Unknown Speaker 0:00 Stay put. Unknown Speaker 0:08 Hello and welcome to today's autm webinar, the consulting conundrum, balancing faculty expertise, industry engagement and institutional integrity. My name is dongio Young. I'm a member of autumns educate team and today's staff host. All lines have been muted to ensure high quality audio, and today's session is being recorded. If you have a question for the presenters, we encourage you to use the zoom Q and A feature on your zoom toolbar. Should you need closed captioning during today's session, the Zoom live transcript feature is turned on and available on your toolbar before we begin, I would like to acknowledge and thank autumn online professional development sponsor, Marshall Gerstein, we appreciate your ongoing support. I would now like to introduce today's session. Moderator, Hemi Chopra. Unknown Speaker 1:00 Oh, hi, hi everybody. Thanks for joining the call. We all appreciate it. So the distinguished panelists on this channel are Jamie Wacha from Davis and mom, and then Irene Abrams from Children's Hospital and Boston, and Jamie and Todd Wolf from BIDMC. So just a couple of things I wanted to talk about, and we will. I will let the three panelists talk a little bit more about themselves. I just gave a little sentence, but they can talk more, and they can get some more information. We will start with Jamie, who will talk to us about, can I have the next slide? Please? Unknown Speaker 1:47 Don Unknown Speaker 1:51 Okay, so, Unknown Speaker 1:56 so we'll start with Jamie, talking about consulting agreements and how they are processed. Irene will talk about the researchers point of view in this, in these consulting agreements, and Unknown Speaker 2:09 Todd will wrap it all up and to and talk about his how he handles these consulting agreements. But in all of them, there are 2.1 is the researcher side, the other is the institution side, and both sides have to be happy in these consulting agreements. So all three panelists will talk about it from their views and and we can go from there. With regard to questions. You're welcome to interrupt the speakers when you when you want, but it would be great if you can hold them towards the end. Unknown Speaker 2:41 Third, the panelists will talk for 30 minutes, and then the last 30 minutes will open to questions. Now, if you have a burning question that you just have to put it in there, please do so using the chat button, and people get to them as soon as we can, but the big question and answer session will be the last 30 minutes. I hope that's enough time for everyone to have a good discussion. We had planned on having, you know, an open question and answer webinar, other than, you know, people giving presentations. So this was the model we are going with. So I hope it's acceptable to everybody, and I will Unknown Speaker 3:20 have Jamie pick up the topic first, sure I'd be happy to thank you Amy and thank you donville for inviting us. And just brief introduction, my name is Jamie Wacha. I'm an attorney at Davis mom and dagestine in Boston, and I've been representing institutions, individual physicians, Unknown Speaker 3:42 healthcare providers, researchers, scientists and executives and consulting agreement arrangements and other similar arrangements. With respect to services to third party industry companies. For about 33 years, I've also represented companies and the institution. So I have covered all sides of this conundrum. So if we could go to the next slide please. Unknown Speaker 4:12 Okay, next one. Unknown Speaker 4:15 There we go. All right, what is a consulting agreement? What we're going to be talking about here today are any type of service provider agreements that whether they be, however their name, consulting agreements, advisory agreements, Scientific Advisory Board agreements, speaking agreements, they all have basically one thing where there is an individual working on their own time that are associated with an institution, whether that be an academic institution or a medical institution, and they're engaging in these services for payment from third party, outside industry. So what we're trying to do here is focus on what are the institutional concerns? Unknown Speaker 5:00 For their faculty or professional staff members, and why does the institution get concerned over certain provisions of consulting agreements? Next slide please. Unknown Speaker 5:15 So some of the basic provisions that you will see in consulting agreements that do trigger institutional concerns are if there the institution has any policies concerning conflicts of interest, intellectual property, or anything else that would be implicated either directly or directly into a consulting agreement, that is probably the most important aspect of any kind of Unknown Speaker 5:45 medical or academic institutional review of consulting agreements, we want to ensure that there is compliance with such policies, especially intellectual property. Now, one of the ways that we go through this, whether Unknown Speaker 6:01 representing an individual or representing an institution, as we want a very narrow definition of the services. Companies generally prefer a very broad definition, so that when they come to the IEP, they can really group in an awful lot of whatever services that the consultant provides institutions prefer a very narrow definition of services, so that is a critical component of making sure that the consulting agreement is compliant with institutional policies. Another big concern is whether or not the consultant is getting fair market value. Unknown Speaker 6:42 The institution does not want to have any type of federal oversight or overview looking at this and typically, what you'll get from institutions where consultants are getting paid in some type of lump sum, such as an annual retainer, quarterly retainer, where it's not tied to hours or a specific rate. They want to have an hourly rate and an estimated number of hours, or a maximum number of hours, that a consultant will perform for the individual companies, and also that make sure that there are certain limits on how much time they could perform services on their own time for these companies, Unknown Speaker 7:31 another institutional concern are confidential obligations. The confidentiality section Unknown Speaker 7:40 has a lot of concerns, because typically companies draft them so that everything that they have is confidential, everything that the consultant tells them is confidential. And many of these agreements, the initial draft is in perpetuity. So we try and on behalf of the institutions, limit the confidentiality period to three to five years. However, there are certain instance, instances where a longer period of time may be appropriate, if the consulting is for some type of patent work where it's going to take a long time to come to any kind of commerciality. So seven to 10 years might be more appropriate, but always have some type of limitation. Next slide, please Unknown Speaker 8:30 and thank you. In addition, we want car votes in the Unknown Speaker 8:38 confidentiality section. Want to make sure that confidential information does not include information that was in public domain Unknown Speaker 8:47 before the services were performed, was known to the consultant. And many times the company will say, Well, you know, provide us evidence that you knew it, which you know, if the consultant knew, can do so independent development, either by or on behalf of the consultant. So that's a key, key aspect, because remember, this is a side job for the consultant. This is not their full time job. Their primary employer is where they spend all of their time, or most of their time, and therefore we want to make sure that that is carved out. Unknown Speaker 9:27 If they receive any information from some third party without any knowledge that that there was any obligation that that third party had to keep confidential information that also should be carved out. We want to ensure that subsequently, if any information that the company had disclosed was to be Unknown Speaker 9:50 public knowledge, again, that's similar to the first category. It falls into the public domain and should be a car vote from confidential information. Unknown Speaker 10:00 And the last one is anything that's required by operation of law to be disclosed. I will say that a lot of Unknown Speaker 10:11 companies don't want to state that confidential information has to be marked proprietary or confidential, but I found that many companies will at least be willing to mark it, or if disclosed, orally, confirm it in writing within 10 to 30 days. That's certainly preferable, because then there can be no doubt later on in a battle level. Well, was it confidential? Was it was it not? Unknown Speaker 10:41 Next slide, please. Unknown Speaker 10:47 I already talked about the oral disclosure. Another Unknown Speaker 10:52 issue in some institutions is indemnification. Is the party go? Is the consultant going to be indemnified? Well, the institutions doesn't care so much about that. If I'm representing the individual, I certainly care on behalf of the individual about that. But with respect to some institutions, want to be indemnified to the extent that any Unknown Speaker 11:16 lawsuits or any kind of actions losses, damages that result from the consultant participating in the services agreement with the Unknown Speaker 11:26 third party company Unknown Speaker 11:28 are made fully whole and indemnify a lot of companies resist that they may agree to indemnify the consultant, but resist The institution. I'm sure that Todd and Irene can talk later on about whether their institutions really care or have a policy on indemnification. Unknown Speaker 11:51 Use of name. Unknown Speaker 11:54 Institutions don't want companies using their name, except for the factual reporting that you know, Jamie watched is a consultant for X Unknown Speaker 12:05 institution, and it's a factual representation, that's okay, but they don't want anything that could be construed as being promotional of the services or products that the company provides, and certainly doesn't want any kind of Unknown Speaker 12:24 indication that the Unknown Speaker 12:27 institution provided the consultant to the company. These are Unknown Speaker 12:35 consulting agreements where the consultant is contacted by the company, Unknown Speaker 12:42 and there is no institutional party to the agreement. Unknown Speaker 12:47 The other thing is, and again, Todd and Irene can go into this further detail with respect to their institutions, but intellectual property is, is, is the big one here. Institutions want to ensure that none of their know how and intellectual property goes out the back door through a consulting agreement where somebody is working on something in their lab, and they decide that we're going to go ahead and get this consulting agreement and, oh, I found this really great thing that would that would be wonderful for your company that I was working on in my lab. No, that's for another type of agreement where the university or the medical institution is a party, whether it be through sponsored research, clinical research, or some other type of joint collaborative agreement. These are consulting agreements, and institutions have every right to expect that none of their know how, none of their intellectual property that was developed using hospital or academic resources or personnel are used and assigned to companies. Next slide, please. Unknown Speaker 13:56 I already talked about the promotion. No marketing. No promotion. Institutions aren't in the business of giving free promotional Unknown Speaker 14:06 kudos to companies, products or services, so that's a non starter for institutions. Unknown Speaker 14:13 And the other thing too is non competes. Unknown Speaker 14:16 Non competes Unknown Speaker 14:20 are are a problem for institutions to the extent that they might conflict with the consultants obligations to its primary employer, which is the institution. So Unknown Speaker 14:30 what we want to make sure is that the agreement is clear that there is nothing in the agreement that can lock up the consultant in any way that would provide that would prevent him or her from prevent from providing Unknown Speaker 14:48 services to the hospital. For instance, Unknown Speaker 14:52 you have a consulting agreement that says X Unknown Speaker 14:55 consultant cannot provide services. Unknown Speaker 15:00 Or in his field for any other company, Unknown Speaker 15:04 whatever that field is defined as. But the hospital may come back and say, Well, wait a minute, we have another company that we want you to provide services in that field for and the responsive research for which we're going to get paid. And so the institution has every right to come in and say, no, no, we want language in there that does not prohibit you from from working with any company that we want you to work with on behalf of the hospital. Next slide please. Unknown Speaker 15:38 And I guess that's it for me, unless I see any questions, no, yes, maybe. Unknown Speaker 15:48 Okay, thank you, Emmy, Unknown Speaker 15:52 yes. The next the next speaker is going to be Irene, and she'll be talking about the researcher perspectives in a consulting agreement. So go for it. Irene, great. Thank you. Thank you, Amy. So I'm Irene Abrams. I'm the Senior Vice President for Research innovation at Boston Children's Hospital, and I also happen to be the chair Elect of autumn. So happy to be here on an autumn webinar. Unknown Speaker 16:16 And in my role at Children's, I oversee our tech transfer function as well as our accelerators, we have a therapeutic and medical device accelerator. Next slide, please. Unknown Speaker 16:28 So what I wanted to talk about today is, Unknown Speaker 16:32 from the researchers perspective, how to think about consulting agreements. What you know? Why do researchers want to do them? What do they get out of them? What are the potential risks? And then I'll get to some ways that that institutions and investigators manage them. Unknown Speaker 16:49 I think, before I before I jump into all the details, I just want to say, Unknown Speaker 16:55 in most cases, the consulting agreement is, is between the consultant and and the company. It doesn't always include the institution. I think, you know, James can talk about this more too, but it's often a Personal Contract with the consultant. So as we talk about these things and what the issues are, they often fall to the to the researcher to sort of navigate and figure out, with the help of someone like Jamie in certain cases, or the resources within your institution. All right, so why do researchers want to do enter into consulting agreements? What are sort of their own goals and what are the benefits for them? Well, lots of researchers want to share their expertise. They know a lot about a particular field, or, in my case, where I work at an academic medical center a particular clinical Unknown Speaker 17:41 disease or area, and they may be very interested in sharing their expertise. Unknown Speaker 17:47 Many of them are also interested in contributing to the actual application of their research. So if there's a company out there working in their field, they might be very interested in helping that company Unknown Speaker 17:58 as they work on developing the application of the research, you know, not necessarily the consultants, independent research, but research in their field, Unknown Speaker 18:07 helping the companies in the field. And it also can be terrific for the investigators. Reputation. If you become known as a, you know, sort of a wise consultant, a wise guide and counsel, you might be invited to many, many more consulting opportunities or other opportunities where people seek your your advice. So can be very, very good for the consultants reputation. And of course, we can't forget that they are usually compensated for consulting, and so it's a way to Unknown Speaker 18:34 to earn some extra compensation, and that can come in the form of cash or in the form of equity or options, and all of those will have implications for some of the risk that they have to manage, but there are a lot of benefits for for consultants, and depending on your institution, it can really be encouraged. So for example, at Boston Children's Hospital and Todd, can talk about a Beth Israel, where we're both Harvard affiliated teaching hospitals, which mean, which means that our faculty well employed at the at the hospital, their actual academic appointment is at Harvard Medical School. So in addition to being subject to hospital policies, they're also subject to Harvard Medical School faculty policies. And under under the Harvard Medical School policies, our faculty are allowed to spend up to a day a week on outside activities, and so it really is encouraged in certain ways by the institution, for the faculty to get out there and be engaged in in the community beyond just the academic community. So lots of reasons for consultant, for faculty to want to consult, and I left off a really critical one. So I'll just say it. It's not on my slide. It's also important. When Unknown Speaker 19:46 you have spin off companies, there is a very important role for consultants in helping the technology actually transfer to the company. And so that's a little bit of a special case, and we can talk about that more, Unknown Speaker 19:58 but it's often the case when you. Unknown Speaker 20:00 At a company that the researcher, or maybe the postdocs or maybe other folks in the lab may spend some time consulting with the company to help the company successfully bring the technology in house. All right, so what are the areas of risk? So there could be conflicts with your institution or with your obligations to the institution, and they can take a number of forms. So one of them is conflict of commitment, Unknown Speaker 20:25 and this really has to do with their time and effort. So I did say that under Harvard Medical School policies, faculty can spend up to 20% of their time a day a week, on outside activities, but that is subject to, in our case, approval by the chief to make sure that they still have the time to do Unknown Speaker 20:44 all of the all of the things that they're obligated to do in their role as a faculty member. And so it's important to make sure that that the researchers in your institution know what the particular obligations are and how they would get approval for that. Conflicts of interest we can certainly talk about in more detail. Unknown Speaker 21:06 The issue there is that the faculty member's primary responsibility is to their academic institution, and so we want to make sure that they're not in a position where they are in conflict with their primary responsibility. And at our institution, again, under the Harvard rules, there's a lot of focus on equity. And so if the consultant receives equity in the company as part of their compensation, there's a higher level of review of the conflicts, and it has to go through a conflict of interest management process, and they need to disclose that, both to children's and also, if they get any federal funding, they need to disclose any of these conflicts. If they have equity Unknown Speaker 21:47 there, there can be conflicts around IP and James touched on this, Unknown Speaker 21:51 if there, if the faculty member happens to be an inventor on a patent that they make during the consulting who do they have an obligation to assign to that's very different based upon the institution and the and the policies of the individual institution and the details of the consulting arrangement, but it's very important that they understand what those conflicts are. I mentioned reputation on the positive side. Of course, there's always risk with with reputation. If you consult for a company that has particular problems, maybe your faculty member doesn't want to be associated with them. And certainly in this time where there's heightened focus on relationships with with companies in different countries, particularly at the moment, there's a lot of focus on China. If you have a faculty member consulting for a company in China, I think you would want to look at that. They would want to look at that pretty carefully to make sure they know what kind of risks they might be for them personally and and for their ability to get federal grants. And then finally, around the confidential confidentiality obligations if they're consulting for a company in an area that's very close to their research, and they learn something in the course of that consulting that is confidential to the company but is relevant to their research, they might be prohibited from using that information, right? And so it could be that their research can be contaminated by it, by confidential information from the company, that could limit how they do the research. So it's also really important when when looking at the scope of the research, making sure that there's some distinction between what they're doing in their consulting role for the company and what they're doing in their own research. And this is a really difficult one to navigate, as as are many of these others, because Unknown Speaker 23:37 your faculty member will be you know, the companies that want to hire them want to hire them for their expertise, which is right in their field of research. And so navigating that is is Unknown Speaker 23:48 can be tricky. Unknown Speaker 23:50 Next slide, please. Unknown Speaker 23:53 Okay, so how do you manage the risk? So there, within, within all of our institutions, we have a lot of resources for managing the risk at Children's Hospital. We send folks to the general counsel's office Unknown Speaker 24:07 or the conflict of interest office. In certain cases, our faculty need to talk to their department head or their chief, and they should certainly learn what the institutional policies are, which hopefully are posted somewhere that they can find. Unknown Speaker 24:20 I left off the tech transfer office. Maybe I shouldn't have, but I try to discourage the people on my team from giving faculty too much advice about consulting agreements. And there might and other people might feel differently about it, but because it's a personal agreement between the consultant and the company and it's not an institutional agreement, I want to make sure that we don't give them guidance that you know doesn't really help them, or make sure that they understand that we're not really representing them in the negotiation. So that can be a little bit tricky. It's especially true if they start to ask you questions about compensation tax issues, issues around what kind of equity they can get, options versus warrants versus. Unknown Speaker 25:00 Um, shares, I try to discourage my team from getting giving too much advice along those lines, because we don't want that to come back and sort of hurt us later if we, if we gave advice about something that we don't have expertise in. So I would send them to the general counsel's office or the conflict of interest committee for for most of the help there and then, what are the models for managing risk? There are lots of different models at different institutions, and they range from the institution being very involved to not very involved. So some institutions, there's actually an office that reviews, negotiates, consulting agreements on behalf of the institution. That's not the case at Boston Children's, but that is the case, at Mass General Brigham, they have an office that reviews them and actually co signs along with the investigator. Unknown Speaker 25:47 Some institutions like mine take a somewhat lighter hand and they add a rider to the contract. So in this case, Boston Children's does not negotiate the consulting agreement. It doesn't review the consulting agreements, but it requires the faculty to add a rider, and the rider is basically an appendix, and the appendix more or less says Unknown Speaker 26:09 this, this. The consultant is subject to Boston Children's and Harvard Medical School policies, and those supersede anything they might have agreed to in this agreement, should there be a conflict, and that relates to intellectual property and confidentiality, Unknown Speaker 26:22 and there are other obligations to the hospital, and that can be Unknown Speaker 26:28 a little bit tricky most of the time. Companies accept it. Once in a while, we get pushback, and we have to navigate that. And then I always advise the faculty to get their own attorney, because this is a personal agreement to them, and the obligations are on them now that requires them to, you know, to spend some money, which they may not want to do. But I, you know, I think it's wise, especially if they're taking on obligations and responsibilities that they know what they are and that they're not Unknown Speaker 26:58 going out there with that without any advice? I don't know if that was my last slide. Can you advance it one more? Unknown Speaker 27:07 Okay, so that was my last slide, generally on how I how I view the issues from the researcher perspective. And happy to talk more when we get to the Q and Unknown Speaker 27:16 A, all right, Todd, you're next, and he will Unknown Speaker 27:22 talk about it further, and you will come out to be a better person at the setting agreement. So you can sort of sum up a little bit also Todd as what we've heard so far. Okay, thank you. So yes, I'm the executive director of the technology ventures office at Beth Israel Deaconess Medical Center, which is now morphing into the Beth Israel, Leahy health ventures office, as we merged with Unknown Speaker 27:48 Jocelyn and Leahy years ago. I'm also a lecturer on medicine at Harvard Medical School. Next slide, Unknown Speaker 27:58 so Unknown Speaker 28:00 we have an IP policy, as all institutions probably do. And the ours is, you know, it's IP developed by BMD first personnel outside for outside consulting agreements. And this is ours is quite strict, even outside of normal working hours or off campus, still has to be assigned to BIDMC with certain exceptions. So Unknown Speaker 28:26 and they also have outside activities in general have to be reported in the COI disclosure system, conflict of interest disclosure system. So this is a tricky point, the first one on IP, especially now post COVID that everybody's zooming as we are today, and people are working from home and all over the place. So the question is, are you working on your time at the institution or for the company? And because that's not so clear, we take a default that they have to assign any IP to us, and then we'll, you know, can address a waiver if there's a particular reason. There's other reasons why we do that too, I'll talk about later, and Unknown Speaker 29:08 that we have this addendum that we like that Irene mentioned that we have to add two agreements, and it is generally recommended that these outside consultant agreements should be reviewed by the BMC Office of Compliance and business conduct. They only review those for compliance with our rules, because the addendum says everything in the agreement has to comply with the rules. But it's not good to have an agreement where many of the terms don't comply with the rules, and there's addendum that reverses that. And we've even seen notes from outside counsel of a company saying, well, the addendum says it's the opposite, but since it's an addendum, the body of the agreement would rule. So we don't care about that. So anyways, it's a we our COI office reviews these and often puts light red lines in where they put the. Unknown Speaker 30:00 Words subject to the addendum, in front of critical clauses and cross off certain things. So even if the addendum would rule it's good to make sure the company understands the limitations of what the consultant can do. So that's why we do that. Now it is true that the PI should have representation of outside counsel, but they almost never do. And sometimes, for free, we give them our two cents reminding them, I'm not a lawyer. Certainly don't let anybody in our team do that. But sometimes I say, you know, some of these things are kind of onerous. You might want to consider crossing this off next slide. Unknown Speaker 30:41 So they all must state the outside consulting agreement that they won't make use of our vid, DMC time resources or proprietary information, and it won't involve students, employees, postdoctoral trainees, or any any other personal personnel other than the consultant. I mean, this is to protect the IDMC and the pi and the company, so they agree with that. And then there's other ones about Unknown Speaker 31:13 granting Authorization for Use of video recordings likeness Unknown Speaker 31:18 that we may or may not want to have in there, but certainly not to influence the healthcare perfect practitioner to prescribe a product. So it gets pretty, pretty tricky when you're talking about an MD, and we have some outrageous ones that come to us, where we get proposals to be a center of excellence, where our PIs, and that's more at the IDMC even, but where the PIs Unknown Speaker 31:44 are going to promote the company and do webinars for the company. And we were just like, we stopped those right away, usually, because it's just not what they're supposed to be doing as part of Harvard professors and members of our medical team. Next slide, yeah, Unknown Speaker 32:03 yeah, so sorry for the small letters, but hopefully, if you get a copy of this presentation, these might be useful. There's levels of strictness for IEP assignment that I've seen out there in outside consulting agreements, and we have the most strict number one, where we're saying you can't assign any rights in intellectual property, whether patentable or not or copyrightable. That usually draws the attention of the company and they want to negotiate it, which sometimes we do, but our first offer is no if there's going to be an assignment of IP, it's not going to happen through the consulting agreement, As Irene mentioned, it would be through a sponsored research agreement or a collaboration agreement. Then there's the moderately strict which we have where we carve out a field. And this happens a lot. Let's say the company works on a particular drug that they already developed. It's already existing, and the field is in the consulting is narrowed to that drug, then we sometimes allow them to assign for new uses of that particular drug, and new like clinical trials with that drug, because we're not so concerned about clinical trials and new uses, as opposed to if they're doing innovative work where they're developing a new compound. Then then we really want to own that if you don't have a wave a waiver for uses of the company's existing compounds, then it can really cut down on their ability to do a lot of this clinical consulting, which is important for them, but also for the field. And then the least strict, which I sometimes people do, is just says, Oh, they can assign anything to the company, as long as it's during the consulting hours. And we feel that's very unfair. Cause a lot of issues, but also the it's not a good deal for the consultant sometimes, uh, our PIs are mad at us for saying, oh, you can't do this. But then we tell them, Well, if you assign it to the company, they pay you $1,000 for three hours and they own it, you get nothing if they assign, if you assign to us, and there turns out to be something coming out of this, then you get your inventor share. So they realize that, and then tend to like our, our position, at least the PIs do. So does what I have to say about IP, and I think that's the last slide. Unknown Speaker 34:22 Yeah. Great. So we can we leave it to hammy to talk about opening the floor for questions. Unknown Speaker 34:29 So anyone has any questions right now, or should I wait for a few minutes while you ponder? What I've done is I have listed some questions out there and some issues and some comments that you guys might find useful. So if you get I'll keep the slide on so you can pick and choose if there are questions in there which match your interest. Second, wait for a minute, you know, for a few minutes to see if anyone is interested in a question. Yeah. Unknown Speaker 35:00 Yeah. Unknown Speaker 35:03 Okay, I guess that, you know, I Yeah, if I may, one of the things that that comes up in these consulting agreements we haven't touched upon, too, Unknown Speaker 35:15 is the concept of prior intellectual property, where you'll see consulting agreements that have clauses in there that they want a consultant to disclose to the company every single invention or discovery, know how, etc, that the individual consultant has brought to the table before the effective date of the consulting agreement. In many cases, that could be extremely problematic, because there is a balance of, Do I own it? Does the institution that I'm affiliated with own it? And the company's language typically says something to the effect of, well, if you don't disclose it on schedule a one, then we don't consider it your prior intellectual property, and we're going to try and scoop it up to the extent that you perform any services for us under the agreement that's in any way related to that. Unknown Speaker 36:11 If I'm representing the institution or the individual consultant, I resist that and basically go to a generic prior IP, which is whatever I owned or whatever the consultant owned prior to the effective date, with respect to the field, with respect to the services, with respect to anything outside the services is entirely the consultants, and nothing gets assigned to the company with respect to that prior intellectual property. Unknown Speaker 36:39 But that sometimes can be a big Unknown Speaker 36:42 point of negotiation, Unknown Speaker 36:46 right? Unknown Speaker 36:48 So donville, do you see some questions? Do you want me to I don't think I can open them, but if you can, you can ask the question, because I can't see it. Yeah, it looks like there's five under the Q and A Q and A one Unknown Speaker 37:01 under the chat. Unknown Speaker 37:03 So Don will you want, do you want to just ask the question or just repeat the question? Or how do you want to go? Sure. Okay, first question I see is, do you advise a consulting agreement and a sponsored research agreement with the company? What are some considerations if you have done this before, thank you. Unknown Speaker 37:25 So it's a two part question. Unknown Speaker 37:28 I would say if they're going to be Unknown Speaker 37:33 a personal consultant, I would not recommend mixing that up with a sponsored research agreement, but it does happen, particularly if they're sort of a Unknown Speaker 37:46 founder of the company, and let's say there's a SBIR. So they could do Unknown Speaker 37:52 both, but it's best to separate their you know, to try and if it's SRA, the sponsored research agreement can include consulting. Part of the work plan could include the consulting, right, but, but, but Todd under, under the sponsored research agreement, that's a party that includes the institution, yes, institutions getting the funding for that, right? So, you know, it could very well be, and I've seen the separate consulting agreement, but those are highly scrutinized, right from the institutional perspective, to make sure that there's no overlap. Because if you know Beth Israel is saying, Okay, we're going to give you some of our resources through a sponsored research agreement. You don't want a bunch of of consulting agreement work going out the back door there through a consulting agreement that you're not getting paid for? Exactly, yeah, yeah. I think the only time I've seen it is when, as as Todd said, when it's a startup company that is funding research and the faculty members on the sab and has a consulting agreement, they would have to be closely coordinated to avoid, Unknown Speaker 38:59 you know, having having terms that conflict with one another, and also there's often equity involved in that situation, if they're a founder and an SAP member, and then we have to deal with the conflict around the sponsored research. So those would be highly scrutinized, but, but we've done it. Unknown Speaker 39:16 Great. Any follow up questions, a question on that, folks? Unknown Speaker 39:21 Okay, Don will. There's a question in the chat button, do you see that? And then there are some in the Q amp a yes, there's, there are quite a few in the Q amp a box, yeah. So we'll keep working through those, and then we'll move over to the chat. The next question from Scott is, how does an institution obtain indemnification when it is not a party to the consulting agreement. That's an excellent question. Scott, from my perspective, what I've seen is that when an institution does that, there we insert a third party beneficiary clause whereby the institution is a third party beneficiary. Unknown Speaker 40:00 And can enforce its rights under the agreement pursuant to the you know, what do you whatever you want to call it the writer, the addendum, the appendix that has the conflicting provisions that govern any Unknown Speaker 40:14 conflicting provisions, I should say, in the consulting agreement. So if you have that third party beneficiary in there, then the institution can get that indemnification language. It's an aggressive approach. Not all institutions seek to do that, but as with everything in this world, there are different gradations of strict, less strict and openness with respect to these agreements and institutional policies. So that's basically we insert a third party beneficiary clause in the air and get the indemnification that way, because what we don't want, and one of the concerns that individuals also have, with respect to indemnification, is that they've done nothing wrong if they don't have indemnification, but they get sued simply because their name is associated as a consulting agreement on a service or product that injures a patient or an individual, and they seek redress through the legal system. There's no indemnification there, the consultant purportedly could be out 10s, if not hundreds of $1,000 in legal fees alone just to extricate themselves from the from the case, Unknown Speaker 41:32 even if it's a specious lawsuit, and without indemnification, Unknown Speaker 41:38 they're out of pocket for that which in many cases would be far exceeding any compensation to get under the agreement. Unknown Speaker 41:47 Okay, Unknown Speaker 41:49 any follow ups. Unknown Speaker 41:53 So Don maybe the next question at the Q A Hannah asked, How do you reconcile not reviewing, advising on consulting agreements with requiring all these provisions if the institution isn't involved in negotiating the agreement and isn't a party to it, what's the mechanism for putting in the rider, redlining, etc, Unknown Speaker 42:18 right? Well, in my case, what I always do is I put in a paragraph that says Unknown Speaker 42:24 the consultant is a professional staff member of X institution and subject to their policies on conflicts of interest, intellectual property, et cetera. If they're a Harvard Medical School Unknown Speaker 42:37 faculty member as well, I include HMS policies also putting that in there. We just put in there that the purpose of this paragraph is to ensure that this agreement is in compliance with those policies. And as a result, attached is the two page addendum that governs any conflicting provisions in the agreement. And by doing that and also putting in the clause, usually at the end of contract where it says something to the effect of this agreement represents the entirety of the contract between the parties and agreements with respect there too, we put in there this agreement together with the addendum attached, serves that purpose. Unknown Speaker 43:22 I can answer that for how we do it at Children's Hannah. So we Unknown Speaker 43:28 so the faculty are required to to go to the Office of General Counsel, and they add the addendum on, Unknown Speaker 43:38 um, you know what? Ha so. And the addendum says, essentially, Unknown Speaker 43:44 the terms of this rider to the core consultantly contract supersede and amend, in their entirety, any conflicting or contrary terms regarding similar subject matter. So Unknown Speaker 43:58 the theory, I don't know if it's ever been tested in court, is that the rider will supersede the terms of the consulting agreement. Unknown Speaker 44:08 Are there? Is it sort of a leaky process? Because I think you asked the process question, and I think it is because I do know there are faculty who sign consulting agreements that have not gone through the OGC process. To date, we have not had any conflicts. But I can imagine Unknown Speaker 44:26 that we that we could, over time, where a faculty member would assign patents to a company that they, you know, in our review, didn't have the right to assign, Unknown Speaker 44:36 but we haven't. We haven't had that issue. Most of the faculty go ahead and, you know, go to the OGC and get that their addendum added on. Unknown Speaker 44:48 But I know that some that some don't. Unknown Speaker 44:52 So, so we have, we have a training module that tells them that they have to take when they start at the institution, that includes a. Unknown Speaker 45:00 IP, and it tells them, reminds them, or indicates you have to have this addendum, because, of course, we have a lot of policies, but who can read all those policies? In any case, we the interesting ones have come up where there is no patent, or it's know how, and we usually hear about it later if they didn't sign the addendum, or if there's a question with IP when the company is successful, if they're working with the company, if it's a spin out, or if they're consulting for another company that grows, and they're doing a next big round or going public, then somebody comes and says, This looks a lot like the work your PI did at Beth, Israel. And they come to ask us to assign the agree that they're allowed to sign all those rights to them. And we usually say, well, in fact, you're not. And then we negotiate some sort of, you know, stock or some something for BIDMC in that discussion before we let them have the IP. Unknown Speaker 45:56 So I have a question. Why we are talking about this. I think we talked about it earlier. What about the, you know, the collegial risk people just, you know, the company, just chatting with a consultant, and before you know something, you know, there's been a eureka moment, and something's come up out of that to chat. So do you guys want to address that? Because a lot of it is, you know, just chatting, and it's hard to follow that or to even enforce the agreement in that because there is no agreement. So if one of you, or all of you, can address that issue, that would be great. I think in in our case, in those situations, we rely on our IP policy, right? And the faculty sign a participation agreement, and we have a IP policy that they're subject to, and the hospitals tend to have very broad IP policies. Todd, I'm sure this is true at bid. MC, too, where we more or less say anything that you invent independent of the circumstances of invention belong to the hospital, so the faculty member doesn't have the right to assign, and if they did assign, then we have, in many cases, challenged it, what, where? What we find more often. And we've had a number of situations like this, the faculty member does consult the company files a patent and does not include the faculty member leaves them off, Unknown Speaker 47:22 either through consulting or confidential, under confidentiality or totally collegial with no agreement. And we've, you know, sadly, had a number of situations where we found, Unknown Speaker 47:34 you know, upon publication of the patents that our faculty members work has been patented without, without acknowledgement, or, you know, not including them as an inventor. So there's, you know, there's no assignment, like Todd said, and we've had to, we've had to kind of come, come to, you know, resolution with these companies. And we have, and we've, we've, you know, gone into, you Unknown Speaker 47:57 know, negotiations, and Unknown Speaker 48:00 in some cases, a level of mediation. And we usually do resolve it with at least some level of joint ownership and acknowledgement that they've left our you know, that our inventor is a true inventor, but those have been, those have been, you know, really challenging to work out, but that's what we do. We we rely on our IP policy. And it is, it is pretty broad. So it it does give us the ability to Unknown Speaker 48:24 to make the case that they didn't have the right to assign or that that is subject to our to our policies. I Unknown Speaker 48:33 have a follow up to that, but there are more questions. So donville, please do go ahead there. I don't know. We have 10 minutes left, so I want the questions answered first before I have a follow up to that. Unknown Speaker 48:46 All right, our next question, are there any specific considerations when a PI wants to apply for SBIR with a company down the lane, but start with a consulting agreement? Unknown Speaker 49:02 So so we do that. I mean, if they do it right, they they've already put when they have a if it's a company they started, and this is the trick, is they don't often they should have a consulting agreement with the company. But if they just started with their friends, sometimes they just start doing and they don't realize, okay, we got to set a consulting agreement. But if they do have a consulting agreement, they should attach the addendum, and then the consulting they do has to be assigned to us. And then when they do the SBIR, though that language is the NIH language that says that, you know, we would the institution would get assigned the rights to things they did under the SBIR. The company would get it from its own employees, but we would get it from our our people for the work done under the SBR. So those work out if done properly, okay? They wind up having to take a license from the work done under the SBIR if they wanted whatever the terms are. They usually have to pay if they want an exclusive license to the work. Yeah. Unknown Speaker 50:00 Yeah. Now the interesting one we've had is when there is no IP. So we had a company that was spun out, and they have a product on the market. And they said, well, there's no IP. We just want a letter from you saying that nothing else was taken from the university. And we said, Well, why did you hire our people? They seem to be accurate experts in this field, and they stand and I said, is your product on the market? They said, Yes. I said, Well, why did you hire our people? They said, well, it wasn't working when we started. And I said, is it working now? They said, Yeah, it's working. I said, Well, somewhere between when it wasn't working and it's working was the know how that you got from us, and we wound up getting 2% stock in that very successful company? Unknown Speaker 50:40 Great. That's just for a know how? License, excellent. Unknown Speaker 50:47 Don't know the next one, all right. The next question is from Luna regarding the writer mentioned that some institutions require in consulting agreements. Is this something that you have publicly posted or something that is shared one on one of our requests. I assume this language was developed with some council, general counsel for the institution, rather than external IP council. Unknown Speaker 51:16 So I don't actually know if we publish our rider. I'm guessing that we don't but it is, it is managed one on one, between the researcher working with our General Counsel's Office. We have a, you know, a process for managing that, and our General Counsel's Office drafted the rider. Unknown Speaker 51:37 They may have gotten advice from outside counsel, but the the GCS office is the one who drafted it. I can find out it, you know, if you're interested in us sharing it, I can find out if, if our GC would have any problem with that. I honestly can't imagine why they would, but I would just want to check Todd, how you do it. I'm sorry, we share all. I mean, TDO shares all its agreements. So, yeah, we would share that to people if they wanted to ask about it. Because, yeah, we would share it if they want to see it. Yeah, I know that some of the institutions that I've represented have all of their policies online. Some of them are exhaustingly long, such as intellectual property policies, conflict of interest policies in some selected forms. Unknown Speaker 52:25 Also, some institutions have their own short form or long form consulting agreement that complies with all of the policies. So if the consultant wants to generate a consulting agreement and give it to the company first, Unknown Speaker 52:39 as I say, Some institutions have model agreements that are totally compliant, Unknown Speaker 52:45 but again, in those instances, those agreements protect the institution, but not necessarily the individual consultants. Unknown Speaker 52:56 Okay, Unknown Speaker 52:59 yes, Unknown Speaker 53:01 yeah. Next question. Okay, the next question is from Hannah regarding the background IP. Often the language asks the consultant to disclose prior IP that they own, but often the consultant doesn't own earlier developed IP the university slash hospital does. How should that be handled Unknown Speaker 53:24 well, you know, from my experience, when I encountered this type of situation, obviously the lawyer that's reviewing on behalf of the consultant has to know what the prior IP is and whether or not the consultant owns it or not. If it's institutional, it's a non starter for the institutional they're not going to assign that because that was entirely on on the institution side. So that gets carved out of the agreement. With respect to personal IP owned, again, I don't like listing, because if you list and you forget something, or you you just don't list everything, it can lead to a perilous situation for you with consequences. So I like language that states basically that no institutional IP whatsoever is being granted under this prior IP clause, prior IP owned entirely by the consultant, remains the consultant's IP, and the only IP that is getting assigned, if permissible under institutional policies, to the company, are those that are done during and in the performance of The services as narrowly defined under the agreement period. Unknown Speaker 54:45 I also like to you know, discuss it just a gem that Irene mentioned to me about the seemingly their policy that is perhaps you should have when people do outside consultants, it's best for them to be on a Scientific Advisory Board. Unknown Speaker 55:00 So it is kind of problematic. No matter what the agreements say. If they're doing research, they put on their gloves and start doing research or an invented thing where they're, you know, coming up with ideas and compounds. That is, is going to be dicey. No matter what the agreements are. If they're on a on a high level Scientific Advisory Board, it's much easier to give their general advice and leave it to the scientists of the company to do the inventing, and that avoids, perhaps some of the government the conflicts, or the rules of federal funding, where you can't do research in the exact same field as your lab for a company. Unknown Speaker 55:37 So that's my advice. Is to do that is to restrict them as possible, unless they have some big permission from like the chair and the head of the TVO that they're not going to be a research scientist at one of these outside consulting gigs. Unknown Speaker 55:53 So donville, we have four more questions, I think. And if you can go through those four quickly, then I think we'll reach our goal of like, one, you know, at one o'clock. So I don't, I'm respectful of everyone's time, so I don't want it to be to go over too much, but, and by the way, anybody who has any questions, I have emails for all the three panelists, so you're welcome to email them to get answers to your questions. And Unknown Speaker 56:19 I just saw one question of, do we have outside counsel we recommend? And yes, it's Jamie Wachter. Unknown Speaker 56:29 I've known Jamie for, like, I don't know how many years, a long time, 30 years, maybe a long time, let's just say a long time. Unknown Speaker 56:38 Amy, yeah, and then he used to do the Brigham consulting agreements, and I think that's general also. So anyways, donville, quick, quick questions, and then I think we are done. Alright, our next question. Excuse me. Unknown Speaker 56:53 Just so that anyone wants to email me, under the email, my email is incorrect. It's Jay, the initial J, watched that Davis mom. Oh no, I forgot the Jay. I'm sorry. Sorry, that's okay. I just want to let people know that they'll get a bounce back if they don't include the J You can blame me for that. Unknown Speaker 57:13 Our next question, do your offices offer consultants a list of suggested attorneys to review consulting agreements. Unknown Speaker 57:24 Yeah, I get some referrals from some institutions, the tech transfer office, however, it's named simply because Unknown Speaker 57:33 I'm familiar with their internal policies, so I can make sure that the consultant is aware of their obligations to the consultant, to the to the to the institution. The only thing that's tricky with respect to that is whether or not I also represent the institution, in which case we usually put in the engagement letter A clause, something to the effect that we're going to represent you to the best that we can Mr. Consultant or Mrs. Consultant. But what we're not going to do is we're not going to represent you to the extent that there is any conflicts with your institution. Unknown Speaker 58:09 Rarely, if ever, does that happen. So Unknown Speaker 58:16 go ahead, Unknown Speaker 58:17 have one more question. How has remote work impacted consulting agreements. Unknown Speaker 58:26 From my perspective, I don't see how it's how it's affected consulting agreements in the least bit, I work 100% remotely myself, so I do all of my work on behalf of institutions, companies and individuals Unknown Speaker 58:44 from my upstairs office, and I haven't seen anything that in any consulting agreement where Unknown Speaker 58:52 consultants have been told that they have to be anywhere in person with respect to the company, except for certain high level meetings Unknown Speaker 59:03 and and that raises other questions about Unknown Speaker 59:08 fraud and abuse with respect to what they're going to be compensated for, as far as travel, meals, things of that nature, which is another area of scrutiny, kind of, kind of a corollary to these consulting agreement provisions. Unknown Speaker 59:24 So I have one last question, which I think is very interesting. Donville, so from my selfish point of view, I was hoping the panelists could answer that. So could you Unknown Speaker 59:33 repeat say what the question is? Unknown Speaker 59:39 Donville, okay, all registered one second. Where did it go? Unknown Speaker 59:45 Yes, the requirement that investigators assigned to the institution assumes the work is within the scope of their work for the institution. How do you define that? To Irene, point that consultants. Unknown Speaker 1:00:00 May be important to advancing licensed IP the work they do for the company may be very connected to the work they do in the lab, but further along in the development process, ie not work likely to be done in an academic land, in an academic lab. How do you draw the line? Unknown Speaker 1:00:21 If I can jump in, because it's a really, it's an excellent question. Kids and the at Children's, we take a very broad view of what's within the scope. And there's actually a definition in our rider, and it's pretty much anything that they do Unknown Speaker 1:00:38 related to their appointment, their job description, customer responsibility, on and on and on. So it's pretty broad, Unknown Speaker 1:00:47 and so it does lead to conflicts. In the case of startup companies, what we what we've done sometimes successfully. In fact, more often than not, we've been managed to do this is to define in the license agreement a consulting invention. So made you know on which the consultant is an inventor, and we agree to Unknown Speaker 1:01:09 add those to the license at no additional cost. However, they will be subject to royalties and so forth, right, roll it into the license. And we've had some success with that, with startup companies, and when we do it, we don't do it in every case, but when we do it, it sort of reduces that, not Unknown Speaker 1:01:28 100% but reduces that anxiety they have that the consultant is going to develop something that will block them or that will hold them hostage. For some, you know, huge payment, because the payments are already determined ahead of time. I would say they would way prefer that we just assign it to them. But if we're not willing to do that, this kind of concept of a consulting invention being basically pre option to them has been the way we've we've navigated that in in some cases. Unknown Speaker 1:01:58 So I'm here, guys, but the last question, I swear, the very last question, you guys had mentioned horror stories. Can anyone share your horror story in the last minute? Unknown Speaker 1:02:09 Those that's a whole other session on horror stories. One story each would be good. Irene Unknown Speaker 1:02:16 Dodd, well, somehow, particularly young people, but in general, people think somehow that software doesn't count. So we often, more recently, a rash of people to say, oh, yeah, develop this software. It has to do with where I work here, but I wrote it at home, or my husband wrote it and he's a programmer, and think they own it, or all like it's, you know, they know when they're working in a lab that we own it. But there's a lot of software things that people just assume that it's only software and they developed it on their own. They should own it, right? This sort of relates to the earlier question about remote work and how it affects the consulting agreements, but this would be a good example of how it can Unknown Speaker 1:02:59 Okay. Thank you all. If you have questions, please do send them to the Unknown Speaker 1:03:07 panelists, and once again, thank you all for participating. I hope you all have been have learned a little more about this exciting topic and from our learned and illustrious panelists. So thank you all and have a great afternoon. Bye, bye. Take care, everyone. Unknown Speaker 1:03:25 Bye, you. Transcribed by https://otter.ai