You want to license an asset into or out of Europe or Asia-Pacific.
A cross-border license is negotiated against people working to different rules, a different regulator, and a different idea of what the asset is worth. I have run these from both sides.
Book a 20-minute intro call →Whether this is you
The failure mode is almost never the science. It is that both sides assume the other is running the process they are used to.
- A Japanese or Korean partner has gone quiet and you cannot tell whether that is a no or a committee.
- You are being offered Asia-Pacific rights for a number you have no way to benchmark.
- You want to bring an asset in from Europe or Asia and the seller wants a structure your investors will not recognize.
- You are told there is government money available in the market you are entering, and nobody in the company knows how to ask for it.
What the work is
In-licensing and out-licensing across Europe, Japan, Korea and China, plus the joint ventures and NewCo structures that sometimes work better than a straight license. I have done these deals from both sides, including the government money and the local approval paths that US teams miss.
The direction is a real choice, not a given. Bringing an asset in can be a faster route to a second program than developing one, and licensing out can be a faster route to cash than a round. I run Arcstone Japan from the same desk as the rest of the practice. Before that I served as a diplomat at the World Bank and represented the United Kingdom at the UN General Assembly on pharmaceutical policy, which is a long way of saying I have spent fifteen years negotiating across institutions that do not share a decision-making culture.
How it runs
- The counterparty
- Who they are, who they answer to, and how a decision of this size actually gets made inside that company. Across much of Asia-Pacific the person you are meeting is not the person who decides, and the silence after a good meeting is a committee rather than a rejection. Knowing which it is changes what you do next.
- Which direction
- Whether you are better off licensing your asset out or bringing someone else's in, run as one comparison rather than two. Companies usually arrive having decided, and the decision is usually inherited from whichever conversation happened first.
- The structure
- Regional license, joint venture, or a NewCo built around the asset, with the tax and control consequences of each. A NewCo can raise capital the parent cannot, and it can also strand you as a minority holder in your own program. The structure gets chosen for who has to fund the next stage, not for elegance.
- The money you are not counting
- Government grants and matching funds most US teams never think to ask about. Japan and Korea both run programs that will co-fund development alongside a local partner, and they run to their fiscal calendars and not to yours. Missing the window costs a year.
- The approval path
- What the EMA, PMDA or MFDS will want that the FDA did not, and what that adds to the timeline. Bridging requirements and local trial expectations are the two that most often move a launch date, and they belong in the deal model rather than in a footnote discovered after signing.
What you end up with
A counterparty map traces the decision path inside the partner company, not only the name on the business card. Before that gets built, the direction has to be priced: licensing out against bringing an asset in, so you choose once instead of inheriting whichever conversation happened first. The structure recommendation covers license, joint venture and NewCo, with the tax and control consequences of each written down. You also get a schedule of the non-dilutive money available in the target market, with deadlines and local-partner requirements attached. Last comes the regulatory delta: what the second regulator wants that the FDA did not, and what that adds to the timeline and the cost.
Scope and fee
Cross-border engagements run longer than domestic ones, because the counterparty's calendar is the constraint and the fiscal years do not line up with yours. Plan on three to nine months on retainer for a deal, less for the narrower briefs: a market entry read, a structure recommendation, or a screen of the non-dilutive funding available. Travel is part of this side of the practice. I am in Tokyo and Seoul on a regular schedule. Nothing gets quoted until the shape is clear, which means after the first call. Never by the hour.
When not to call me
Translation and market entry are somebody else's business. If what you need is a distributor in Japan or a regulatory consultant to file the application, those are different firms and I am glad to name them. Deals where the counterparty was chosen for you by a broker whose fee depends on that particular deal closing, I turn down. And if the asset has never left a US development plan, the first question is whether a second regulator is worth the money at all, which is sometimes no.
Questions founders ask
- Our Japanese counterpart has stopped replying. Is it dead?
- Probably not, and reply cadence is a poor signal. Large Japanese pharma runs a consensus process that produces long silences between meetings by design. The useful question is who inside the company has been made to own the file, because a deal with no internal sponsor is dead whether or not anyone is replying.
- Should we sell Asia-Pacific rights or hold them?
- It depends what the proceeds buy. Selling the region to fund the US program can be the cheapest capital you will ever raise. Selling it because a bidder appeared, in a year when you did not need the money, tends to price the region at a discount and removes the asset most likely to attract the next acquirer.
- Is there really government money available?
- Yes, in Japan and Korea in particular, and it is routinely left on the table by US teams who do not know to ask. It comes with conditions: a local partner, local activity, and application windows tied to a fiscal calendar that is not yours. It is worth building the deal timeline around. It is not worth distorting the deal to chase.
- Do you cover Europe as well as Asia?
- Yes, though the two draw on different things. The European side of the practice runs on policy and regulatory background rather than on deal volume in the region. Where the counterparty is European and the question is regulatory or pricing more than relational, that is the stronger half.
If that is not the one
- You have to raise capital, and the money is harder than last time.
- You are talking to pharma and you have never done a licensing deal.
- You have a buyer or a partner at the door, or you are thinking about going public.
- You will run out of money before the next readout.
- You are a scientist-founder, and now you need help running the company.
