Thank you, Ashley. We have a great panel today, with panelists from both the UK and the US.

And we hope to have a lively discussion with questions from you, the audience.

Before we introduce the panelists, I'd like to set the table with a little bit of history.

The long-standing and strong relationship between foundations, also known as charities.

And academic research institution has been complex. As background, in May of 2000… When foundation-funded research was the fastest-growing funding sector at U.S. Universities.

Snaverd held a small meeting with about 4 other universities.

to discuss how to enhance constructive collaboration with foundations.

The result was a short document. Entitled, Points to Consider When Universities Partner with Foundations.

colon, a university perspective. This four-point document emphasized working together on questions of IP control.

revenue sharing, indirect costs. All from a university perspective only.

In order to broaden the conversation, the next year, 2014.

Uh, Stanford hosted a much bigger meeting, which included many foundations, big and small, and many universities from all over the country.

to talk about the issues that can be sticking points between foundations and research institutions.

A second document was written and focused on IP.

It was entitled, this is a long title. A proposal for new principles and agreements for management of intellectual property.

Arising from research institution programs supported by disease. Foundations.

There were 7 points in this document addressing specific issues around IP. For example, what is the definition of a foundation invention?

So ultimately, I don't think. Anything really came out of the documents or the meetings.

So here we are today, more than 10 years later.

to share various perspectives, and to see if we can continue this discussion as to strengthen our collaborations.

So let's have the panelists introduce themselves. Not who?

Thank you, Kathy, and thanks, Catherine and the team. And my name is Madhu. I am the Head of Charities and Patient Engagement at LiveHeart.

I am a repurposed academic scientist. I moved into tech transfer quite a long time ago.

been in IP consulting, and then moved to LifeArc about 14 years ago, which is, um… so LifeHark is a not-for-profit charity based here in the UK, uh, with our own research and development capabilities, and a mission to create impact for patients.

Specifically in the underserved areas, and we use our funds and expertise to bridge the gap between academic discovery and clinical development.

Uh, through convening, you know, researchers, funders, and the patient voice to translate these early discoveries to the clinic. And I have been leading on a program that has been long-standing here at LifeArc.

Which engages with over about 200 charities. And trying to sit as an honest broker in between to understand and.

Essentially, look at how foundations, charities can engage with institutions and navigate these challenges. I look forward to this webinar.

That's great. Catherine?

Thank you, Madu, and thank you, Kathy. Um, Catherine Doe here. I'm a Senior Program Officer at the Gates Foundation.

Um, I'm the industry and technology transition liaison in the water sanitation and Hygiene Division.

The Gates Foundation is a private foundation that has invested in research and development to achieve.

a charitable impact for the people most in need.

Um, at the WASH division, I'm responsible for managing all intellectual property flows and licensing between the foundations.

technology partner and potential commercial partner who will commercialize the technology.

Before joining the foundation, I work at the tech transfer office at Harvard and Thomas Jefferson University from mid-1990s until 2015. Over to you, Kathy.

Tony?

Thanks, Kathy. Hi, everyone. Yeah, I'm Tony Hickson. I'm the Chief Business Officer at Cancer Research Horizons.

We are a wholly owned subsidiary of Cancer Research UK, and Cancer Research Rises acts as the tech transfer arm of the charity.

The charity, the foundation, funds about £400 million worth of cancer research in the UK and beyond.

every year, so he's a major funder of life science research in the UK. And my background, a bit like Catherine's, is prior to being at CLUK for about 8 years, but prior to that, I was 15 years at Imperial Innovations, the tech transfer company of Imperial College London.

And Catherine, you have a much more interesting background than me. I need to get one like that.

Ming Jing.

I am mentioningly, um, am a senior licensing manager.

at the Stanford Tech Transfer Office. Uh, I've been with Stanford for a little over 5 years.

happy to be here, um, and looking forward to a great discussion.

One of the things that came up, um, in our pre-discussion was that 50% of public life science research in the UK is funded by charities.

And in the U.S, the AAU says that private foundations represent about 6%.

of academic R&D funding, so it's quite different in the U.S. From.

the UK. So I'll just start with the… Biggest issues. Um, I think the two biggest issues for academic institutions are, one, the indirect costs.

And the royalty sharing. Interestingly enough, these two issues are also now causing big problems in the U.S. With the federal government.

Thinking they also want to reduce indirects and possibly get a share of royalties.

So we'll start with mincing, um, from Stanford. What are your perspectives on this?

Uh, yeah, thanks, Kathy. Um, so first. Um, you know, I want to.

give a quick overview of our process when we work with foundations.

So we have a separate office called Office of Sponsored Research.

who is in charge of negotiating all the agreements with foundations.

And our office, the tech transfer office. Um, usually helps with IP term reviews.

Um, so, you know, in terms of. Indirect costs and revenue share, I would say that.

You know, indirect costs. is mainly, um… negotiated by our Office of Sponsored Research.

Um, but, um, you know, we all want to acknowledge that, you know, the indirect rate for federal government grant, I think for Stanford this year is about.

54%. But the foundations, you know, they pay much less indirect rate.

you know, I don't know the detailed number, but I think the range is around 10%.

So, you know, there's this almost. four or five times difference in terms of indirect cost.

Um, and, you know, at least for now, you know, the federal government, we're not sharing any revenue with the federal government, right?

So, um, I think as you can imagine, just based on the fact.

Um, I just described. Um, you know, there's some concern with, um, the universities.

sharing revenue with the foundation. That being said, I think one thing we want to.

um, considers in terms of revenue share. Um, I think first, you know, the portion we're talking about here needs to be limited to whatever the university receives.

from the licensing of the invention funded by the foundation.

Um, and also, um… you know, we'd like to deduct, you know, certain standards.

from the gross income. For example, you know, if there's a difference in indirect costs.

Sometimes, between the foundation and the federal government. Sometimes we take that into account.

And then we also want the foundation to acknowledge.

Um, the effort, the tech transfer office used. Um, to market and license the inventions.

And also. Um, you know, the risk we take, you know, to bear all the patent costs.

So, you know, consider deducting admin fee for the tech transfer office.

As well as, you know, patent costs were costs related to commercialization.

Um… Yeah, so I think there are concerns, but we do have flexibility, and we… you know, hope the foundations.

Um, can be flexible as well, you know, when we negotiate.

Um, revenue sharing terms.

So, Tony, I'm curious, do you ask for a royalty share?

Yes. Yeah, so it's… I think it's a little different in the UK, um.

And what?

So, uh, in terms of, um… Indirect costs, first of all, obviously the government is funding.

Not all of the universities, not all of their costs, but most of them.

And the government obviously cares very much about research and teaching and civic.

duties and local economic development, and all the things universities do.

It's a little bit different for research charities who are focused very much on their donors.

And that particular, say, specialist disease that they are funding.

So they're not… they don't necessarily see themselves there as needing to support the overall overheads of the university, but are more interested in the particular piece of research that they're funding.

And showing that their donors, that the money that's been given is being spent particularly on that particular piece of research. It's very important for them.

to be able to account for that. So that's part of the, probably the genesis of why.

charities, certainly in the UK pay, um. Virtually no overhead or indirect costs.

Hmm.

Um, the… the way it works in the UK is, in order to recognize that the government provides a separate fund called the Charity Research Support Fund that then tops up.

universities to account for the fact. that charities are not funding the full indirect costs.

Now, it doesn't… it's fallen behind in terms of inflation, so it probably is not providing, it's not completely covering the gap.

Which means it's still a source of concern for universities in the UK.

Um, but nonetheless, there is at least an effort to acknowledge that, and the reason it is probably acknowledged in the UK is because charities are such a big proportion of life science funding.

you know, you see charities finding a lot of research in life sciences, you also see them in, sort of.

social enterprises, poverty, you know, sort of, um, food, that sort of thing. You don't tend to see them funding deep tech research or engineering research. You know, it tends to be in those sort of areas.

But there's over 200 medical charities in UK funding, as Cathy said, 50% of all the life science research, so it's very important that.

Yeah, an accommodation is reached between universities and charities.

And so that's, I guess, where we've got to on indirect costs. As I say, the universities generally are still.

dissatisfied with that arrangement because they're not getting. fully topped up by the government in terms of that.

In terms of revenue share, um. There is an organization in the UK called the AMRC, the Association of Medical Research Charities. It sort of acts for all 200 of those charities.

And exactly the same as Kathy described at the start, it brought everyone together in 2020 as it happened.

the universities and the charities, because this was becoming an issue.

Uh, around, sort of, differing attitudes from different charities.

And try to sort of thrush out an accommodation. And part of that was general guidance that charities would get 50% of.

revenue share after costs were deducted by universities, and it put out general guidance on that.

Um, so that is the general mechanism that every charity negotiates around that.

So that's just the starting point, but that's the general, sort of, starting position.

Of course, the reality is a charity never receives 50%, because it very rarely will have funded 100% of the research.

So there'll be a pro rata adjustment down as to what they actually get at the end of it. But that is the sort of general mechanism in the UK, which I understand is very different from that in the US.

Catherine?

Well, actually, for my division, actually, we do not ask for profit sharing.

Um, what we care about is the technology can.

you know, reach the people, um, most in need. So, my answer is very short, uh, we are not looking for profit sharing.

We want people to have access to the technology.

Um, over.

And what indirect do you usually?

Well, we actually, um, has a… Has a policy, the indirect cost is 15%.

Um, and so that's, uh, regardless, uh, you know, you are a for-profit or not-for-profit, um.

institution. And, you know, for, um, I… I cannot say I speak this, you know, on behalf of the foundation, but.

Um, you know, usually when we tap on the PI to conduct the research.

we are expecting that the PI will be equipped, so that's why, for me, you know, the… Indirect costs is kind of like… I won't call 15% a minimum, but we do not believe that, you know, we should.

be paying for all those indirect costs. But with this say, I do understand from the, um.

When, um, on the, um… uh, you know, university's burden. I do feel the pain, so don't get me wrong, I do want to say that, right? Somebody needs to pay the utility to the bathroom everybody is using.

Oh, okay. Madhou?

Yeah, I mean, I think Tony's really… articulated what we do here in the UK, and from LifeArc's perspective, we are actually going through.

Uh, a little bit of assessment at the moment to develop a funding framework that kind of talks to.

What we'd like to do in the future, but at the moment, we don't fund the indirect costs, and um… Again, I think the discussion has been around how to make it fairer, because things are changing.

Uh, whether we might move towards, you know, the gates approach or not.

Remains to be seen, but I think. Fundamentally, you know, it's, it's, it's… We've been following the MRC guidance and aligning with, as Tony said, the Charity Desert Support Fund, which is the government initiative and the mechanism to do that, but avoid largely duplication of overhead recovery. But I know that, you know, the other big funders like Wellcome are also trying to do.

and align. However. I think the point here is… trying to understand that.

as, as, as, you know, um… classroom put out, you know, it's… somebody's got to pay for the compliance and infrastructure. Without them, the research delivery will fail. And each charity, again, from a UK perspective, being disease-focused, or in our case, slightly broader.

with a few challenges associated. I mean, disease-focused challenges that we are trying to resolve.

Our approach might be tailored in a different area. For example, we have, you know, we're now completely pivoting towards rare disease.

But then there is a slight related one, which is in global health, where we may take.

Uh, you know, a different view. So, horses for courses is our approach at the moment, while trying to sort of maintain that AMRC and.

Completely aligning with what the UK is trying to do as well.

So how can we make it fairer is the thinking around that.

I think Tony has his hand up.

Yeah, Tony.

Yeah, I was just gonna add one thing, I think the context is important, isn't it? That not all… just as not all universities are the same, some are more research, some are more teaching, some are more student duty.

Uh, not all charities are the same, or foundations are the same, and if you just look at the charities on this call.

LifeArc, and, uh, the Gates Foundation are endowment-backed. So they… they're not going out to the public every year and trying to sort of rattle tins and run marathons and raise money.

see how you carry many of the, uh, smaller medical charities have to go out and mass fundraise every year.

And that's a lot of effort to try and do that.

So, they're, uh, being able to at least get some sort of return if there is a successful invention in future, is very important to them in terms of just trying to top up their research income.

Whereas it may be less important to an endowment-backed charity.

I'm curious, um, one of the issues that always comes up is, like, allocation of value.

If the charity doesn't fund the whole invention, which it rarely does.

How do you determine. what percentage the charity should get?

I can… I can try and, uh, jump in first with, I'd say, sort of my bread and butter for the past 10-15 years. I mean.

There is no right way, it's… I mean, you can go down, so fundamentally, you can go down two routes. One is inventive contribution, which is hard to justify, hard to, you know, really hard route to kind of go down. Most charities don't have the resource to actually put, and which is where.

We've tried to help, and looking at it from.

prorating it, as Tony said, you know? We'd like to see what the contribution is.

What… so, the AMRC guidance, if you take that as an example, we always allow… I mean, I think the guidance says 50%, and that 50%.

takes into account the fact that. Indirect costs were uncovered. I think, I think that's the beginning.

After, after, you know, you understand that it starts. And then you take a 50% off, let's say, in a recent case, for example, we had a program which.

The medical research charity funded. sequential programs in the institution that led to two patterns.

the licensing package included 3 patents that were licensed to the spin-out.

Now, the simplest way would be to say, you know.

two-thirds, or 33% of… and then calculate from there. So… and then you bring in calculations of… Uh, what the total funding that went into it.

And then make a calculation through that. It allows for the AMRC guidance, also allows for a nominal.

to Catherine's point, I think… no, sorry, Vincent's point, about Stanford.

requiring, you know, you have to account for the value add from the tech transfer office, so there is a… if you… Just want to call it a technology transfer fee, as it is known in the UK. And then…

you have other deductions that are allowed as direct, so the actual costs that are contributing to the commercialization.

And then you make up. What I try and do is, with most charities, when I help them, we.

add a template cheat sheet to allow that. So you kind of explain what direct costs are, and direct costs are, what is allowable by the charity, and what is flexible. For example, if.

the institution and larger institutions do that here sometimes in Cambridge or Oxford, where they have a dedicated drug discovery program, and if that program actually has contributed, they too would be added to the contributory.

calculations, if that makes sense. And then we come to a conclusion, and to Tony's point, from 50%.

the best I've managed to do for an institution is about 25%, where there was a lot of investment, significant input, as well as an absolutely cracker of a patent that went into a.

A spin-out.

Mitching, you have any experience with, uh, negotiations?

Yeah, I think our end, um… We've seen, like, two different approaches from the foundations. I think the first approach is some foundations.

They have a preset percentage, right? So regardless of.

The contribution of the actual funding. Um, this is the fixed percent.

Another approach, I think, as Mandu mentioned is, you know, proportional to the contribution of the foundation funding.

Um, out of, like, the total funding. Um, so I think there are pros and cons for each of these approaches.

You know, the first, you know, fix the fee, um, you could argue that, you know, in some cases.

Um, the person might not be fair, right? Because sometimes the foundation contributed a little bit, but then you have to agree to the fixed fee.

But on the other side, it makes our life easier.

Because there's no back-and-forth negotiation, talking to the PI, understand all the funding that went into the invention.

Um, because, you know, just a fixed… pre-negotiated percentage.

Um, and then, you know, for the proportional, um.

approach, I think, at least at Stanford, we rely a lot on the PIs.

So, you know, we need to have a conversation with the PI, go through all the funding sources for that particular invention.

understand the total amount, because sometimes the PI, they got confused. They just thought, okay, this is the whole amount I got from this, um… sponsor. But then you really need to guide them and make sure, you know, they give you the amount that actually went into this particular invention that we're talking about here.

Right, so it's a lot of conversation and communication with the PI, understand, like, the total funding.

the contribution of, um. this particular foundation, so that we can calculate the percentage.

Um, and… Um, you know, I know Mandu and Tony, you talk about, like, 50% in the UK, but sometimes in the US, some foundation just said, you know, proportional.

So, for example, if the foundation founded 100% of the research.

That means we share everything with the foundation. There's nothing for our, you know, inventors who conducted the research, nothing for the school and department who supported all the, you know.

utility, the space, the facility. So, yeah, I think it's, you know, a point to think about, you know, if.

directly proportional makes sense. So maybe, you know, we can think about, like, a cap, right? So.

Not to exceed certain percentage, so we still have some.

Left over to share with our inventors. Or, you know, the total.

sharing amount not to exceed, you know, I don't know, 3 times of the funding provided by the foundation.

So I think, you know, something for us to think about.

Um, you know, to make it fair. To all the parties.

Um, so one of the… one of the issues is the definition of a foundation invention, so I guess it's the PI that decides.

Whether the foundation funded that invention? But again, um, do you have issues with that?

Tony?

Yeah, well, I think, yeah, generally it's an agreement with universities, so it is transparency is provided by the university as to what grants went into it, and how the university comes up with the formula.

And then presents its findings to the different charities that funded research, and then the charities generally will accept that, or they.

may argue. Where I've seen the most difficulty is, perhaps, is some very small charities where they have funded a particular PI for a long time.

Mm-hmm.

At the university, um… takes a very strict interpretation of conception versus reduction to practice.

And says, yeah, okay, you may have funded 10 million pounds into this lab over the last 10 years.

But we use this other source of money. To provide the last £100,000, and we filed a patent using that particular grant, so you're due nothing.

And that's very hard for a small charity. You know, that's probably an over-exaggeration, but you can see what I mean. That's very hard for a small charity to understand.

how I got to that position. So I think there's that sense of reasonableness, which is generally provided by the PI.

the PIs generally have a sense of loyalty, and will generally say, no, I think, actually, you know, the charity should get something here, and they did provide some of the lead-up work towards that. So as long as there's that sense of.

reasonableness applied, and no one's too hard-nosed on the rules. Generally, I think most charities can be satisfied that they're.

Like, they… what the proportional share calculated by the university is.

One of the things that I remember being at Stanford that, um, the charities and foundations often thought of the PIs as their PI.

And, you know, of course, the university thought of them as their PI, so… It was a mixed bag there.

Um, one of the issues in the 2014 document that Stanford put out was, um, consent rights before commercializing.

And I'm wondering whether you have that. Madhu, sound like you.

Yes, yes, I mean, and I think, um, that is generally the.

desired, um, sort of approach. And I think, I mean.

And fundamentally, I think the reason for that is.

Again, sometimes it's because of bad practice or some misalignment, that, that.

Um, there is a little friction around that. But fundamentally, it allows for the charities to understand what is.

What has been created. And then take it forward. I think that is the intent.

The flip side of that is, again, you know, Tony's made this point about small charities, it's a resource issue.

Often, and from the institution side. it's not great when it takes a long time.

For the charity to provide a yes or no. And from the charity's perspective, usually it is because they just don't have the wherewithal or the expertise to actually decide on it, and therefore, I mean, that's one of the things we've helped out quite a lot in understanding, saying.

provide a consent with some conditions, and that's… that's it. Again, what we've done and evolved over a period of time is consent based on X, Y, and Z. And what is that usually is reliant on being reporting back on progress. What do charities want? They want to see.

Whatever they funded moving towards the patient. That is the primary motive. It's that patient impact is the primary motive. Again, you know, to Tony's point about disease-focused charity, that is it, regardless of whether it's LifeArc or whatever.

you know, welcome, um… That is the primary motive. Um, you know, gates have clearly said, you know, that is not it, it is about getting it to the patient.

Where we come in, I think, is that hybrid model, where there is some money to be made, and that's where we follow the.

The tax man's guideline here in the UK, you know, as to incidental benefit.

Because of two reasons. One is it's financial, maybe, but more importantly.

the Board of Trustees shouldn't be made to look like, you know, they missed an opportunity here. If a key truth happens, for example.

You know, there's a lot of money that's made, and then… It helps the foundation to be sustainable. So, the consent, it starts with the consent.

So that, um, we have line of sight. And reporting, so that the institutions have the obligation to say, okay.

This is somewhere, because let's face it, you know, 80-90% of the grants might not lead to outputs that require that.

But, when it does happen, when a filing of a patent or something like that happens.

We would like to see where it's going. It's about that line of sight.

To the patient. I think, I think Tony might be able to elaborate, or others might want to chip in.

And it feels like, though, do the charities and foundations trust the tech transfer office?

I mean, they… the Tech Transfer Office wants to see.

The invention, you know, be… Translate it, go to patients.

I think it is understanding and arranging that misalignment, I think, is where it is. And the models in which each area operates, you know, are you operating on a model that is cost recovery?

What are you trying to achieve? And one of the reasons, I think.

at least from my experience in the UK here, is that.

typically, where will you focus? Where will the tech transfer office focus? Depending on the model, will be on, you know, high-value.

patterns where there is ability to claw back something as well. So there is an intent there, as opposed to rare disease strategies that are funding something that is not seen as highly commercially valuable.

So there is a little nuance there. I'm not saying that that is the general thinking, but.

Mm-hmm.

adjusting, and I think Tony mentioned this earlier, you know, we had a… I think it was.

One proper meeting and a group that was formed called the Intellectual Property Advisory Group.

That contained both of the charities and the universities. And these are the things that were discussed to try and see how we can meet in the middle.

How do we overcome the common challenges? And a fundamental thing is about, A, we are both aligned, if you look at it from the highest.

But then we deviate depending on whether it's an institution as a charity.

a disease-focused strategy as a charity, and then see where we can meet in the middle.

the fundamental thing is that the charities typically, unless, you know, you are a CRUK, or large charity, do not have the expertise, the ability to invest in a group that focuses on this. It's usually… I mean, my contacts usually are the head of policy or somebody in a small charity who is trying to understand the nuances of IP and revenue sharing.

And then there is a learning to be there. How… and part of it comes from nervousness of signing something away.

Without understanding. So, even… I mean, there's a new trend here where law firms are actually offering a lot of pro bono advice on this as well.

To try and get them to move things. Such that you meet in the middle, and because a lot of this is not about.

The actual science behind it. There is a lot of to and fro, and how do you make that as smooth as possible against a background of a lot of uncertainty?

How many?

Yeah, and just to add to that, so a consent right is not an unreasonable thing to ask for, providing you know how to use it appropriately.

And I think that, um, you know, what we discovered in the exercise in chatting with the universities and the charities were.

There were some charities who, um, saw a lot of these type of deals, understood how to handle them, could move relatively quickly, make a decision.

Uh, and move on, and there were… other charities who were less experienced with that process.

who didn't know what to do, and would do things like hire a law firm to come in, who would then attempt to do things like, uh.

exert a veto right over the deal, demanding a larger revenue share for them, or trying to adjust the deal terms.

which were all entirely inappropriate uses of the consent right. That's not what it's there for. As Madry said, it's to track.

To ensure they know what's happening to the research, so they can show their donors where this technology is going.

So, um, that AMRC process was deliberately… deliberately calls out bad behaviour.

So it says, if you try and do these things, that is inappropriate use of the consent right. It is not for that.

and tries to almost, um, give, uh, charities who are less experienced guidance.

The other issue was turnaround time. Yeah, if you can have a consent right in these agreements, do your transfer offices, and we've all worked in them, you need to move fast.

You know, you can't sit around by a charity who doesn't really know how to handle the request tries to find someone who can help them interpret the request.

So the other thing the AMRC document did is it used deemed consent, so it sort of said that.

If you are provided with a consent right, you have 30 days to provide an answer.

to the consent, right? And if you have not responded by then.

Then the university's going to get on with it anyway, because we've got patients to think about, and that seems to be generally accepted as practice now.

mentioned you have, um, have you had to… to fight about consent rights?

Uh, yes, sometimes, I think. For us, um.

Uh, in terms of concern rights, I think they're, like.

Maybe two different, um, things we're talking about here. I think one is more for, like, scientific reporting, right? That's the.

communication between the PIs and maybe, like, a project manager.

Um, within the foundation. So, you know, I think as long as, you know, the scientific reporting we're meeting.

Um, frequency makes sense. Um, usually we accept, you know, um.

the terms in the agreement, and then we'll also make sure the PI knows, you know, once you accept this funding.

then this is the frequency of meeting or report on submission to the foundation, just to make sure the PI knows and they're okay.

And then I think a second aspect is more about IEP, right? So, when we, uh… invention disclosure, we notify the foundation, we file patent, we notify, we have.

potential licensee. I think we're happy to keep the foundation in the loop of our commercialization policy, because I agree with what Madhu said.

high level, we share the same goal, right? We also want, um… the technology to go out to benefit the public.

Um, so, yeah, so I think, you know, the communication with the foundation during the process is very important.

Yeah, and sometimes I do understand the foundation just want to know, even if, you know, they have other language in agreement.

all their intent is, they want to know what's going on.

with their invention, or with their funding. Um, I think, you know, I think in general, Stanford, we're compliant with our IP obligations.

But I also agree with what Tony said, you know, in terms of concerned rights, like the.

Um, like, the review time on each side. I think we need to be mindful, because sometimes that can delay the process, right? So, you know, if we see something, like, we don't hear back from you within 30 days, or even, like, a shorter period of time, then we just move forward.

I think that works for us as well. But sometimes, you know, some of the foundations.

Um, I guess they don't quite understand commercialization. takes a long time, right? So Summer Foundation require, for example, you know, one year from the invention disclosure, or one year from the.

first patent filing, if there's no licensee. Um, you know, the university needs to assign to the foundation or grant exclusive license to the foundation.

Um, I just want to say that, you know, that time period is too short.

If, you know, we can, um… give us, like, more time, and even, you know, after a few years.

Um, we're not successful, we're happy to have a discussion with the foundation to let you know, like, all our efforts, the feedback we got, and the difficulties.

Um, we, you know, encountered during the process. So again, I think, you know, open communication.

Um, and being flexible on both sides would help.

Maine, we have a question from the audience. How often do you find the foundations unwilling to negotiate?

the template agreements. Take it or leave it kind of thing.

Yeah, I… I think, uh, in this.

current environment. I would say it might be more often than before, and you know, before, I think.

Sometimes when we tell the PI, you know, these are the terms you have to accept.

In order for you to get this funding, you know, before, I think when the federal.

Funding situation is better. Some PIs will say, okay, then I'm not going to take this.

But then, in the current environment, you know, we felt like RPIs, they also need more funding from different.

sources. Um, so, you know, if some. foundations see that, okay, you know, the terms are non-negotiable. So first, I think we need to assess the risk, right? So if we feel like.

Um, the risk is manageable, don't we. communicate with the PI, you know, this is all the… terms we have to accept.

In order for us to get the funding, so if the PI is okay.

Um, yeah, sometimes we… We do, um, accept.

You know, as long as we assess the risk, you know.

sometimes it's minimal risk. For example, it's unlikely to have IEP coming out of this research.

But I think you need to, you know, look at the whole thing and understand the risk you're willing to take here.

Sounds good. Tony, we have a question about the, um… A challenge grants.

Um, can you tell us about them? sort of in general, and then talk about the… your… your challenge grants?

Yeah, yeah, I just had a look at the question. So, um, Councillor and challenges are, um, global awards. They're $25 million per award. Um, we put out a call.

Uh, every few years or so, they're jointly funded by Cancer Research UK and the NCI.

In the US, and they are… they're designed to encourage team science to go after major challenges in cancer.

So, um, the end result of that is that what we see is that we are funding multiple institutions under the same grant.

In fact, you know, one example is it's got 11 different universities as parties for the same agreement.

Um, the issue with that is that… well, two things. One, if you're going to have an option to take assignment of the IP, you need to be capable, as a charity, of actually commercializing it.

And not many charities have a commercialization arm. But CLUK does. It's got, you know, over 100 people in its transfer offices and focus is solely on oncology.

So firstly, it does have the ability to do something with this IP that it collects.

Secondly, that option is designed to protect against fragmentation.

So you've got 11 parties, all working on the research. There is danger.

that the IP is spread across multiple parties who can't agree how to do something with it. So, in that scenario, Cancer Research Horizons could step in as the spider in the center of the web.

accumulate it or commercialize it, and share it back with everyone.

It is not designed to be implemented if there was a single university with a single pattern. It would probably have a conversation with the university.

It wouldn't have to exercise its option, it would simply take a revenue share and let the university get on with it. So it's a safeguard measure.

It will only be enacted, I think, if we see a very complex IP scenario arise.

Catherine, do you have… you have a grand challenge, too.

The Gates Grand Challenge?

Yeah, we do, and it's really depending on which division, um.

So, actually, I'm gonna… This is, uh… I try to address this. Actually, when we are talking about indirect costs, I'm going to bring everybody back to the indirect costs, because I think it will be very important.

Uh, for the other member. Um… you know, yes, the integral cost, for example, the Gates Foundation is 15%.

But we do fund tech transfer. manager, um, as the direct cost.

So, I would encourage. Um, the university, the academic institution be more creative and think outside of the box.

So, for example, the Gates Foundation, the Wash Division, we actually found patent, um.

expenses. We fund marketing, we fund, um, you know, the, um, the landscape.

study. So, you know, instead of taking, like, you assign 10%, um, you know, I mean, it… my suggestion is.

think outside of the box. The foundation may be open.

to fund, for example, commercialization-related activity, and that is not.

part of the indirect cost. So overall, you will find out that you actually get more funding, especially right now, the federal funding is really tight. So I apologize, I did not address your question, Kathy, but instead of addressing here, I think it is important because this is important for the academic institution.

Another thing is, um, this is what I observed.

is there's a disconnect between the sponsor research department and the tech transfer office.

I think early on, the tech transfer office should be involved in negotiating the agreement with the foundation.

Not just the IP term, but overall. And, and, you know, outreach to the faculty member about what rights they have. And I think lots of times the.

I feel that there's a gap. in terms of even within the university, there's the miscommunication.

You know, so… so, um, because I came from the academic, and I know there's two different departments, and sometimes we got pulled in last minute.

to review the IP terms. So, we do not get the benefit.

Or be part of, you know, the group negotiating, you know, the whole agreement. So that is something that, you know, just two things that I think it will benefit.

the university, the academic institution. So, sorry. Kathy, I was not addressing your question. And so, um, in terms of the grand challenge.

Um, all the terms will be, depending on which division, but at least for the wash division, we have the.

very consistent practice. So again, you know, like I say, even with the tech transfer, we do fund tech transfer.

So, I just want to… I don't have anything specific, but what Tony talked about, uh, in terms of if there's.

Um, we do fund very big research projects with many universities together. We usually like to pick.

One university as the lead. to manage the commercialization.

Um, you know, activity. So, hopefully that addressed your question. Over.

So are all… I mean, because I'm not familiar with it, are all grand challenges involving.

Multiple institutions? Therefore, an IP complexity.

Um, it really depends, um, you know, the amount. Like, we have this one, um.

research program, it was led by one university, it was 30 million.

So then, you know, this particular PI will pull in, you know, different expertise from various universities, and then.

you know, there will be an IP management plan.

And then there will be the Lee University taking the lead, and then they will do the profit sharing, because we won't.

involved in that. So, and then, we support, you know, all the patent costs.

Because then there's no dispute, because otherwise there will be dispute, right? Who pay for how long, and so we decided, okay, we will fund that to eliminate all the barriers. We want the.

you know, PI to focus in on the research.

And development. Over.

So, um, Madhu, you were talking about the charities working with each other and with universities to try to tackle particular therapeutic areas. You want to describe what you were thinking about?

No, no, I mean, this goes back to Tony's original point about, you know, trying to address this. So, I'll take a step back, like Aina taking a leave out of Catherine's book.

Um, I think what we're trying to do is to create awareness about this, so that this is not.

it doesn't become… it doesn't fester. So that all these topics, you know, if you look at it broadly, concern rhymes, because, I mean, going back to where we are aligned at the top.

Bringing it down to where we are slightly misaligned and building trust there. And I think the point goes back to.

a value-driven model, thinking creatively, as Catherine was saying earlier, to see how we can bring the foundations along.

to actually create the value to whatever it is, whatever technology it is. I mean, it's easier said than done, I know, because there's resource constraints, there's financial constraints.

But I think what we can do, I think, is to address the key facts and understand why we are doing it.

Why is consent required? Why is revenue sharing required? And I dare wade into, you know, the marching as well. You know, why is that required?

to actually an outcome-based approach where both can work together. There will always be differences, fundamentally from what is being paid, what is reasonable. There will be different views on foundations, but I'm seeing, personally seeing on this side, sitting in the middle, a real positive trend on both sides.

The charity is really here understanding, to Tony's point earlier, that, you know, the speed of turnaround is actually getting a lot better.

Because they have been trained, and I'd like to say that, I'd like to think life hack has done, you know, a big, you know, piece of work in trying to bring it together. I mean, it's been 14 years.

And we've dealt with about 200 charities. And looked at over 100 agreements, you know, the terms, funding agreements. And I think to try and bring it together in such a way that.

Both can meet in the middle, and so, two points. One.

the time of, you know, negotiation is shortened, which is crucial, you know, you're trying to do a license deal, and for that part, if you take an example, getting notification of a patent abandonment at the last minute from the institution really doesn't help the charity to decide.

On the other hand, you know, the charity really proactively trying to resolve the consent, etc.

That… and therefore move the needle. to your point, again, coming back, I think.

understanding the value of the foundation in enabling this and taking it to the patient, or whatever the output might be. It doesn't have to be medical research, it can be in any sector.

And saying that, okay, this is where the foundation sits, this is their expertise, this is what they can offer, um, to Catherine's point, new models around how we can… I mean, I've been advocating, but it hasn't really gone far about, you know, a patent budget, etc, because that, I think.

is one of the prime reasons I see patterns being… not prime, one of the biggest reasons why.

You know, budget at the national phase. should I really keep this patent? Yeah, understanding that. How can we address that as a whole, and then take it further? I hope… I mean, it's a roundabout answer, but I think bringing it back to building trust and reducing the time, understanding the fact that both sides there is a resource issue and a financial, uh, you know, issue to consider.

One of the questions that was in the chat is defining consent right.

Um… not who you are, since you were. On top of that.

Yeah, yeah, how can we define consent rights? So, essentially.

Um, why is it there, right? So, if you want to define it, you know, it gives some kind of a methodology to approve any proposed commercial use or assignment of IP.

developed with its funding. Before any action is taken. I think that's the key.

And there is a time here. And why is it necessary? I guess it ensures that.

the exploitation of. the IP aligns with the mission of the charity. The charitable objective, and patient benefit commitments. I mean, we call it public benefit.

So that's, I think, where we're coming from. So, essentially, I mean, if you look at a definition, it's to seek approval.

Of any proposed commercial use or assignment. I think that's the intent. There is a time lag.

And then there are relat… you know, I've seen variations of this, you know, the charity must consent. Again, time limited, to Tony's point, licensed or assigned or otherwise commercially exploited, and to see. So, for example, Welcome will seek an IP.

report, exploitation report. But welcome is a different beast, you know, I mean, it funds a lot of.

grants in a particular institution, so they seek. something at the end of the year that combines the whole thing and takes a look at whether it is feasible, it fits in with what was set out to do.

And then the variations would be, you know, recognition of the charity's funding contribution and publication and filings.

affordability, were there any compliance with downstream agreements, reporting obligations. It's the time, I think, the charity has.

To see whether it's going in the right direction. And it's not about holding things back, it's about understanding.

Whether it's going in the right direction. And if not, why not? Could we have a small say in that process? I think that's where they're coming at.

Does that make sense?

Yes. I'm wondering how often you don't give a consent.

I personally have not come across any, but Tony might have more experience with that.

Yeah, hardly ever. I mean, consent is nearly always given. I think the only time it's.

given.

It's not given as if, um… if the charity can't get a straight answer on… on revenue share.

Um, and generally, even then, generally exceptions are made to go ahead and do the deal, and then we'll sweep up afterwards.

That's right.

Or the only other real one that would stop, say, for us doing it would be tobacco or something like that, because we're a cancer charity, so we put a prohibition in against that type of deal, so it would have to be something really.

Important like that for us to stop it. I've never actually seen it enacted, but it's there as a safeguard.

Um…

Okay. So I was curious, um, it sounds like the UK is.

Foundations and charities are connected. But in the U.S, Catherine, do you belong to some group that.

talks about these issues.

Um, yeah, so we don't have the so-called consent. We do have reporting requirement, because Madu talked about, you know, the recording requirement. A reporting requirement.

So, that's not a concern, actually, in my head. We do have standard language to make sure that the technology get to the people most in need. So we call them global access.

It's a standard language that we provided to the tech transfer office. So basically, they need to.

include that in their license agreement. So we do… Uh, the foundation to reserve the right to review the Global Access Language.

If they are going to deviate from the language, they need to come back and then.

Um, you know, um, have the foundation's legal department review, because if.

They say they have the technology and they just want to go to the rich country, and they just want to provide it to the rich people. I mean, that's really, you know, I'm simplifying it.

If that's the case, we do have a problem. Then.

you know, I won't say there will be the consent or not consent. We will, um… we will negotiate with the grantee about the language. Again.

you know, the final goal is to make sure that the technology gets to the people in need.

So, if the… another time for me is. the standard language is very important. Secondly, I think it's very important.

Both parties understand. what the other party's mission.

Or what's the goal? Then it will be much easier to reach, um, you know, I mean, at least from a foundation perspective, I feel like somehow listening to Tony and Madhou, I have a much easier job, you know, so, uh, you know, we don't want profit sharing, we don't want anything, and even with the indirect costs, you know, like I said, we fund our tech transfer. So.

Um, you know, I just feel that, um, as long as, you know, you, you know, people can, like I said, we are trying to make things easy for our counterpart.

Again, standard language, I found it is very helpful. And once you deviated from that.

you know, like, how we can come to the middle ground.

Yeah, over to you, Kathy. Thank you.

I'm gonna change the topic. Um, many of the charities are starting to, um, invest in startups.

And the spin-outs that are coming out of the universities.

So, what… what are you guys doing with that?

Madhu?

Um… oh my god. Oh, yes, I'm unmuted.

Um, I think we haven't… I mean, we are in the process of actually understanding how to do that because of the charity law in terms of trying to invest directly. So we have a separate investment arm that does that at the moment. But as quote-unquote grant type funding, we are still in the process, although it's happening, we're learning as we go along as to how we can remain within the perimeter of.

charity law and do that. But certainly, there is, as we expand, especially into the clinical trial area, we are trying to see what that is. But I think.

The general view is that, why not? But… and it's the how that we're still working out the nuances of. Although it is already happening, and we also have.

what is called the translational challenges in 5 different areas, and I think in each area.

What we're trying to do is to develop a methodology that actually works for each sector.

And try and see… and there is an additional nuance of what happens when we fund overseas, because we have the.

We have to look after what… how would the value-added tax, so the VAT.

is actually administered here in the UK as well, and that has a slight… so we have to work within that, and our legal team and the business development team is actually trying to work out the nuances for that, and see, come up with an approach.

And Tony, I know that you have a venture.

group?

Yeah, absolutely. I mean, I think we… We see it as a continuum. Our job is to try and help these ideas emerge from universities to bridge the gap to the point that industry or investors will pick them up.

Because then we can demonstrate impact to our donors, that we actually may have an effect on cancer patients.

So we are increasingly providing a suite of different grants and investment products to try and help sort of move the baton, pass the baton along that chain.

So we provide basic research grants, um. We provide translational grants to try and help, sort of, proof-of-concept stage, and sort of move the technology on.

They're more milestone-driven, sort of, you know, more, as you would expect to see, like, a drug discovery award having certain stages.

And then we now have a sort of a CDOM, a seed investment arm.

That will, uh, when a company is formed, a new startup company is formed, will actually put an equity investment into it.

to try and stimulate other investors to come in alongside it.

So it's not judged on a return on investment basis, it's not there to make money, it's there to try and attract other investors around it to give it the best chance to actually go on and develop a product that helps cancer patients.

And we see this as a bit of a trend. I mean, we are making investments in US as well as UK companies.

We see, uh, charities like ACS with their Bright Edge arm, the Sontag Brain Fund in the US.

In the UK, we have LifeArc, we have Macmillan, so a number of charities and foundations are setting up venture arms.

Because they see this as a way of moving technologies forward, increasing their chance of them being picked up.

Do you fund companies with translational grants?

Not without translational grants, we deal with our investment, with our seed fund.

But with the translational grant, they tend to go to universities.

Sometimes, uh, if a university forms a spin-out as a result of the translational grant.

We might have a discussion with the university about the revenue share being converted to equity instead.

But that's… that's the discussion we could just have at the time.

Hmm.

And Catherine, I don't know whether you have a venture fund.

Um, actually, it's a different arm. Um, we actually fund people's expertise.

So we… we… because… every investment, the foundation provides need to have a charitable purpose, and we need to be very careful. There's no private benefit.

to the company, and we cannot fund. to the company to build their capacity. So it's a… it's very… it's very tricky. We do fund some of the company, they're kind of, like, in the startup format.

But, again. we try to be very careful, um, you know, again, it's not to build a company for them to commercialize the technology, but rather to develop the technology.

Hmm.

Um, so… so I'm trying to be very, very careful because, you know, when I talk with a foundation lawyer, it's always, you need to be very careful, you know, we cannot.

you know, have any private benefit to the company, yeah, over.

All right, we're at 10 o'clock! Thank you, it was a very great discussion.

Um, it was lively, it's fun, very honest, so thank you very much, all of you.