Technology Transfer Checklist: Sponsored Research Terms, Material Transfers, Bayh-Dole Compliance, Licence Diligence, and Spin-Out Formation

By Casey Scott McKay · 2024-10-04

This checklist works a technology transfer relationship from first contact to spin-out financing, in the order the decisions arise. It opens by sorting terms into statutory, policy, and open, because that classification determines where negotiating effort produces movement. It covers sponsored research options and the publication mechanism, material transfer review and the reach-through terms to refuse, and the title verification that a licence should never be signed without. It works Bayh-Dole compliance verification, the exclusive licence terms that matter to investors, and the eight-point review to run before any financing. It closes with spin-out formation, conflict management, equity terms, and the cadence that keeps option windows and milestone obligations from lapsing unnoticed.

IP and Technology > IP and IT in Corporate Transactions | Checklist | Published 4 October 2024 - Updated 25 May 2025 | Casey Scott McKay - marksy.us

Summary. This checklist works a technology transfer relationship from first contact to spin-out financing, in the order the decisions arise. It opens by sorting terms into statutory, policy, and open, because that classification determines where negotiating effort produces movement. It covers sponsored research options and the publication mechanism, material transfer review and the reach-through terms to refuse, and the title verification that a licence should never be signed without. It works Bayh-Dole compliance verification, the exclusive licence terms that matter to investors, and the eight-point review to run before any financing. It closes with spin-out formation, conflict management, equity terms, and the cadence that keeps option windows and milestone obligations from lapsing unnoticed.

Keywords: technology transfer checklist · term classification · sponsored research option · publication delay · invention disclosure timing · material transfer review · reach-through refusal · title verification · assignment language · Bayh-Dole election · utilisation reporting · march-in exposure · manufacturing preference · field of use drafting · diligence milestones · sublicensing share · patent cost cap · spin-out licence review · equity and anti-dilution · conflict management plan

How to use this checklist

| Phase | What it covers | |---|---| | 1 | Term classification | | 2 | Sponsored research scope | | 3 | The option | | 4 | Publication | | 5 | Material transfers | | 6 | Title verification | | 7 | Bayh-Dole compliance | | 8 | Publication history | | 9 | What the technology is | | 10 | Field and territory | | 11 | Financial terms | | 12 | Diligence milestones | | 13 | Sublicensing | | 14 | Patent costs | | 15 | Improvements | | 16 | Enforcement | | 17 | Assignment and insolvency | | 18 | The investor review | | 19 | Spin-out formation | | 20 | Cadence |

Boxes marked [Gate] must clear before a licence is signed, a material is accepted, or a financing process opens.

The matter. A three-year sponsored research programme, two patents, and an option nobody diaried. The window closed, the university licensed the technology in the same field to a competitor, and nothing was breached.

Phase 1. Term classification

[ ] [Gate] Sort every term into statutory, institutional policy, or genuinely open before opening the redline.
- Why. Two-thirds of what a company objects to is not a negotiating position, and pushing on it costs months.
[ ] Statutory: government licence under 35 U.S.C. § 202; march-in under 35 U.S.C. § 203; manufacturing preference under 35 U.S.C. § 204; inventor royalty sharing; reporting under 37 C.F.R. § 401.14.
[ ] Statutory for public institutions: limits on indemnification, governing law, and forum.
[ ] Policy: publication mechanics, research reservations, standard royalty and sublicensing shares, equity policy, conflict management, warranty disclaimers.
[ ] Open: field of use, diligence consequences, sublicensing share, patent costs, improvements, assignment, enforcement, territory carve-outs.
[ ] Ask the office directly, for any ambiguous term: is that statute, state law, or policy?
- Trap. Escalating over a statutory term, which costs credibility on the terms that are actually open.

Phase 2. Sponsored research scope

[ ] Name the principal investigator and include a substitution mechanism.
[ ] Define the scope of work with deliverables and a reporting cadence.
[ ] Confirm the budget, payment schedule, and what happens to unspent funds.
[ ] Include a termination right for failure to perform, with payment only for work done.
[ ] Accept that the institution owns inventions made solely by its personnel.
- Trap. Spending three months trying to own results, which is prohibited by policy and damages the laboratory relationship.
[ ] Confirm the company owns inventions made solely by its personnel.
[ ] Address joint inventions expressly rather than leaving them to 35 U.S.C. § 262.
[ ] Take a non-exclusive research licence to results.
[ ] [Gate] Ask directly whether federal funds support the laboratory, personnel, or equipment.
- Why. If so, results may be subject inventions with Bayh-Dole obligations regardless of the company's funding.
[ ] Accept the warranty disclaimer, the liability limit, and the absence of institutional indemnity.

Phase 3. The option

[ ] [Gate] Secure an exclusive option to a licence, not a right to negotiate.
- Why. A right to negotiate obliges the institution to nothing, and the company's leverage is lowest after it has funded three years of work.
[ ] Define the exercise window from written invention disclosure to the sponsor, not from an undefined event.
[ ] Annex a licence term sheet, or at minimum a framework fixing royalty range, field, and milestone structure.
[ ] Include an extension mechanism where technical or regulatory evaluation takes longer.
[ ] [Gate] Diary the window and name an owner.
- Trap. The scientist managing the relationship leaves and the option lapses silently. This is the most common avoidable loss in the field.
[ ] Confirm what the option covers: inventions arising in the funded work, or a broader category.
[ ] Confirm whether the option survives early termination of the research programme.
[ ] Confirm the institution will notify the company of each disclosure, in writing, within a defined period.
[ ] Record the option in the company's contract register with its trigger and expiry.

Phase 4. Publication

[ ] Set manuscript and abstract notice at thirty to sixty days before submission.
[ ] Set the permitted delay for patent filing at thirty to ninety days beyond that.
[ ] Confirm the sponsor may require removal of its own confidential information.
[ ] [Gate] Confirm the sponsor may not veto publication or require removal of research results.
- Why. Faculty publication freedom is institutional policy and, for many institutions, non-negotiable in principle.
[ ] Set the delay length by reference to the filing timetable, not by preference.
- Why. Publication is prior art under 35 U.S.C. § 102; the US grace period covers the inventor's own disclosure for a year, but most foreign systems have none.
[ ] Confirm the notice obligation covers posters, conference abstracts, preprints, theses, and repository deposits, not just journal articles.
- Trap. A notice clause limited to "publications," under which a conference abstract goes out unreviewed.
[ ] Confirm who at the company receives the notice and who is responsible for responding within the window.
[ ] Confirm what happens when the company does not respond: publication proceeds, which is the correct default.

Phase 5. Material transfers

[ ] [Gate] Route every material transfer agreement through counsel. No exceptions.
[ ] Accept: licence to use the material for the stated purpose; no onward transfer without consent; acknowledgement in publications; non-exclusive licence to the provider to use resulting research results internally; return or destruction on completion.
[ ] [Gate] Refuse: ownership of or options over recipient inventions; reach-through royalties; publication approval rights; any grant covering recipient background technology.
- Why. The material may be a minor input, and an obligation proportionate to a reagent is not one proportionate to a product.
[ ] Counter with a standard form — the uniform biological material transfer agreement or its letter variant — which offices recognise and usually accept.
[ ] Request the chain of transfer where the provider obtained the material elsewhere, and confirm it had the right to transfer.
[ ] Where the material derives from human subjects, confirm the consent covers commercial research.
- Trap. No agreement between institutions can expand the scope of a research participant's consent.
[ ] Maintain a register: material, provider, date, purpose, restrictions, and the programme it touched.
[ ] Review the register before any transaction, because a four-year-old agreement surfaces in diligence.

Phase 6. Title verification

[ ] [Gate] Obtain and read the inventors' assignments before negotiating terms.
- Why. A licence from an institution that does not hold title is worth nothing, and Board of Trustees of Leland Stanford Junior University v. Roche Molecular Systems is the case that proves it.
[ ] Confirm present-tense assignment language rather than a promise, per Filmtec v. Allied Signal.
[ ] Confirm recordation under 35 U.S.C. § 261.
[ ] Ask specifically about visiting researchers and their home institution obligations.
[ ] Ask about postdoctoral researchers on external fellowships.
[ ] Ask about students, whose obligations vary by institution and programme.
[ ] Ask about faculty with joint appointments, including at affiliated hospitals.
[ ] Ask whether any inventor consulted for a company during the relevant period.
- Trap. These five categories are where assignment defects concentrate, and none is visible in the patent record.
[ ] Confirm inventorship against the Pannu v. Iolab standard, noting that an author list is not an inventor list.
[ ] Where an inventor is omitted and unassigned, note that they can license the patent to anyone; correction runs through 35 U.S.C. § 256.
[ ] [Gate] Where the technology is jointly owned, confirm an inter-institutional agreement designates a lead for prosecution and licensing.
- Why. Without one, 35 U.S.C. § 262 lets the other owner license a competitor and the exclusivity paid for is illusory.

Phase 7. Bayh-Dole compliance

[ ] Obtain, in writing, the date of invention disclosure to the funding agency.
[ ] Obtain the date of election of title under 35 U.S.C. § 202.
- Why. A missed election can mean the government holds title, and there is no cure.
[ ] Obtain the patent filing date and confirm it fell within the required period.
[ ] Confirm utilisation reports have been made.
[ ] Confirm the government support statement appears in the patent specification.
[ ] Confirm the government licence is recorded in the company's encumbrance register.
[ ] Assess march-in exposure under 35 U.S.C. § 203 and note it in the risk register, whether or not it has ever been exercised.
[ ] Confirm the manufacturing preference under 35 U.S.C. § 204 against the intended supply chain, and assess whether a waiver will be needed.
[ ] Confirm what utilisation information the company must supply to the institution, and diary it.
[ ] Where the technology came from a federal laboratory, confirm the 15 U.S.C. § 3710a framework and any 35 U.S.C. § 209 notice requirements were satisfied.

Phase 8. Publication history

[ ] [Gate] Ask what has been published, presented, posted, or deposited, with dates.
- Why. It determines whether foreign rights exist and therefore whether a worldwide exclusive licence is worth what it appears to be.
[ ] Include conference abstracts, posters, invited talks, preprints, theses, and grant abstracts.
[ ] Compare each date against the priority date.
[ ] Where a disclosure preceded filing, assess the US position under 35 U.S.C. § 102 and treat foreign rights as lost absent evidence otherwise.
[ ] Confirm the application publication date under 35 U.S.C. § 122 and whether a non-publication request was made.
[ ] Confirm what is currently in review or scheduled, from the principal investigator directly.
[ ] Assess whether the provisional as filed supports the claims being pursued.
- Trap. A provisional drafted under conference-deadline pressure that does not support the eventual claims, which makes the priority date worthless.
[ ] Read the file history for eligibility rejections and the amendments made to overcome them, under 35 U.S.C. § 101 and the framework in Alice v. CLS Bank International.
[ ] For life science claims, assess exposure under Association for Molecular Pathology v. Myriad Genetics and Mayo Collaborative Services v. Prometheus Laboratories.
[ ] Assess enablement and written description on broad claims supported by limited examples, per Amgen v. Sanofi.
[ ] Price the licence against surviving claims, not against patent counts.

Phase 9. What the technology is

[ ] List every component: patents, applications, software, datasets, biological materials, know-how, and reagents.
[ ] For software, ask what has been published to a public repository.
- Why. An open source release is generally irrevocable as to the code released, and a later exclusive licence covers only what remains. See Copyleft and Consequences.
[ ] For datasets, confirm provenance, consent scope, data use agreements, and privacy constraints.
- Trap. A dataset assembled under academic-only consent cannot be commercialised, and no licence cures it. See Who Owns the Data.
[ ] For biological materials, obtain the chain of material transfer agreements and their onward transfer restrictions.
[ ] For reagents and instruments used in the research, confirm whether they are third-party licensed and whether the licensee inherits anything.
[ ] [Gate] Identify who actually knows how to make the technology work.
- Why. A patent licence without the postdoctoral researcher who can run the protocol is frequently a licence to nothing.
[ ] Negotiate consulting or transitional support explicitly, and route it through the conflicts office.
[ ] Assess freedom to operate separately from the licence.
- Why. Madey v. Duke University means there is no general research exemption, and institutions rarely clear anyway; the regulatory safe harbour in 35 U.S.C. § 271 as read in Merck KGaA v. Integra Lifesciences covers submissions, not tools.

Phase 10. Field and territory

[ ] Define the field by application rather than by product.
[ ] Address expressly what happens if the licensee's product evolves outside the field.
[ ] Ask what other fields the institution intends to license, and to whom.
[ ] Consider a right of first negotiation on adjacent fields.
[ ] Confirm territory, and confirm the underlying rights actually exist in each jurisdiction claimed.
[ ] Accept the institutional research and educational reservation and the nonprofit research reservation.
[ ] Accept the government licence where Bayh-Dole applies.
[ ] [Gate] Confirm the field is broad enough to support the business plan as an investor would read it.
- Trap. A field defined narrowly at signature that no longer covers the product two pivots later.

Phase 11. Financial terms

[ ] Issue fee: negotiate against the institution's standard and the stage of development.
[ ] Annual minimum: negotiate the amount, the start year, and creditability against running royalties.
[ ] Milestones: tie to events the company controls or can predict, not to calendar dates alone.
[ ] Running royalty: negotiate the rate and, critically, a stacking provision reducing it where third-party licences are required, subject to a floor.
[ ] [Gate] Sublicensing income share: negotiate hard, because it is frequently set far above the running royalty.
- Why. A business model built on sublicensing lives or dies on this number, and it is negotiable.
[ ] Confirm the definition of net sales, including permitted deductions and treatment of combination products.
[ ] Confirm audit rights, their frequency, and who pays when a discrepancy is found.
[ ] Confirm reporting cadence and format.
[ ] Confirm currency, withholding, and payment mechanics for foreign sales.
[ ] Model the total payment obligation across the licence term before agreeing any single number.

Phase 12. Diligence milestones

[ ] Accept that milestones will exist; the institution's statutory objective is practical application.
[ ] Negotiate achievability against the company's real development plan, not the plan in the pitch deck.
[ ] Negotiate a cure period of meaningful length, on written notice.
[ ] [Gate] Negotiate conversion to non-exclusive rather than termination as the consequence of uncured failure.
- Why. A company that has invested years and capital should not lose everything for a slipped date, and the institution's real objective is served by conversion.
[ ] Include a mechanism for renegotiating milestones on a defined event — a regulatory change, a clinical setback, a financing failure.
[ ] Confirm what evidence satisfies each milestone, so compliance is not contested later.
[ ] Diary every milestone with a named owner and a notice date in advance.
[ ] Report milestone status quarterly internally.
- Trap. Falling behind without notifying the institution, which converts a manageable renegotiation into a breach.

Phase 13. Sublicensing

[ ] Confirm the right exists without prior approval, or with approval not unreasonably withheld and deemed given after a defined period.
[ ] Confirm sublicensees may grant further sublicences where the business model requires it.
[ ] Confirm sublicences survive termination of the head licence where the sublicensee is not in breach.
- Why. Without this, a sublicensee's diligence will find that its rights depend on the licensee's compliance, which is not financeable.
[ ] Confirm what terms must be passed through to sublicensees.
[ ] Confirm reporting obligations on sublicence execution and on sublicensee sales.
[ ] Confirm what counts as sublicensing income, and exclude equity, research funding, and reimbursements where possible.
[ ] Confirm the treatment of sublicences granted to affiliates.

Phase 14. Patent costs

[ ] Quantify past costs before signing; they are frequently the largest early cash item.
[ ] [Gate] Negotiate a cap and an instalment schedule.
[ ] Negotiate consultation rights on prosecution strategy in return for paying.
[ ] Negotiate the right to review and comment on responses before filing.
[ ] Negotiate the right to decline funding in nominated jurisdictions on notice, with rights there reverting.
[ ] Confirm who instructs counsel and who receives the correspondence.
[ ] Confirm what happens to costs on termination or conversion.
[ ] Confirm whether the licensee may take over prosecution if the institution declines to pursue a case.
[ ] Budget annual foreign costs across the family for the licence term.

Phase 15. Improvements

[ ] Define improvements narrowly and accept that anything wider will be refused.
[ ] Limit to inventions by the named inventors.
[ ] Limit to a defined period from the effective date.
[ ] Limit to inventions dominated by or dominating the licensed claims.
[ ] Set the terms on which improvements are added — automatically, or on notice at stated terms.
[ ] Confirm improvements arising from company-funded sponsored research are treated under that agreement's option, not swept into the licence.
- Trap. Two overlapping mechanisms covering the same invention, with different terms.
[ ] Confirm what happens to improvements after the improvement period ends.

Phase 16. Enforcement

[ ] Confirm the licensee may enforce the licensed patents at its own cost.
[ ] Confirm the institution will join as a necessary party at the licensee's expense.
[ ] Confirm who controls the litigation, including settlement authority.
[ ] Confirm the recovery-sharing formula after costs.
[ ] Confirm the institution's right to enforce if the licensee declines within a defined period.
[ ] Confirm the licensee's obligation to notify the institution of infringement and of any challenge to the patents.
[ ] Confirm cooperation obligations on both sides, including inventor availability.
- Why. Inventors are necessary witnesses, and their cooperation is not automatic after they leave.
[ ] Confirm what happens where the institution's other licensees in other fields are affected by the same defendant.

Phase 17. Assignment and insolvency

[ ] [Gate] Confirm assignment is permitted without consent on a change of control or sale of the related business.
- Why. Investors require it, and its absence is a financing problem rather than a legal nicety.
[ ] Otherwise, consent not unreasonably withheld, with a deemed-consent period.
[ ] Confirm assignment to affiliates without consent.
[ ] Confirm the licence survives the licensee's insolvency and that rights are retained on rejection, consistent with Mission Product Holdings v. Tempnology.
[ ] Confirm the position on the institution's own insolvency or restructuring, which is rare but not impossible.
[ ] Confirm termination rights and their triggers, and negotiate cure periods for each.
[ ] Confirm what survives termination: sublicences, confidentiality, accrued payments, and any licence to know-how.

Phase 18. The investor review

Run this before any financing process opens, not during diligence.

[ ] Exclusive, worldwide, and in a field broad enough for the business plan.
[ ] Survives insolvency.
[ ] Assignable on a change of control without consent.
[ ] Sublicensing permitted, with sublicences surviving termination.
[ ] Diligence milestones achievable and currently met.
[ ] Patent costs quantified, capped, and scheduled.
[ ] Enforcement rights adequate, with institutional cooperation committed.
[ ] Government rights, march-in exposure, and manufacturing preference disclosed and understood.
[ ] [Gate] Start amendments a full quarter before the process opens.
- Why. Institutions are generally cooperative and institutionally slow; term sheets do not wait for committee cycles.
[ ] Prepare a one-page licence summary for the data room, so investors read your description rather than constructing their own.
[ ] Confirm title verification and Bayh-Dole compliance evidence are in the data room.
[ ] Confirm the material transfer register is current and reviewed.

Phase 19. Spin-out formation

[ ] [Gate] Engage the institutional conflicts office before formation, not after.
[ ] Obtain a management plan addressing the founder's company role, student supervision, sponsored research review, and publication disclosures.
[ ] Treat the plan as a deal term and diary its reviews.
- Why. A conflict handled badly damages the founder's career, the institutional relationship, and access to the laboratory that created the technology.
[ ] Confirm whether the founder may serve as an officer or director while holding a full appointment.
[ ] Confirm limits on consulting days and route consulting agreements through the conflicts office.
[ ] Negotiate the institution's equity percentage.
[ ] [Gate] Negotiate anti-dilution protection hardest — the threshold round, the mechanism, and whether it applies at all.
- Why. Protection through a Series A materially changes founder and early investor outcomes, and investors price it.
[ ] Confirm the class of equity, voting rights, and whether the institution takes a board seat or observer rights.
[ ] Confirm treatment of institutional facilities: what happens to inventions made in institutional space, and by whom.
[ ] Confirm student and postdoctoral involvement, their assignment obligations, and the conflict implications.
[ ] Confirm the licence terms against the eight-point investor review before signature, not after.
[ ] Negotiate know-how transfer and transitional support explicitly.

Phase 20. Cadence

[ ] At disclosure. Confirm inventorship, publication history, and federal funding status.
[ ] At option grant. Diary the window; name an owner; register the option.
[ ] Before signature. Verify title, recordation, and Bayh-Dole compliance dates in writing.
[ ] On any material transfer. Counsel review and register entry, without exception.
[ ] Quarterly. Milestone status; notice obligations; option windows approaching.
[ ] Annually. Utilisation information to the institution; patent cost reconciliation; review of funded jurisdictions; conflict plan review.
[ ] Before any financing. The eight-point review, with amendments started a quarter ahead.
[ ] Before any transaction. Assignment provisions, milestone compliance, government rights disclosure, and the material transfer register.
[ ] On any personnel change. Confirm the option owner and the milestone owner are still in post.

Phase 21. Escalation

[ ] Licensing associate. Standard terms, limited financial authority.
[ ] Director or office head. Departures from policy, unusual structures.
[ ] General counsel. Indemnity, liability, governing law, forum, institutional risk.
[ ] Vice president for research. Publication, conflicts, faculty relations.
[ ] Principal investigator. Not a negotiator; an ally whose support moves internal decisions.
- Trap. Negotiating terms with the researcher, who has no authority and whose position between the company and the office damages both relationships.
[ ] Escalate with a commercial reason, not a legal position — explain how the term reads to an investor.
[ ] Use comparables from other institutions, which are checked and are persuasive.
[ ] Never escalate over a statutory term.
[ ] Build institutional decision cycles into the transaction timetable rather than reading delay as resistance.

Phase 22. What to keep

[ ] The executed agreement and every amendment.
[ ] The inventors' assignments and recordation confirmations.
[ ] Bayh-Dole compliance dates in writing from the institution.
[ ] The publication history relied on when assessing foreign rights.
[ ] The option diary with named owners.
[ ] The material transfer register.
[ ] The inter-institutional agreement where jointly owned.
[ ] Milestone compliance records and every notice given or received.
[ ] Patent cost invoices and the reimbursement schedule.
[ ] The conflict management plan and its review records.
[ ] A short internal note per institution: who has authority over what, what was statutory versus policy, how long each approval took, and which terms moved.
- Why. The second deal with the same institution costs a fraction of the first, and this note is worth more than any template.

Phase 23. Questions for the principal investigator

[ ] What has been published, presented, posted, or deposited, with dates?
[ ] What is currently in review or scheduled for a conference?
[ ] Who contributed to conception, as distinct from who is on the paper?
[ ] What is not in the patent that the technology needs in order to work?
[ ] Who in the laboratory actually knows how to run it?
[ ] What materials or reagents came from elsewhere, and under what terms?
[ ] What else in this laboratory is federally funded?
[ ] Has anyone in the group consulted for a company on related subject matter?
[ ] What would you do differently if you were building this commercially?
- Why. The last question is the most useful in the list and is almost never asked.

Phase 24. If you can only do four things

[ ] Diary the option window and name an owner. The single most common avoidable loss in the field, and it costs nothing to prevent.
[ ] Read the inventors' assignments. Stanford v. Roche is the reason, and an afternoon is the cost.
[ ] Route every material transfer agreement through counsel. A reagent is never worth a reach-through royalty.
[ ] Run the eight-point investor review a quarter before financing. Everything on it is fixable; none of it is fixable in three weeks.

Phase 27. Metrics

[ ] Option windows diaried with a named owner, as a percentage of options held.
[ ] Options lapsed unnoticed. Target zero.
[ ] Material transfer agreements routed through counsel, as a percentage executed.
[ ] Reach-through terms accepted. Target zero.
[ ] Licences signed with title verified by reading the assignments, as a percentage.
[ ] Licences with Bayh-Dole compliance dates obtained in writing.
[ ] Licences clearing the eight-point investor review at signature.
[ ] Milestone compliance across the portfolio, and notices received from institutions.
[ ] Median time from term sheet to signature, by institution.
[ ] Patent cost reimbursement against budget, and jurisdictions declined.
[ ] The return measure. Whether any financing or transaction was delayed by a licence term that could have been negotiated at the outset.

Phase 28. International institutions

[ ] Confirm who holds title, since some systems vest it in the individual academic rather than the institution.
[ ] Confirm employee inventor remuneration obligations, which survive assignment in many systems.
[ ] Confirm national or regional funding conditions on exploitation, manufacturing location, and reporting.
[ ] Treat pre-filing publication as an absolute bar outside the United States, since equivalents to the 35 U.S.C. § 102 grace period are rare.
[ ] Confirm export control and research security requirements, which operate independently of intellectual property terms.
[ ] Confirm constraints on governing law and forum, which public institutions abroad share with US state institutions.
[ ] [Gate] Engage local counsel for the first agreement in any new jurisdiction.
- Trap. Porting a US template, which will be wrong in ways that are not visible on the face of the document.
[ ] Record what you learn per jurisdiction, because the second agreement costs a fraction of the first.

Phase 25. The one-page position

Technology transfer matter — [institution], [date]. Technology: [description]. Patents: [numbers], priority [date], granted [jurisdictions], pending [jurisdictions]. Foreign rights: [intact / forfeited by publication on date]. Title: assignments read [date], language [present / promise / absent], recorded [yes/no], defect categories checked [visitors / postdocs / students / joint appointments / consultants]. Joint ownership: [none / with institution, inter-institutional agreement dated]. Bayh-Dole: funding agency [name], disclosure [date], election [date], filing [date], utilisation reports [current / outstanding], government support statement [present], march-in exposure [noted], manufacturing preference [compliant / waiver required]. Publication history: [items and dates]. Technology components beyond patents: [software / datasets / materials / know-how], rights position for each [description]. Field: [definition]; other fields licensed [to whom]. Financial: issue fee [figure], minimum [figure from year N], milestones [list], royalty [rate, stacking floor], sublicensing share [percentage]. Patent costs: past [capped figure, schedule], future [arrangement, jurisdictions declined]. Diligence: milestones [list], status [met / at risk], consequence [conversion / termination], cure [N days]. Sublicensing: [permitted on notice / approval], survival [yes/no]. Enforcement: control [licensee], joinder [committed], recovery split [formula]. Assignment: change of control [without consent / consent not unreasonably withheld]. Insolvency: [survives]. Investor review: [8 of 8 clear / items outstanding]. Spin-out: equity [percentage], anti-dilution [to round], conflict plan [dated]. Recommended actions: [list].

Phase 26. What this costs

[ ] Term classification takes an hour and saves a quarter.
[ ] Title verification takes an afternoon and is the highest-yield step in the checklist.
[ ] Bayh-Dole compliance confirmation takes an email and a week of institutional response time.
[ ] Publication history takes one conversation with the principal investigator.
[ ] A licence negotiation runs six to twelve weeks with a cooperative office, longer with a federal laboratory.
[ ] Amendments before a financing take a quarter; the same amendments during diligence take longer and cost the term sheet.
[ ] Material transfer review takes twenty minutes per agreement and prevents the four-year-old encumbrance.
[ ] Conflict management planning takes weeks and cannot be compressed.
[ ] The asymmetry. Every item above is cheap in advance and expensive in front of an investor or a buyer, which is the entire argument for running the checklist at the start.

Outcome. The programme was reframed in week one. The company stopped pursuing title to institutional results — prohibited by policy, and three months had already gone — and took an exclusive option exercisable within six months of written disclosure, with a licence term sheet annexed setting field, royalty range, and milestone framework. Publication was set at forty-five days' notice with a sixty-day filing delay, covering abstracts and preprints as well as articles. The option was diaried with a named owner in the contract register. Title verification found that a visiting researcher from another institution was a named inventor and had assigned to their home institution; an inter-institutional agreement was executed before signature, designating a lead for prosecution. Bayh-Dole dates were obtained in writing and were clean. The principal investigator disclosed a conference abstract scheduled for the following month, which moved the provisional filing forward by three weeks and preserved foreign rights. At financing, eighteen months later, the eight-point review cleared on all eight points because the amendments had been made at signature. The term sheet was not reopened on intellectual property.

Key Authorities at a Glance

| Authority | Proposition | |---|---| | 35 U.S.C. § 200 | Bayh-Dole policy | | 35 U.S.C. § 201 | Subject invention definition | | 35 U.S.C. § 202 | Election of title; government licence | | 35 U.S.C. § 203 | March-in rights | | 35 U.S.C. § 204 | US manufacturing preference | | 35 U.S.C. § 205 | Confidentiality of disclosures | | 35 U.S.C. § 209 | Licensing federally owned inventions | | 35 U.S.C. § 261 | Assignment and recordation | | 35 U.S.C. § 262 | Joint owners | | 35 U.S.C. § 256 | Correction of inventorship | | 35 U.S.C. § 101 | Eligibility | | 35 U.S.C. § 102 | Novelty; grace period | | 35 U.S.C. § 122 | Publication at eighteen months | | 35 U.S.C. § 271 | Infringement; regulatory safe harbour | | 37 C.F.R. § 401.14 | Standard patent rights clause | | 15 U.S.C. § 3710a | Cooperative research and development agreements | | Board of Trustees of Leland Stanford Junior University v. Roche Molecular Systems | Bayh-Dole does not vest title | | Filmtec v. Allied Signal | Present assignment versus promise | | Madey v. Duke University | No general research exemption | | Merck KGaA v. Integra Lifesciences | Regulatory safe harbour scope | | Association for Molecular Pathology v. Myriad Genetics | Isolated DNA ineligible | | Mayo Collaborative Services v. Prometheus Laboratories | Diagnostic eligibility | | Alice v. CLS Bank International | Abstract idea framework | | Amgen v. Sanofi | Enablement of broad claims | | Pannu v. Iolab | Joint inventorship | | Mission Product Holdings v. Tempnology | Licence survives rejection |

The five things people get wrong

One. They negotiate the statutory terms. The government licence, march-in under 35 U.S.C. § 203, the manufacturing preference, and inventor royalty sharing are not positions. Arguing with them costs a quarter and signals that nobody read the framework.

Two. They let the option lapse. An exclusive option to a licence is worth a great deal and expires silently. Diary it, name an owner, and pre-agree the licence terms so exercise is a decision rather than a negotiation from zero.

Three. They let scientists sign material transfer agreements. A two-page document obtained to get a reagent can carry a reach-through royalty that encumbers a lead programme and surfaces four years later in diligence.

Four. They accept the title representation. Board of Trustees of Leland Stanford Junior University v. Roche Molecular Systems exists because a well-run institution got assignment language wrong. Read the inventors' assignments and check recordation.

Five. They discover the licence terms during financing. Assignment on a change of control, sublicensing rights, and achievable milestones are what investors read. Institutions will amend, but amendments take a quarter and term sheets do not wait.