential information sometimes we'll be asked to destroy trying to think of the exact language but embodiments or summaries or anything that just that becomes unwieldy, you know, so trying to we try to say tangible copies because it kind of narrows what, what we'll be obligated to destroy like that simply because I don't I'm not necessary. They're really sure that without help from it and the investigators and a huge process, you can really confirm that you've destroyed, truly destroyed everything. And that's not a great Speaker 2 30:18 wire that that we use the language of upon written request from the Discloser. We will. So we try not to agree to that term just like when the CDA expires or terminates, because we have so many of them to keep up with. And you don't know sometimes the CDA is superseded by subsequent agreement. So we try to use the written requirement. And that way, if you have to deal with looking into that kind of thing, it's only on the ones that you actually receive a written request for. You. You mentioned the allowing us to keep one copy, do you allow that term to stay where that copy has to be located? Because sometimes I've seen CDs that say, except for the one copy that's going to be stored in your legal department or that kind of thing? How do you deal with that? Unknown Speaker 31:21 So I tend to strike that I will, I'm happy to include in, in our secure files. Because, you know, in theory, I'd like to assume that our, you know, our cybersecurity will make make make our files secure. But I try to avoid, you know, in your legal department, for instance, simply because we just, again, it's just there isn't necessary isn't necessarily a process for going to an investigator and saying, you know, we're going to keep this one copy and you're going to, you're going to delete it but we're going to keep it in our in illegal files it just so I tend to remove that language, I feel the same. Okay, so something else you may want to include in your CDA is a governing law and venue. We've recently moved to a bit of a more in depth CDA, then we template and we've previously used and, you know, you would think that the simpler the CDA, the the quicker the the negotiation and completion process. But what I actually found is that a lot of companies will have, you know, certain provisions that they require. So even though we've left out governing law and venue, you know, we initially did from our template, constantly, people would come in, you know, ask for that to be included. Remaining silence tends to be our we either require, you know, our New York law, or remaining silent, which often is, is the, what we what we agree on, we've also used law, the defendant. But that doesn't come up as much in CDs as it does in other other agreements. You also may want to include a retention of title and a no license provision, as well as a provision on AFN to whom the agreement can be assigned. at Rockefeller, we we tend to strike affiliate language, simply because sometimes you work with an organism, you know, a for profit company that has so many affiliates, that it may be impossible for us to track and we want to, you know, this is, of course, you know, it may be specific to the information that you're talking about in this specific CDA. But we want to keep as tight a lid on our confidential information as possible. Sometimes, you know, if you allow a company to share it with all of its affiliates, you know, you can be talking about 20 different organizations and, you know, the more the more individuals that can receive the information, you know, the less likely it will be to be safe. Now, although we try, we don't often not not super successful all the time. So my to, to deal with that. What I always ensure is that there's language in the agreement that says that the the other party is responsible, excuse me, for any breach of the agreement by its representatives. That kind of goes back a bit but also related because a lot of times parties will want to assign to their affiliates. We tend to keep track I can't say that they can, you know, the agreement can't be assigned unless, you know, there's a merger or an acquisition. Just because, you know, while we may want to work with one, one company, we may not necessarily want to work with one of their affiliates. We want to we want to be able to have the ability to say yes, or no. Do you may also want to include language regarding the relationship of the parties, that's your, you know, the parties are, you know, not joint contractors, and etc. And then also how the agreement can be executed. at Rockefeller we use we typically use Docusign. You know, I think, especially after the given the time we're in now it's pandemic. Executing, you know, by hand is not very common anymore. So there's a lot of, you know, exchanging signatures by either by PDF or by, you know, through an electronic signature system. So, we've taken to including some language in the CDA that says that, you know, any any facsimile PDF, or electronic signatures have the same effect as, as an original signature. Speaker 2 36:22 I have one thing I'd like to point out about the affiliates and subsidiaries that you were mentioning a minute ago, I think that that probably would be especially important, depending on what type of information you're disclosing, and if it is anything that might be subject to export laws and things of that nature, knowing exactly who those affiliates and subsidiaries are and where they're located. I mean, I don't I don't know for sure, but I would think that that would be important. Unknown Speaker 36:56 Definitely. And one thing that, you know, first, for some organizations that have said, No, we absolutely need the silliest language, understandable, of course, because they don't necessarily always know which, which of their affiliates would be, you know, working with us down the road. You know, sometimes I've asked them to, to kind of list a few of them, you know, so that we have a good idea. You know, it doesn't, we don't necessarily include which ones those are in the agreement. But it gives us an idea, and it allows me to go back to our investigator and say, you know, just just an FYI, these other affiliates may receive your confidential information and those that seem like an issue to you. Speaker 2 37:45 So now we're going to talk a little bit about the benefits of these agreements. So the benefits of a confidentiality agreement to our institutions is pretty straightforward. And we use them to protect know how and unpublished research results, inventions that haven't been patented yet. current and potential research plans and protocols that our researchers are working on things of that nature. CTAs document what information was disclosed, and to whom, as well as how that information can be used and further disclosed. Some institutions require the person receiving the confidential information on behalf of the institution sign the CDA to acknowledge that they've had the opportunity to read the terms that they're responsible for up holding. This allows us to document our compliance with terms in the agreement requiring us to ensure that our representatives have been made aware of the terms and agree to abide by them, as well as giving us a starting point. If there happens to be anything in the future that we need to look into like a potential breach or anything like that. We at least have the main point of contact to do received the the information to go and start looking into that and do our due diligence. But our researchers, they're busy doing what they do best and sometimes they get a little frustrated with having to execute agreements before they do absolutely anything. And and sometimes that frustration gets taken out on us and we're just a messenger. So because of this, I feel like it's really important to be able to communicate to our researchers how agreements can benefit them. So when you receive requests for CDA is it gives it gives you the opportunity to remind your researchers about your institutional policies in your state and federal regulations such as HIPAA or FERPA and that type of thing. Depending on how your institution tracks agreements, you might be able to easily see all of the other agreements that have been executed for that researcher, and be able to tell remind the researcher that he or she received similar confidential information from other parties, and remind them that it's very important to keep the information that they receive from each party separate. And absolutely not till one with the other told you, you know, and at sometimes that's a big concern for me. When you have PRs working with multiple companies in, excuse me, clinical trials and things of that nature, that's where I get a little bit concerned. Excuse me. Let's see, we have a question. This question is about distinguishing between trade secrets. And CDA, this is a good question that I actually just asked one of our attorneys at tagine. Like I said, I'm new and learning how they handle it at AU, we would have not, we try not to accept trade secrets at all the same way as Rockefeller does. But at AU, they don't have that requirement. at AU, we would have if we did have to allow that language about trade secrets. I would include language that said that the trade secret information, at least the trade secret information, if not all information had to be shared in written form, or followed up in writing, and trade secret. information had to be stamped as trade secrets so that we knew for a fact what we were obligated to hold confidential indefinitely. Do you handle it any differently than? Unknown Speaker 41:49 I know, so I actually have not we've we've been successful and having Tracy secret excuse me, language removed from from RCA. But I would I would handle it in a very similar way. It would need to be glaringly obvious to anyone who received that information that it was a trade secret. And you know, that would also include making sure that the investigator was aware that anything they received with that type of notice on it would need to be kept confidential indefinitely. Speaker 2 42:20 For you the biggest problem. I'm so sorry, the biggest problem with trade secrets was that we weren't, we weren't permitted to enter into agreements with open ended obligations. And that was really hard for some companies to understand. But I couldn't make them understand. And at the at the early stage that we were at work right now we're just evaluating whether we're going to participate in your clinical trial. And there's no reason why trade secrets should have to be disclosed. At that point in a conversation. We don't even know if we're going to participate. We don't even know if we have the patient population. So I just, I just couldn't understand why they couldn't understand what officer and say, at tagine, we don't really have that problem because our CDA is aren't you arm we don't have many related to clinical trials in that regard. So anyway, so anyway, let's see where it was. So if your research so another thing, another way that you can protect your researchers or how CDA is can protect your researchers is if you're if if they're requesting a CDA that is related to a discussion with a for profit, a publicly traded for profit company, and they're receiving, receiving information, or and later on maybe working in different ways with that company, and it's publicly traded. It gives you the opportunity to remind them about securities laws and insider trading, which I'm going to talk a little bit about later. But you also have the chance to remind your researchers that without a CDA in place to protect the confidential information that they're going to disclose, the recipient would be able to do anything they wanted with the information, which could possibly interfere with the researchers future publications, and with the potential to obtain patent protection due to public disclosures by the other party that could be considered prior art when it comes to patenting. So I have found that when I talk about these kinds of things with my researchers, they kind of cut me a little bit of slack because a lot of them upfront, just think the only reason we're executing these agreements is to protect the institution, but when You can give them an idea of, yeah, it is protecting the institution, but it's also protecting you in some very important ways. They kind of understand a little bit more and are a little bit more willing to help you execute the agreements that need to be executed. Jenna, do you have anything that you want to add? Unknown Speaker 45:20 Yeah, so I, you know, I've definitely experienced the investigators come and said, but this is holding things up. You know, because I'm in the tech transfer office, I rely a great deal on our business development and licensing group, especially when a CDA is related to a technology that we wait we may want to discuss with, with a for profit, they sometimes have a better, they may have a more more of a report, because they're, they're often assigned to a specific investigator. So they know, you know, the full gamut of their research, and they can, you know, plain explain a bit better to them, or relate them a bit a bit better. So, you know, I'm, I'm, of course happy to, to have those discussions, but sometimes it is helpful to to go to, you know, involve someone, like, if you have a business development, or you know, someone else that they work with regularly, who can, you know, help you? We're, we like, I like to approach things sometimes like, like a team just so people don't necessarily think as well, you know, sometimes I think they think I'm the one that's requiring it, you know, and they have a hard time understanding No, it's, you know, not only me, it's the institution, and, and we're all on board, and we're doing this, you know, to help you and not not to to hinder you. Right, we're Speaker 2 46:49 gonna have to move through these last slides probably a little bit quickly. It's, we've got about 12 minutes left. So we're gonna move into some best practices for executing CTAs. And if we don't get to the last section, for anybody that's interested in those when you get the slides, you can just reach out to us individually. Okay, Jenna. Unknown Speaker 47:10 Okay, so we'll move through those these pretty quickly. So things to consider, you want to think about whether or not your your institution has a website that clearly talks about when a CD is required, who's allowed to sign on behalf of your institution and the process for requesting a CDA, one that you know, is there, your website can be a very valuable resource. I know a lot of not every institution has a very expansive website, and not and I imagine a lot of the folks on this webinar don't have the right to control what was on there. But it can it can be can be helpful. Something else to consider is whether or not you utilize or would like to utilize an intake form, to receive the necessary information to draft or to review agreements. This is something that Rockefeller uses for its material transfer agreements. But we've we've steered away from using it for CPAs. Simply because they think they tend to involve less need for input from an investigator than then perhaps something like a material transfer agreement would, you know, they are great for documenting, you know, the investigators or somebody that to set the request, you know, for documenting requests, but it's also extra paperwork, and extra paperwork can slow things down. So you just have to, you know, weigh the weigh the pros and cons of doing something like that. Also, you may want to ask, you know, does your institution allow employees to sign CDs on their own behalf? I think a lot of us based universities don't actually allow that. Rockefeller, you know, is also one of those. So, just want to make sure that your investigators know that because you don't want them to have a situation where they've received a CDA, they signed it on behalf of the institution and they've attempted to bind the institution when they can't, you know, that can create all sorts of issues down the road. And it also, you know, a lot of times in that situation, you won't be made aware of the CDA. So there are obligations out there potentially that you're not, you know, the important offices are not aware of. You may also want to utilize an annual acknowledgement to remind employees of obligations related to the receipt of third party information. And you also may want to have an outreach program to provide agreement related education to employees. I think this goes back to what Julie was mentioning. A few minutes ago about you know, helping your investigators understand why some of these agreements are required. So, at least if not requiring at least having those that education available may be important, helpful. Unknown Speaker 50:24 So some things to keep in mind with regard to CDA is there are pros and cons to including the CDA topic in the CDA or keeping the CDA open and more broad. It's, it's, it's our, our practice at Rockefeller to be as specific as possible, just so that we can, we can keep track of exactly what discussions are taking place. But that may not that may not make sense in certain situations you may have in a situation where a company is going to receive information about multiple projects in multiple labs, all under the same CDA. So they're that, you know, deciding exactly the what nature what the nature of discussions are going to be, is important. You also may want to keep in mind, you know, do the people who are negotiating the CPAs, work with the people who are negotiating the license agreements and the other agreements that may result after the initial discussion. You know, in effect, like I said, Before, in the tech transfer office, you know, we're small, and we there's a lot of a lot of collaboration amongst us. So a lot of my requests for CPAs will come directly from the individuals who would be working on the license agreement or the sponsored research agreement. If the project moves forward. And you know, they, they bring a lot of valuable information, but making sure that you're talking with all the necessary parties during the negotiation process is important, because they may know something that you may need to include or strike from a CDA that you would not necessarily know unless you do have that record. It's also very, very, very important to make sure that you don't assume that all of your colleagues understand the university policies, or the terms that you included in agreements. You know, sometimes policy manuals are very long. And even if there is some type of annual requirements to read and acknowledge the policies, you know, the no guarantee that everyone understands everything that's included in there. And, you know, a lot of investigators while you know, leaders in their fields, they're not familiar with the legal language, or the common things that are included in a CDA. So making sure that you know, they're aware of anything that they need to abide by is extremely important. And also things the other thing to keep in mind is securities laws. I know, Julie, you wanted to mention something about them. And Speaker 2 53:21 I do, but first, we have a couple of questions that have come in that we'll address because probably most people will, anyway, are there CDA is that it would make more sense for individual employees to just to sign on their own behalf, such as unilateral from a company with no university confidential information being disclosed. These are often non negotiable documents, researchers are asked to sign when they go visit a company, for example. So do you have anything? I have some I have an example that I can give. But if you have anything, I'll let you cheer? Unknown Speaker 54:01 No, no. Does this take example, then, you know, unfortunately, that's just not something that we allow, you know, everything has to come through us the only the only thing we would not required to come through our office is something that's a consulting arrangement that is not being done on behalf of the university. In those instances, we allow investigators to sign of course, on their own behalf. And we actually, you know, make clear that, you know, we're not going to offer them any type of like, I'm for instance, I'm not I wouldn't be allowed to review something like that and make suggestions for edits. If that was the case. Speaker 2 54:41 I know an executing CDA is related to clinical trials. We had the kind of instances come up similar to what's being asked about, but usually the template CDA from the company usually had a section in it that talked about when the investigator went for visits to the company and things of that nature. And that there were times there were things like that, that the company originally would approach the PIO and want the PR to sign on their own behalf. But we did not allow that the BIA is new to still send those to me so that I can execute them like a regular CDA. And always would just go back to the company and say, you know, there's nothing I can really do. They're not allowed to sign this on their own behalf. And so, but because our and this was all when I was at AU, by the way, but because au required the PIs to sign an acknowledgement of the terms of the CDA, most of the times the companies would, would go with with that, instead of the individual agreement that they were wanting to do design. So that that would be my recommendation to push back and just tell the company that you just can't do it. But sometimes it's a take it or leave it type thing. And depending on who your researcher is, and how much pool they have, and how important whatever the conversation is, sometimes you're in a position where you don't really have a choice. And you've just got to figure out a way to handle it. In that case, I would say go to your legal department and say, This is what's going on, and you got to figure out how we can get it done. That's my recommendation. And then there was another question, do you have any examples of an actual dispute or other major issue arising out of a NDA done by university? I, we years and years and years ago, we did have we received a letter about PII, breaching a CDA, but I wasn't really involved in how it was handled or anything like that. But we were able to get it cleared up, that PII wasn't any was no longer employed by the institution at that time. And they were able to get it cleared up. So I don't have any, like, juicy kind of things that I can share. Jenna, do you have anything that you know about? No, Unknown Speaker 57:22 no, I would I would say no, unfortunately, but I think that's probably a good a good thing. Nothing, nothing specific. Speaker 2 57:30 I mean, I will say that, you know, because when I was researching securities laws, you know, I did come across some articles about researchers, university researchers who were involved in clinical trials, who either told someone about whatever they knew, or whatever research they were doing, and that person, you know, bought stock or sold stock and that the company involved. So, sometimes clinical trial CPAs will, will have language in there about securities, you know, that you're not allowed to, to exchange securities for that company, and, and your employees are also not allowed to do that. So I don't we don't have we don't have a whole lot of time at all. But let me just the securities laws are federal and state laws that govern the sale of securities, such as insider trading in a public company. insider trading is the trading of a public company stock or other securities, such as stocks and bonds by individuals with access to material nonpublic, which can also be called confidential or proprietary information about the company that if publicly released can affect the company stock. So if your researcher is doing work with the company, and it has access to information or say a drug compound, and you're researchers research shows that that drug compound can cure every single type of cancer in the world for everybody in the world and that company is beginning to make mega money. And then your your researcher or somebody the researcher knows and told this information to you went out and bought stock. That's insider trading. Likewise, if they that if your researcher discovered that the compound was horrible and didn't do anything it was told to do so they went and sold a bunch of stock they had in that company that is also insider trading. And we need to make sure that RFPs that are working with publicly traded companies are aware that they should not be buying and selling stock in that company nor should anybody that they know the know any of the information that they have on that company and things of that nature. So So best practices, I'm gonna go really quickly. You have pre approved everybody has their pre approved templates, you can use your pre approved template and save your time and negotiating that's that's great. go that route. Master see EDA because I did a bunch of CPAs with for clinical trials, I worked a lot with the same companies over and over again. So I just took their template and I made it into a master CDA and included exhibit A, that was a notice of transfer. So going forward, after we had executed the master CDA, we only had to sign the one page notice of transfer, which told me which of my PRs was evaluating the study what the study title and protocol number were and things of that nature. But you can do it with research collaboration agreements, do you do CDs with the same people over and over again, I strongly advise you to execute master CDs. But make sure you include that note as a transfer that has to be executed every time so that you have the documentation for your records that you need. We already mentioned Docusign. Jenna had mentioned to me that once she gets an agreement negotiated, she emails her PII a recap of all the important terms in the agreement, which I think is brilliant, because number one it documents that you're doing your due diligence to make sure your PII knows the terms that they're supposed to abide by, and you've got it documented that they that they received that information, and follow up with investigation prior to expiration regarding extension. Which leads me to automate anything that you can automate in your database. 100% recommend that you automate, we did have a poll question we were going to ask y'all what how you were tracking, I use NTm, Jenna uses Sophia. I know I have a lot of things that, uh, tips that I can give you on NTm. And I'm sure Jenna does with Sophia as well. So if any of you use those databases, if you want to reach out to us about anything of that nature, we'd be happy to see what we can do to try to help you out with your automation. But you can create activities to notify you when your agreements are expiring. You can in team at least you can set up Sentinel rules that will automatically email, your PII or whoever was working with you on that agreement to ask if they want an extension and things of that nature. Anything that you can automate, that you don't have to stop and do gives you more time to do the things that you do have to stop and do. You're going to get these slides. So I'll let you all read that on your own. And then the last slide is just an example, the first page of a monthly report that I had to do when I was at AU, which are pulled out of NTm. And I'd be happy to tell you how I go about doing that kind of thing. So we're a little bit over. So if there were if we have, I think Sammy had said we have till 115 If there are any questions. I'm so sorry, we ran over. Speaker 1 1:02:57 Apologize. No, all good. That timing is excellent. And I know that we were taking questions throughout but attendees, if you do have any final questions, feel free to submit those. But I know we covered a lot along the way. So we'll give it a couple moments, I guess Jenna or Julie, any kind of final parting words of if there's one thing to remember from today's presentation, what would be that, that takeaway for attendees? While we wait for final questions to come through? I know there was a lot i Unknown Speaker 1:03:36 i would just say I kind of already mentioned this in the beginning. But I think it's just very important to make sure that what you're agreeing to in your CTAs as well as your other agreements is in line with what you can realistically achieve. And you know, with your university policy, your organization policies. Speaker 2 1:03:55 And I would say don't let your researchers push you into using too general of a description of the topic and purpose of your agreement. I feel like that's that's the pushback, we get the most. And if your CDA does not say what is being discussed. I don't see how that can possibly hold up in court. I mean, how can you prove that someone breached the agreement stole your information? How can the other party prove that against you to which that's on them, but how can you prove what belongs to you? And what is protected by that agreement? If it does if the agreement doesn't state, what it covers? Speaker 1 1:04:37 Awesome, I think those are two both very wise words of wisdom. So thank you both for sharing that. It looks like I think we've covered all the questions throughout. So on behalf of autumn I would just like to thank both of you, Jenna and Julie, so much for this informative discussion, and attendees. Thank you all so much for joining today and for contributing your questions to keep this a robust conversation throughout the session. As a reminder a recording of the webinar will be available for viewing on the autumn Learning Center within a few days of this event and is included in your registration the previous sessions from the webinar series are already all posted in the autumn Learning Center for you so you can review and go back to those sessions as well Transcribed by https://otter.ai