Development Committee Charter

Vitalis Therapeutics Inc. — The governing instrument for the VitaFlow (VTX-401) development program. Constitutes the Development Committee, defines the five gate outcomes, and bounds what the Committee may decide. The Program Charter operates under this document.

Seats

Votes

Quorum

Defined outcomes

Contents

Constitution & Standing
Composition
Quorum, Voting & Abstention
Gate Outcomes
Outcome Mechanics
Delegated Authority
Conditions
Conflict of Interest & Recusal
Authority Boundaries
Cadence & Between-Gate Operation
Gate Preparation
Escalation
Board Interface
Dispute Resolution
Alternates, Succession & Induction
Reviewing the Governance Itself
Records
Document Control
Amendment

1. Constitution & Standing

The Development Committee is the decision authority for the VitaFlow (VTX-401) development program. It is constituted by the Board of Vitalis Therapeutics Inc. and holds delegated authority to release funding tranche by tranche against the gate structure, up to the $243,040,000 ceiling recorded in the Program Charter.

The Committee is not a steering group and not an advisory body. It decides. A gate outcome is a Committee decision, minuted, and is not subject to reversal by any individual member including the Executive Sponsor. Where the Committee cannot decide, the outcome is HOLD — not an informal continuation.

Delegation boundary. The Committee may release tranches, issue and close conditions, approve changes within the authorized ceiling, and terminate the program. It may not raise the ceiling, alter the gate structure itself, or approve a change that takes the program outside the indication scope recorded at §3 of the Program Charter. Each of those is a Board matter.

2. Composition

Member	Seat	Vote
C. Tyrrell	Program Director — Chair, seated from the PMO	No vote
Dr. A. Okoye	Chief Medical Officer — Executive Sponsor	Voting
Dr. H. Vasquez	Chief Scientific Officer	Voting
Dr. P. Raghunathan	SVP, Regulatory Strategy	Voting
M. Thornbury	Chief Financial Officer	Voting
J. Barrington	SVP, Market Access & Commercial	Voting
Dr. I. Solberg	Chief Quality Officer	Observer, no vote

Seven seats, 5 votes. Two seats do not vote, for different reasons.

Why the Chair does not vote

The Chair is the Program Director — the person accountable for the program's progress. A person accountable for progress who also votes on whether progress is sufficient is being asked to mark their own work, and the structural conflict does not disappear because everyone in the room is acting in good faith. Decision D-09 separates the two roles: the Chair certifies that evidence meets the recorded standard, and the Committee decides what the evidence means.

Why the Chief Quality Officer observes rather than votes

Quality obligations are not tradeable. A vote implies a position that can be outweighed by four others; GxP compliance cannot be outvoted (§7). The CQO therefore sits with full access, full speaking rights and a standing entry in the minutes, but no vote — because a vote would mischaracterize the nature of the obligation.

3. Quorum, Voting & Abstention

Quorum is four of the 5 voting seats, and must include the Chief Financial Officer for any gate that releases a tranche.
Decisions carry on a simple majority of votes cast. A tie is not a pass: the outcome reverts to HOLD and the gate is re-convened.
Abstention is recorded and explained. An abstention is not a neutral act — it is a statement that a member cannot support the decision on the evidence tabled, and the reason is minuted. The Gate 4 record shows GO WITH CONDITIONS (5-0-1); the abstention there is part of the permanent record, not an administrative note.
Proxies are not accepted. A member who cannot attend does not vote. If that takes the meeting below quorum the gate is re-scheduled rather than held short.
The Chair does not break ties and does not vote in any circumstance.

A gate cannot be held early. A gate may be re-scheduled later, but not brought forward to suit a calendar, because the criteria at §5 depend on evidence that exists only after the work is done. Gate 4 was scheduled deliberately after the End-of-Phase-2 meeting of 19 May 2026 for exactly this reason.

4. Gate Outcomes

Five outcomes are defined. A gate produces one of them and nothing else — there is no informal “proceed and we will sort it out”.

Outcome	Effect	When it applies
GO	The stage passes. The next tranche is released in full and work proceeds against the approved scope.	All must-meet criteria satisfied; no should-meet criterion scored below the threshold.
GO WITH CONDITIONS	The stage passes and the tranche is released, but named conditions are attached with owners, due dates and a recorded evidence standard. Failure to close a condition is itself a gate matter at the following gate.	All must-meet criteria satisfied; one or more should-meet criteria scored at the threshold, where the gap is closeable inside the next stage without changing scope.
RECYCLE	The stage does not pass, but the concept survives. The program returns to the stage it was in, with a defined remediation scope and a re-convening date. No new tranche is released; remediation is funded from contingency against a named draw.	A must-meet criterion is unsatisfied but is remediable with work the program can actually perform.
HOLD	Work stops and funding is suspended pending an external event — an agency response, a competitor filing, a portfolio decision above the program. The program is not cancelled and the roster is not released.	The decision cannot be taken on information the program is able to produce.
KILL	The program terminates. Remaining tranches are not released, the roster is released, and a closure accounting is produced within thirty days recording spend, salvage and what is transferable to other programs.	A must-meet criterion is unsatisfied and is not remediable, or the business case no longer clears the hurdle on any defensible set of assumptions.

RECYCLE is the outcome most often missing from real governance models, and its absence is why programs drift. Without it, a committee facing an unsatisfied must-meet criterion has only two usable options — pass anyway, or kill a viable asset — and will almost always choose to pass anyway with an informal understanding. RECYCLE gives the committee somewhere to put a genuine “not yet”, with a remediation scope, a funded draw and a dated re-convening.

5. Outcome Mechanics

§4 defines what each outcome means. This section defines what each one requires, because an outcome with no procedural consequence is a label rather than a decision.

GO

The Chair issues a release notice against the next tranche within two working days. Vendor work packages for that stage are authorized by separate notice (see the Program Budget §6). No further Committee action.

GO WITH CONDITIONS

The tranche releases in full — conditions do not withhold funding, because a condition that starves the stage it attaches to cannot be closed. Each condition is entered in the register within five working days with owner, due date and verification method. The Chair reports condition status at every monthly checkpoint, and open conditions are a standing item at the next gate regardless of whether they are due.

RECYCLE

No tranche releases. The Chair produces a remediation scope within ten working days: what specifically must change, what it costs, who owns it, and the date the gate re-convenes. Remediation is funded from contingency against a named draw, which makes the cost of a recycle visible rather than absorbed. The roster is retained — releasing a team and rebuilding it is almost always more expensive than carrying it through a remediation window.

HOLD

Work stops on everything except the standing pools identified in the Program Budget §3 — regulatory affairs, program management, and the minimum required to maintain regulatory obligations and participant safety. A HOLD does not suspend pharmacovigilance, safety reporting, or the care of participants already dosed. The Chair sets a review date; an indefinite HOLD converts to KILL at the second review.

KILL

Remaining tranches are cancelled. A closure accounting is produced within thirty days recording total spend, contractual exit cost, salvage value, and what transfers to other programs — data, methods, qualified vendors, regulatory precedent. Participants already dosed are managed to protocol-defined follow-up; a program may be terminated commercially while continuing clinical obligations, and the two are budgeted separately.

KILL is not failure and is not treated as such. Given the probability of success recorded in the Program Charter §2, most development programs should end in KILL — that is what a portfolio of options means. A governance system that treats termination as a career event will not receive honest evidence at gates, which makes every other provision in this charter decorative.

6. Delegated Authority

Not every commitment reaches the Committee. Authority is delegated by value, and the thresholds exist so that the Committee's time is spent on decisions that matter rather than on approvals that merely feel important.

Level	Threshold	Conditions
Functional lead	$250,000	Within an approved stage tranche and against an approved work package.
Program Director (Chair)	$1,500,000	Within an approved stage tranche. Reported to the Committee at the next checkpoint.
Development Committee	$24,960,000	Any commitment within the authorized ceiling, including release of the full contingency reserve. Requires a minuted vote.
Board of Directors	No limit	Any increase to the ceiling, any change to the gate structure, any indication-scope change.

The thresholds bind within a released tranche, not against the ceiling. A functional lead with $250,000 authority cannot spend it against a stage the Committee has not funded. Delegation governs who approves; tranche release governs whether the money exists. Confusing the two is how programs commit spend they have no authority to make.

Delegated commitments are reported upward at the next checkpoint, not sought in advance. A lead who splits a commitment into portions below their threshold to avoid escalation has breached this provision regardless of whether each portion was individually within authority.

7. Conditions

A GO WITH CONDITIONS outcome attaches conditions. Every condition carries, at issue and in the minutes:

A named single owner — never a function, never two people.
A due date, which may fall inside the stage or at the following gate.
A verification method — what specific evidence will demonstrate closure.
The criterion or risk the condition addresses, cross-referenced.

The verification method is fixed at issue and cannot be renegotiated at closure. This is the single most important provision in this document. A condition whose evidence standard can be softened when it comes due is not a condition; it is a note. The Chair verifies against the standard recorded when the condition was issued, and a request to change that standard is a Committee decision requiring a vote, minuted as such.

Live conditions at the status date

Ref	Condition	Owner	Due	Status
GC-01	Complete analytical method re-qualification at Aldergate for all three methods	Dr. K. Oyelaran	18 Dec 2026	open
GC-02	Confirm the cardiovascular sub-study protocol with the DMC before first CV-cohort dosing	Dr. S. Aldridge	30 Nov 2026	closed
GC-03	Stand up the payer evidence plan and hold the first advisory boards	J. Barrington	31 Mar 2027	at-risk

Full issue records, evidence standards and closure evidence live in the Gate Conditions Register.

8. Conflict of Interest & Recusal

A member declares a conflict where they hold a personal or financial interest in a vendor under consideration, or where they own the work being assessed at that gate.

A declared conflict results in recusal from the vote and from the deliberation, not merely from the vote. A member who remains in the room while a decision is discussed has participated in it. Recusal is minuted, and quorum is calculated on the remaining voting seats.

The Chair holds a standing structural conflict on every gate — the Chair owns program progress — which is why the Chair holds no vote at all rather than recusing gate by gate.

9. Authority Boundaries

Four matters lie outside the Committee's authority entirely. None of them can be reached by a vote, however unanimous.

Matter	Who holds it	Why
Recommendation to pause or stop a trial for safety	Independent Data Monitoring Committee	Governance may decide whether a program continues to be funded. It may not decide whether it is safe to continue dosing. The DMC is unblinded and the Committee is not; the recommendation is binding (C-05).
GxP compliance — GLP, GCP, cGMP	Regulatory obligation	Not a quality target that may be traded against cost or schedule. A gate cannot authorize a deviation (C-01).
Expedited safety reporting to the agency	Pharmacovigilance, under regulation	Runs on the regulatory clock, independent of program governance and of gate timing (C-04).
Site-level human subject protection	Institutional Review Boards	Site activation follows IRB approval and is not accelerable by program decision (C-03).

The distinction that matters. A committee that believes it can vote on any question in front of it will eventually vote on one it has no business deciding, and it will do so under schedule pressure with the best of intentions. Naming the boundaries in the governing instrument — before the pressure arrives — is the only protection that works.

10. Cadence & Between-Gate Operation

Forum	Cadence	Purpose
Gate review	At each gate	Decision. Outcome per §4, minuted with the vote record.
Committee checkpoint	Monthly	Standing review of conditions, contingency draws and material risk movement. No gate authority; escalates to an extraordinary gate if required.
Program review	Fortnightly	Chair and functional leads. Operational; produces the status report the Committee reads.
Extraordinary gate	On call	Convened by the Chair or any two voting members where an event materially changes the basis of a prior decision.

Between gates the Chair maintains the conditions register and the readiness assessment for the next gate, so that a gate is a decision on a known position rather than a discovery exercise.

11. Gate Preparation

A gate is a decision on a known position, not a discovery exercise. The preparation timetable below runs in working days relative to the gate date and is the mechanism that makes that true.

Day	Step
-30	Chair issues the gate notice, criteria set and evidence schedule to functional leads.
-20	Functional leads submit evidence packs. Late submission is recorded, not accommodated.
-15	Chair certifies evidence against the recorded standard; deficiencies returned once.
-10	Readiness assessment circulated to the Committee with the Chair's certification.
-5	Committee members submit written questions; owners respond in writing before the gate.
Gate day	Gate convenes. Deliberation, scoring, decision, conditions.
+5	Minutes circulated including the score sheet and any conditions with owners and dates.

Deficient evidence is returned once. At day −15 the Chair certifies evidence against the recorded standard. Material deficiencies are returned to the owner with one opportunity to correct. Evidence still deficient at day −10 goes to the Committee as deficient, and the relevant criterion is scored on what was actually tabled.

The alternative — extending the deadline until the evidence improves — converts the gate from a decision point into a negotiation about readiness, which is the failure this timetable exists to prevent.

Between gates the Chair maintains the conditions register and the readiness assessment for the next gate, so the day −10 circulation is an update to a document the Committee has been watching rather than a first sight of the program's position.

12. Escalation

Functional lead to Chair — anything that threatens a dated commitment.
Chair to Committee — any matter that would change scope, breach a tranche, draw contingency, or place a condition at risk.
Committee to Board — a ceiling increase, a change to the gate structure, an indication-scope change, or a KILL recommendation.

Escalation is not a failure state and is not held against the escalating party. The failure state is a program that absorbs a problem inside a stage and presents it at a gate as a fait accompli.

13. Board Interface

The Board constitutes the Committee and funds the program. It does not sit at gates and does not review gate decisions. Four things travel upward:

Report	Timing	Content
Gate outcome notification	Within 5 working days of every gate	Outcome, vote record, conditions issued. Notification, not approval.
Quarterly program report	Quarterly	Spend against released authority, contingency position, condition status, material risk movement, forecast to completion.
Exception report	Within 5 working days of the trigger	Any HOLD or KILL outcome, any DMC stopping recommendation, any regulatory action, any forecast breach of the ceiling.
Ceiling or scope request	As required	The only category requiring a Board decision rather than a Board notification.

Three of the four are notifications; only one is a request. That asymmetry is deliberate. A Board that reviews gate outcomes becomes a second gate, and a program that knows its gate decision will be re-litigated upward will manage the Board rather than the gate. The Board holds the ceiling and the scope; the Committee holds everything inside them.

14. Dispute Resolution

Disagreement between functions is normal in a program where clinical, manufacturing, regulatory and commercial timelines genuinely compete. Three routes, in order:

Between functional leads — resolved by the leads, with the Chair informed if the disagreement affects a dated commitment.
Escalated to the Chair — the Chair decides, provided the decision sits within an approved tranche and does not alter scope. The decision and its rationale are minuted at the next program review.
Escalated to the Committee — where the disagreement concerns scope, cost above the Chair's threshold, or a matter on which the Chair holds a conflict.

One dispute type does not follow this route. A disagreement about whether a safety signal requires action is not a program dispute and does not resolve through program governance. It goes to the Data Monitoring Committee and to Pharmacovigilance, whose obligations run independently of this charter (§8). A functional lead who raises a safety concern and is overruled by the Chair has a route directly to the Chief Medical Officer and the Chief Quality Officer, and that route cannot be closed by any provision of this document.

15. Alternates, Succession & Induction

No proxies and no alternates for a vote (§3). A seat is held by a person, not by a function, because gate decisions depend on the judgment of the individual appointed to make them.
A vacant seat reduces the vote count until the Board appoints a replacement. Quorum is recalculated on filled voting seats; it is not waived because a seat is empty.
A new member is inducted before the first gate they vote at, on the gate structure, the criteria framework, the live conditions register and the decision history. A member voting at their first gate without induction is voting on a program they have not read.
The Chair's succession is a Board appointment, not a Committee one, because the Committee cannot select the person who certifies evidence to it.

16. Reviewing the Governance Itself

A governance system that is never assessed will drift toward whatever is comfortable. The Committee reviews its own operation annually against five measures.

Measure	Interpretation
Gate held on baselined date	Target: within 4 weeks. Slippage indicates evidence production is not keeping pace with the gate calendar.
Conditions closed by due date	Target: 100%. A pattern of extensions indicates conditions are being used to defer decisions rather than to close gaps.
Conditions reopened after closure	Target: zero. A reopened condition means the verification method was inadequate at issue.
Decisions reversed within two gates	Target: zero. Reversal indicates the original decision was taken on insufficient evidence.
Escalations raised by functional leads	No target. A count of zero is a warning sign, not a success — it usually means problems are being absorbed rather than surfaced.

The last measure is the one that matters most and is the easiest to misread. A program reporting zero escalations is not a well-run program; it is almost always a program where leads have learned that raising a problem is costlier than absorbing it. The measure has no target for that reason — it is read as a signal about culture, not as a performance indicator.

17. Records

Minutes record: attendance and quorum, the evidence tabled, the criteria assessment, the vote by name, any abstention with its stated reason, the outcome, and any conditions with their verification methods. Minutes are circulated within five working days and approved at the next forum.

The gate record is not amended after approval. Where a subsequent gate revises a figure or supersedes a decision, that is recorded at the later gate; the earlier record stands as it was. A governance history that is tidied retrospectively cannot be audited, and the tidying is usually where the interesting information was.

18. Document Control

This charter is version-controlled and dated. The version in force at a gate is the version recorded in that gate's minutes, and a later amendment does not alter how an earlier decision is read.
Superseded versions are retained, not replaced. A governance history that shows only the current instrument cannot be audited.
The gate record is the authoritative source for what was decided. Where a downstream artifact and a gate minute disagree, the minute governs and the artifact is corrected.
Artifacts carry a status date and speak as at that date. This suite does not retro-fit later knowledge into earlier documents — a status report written in Stage 2 continues to say what was known in Stage 2.

19. Amendment

This charter is amended only by the Board of Vitalis Therapeutics Inc., on a recommendation carried by the Committee. The Committee cannot amend the instrument that constitutes it. Amendments are effective from the next gate and are not applied retrospectively to decisions already taken.