When two drug companies develop or sell a medicine together, each one spends money and one or both collect sales, yet they agreed to split the result. So every quarter someone in finance adds up both sides under the contract's own definitions and works out one payment from one company to the other. That quarterly work, and the accounting behind it, is alliance profit-share accounting, often called collaboration accounting, or ASC 808 accounting after the U.S. accounting topic on collaborations.
This guide is for anyone who builds, signs, audits or disputes these statements: alliance accountants, assistant controllers, alliance managers, commercial finance, internal audit and leaders deciding whether to automate the work. No accounting background needed. Terms are defined when they first appear, and the example and its screens are fictional.
Imagine you are the alliance accounting lead at Northwind Bio, a mid-size biotech. It is Wednesday, October 7, 2026, working day 5 of the quarter's close. Northwind sells a medicine called Dravenzo outside the U.S. and Canada, and pays its partner, Quillmere Biotech, a royalty, a percentage of those sales: 20% on the first $300 million each calendar year, then 23%. Quillmere owes Northwind money on other lines, so one net payment settles the quarter.
Your general ledger, the company's master accounts, shows $200.75 million of sales this quarter and a royalty accrued, meaning recorded as owed, at 20%: $40.15 million. It looks tidy, and last quarter's spreadsheet worked the same way. Then you read section 7.2 of the agreement again. The year had already reached $194.25 million before this quarter began, so the $300 million line was crossed in Q3. Only $105.75 million of the quarter belongs at 20%. The other $95.0 million belongs at 23%.
General ledger accrual
Q3 net sales
$200.75M
Rate used
20% on all of it
Royalty accrued
$40.15M
The agreement · section 7.2
At 20%
$105.75M = $21.15M
At 23%
$95.0M = $21.85M
Royalty owed
$43.00M
$21.25M from Quillmere$18.40Mis the net payment once the royalty is right. Northwind owes $2.85M more royalty.
Careful alliance accounting catches a rate that changed in the middle of a year, in your partner's favor, before your partner's auditor does.
How drug alliances split profit and cost: the statement, the definitions, the standards and the errors
What the quarterly statement holds, how the contract's definitions move money, what ASC 808 and IFRS 11 do and leave open, the sums worked through, and what goes wrong. Nothing here sells anything. If you are new to collaboration accounting, start here.
01 · In plain words
Two companies, one medicine, one payment: alliance accounting in plain words
Developing a medicine costs a great deal, and selling it around the world takes people in many countries. So companies often team up. A small biotech that discovered a molecule might join a larger company with a sales force. They sign a collaboration agreement that says, in effect: we will share the cost of development, we will each sell in our own part of the world, and we will split the profit.
Usually there is no joint company and no shared bank account. PwC's guide notes these arrangements usually run through contracts, typically without a separate legal entity.1 Each company pays its own staff, books its own sales in its own territory and keeps its own general ledger, the master record of its accounts. Each company knows half the picture. The contract only works if someone adds both halves together.
So every quarter, each side sends the other its figures: sales, deductions, costs and hours. Finance then applies the contract's definitions: what counts as a deduction from sales, what yearly cost an employee carries, which exchange rate applies and which studies a partner has left. The result is a profit-share statement, with each partner's share, each reimbursement and one net payment at the bottom.
The people who do this are alliance accountants, or collaboration accountants. Beside the statement sits a second question for the financial report: where do these payments appear in each company's own accounts? In the U.S. that question falls under ASC 808, the accounting topic on collaborative arrangements. Companies reporting under IFRS, the international standards, start from IFRS 11.2 A wrong line on a statement may stay hidden until a partner's auditor reads it years later, and then every quarter it touched comes back.
One alliance quarter, from closed books to a signed payment
The agreement sets the termsNorthwind Bio and Larkspur Pharma sign an agreement, then amendments, committee letters and an opt-out notice. Together those documents set the money terms.
The quarter closesOn September 30 each company closes its books. Northwind pulls its sales and cost records, and Larkspur prepares its report.
An estimate goes acrossWithin ten business days, each side sends a good-faith estimate, so both can book their quarter.
The statement is built and checkedFinance maps each record to the agreement's categories, tests it against the definitions in force and checks the partner's figures. This is where a stale rate is caught, or carried forward.
Both sides agree and one paysThe controller signs, the partner agrees or raises a question, and one net payment moves. A partner may audit it later.
Step 4 is the subject of this guide. The companies, dates and deadlines in this example are fictional.
Four things about profit-share statements that surprise newcomers
The standard does not give you the sums
ASC 808 addresses presentation and disclosure. For when to record an amount and at what value (recognition and measurement), it sends you to other guidance by analogy, or to a consistently applied policy of your own.3,4
Net Sales in the contract is a different number
Your reported net sales follow accounting rules. The contract's capitalized Net Sales follows its own list of deductions, and one filed agreement lists bad debt where another leaves it out.5,6
A letter can change the money
Filed agreements leave FTE rates to committees or to yearly index changes.7,8,9 So the number in force may sit in a letter, far from the signed contract.
A good check cuts both ways
Half the sample findings in this guide, and about three quarters of their dollars, make the checking company pay more. An honest statement reports errors in both directions, because the partner's auditor can find both.
Four terms on every statement: Net Sales, Allowable Expenses, FTE rate, true-up
Net Sales
Gross invoiced sales less the deductions the agreement lists. The contract defines it, so it can differ from reported revenue.
Allowable Expenses
The costs the agreement lets a partner charge to the shared profit pool. A cost outside the definition stays with whoever spent it.
FTE rate
The agreed yearly cost of one full-time employee working on the alliance, used in place of each person's real pay. FTE stands for full-time equivalent.
True-up
The balancing payment that brings what each partner actually spent back to the agreed share.
What a quarterly profit-share statement contains, line by line, down to one net payment
In shortA statement has three parts: profit in territories where a partner books sales, development cost shared by a fixed split, and sometimes royalties. Each part produces an amount owed one way or the other. They net to a single payment.
The company that records a sale in its own accounts is called the booking party, and in accounting terms usually the principal, the party that controls the sale. In a territory where you book, you hold the money and owe your partner a share. In a territory where the partner books, the partner owes you. Development costs run on their own split, because the spending rarely falls in the agreed proportion. A royalty may apply to markets outside the shared territories.
Six hand-offs lead from closed books to one net payment
The deadlines shown are the fictional sample's. Filed agreements usually redact theirs
1Books closed
Each company closes the quarter and pulls sales, deductions and costs.
Each partner's finance teamDay 0
2Estimate exchanged
A good-faith estimate of Net Sales and Allowable Expenses goes across.
Alliance accounting10 business days
3Records mapped
Records are placed in the agreement's categories and tied to the books.
Commercial finance, alliance accountingWeeks 2 to 4
4Definitions applied
Each line is tested against the definition in force, and the partner's figures are recomputed.
Alliance accountingWeeks 2 to 5
5Final statement
The statement is signed and sent, with questions answered.
Assistant controller, alliance manager45 days
6Payment
One net amount moves to whoever is owed it.
Treasury60 days
Fictional example from this guide
Show the numbers
Step
What happens
Who
Time
Books closed
Each company closes the quarter and pulls sales, deductions and costs.
Each partner's finance team
Day 0
Estimate exchanged
A good-faith estimate of Net Sales and Allowable Expenses goes across.
Alliance accounting
10 business days
Records mapped
Records are placed in the agreement's categories and tied to the books.
Commercial finance, alliance accounting
Weeks 2 to 4
Definitions applied
Each line is tested against the definition in force, and the partner's figures are recomputed.
Alliance accounting
Weeks 2 to 5
Final statement
The statement is signed and sent, with questions answered.
Assistant controller, alliance manager
45 days
Payment
One net amount moves to whoever is owed it.
Treasury
60 days
The Larkspur statement in three net lines
The fictional Veltrimab alliance shows all the parts except a royalty. Northwind books U.S. sales and owes Larkspur half of U.S. profit, plus Larkspur's own U.S. costs. Larkspur books everywhere else and owes Northwind half of that profit. Larkspur also bears 55% of shared development cost and has spent less than that, so it owes a true-up.
Three lines net to the $129.22M Northwind pays Larkspur
Veltrimab, Q3 2026, as drafted, $ millions, in this guide's example
Owed to Larkspur: U.S. share and its U.S. costs245.8 M
Owed by Larkspur: half of ex-U.S. profit82.1 M
Owed by Larkspur: development true-up34.5 M
Net: Northwind pays Larkspur129.2 M
Fictional example from this guide
Show the numbers
Item
Value
Owed to Larkspur: U.S. share and its U.S. costs
245.8 M
Owed by Larkspur: half of ex-U.S. profit
82.1 M
Owed by Larkspur: development true-up
34.5 M
Net: Northwind pays Larkspur
129.2 M
Part of the statement
What it adds up
Where the figures come from
What usually moves it
Your booked territory
Net Sales less Allowable Expenses, then the partner's share, plus any costs the partner spent there
Your general ledger and your records of sales deductions
Deduction definitions, allocation of cost, FTE rates and sales-visit rates
The partner's booked territory
The partner's profit, then your share
The partner's report
Exchange rate method, supply price, what the partner counted
Shared development
Total shared cost, then each share, less what each already spent
Project records on both sides
Opt-outs, budget overruns, FTE hours
Royalties, where they apply
Tiered rates on cumulative sales outside the shared territories
Your or the partner's sales records
Where the year stands against each tier
03 · The agreement's definitions
Net Sales, Allowable Expenses and FTE rates differ from one collaboration agreement to the next
In shortThe statement's real rulebook is the contract. We read parts of nine agreements filed with the SEC. They agree on the vocabulary and disagree on the detail. Most of the numbers are blacked out, so nobody outside can say what is normal, and you must read yours.
Companies file material agreements with the SEC and may keep competitive terms confidential, so the filed texts show how an agreement is built and rarely show its numbers. The nine span 2003 to 2023 and are cited individually below. Their dates matter, since older terms may have changed. We are quoting real contract wording only, and nothing here suggests any of these partners made an error.
Filed agreements show how each term works and black out most of the numbers
Seven of the nine filed texts. Not seen means the part we read did not show it
Not seenRedactedPartlyReadable
FTE rate amountRate change methodReport daysAudit look-backAudit cost shiftBioNTech and Genmab, 2015RedactedReadablePartlyRedactedRedactedSolvay and CV Therapeutics, 2004Not seenNot seenReadableReadableReadableOtsuka and Acucela, 2008RedactedPartlyReadableReadableRedactedCorgentech and BMS, 2003RedactedReadableRedactedNot seenNot seenBayer and Onyx, 2006RedactedPartlyRedactedNot seenNot seenAmgen and AstraZeneca letter, 2023RedactedReadableNot seenNot seenNot seenAstellas and FibroGen, 2009RedactedRedactedNot seenNot seenNot seen
Bad debt alone gets three different treatments in five filed agreements
Take one small item: money a customer never pays. In the BioNTech and Genmab agreement, amounts written off as uncollectible are a Net Sales deduction, and a later recovery goes back into Net Sales.5 The Corgentech and Bristol-Myers Squibb text also allows it as a deduction.7 In the Bristol-Myers Squibb and Pfizer apixaban agreement it sits in Allowable Expenses instead.13 The Solvay and CV Therapeutics and the Otsuka and Acucela definitions do not list it.6,10
An accountant who moves between alliances and applies yesterday's habit gets a wrong answer, and the books of neither company show it, because each company's books are right for their own purposes.
Term
What the filed agreements say
Why it moves money
FTE rate
Set with each year's budget by a committee;8 indexed to a consumer price index such as CPI-W, euro-area HICP or CPI-U West;9,5,10 or capped by the U.S. CPI change.7 Every amount we saw is redacted or withheld.
A rate gap multiplies by every full-time employee charged to the alliance.
Exchange rate
The paying party's usual mechanism, in line with IFRS;5 the method in the party's audited statements, disclosed in writing first;7 or the Bloomberg mid-price on the invoice date.10
The same euro report converts to different dollars under each method.
Budget overruns
Extra cost is borne alone unless the committee approves it, with timing shifts shared;5 quarterly recognition is capped and the excess tracked forward;11 a permitted overrun band, with the percentage redacted.10,7
An unapproved overspend moves from the pool to the party that spent it.
Opt-outs
A window after set points, with effect 30 days after notice, and no refund of amounts already paid.5
The study's later costs leave the shared pool from a specific date.
Detail counts
A detail is defined as a face-to-face product meeting between a physician and a representative, with monthly reports by representative.6
Reimbursement can rest on the count, so the definition decides what is paid.
Audits
Once a year, five years back, with the threshold redacted;10 once a year with no period audited twice, look-back and threshold redacted;5 the preceding three years, with a 10% underpayment shifting cost.6
The look-back sets how many quarters one error can reopen.
Cost disputes
An independent accounting firm as expert, final and binding, loser pays;5 alliance managers, then a steering committee, then a further article.7
It decides who settles a number and how fast.
We found no public benchmark for report days, audit look-backs or overrun bands. The "45 days" and "three years" in this guide's example are the sample's own terms.
04 · ASC 808
What ASC 808 and ASU 2018-18 require, and what they leave to your own accounting policy
In shortASC 808 sets who is in scope, how third-party sales are reported and what to disclose. ASU 2018-18, the 2018 update to it, added two points: a partner can be your customer for a distinct good or service, and a flow, any payment between partners, may not sit with customer revenue when the partner is no customer. The rest runs on analogy or a consistent policy.
A collaborative arrangement, in the words of the U.S. accounting codification as quoted by PwC, is "a contractual arrangement that involves a joint operating activity."1 Both sides must take an active part and be exposed to significant risks and rewards. Deloitte's 2018 note put the gap plainly: the topic gives guidance on presentation, classification and disclosure and "does not address recognition and measurement matters."4
So the company must look elsewhere, possibly by analogy. Deloitte's March 2026 guide says the same of the update that followed: the Board "decided not to include recognition and measurement guidance for nonrevenue transactions in a collaborative arrangement."14
The Financial Accounting Standards Board (FASB), which writes U.S. accounting rules, amended the topic in November 2018 with an Accounting Standards Update (ASU), ASU 2018-18. The update made three things clear.3
A partner can be a customer
A collaboration is partly under ASC 606, the revenue standard, when a distinct good or service goes to a partner acting as a customer (paragraph 808-10-15-5B).
The rest runs on analogy or policy
For what stays outside, the unit of account (the distinct good or service being tested), recognition and measurement rest on analogy "or, if there is no appropriate analogy, a reasonable, rational, and consistently applied accounting policy election" (15-5C).
Customer revenue stands apart
A company is "precluded from presenting transactions in a collaborative arrangement together with revenue from contracts with customers" unless ASC 606 applies to that unit (45-3).
EY's life sciences note makes the same reading.15 PwC adds that the equity method, which records a stake in another entity as one investment adjusted for a share of its results, does not apply when no separate legal entity exists.1
FASB's own example: the same $5 million profit, two very different income statements
FASB's Example 1 is the clearest way in. Pharma and Biotech split a product 50/50. Biotech spends $10 million on research. Pharma sells $50 million to third parties and spends $20 million to make it and $10 million to market it. Pharma owes Biotech $15 million, and each ends with $5 million.3
Example 1 assumes Pharma is principal, and that Biotech has concluded Pharma is its customer for research services. FASB says those conclusions are assumed as facts in the example and do not illustrate the right answer for any real deal.
Same arrangement, same $5M profit: Pharma reports $50M of sales and Biotech $15M of revenue
ASC 808-10-55-3 to 55-5, Example 1, $ millions. Conclusions are assumed facts in FASB's example
Note Pharma's classification in that example: it splits the $15 million by nature, with $10 million of profit share in cost of goods sold and $5 million of reimbursed research in R&D. It is one policy among those a company may reach. Your auditor will ask you to apply yours the same way each period, and to explain it.
ASC 808's collaboration rules changed once in 2018, and FASB's June 30 list names no new project
May 2011IFRS 11 issued
Replaces IAS 31; effective January 1, 2013.
Nov 2018ASU 2018-18
Adds the unit of account test and the presentation bar.
Dec 15, 2019Public companies
ASU 2018-18 applies to fiscal years beginning after this date.
Dec 15, 2020All other entities
ASU 2018-18 applies to fiscal years beginning after this date.
Nov 2026Today
ASC 808 stands as amended; no new collaboration project on FASB's June 30 list.
A dated caution on guides. The newest firm editions we could confirm are PwC's section dated September 15, 20251 and Deloitte's Life Sciences Industry Accounting Guide dated March 2026, which covers developments through March 6, 2026 and has a section of SEC comment letter themes on collaborative arrangements.14 EY's life sciences note was last updated July 10, 2020.15 Read your firm's current edition before you set a policy.
05 · IFRS 11 and IFRS 15
Collaboration accounting under IFRS 11 and IFRS 15: joint control comes first
In shortIFRS has no equivalent of ASC 808. A company asks first whether the partners have joint control. If they do and no separate vehicle exists (a separate legal entity or similar financial structure), it is a joint operation, and each records its own share line by line. If they do not, other standards apply, and IFRS 15 decides whether the partner is a customer.
Under IFRS 11, joint control is the contractual sharing of control, and it "exists only when decisions about the relevant activities require the unanimous consent of the parties sharing control" (paragraph 7).2 Many alliances have a tie-breaking vote on some matters, so read this test closely.
An arrangement that is not structured through a separate vehicle is a joint operation (paragraph B16). A joint operator recognizes its own assets, liabilities, revenue and expenses, including its share of what is held jointly (paragraph 20).2 Where a separate vehicle holds rights to net assets, it can be a joint venture (paragraph 16), recognized as an investment under the equity method (paragraph 24).
IFRS 15 applies to a contract only if the counterparty is a customer, and paragraph 6 says a party that takes part in an activity sharing risks and benefits, such as developing an asset in a collaboration arrangement, is not a customer in that respect.18
Deloitte's March 2013 note, which predates much of today's practice, works a Phase II and III example with no separate vehicle and classifies it as a joint operation, assuming joint control. It warns that presentation "could result in material differences" between IFRS and U.S. GAAP.16
Three paths under IFRS 11, sorted by one question: do key decisions need unanimous consent?
No joint control
IFRS 11 does not apply. Look to other standards, and to IFRS 15 where the partner is a customer (IFRS 15, paragraph 6).18
Joint control, no vehicle
A joint operation. Each records its own assets, liabilities, revenue and expenses, and its share (paragraphs B16 and 20).2,16
Joint control, separate vehicle
Test rights and obligations. Rights to net assets point to a joint venture (paragraphs 15 and 16).2
Question
U.S. GAAP
IFRS
Starting test
Joint operating activity, active participants, significant risks and rewards1
IFRS 18 subtotals and aggregation from January 1, 202720
06 · The size of these flows
How big alliance flows are, and why the same money sits on different lines in 10-K filings
In shortProfit shares can reach billions of dollars a year at one company. Published filings show one partner's share in cost of products sold, in collaboration revenue or in other operating expenses. Licensing activity keeps feeding the work: announced deal value reached $250.2 billion in 2025.
Annual reports filed with the SEC, known as 10-Ks, give the scale. Bristol-Myers Squibb's 2025 alliance note shows $7,181 million of payments to alliance partners in cost of products sold, and $1,684 million owed to alliance partners at year end. Its Pfizer profit share alone was $6,980 million.21
One alliance's profit share grew to $6.98 billion in BMS's cost of products sold
Bristol-Myers Squibb, profit sharing payments to Pfizer in cost of products sold, 2023 to 2025, $ billions
Now see the same kind of flow on different lines, in the table below: Regeneron and Sanofi show the two sides of one alliance. Pfizer's policy note says that where it is principal, amounts paid to partners for their share of net sales or profits go to cost of sales.22 None of these is wrong for being different. ASC 808 leaves room, and IFRS has its own frame.
Filed figures are shown for scale and presentation only. Regeneron also reports a contingent obligation of about $595 million for development funded by its partner at December 31, 2025, repaid out of 20% of its profit share each quarter: such balances can run for years.23
More deals, more definitions: licensing value in the J.P. Morgan and DealForma series
Announced biopharma licensing value hit $250.2 billion in 2025
$ billions, selected years. All R&D licensing deals with disclosed financials, including those with no profit share. Upfront cash was 7% of 2025 value across 516 deals
We found no public count of how many active alliances share profit or cost, or what share of drug sales passes through them. Some licensing deals carry only royalties and milestones and generate far simpler statements. Your own count of active agreements is the number that matters.
07 · The sums, worked
A profit-share calculation worked through: Net Sales, pre-tax profit, shares and a royalty tier
In shortThe sums are simple arithmetic. The hard part is knowing which definition applies to which line in this quarter. All the numbers in this section are the fictional Veltrimab and Dravenzo statements from the example.
From $1,048 million of gross sales to Larkspur's share of U.S. profit
Northwind invoiced $1,048.00 million in the U.S. Deductions allowed by the draft come to $435.60 million, leaving Net Sales of $612.40 million. Six cost lines, each defined as an Allowable Expense, come off. U.S. pre-tax profit is $463.21 million, and Larkspur's half is $231.60 million. Northwind also owes Larkspur $14.19 million for the sales visits it paid for. So Northwind owes $245.80 million before the other two lines.
Of $612.4M of U.S. Net Sales, $463.2M is the profit the partners split
Veltrimab, Q3 2026, as drafted, $ millions, in this guide's example
Pre-tax profit to splitSales and marketingCost of goods, $38.7MLarkspur's co-promotion costs, $14.19MMedical, distribution, patents and insurance, $24.7M
U.S. Net Sales, $612.4M463.2 M71.6 M
Fictional example from this guide
Show the numbers
Pre-tax profit to split
Sales and marketing
Cost of goods, $38.7M
Larkspur's co-promotion costs, $14.19M
Medical, distribution, patents and insurance, $24.7M
U.S. Net Sales, $612.4M
463.2 M
71.6 M
38.7 M
14.2 M
24.7 M
Six small sums that each moved the Larkspur statement
The check
The sum
Result on the line
Northwind pays
Bad debt
$4.40M provision deducted, $1.50M written off. $4.40M − $1.50M
Net Sales up $2.90M
$1.45M more (half)
FTE rate
118 FTE × ($312,000 − $286,440) ÷ 4
Sales and marketing down $0.754M
$0.38M more (half)
Opted-out study
$4.80M × 55%
Shared pool from $100.80M to $96.00M
$2.64M more
Supply price
826,400 units × ($41.20 − $38.90)
Ex-U.S. profit up $1.90M
$0.95M less (half)
Details
(31,400 − 29,850) × $452
Reimbursement down $0.70M
$0.35M less (half)
Exchange rate
Sep 30 rate 1.1612, quarterly average 1.1642
Ex-U.S. profit up $0.42M
$0.21M less (half)
The FTE rate check starts with a letter: $280,000 for 2025, increased by a 2.3% index change to $286,440 for 2026. The payment column reflects how each line splits: a change to shared profit moves half, and a development change moves the partner's 55%. Details are sales representatives' product visits, counted in the shared customer relationship management (CRM) system.
A royalty tier crossed during the quarter
A tier applies to cumulative sales in the year, so the rate changes in the quarter the threshold is passed. Through June, sales were $194.25 million. The next $105.75 million reaches the $300 million line, and $95.0 million falls above it. The accrual used 20% on all $200.75 million.
Almost half of the quarter's royalty base sat above the $300M tier line
Dravenzo sales outside the U.S. and Canada, Q3 2026, $ millions, in this guide's example
Why a statement template goes stale: three facts that changed before Q3 closed
Each of these sums was once correct under a different fact. The study was in the pool until the opt-out took effect on April 2. The tier had not yet been reached. The FTE rate was last year's until the January letter. A spreadsheet carried forward keeps the fact it last knew. That is why a list of definitions in force, dated, matters more than a good template.
08 · Common errors
Why alliance statements go wrong: stale rates, opted-out studies, unsigned prices and unchecked partner figures
In shortMost errors are facts that changed outside the spreadsheet. Others come from trusting a partner's figure, or your own planning rate. No public study gives their frequency, so the classification here is our reading of how the contracts work, and the amounts are the fictional example's.
An opted-out study was the largest of eight sample adjustments, ahead of a bad-debt line and a royalty tier
Gross line change, Q3 2026, across two alliances, $ millions. Total $15.9M, in this guide's example
Opted-out study left in the shared pool4.8 M
Bad-debt provision deducted beyond write-offs2.9 M
Royalty tier crossed, accrued at the old rate2.85 M
Unsigned supply price1.9 M
Global brand spend above budget1.6 M
FTE charged at a planning rate0.754 M
Sales visits above the CRM count0.7 M
Exchange rate at quarter end in place of the average0.42 M
Fictional example from this guide
Show the numbers
Item
Value
Opted-out study left in the shared pool
4.8 M
Bad-debt provision deducted beyond write-offs
2.9 M
Royalty tier crossed, accrued at the old rate
2.85 M
Unsigned supply price
1.9 M
Global brand spend above budget
1.6 M
FTE charged at a planning rate
0.754 M
Sales visits above the CRM count
0.7 M
Exchange rate at quarter end in place of the average
0.42 M
Read that total with care. $15.9 million is the size of the line changes. The effect on what Northwind pays is smaller: $9.63 million if you add every finding regardless of direction, and $5.01 million net, because $7.32 million of the changes go against Northwind and $2.31 million in its favor.
About three quarters of the payment effect in the sample goes against the company doing the check
Effect of eight findings on what Northwind pays, $ millions, in this guide's example
$9.63Min both directions
Northwind pays more7.32 M
Northwind pays less2.31 M
Fictional example from this guide
Show the numbers
Part
Value
Northwind pays more
7.32 M
Northwind pays less
2.31 M
Errors that begin outside the general ledger are the hardest for a normal close to catch
Our judgment of each error type against the place a normal close would look
UnlikelyPossibleLikelyVery likely
Monthly closeController reviewPartner's reviewPartner's auditStale FTE or detail rateUnlikelyPossiblePossibleVery likelyStudy still in pool after opt-outUnlikelyPossibleLikelyVery likelyRoyalty tier crossed mid-yearPossibleLikelyLikelyVery likelyDeduction outside the definitionUnlikelyPossiblePossibleVery likelyPartner's exchange rate methodUnlikelyUnlikelyPossibleLikelyPartner's unsigned supply priceUnlikelyUnlikelyUnlikelyPossiblePartner's visit count above the CRMUnlikelyUnlikelyUnlikelyPossible
An amendment or committee letter changed it, and the template did not
The letter, the minutes, the amendment
A planning rate in the actuals
Your cost centers carry an internal rate, which the contract does not recognize
Cost center detail against the FTE rate letter
A draft treated as signed
A partner's report assumes an amendment still under negotiation
The contract repository's signature record
A cost outside the definition
An item is shared across products or is over the approved budget
Budget minutes, allocation workings, invoices
A reserve in place of an actual
Your books hold a provision, while the contract counts only what happened
Write-off records, true-up calculations
A partner number taken on trust
Nobody has time to recompute a report that looks plausible
The rate source, the signed price, the shared CRM
09 · Audit and dispute risk
How collaboration accounting reaches audit committees, SEC comment letters and arbitration
In shortThe risk shows up in four places: your partner's audit rights, your external auditor, SEC staff comment letters, and arbitration. Public records show each. None of them gives a rate of errors, and these cases are examples of the risk and no comment on any statement.
Where it surfaces
What the public record shows
What to take from it
External audit
Ernst & Young named cost sharing under Nektar's 2022 collaboration with Bristol-Myers Squibb a critical audit matter, an item the audit report singles out, "especially challenging because of the complexity of the data." It tested billed costs against the terms and obtained an external confirmation of the net amount owed.26
Auditors can test both sides' data, read minutes and ask your partner to confirm.
Restatement
CytomX restated 2019 to 2021 after re-evaluating ASC 606 for collaboration and license agreements. It reported overstated revenue of $32.3 million, $31.9 million and $30.6 million for 2021, 2020 and 2019, and a material weakness, a serious gap in its financial reporting controls.27 It concerned revenue timing rather than a profit share.
Judgments about collaborations can reopen several years.
SEC staff
Staff asked Alnylam for tables by year and line item of collaboration amounts, showing separately what was netted.28 Staff asked Blueprint Medicines how it applied ASU 2018-18 to treat part of an agreement outside ASC 606.29
Be ready to show the table, the unit of account and the reasoning.
Arbitration
Exelixis took Genentech to arbitration in June 2016 over a cancer drug's U.S. collaboration, including its cost and revenue allocations. Genentech counterclaimed over cost allocations, then withdrew that claim in December 2016 and changed how it allocated promotional expenses, for past and future periods. The 2017 settlement carried no payment for the claims, and from July 1, 2017 it changed how revenue and costs reach the shared profit and loss statement.30,31
How a partner allocates costs and revenue can reach arbitration, and the settlement can change the statement itself.
Internal control over the statement build
For a public company, the statement feeds reported revenue, cost and payables, so it falls within management's assessment of internal control over financial reporting. The SEC's guidance describes a material weakness as a deficiency, or a combination of deficiencies, such that "there is a reasonable possibility that a material misstatement" will not be prevented or detected on time.32 A controller signing a statement wants to see who set each rate, who approved each change and what evidence stands behind each number.
Tier, opt-out and deduction errors cost most when found late; rate and mapping errors arise more often
Our judgment. Place your own alliances on it
Cost when it surfaces late →
Control it first
Automate the check
Periodic review
Better data
Opt-out in poolRoyalty tierNet Sales deductionFTE rateMapping slipExchange rate
Medicare negotiated prices, expense disaggregation and IFRS 18: what changes for alliance accounting in 2026 and 2027
In shortThe first negotiated Medicare prices took effect January 1, 2026, and some sit inside shared-profit products. New U.S. expense tables and IFRS 18 arrive for periods from 2027. Each one tests definitions written years earlier.
$231 vs $521
negotiated Medicare price from January 1, 2026, against the 2023 list price, for a 30-day supply of Eliquis. Bristol-Myers Squibb reports that product's profits and losses as shared equally with Pfizer worldwide, except in certain countries.33,21
CMS fact sheet · BMS 10-K for 2025
Dec 15, 2026
ASU 2024-03 applies to public company annual periods beginning after this date, with interim periods beginning after December 15, 2027.19
FASB, November 2024
Jan 1, 2027
IFRS 18 applies to annual periods beginning on or after this date, with new operating subtotals and aggregation principles.20
IFRS Foundation
Maximum fair price: a Net Sales question many agreements never anticipated
CMS, the federal agency that runs Medicare, negotiates one price, the maximum fair price, with one "Primary Manufacturer," the holder of the application. Another entity that markets the drug under an agreement with it can be a "Secondary Manufacturer," and the examples in CMS's October 2024 guidance include "royalty agreements, licensing agreements, revenue sharing agreements, marketing agreements, supply agreements" among others.34
CMS's proposed rule, CMS-4215-P, would put program policy into regulation for 2029 and beyond. On November 3, 2026, it is still only proposed, and the White House budget office has listed the final rule as under review since September 9, 2026.35
So ask of each affected alliance: does Net Sales capture the negotiated price correctly, including refunds paid after the sale? Who bears any cost of giving effect to it? Is that stated, or only assumed? We found no public statement of how any alliance has settled this, and it may differ agreement by agreement.
Expense tables and IFRS 18: alliance lines become more visible
ASU 2024-03 requires public business entities to disaggregate, or break into parts, certain expense captions in the notes. IFRS 18 brings new subtotals and rules on aggregation.19,20 If profit share and reimbursements sit in cost of products sold or in operating expenses, the people building those tables will need a clean split of the alliance's amounts by nature, for each period. A statement built with each line tied to its source makes that far easier.
Three dates in the next 14 months touch how alliance flows are measured or shown
Jan 1, 2026First negotiated prices
Ten drugs in Medicare Part D, the prescription drug benefit, Eliquis among them.
Jun 16, 2026CMS-4215-P proposed
Would codify policy for 2029 and beyond; still proposed, final rule under review since Sep 9.
Nov 2026Today
FASB's agenda list of June 30, 2026, names no Topic 808 project.
Dec 15, 2026ASU 2024-03
Public company annual periods beginning after this date.
What AI can do in collaboration accounting, and why financial reporting controls are the rules that govern it
In shortSoftware can read long agreements, map lines, recompute a partner's figures and tie every number to its source. Fixed logic should do the arithmetic, and people should make the judgments. The rules that bear on this are financial reporting controls. Drug regulators' AI guidance covers drug decisions and manufacturing.
AI fits the reading and matching; arithmetic stays fixed and judgment stays human
Our judgment of where each task belongs
How much reading it takes →
AI drafts
AI reads
People decide
Fixed logic
Reading definitionsMapping linesDrafting a replyChoosing a policyRate method testShare arithmetic
Yes, as guidance. It applies COSO's 2013 internal control framework to generative AI, says controls should treat outputs "as claims requiring validation," and covers reliance on AI output as evidence for a financial reporting control.
No. Its scope is information intended to support regulatory decisions on drugs.
EU GMP draft Annex 22 and Annex 11
Still drafts. EudraLex lists Annex 11 at January 2011 and no Annex 2238
No. They concern manufacturing.
EU AI Act high-risk rules
Annex III moved to December 2, 2027, by the AI Omnibus, in force July 27, 202639
The Commission's listed examples name no financial close work. Check yours with counsel if staff or access decisions rely on it.
Three limits on AI in a profit-share statement
A model should not do the sums. Your auditor will ask whether the same input gives the same output. Reading can use a model. Multiplication should use a formula.
A model should not pick your policy. Which line a flow goes on, and whether a partner is a customer, are judgments you must explain and repeat.
Reading can be wrong in confident ways. A low-quality scan or a nested definition can mislead. So every value must open its source, and a person must see the source when deciding.
12 · How teams do it today
Who builds alliance statements today, where the days go and the four ways teams run the work
In shortA small group builds each statement in a spreadsheet, with help from commercial finance, the alliance manager and the partner's finance team. We found no public survey of hours or elapsed days, so the time split below is an estimate you should replace with your own.
Who touches a profit-share statement: accountant, controller, alliance manager, partner
AA
Alliance accounting lead
Builds the statements, decides each adjustment, answers partner questions.
AC
Assistant controller
Signs large adjustments and the classification memo. Owns the control.
AM
Alliance manager
Owns the relationship and committee letters. Escalations pass through this person.
CF
Commercial finance
Releases the sales and cost extract and the account map.
PF
Partner finance
Sends the partner's reports and reviews the statement.
IA
Internal audit
Tests the control and reads the trail.
Filed agreements often name a joint finance committee, which handles rates, payment methods and reconciliations.13,7,8
Most hand-offs in a manual statement pass through one person's spreadsheet
A typical path, our description. Your steps may differ
1Extract released
General ledger lines by product, territory and cost center.
Commercial financeWeek 1
2Partner report arrives
A spreadsheet or portal upload, in the partner's own layout.
Partner financeWeek 1 to 2
3Lines keyed and mapped
Into last quarter's workbook, category by category.
Alliance accountantWeek 2 to 3
4Terms checked
From memory, a summary sheet or a search of the contract.
General ledger lines by product, territory and cost center.
Commercial finance
Week 1
Partner report arrives
A spreadsheet or portal upload, in the partner's own layout.
Partner finance
Week 1 to 2
Lines keyed and mapped
Into last quarter's workbook, category by category.
Alliance accountant
Week 2 to 3
Terms checked
From memory, a summary sheet or a search of the contract.
Alliance accountant
Week 3 to 4
Review and sign
Questions back, variance explanations, sign-off.
Assistant controller
Week 5
Questions and agreement
Email threads with attachments.
Alliance manager, partner
Week 5 to 6
Where 43 days can go on a hand-built statement
Partner questions and mapping take the most days in this estimated split
An estimate for one fictional quarter of 43 days. No public benchmark exists; use your own
Partner questions and agreement10 days
Mapping lines to the agreement's categories8 days
Applying definitions, rates, opt-outs and tiers7 days
Waiting for the extract and partner reports6 days
Checking the partner's figures6 days
Review, sign-off and the accounting memo6 days
Illustrative · replace with your own numbers
Show the numbers
Item
Value
Partner questions and agreement
10 days
Mapping lines to the agreement's categories
8 days
Applying definitions, rates, opt-outs and tiers
7 days
Waiting for the extract and partner reports
6 days
Checking the partner's figures
6 days
Review, sign-off and the accounting memo
6 days
Spreadsheets, outside firms, ERP modules or document-reading software: four ways to run the statement
Way
What it does well
Where it strains
Spreadsheets in house
Flexible, and known to the person who built them. Low cost to start
Key-person risk, version control, no link from a number to its clause
Accounting firm or co-sourced team
Technical depth for a new deal, an audit or a restatement
Partner-audit preparation repeats; independence limits apply if it is your auditor
Revenue management or enterprise resource planning (ERP) settlement modules
Strong calculation, master data and postings
Terms keyed by hand as settings; the agreement's text stays elsewhere
Document-reading software with fixed calculation
Connects clause, source line and result
Needs a real test on your own hardest agreement before you rely on it
Part B · See it working
Botminds Alliance Profit-Share Accounting on one quarter at a biotech with four partners
Part A described the work without naming a product. This part shows how Botminds does it at a fictional biotech, Northwind Bio, on the Q3 2026 close. Every company, product, study, person, clause and figure on the screens is sample data, and the clauses are sample text written for the example. They describe no real alliance.
13 · One statement, start to finish
The Quillmere statement: from a who-pays-whom map to a royalty tier finding and an $18.40M payment
In shortThis is the example from the top of the page, inside the product. Omar Haddad, the alliance accounting lead, opens the quarter on one map, opens the arrow for Quillmere Biotech, reads the finding beside its clause and applies it. AI agents proposed the finding. A person decided it, and fixed arithmetic moved the net payment from $21.25M to $18.40M.
1
The quarter on one map
Wednesday, October 7, 2026, working day 5. Northwind Bio sits in the center with four partners around it. Each arrow points the way money moves and is as thick as the net settlement. So far Northwind pays $3.1M and partners pay $31.1M. Larkspur's arrow is dashed, because its reports came in at 6:10 am and its statement is not built. Estimates are due on October 14 and finals on November 14.
Who pays whom. One line of totals, four arrows and the close dates, with no task list to read first.
2
The statement behind the Quillmere arrow
One click opens the Dravenzo statement beside the map. Quillmere pays Northwind $21.3M, or $21.25M as drafted. Three lines carry it: $56.00M from Quillmere for its share and costs in the U.S. and Canada, $40.15M of royalties to Quillmere, and a $5.40M development true-up. Each source listed below opens at its passage.
The statement behind an arrow. The net amount, three lines, the sources and two findings to decide.
3
A royalty tier crossed in Q3, accrued at 20% throughout
The first finding shows the accrued figure and the figure the tiers give, side by side: $40.15M against $43.00M. The sentence below gives the sum, and the sample's section 7.2 sits highlighted on the right. The panel states the effect: Northwind pays $2.85M more, above $1M, so the controller signs. The allowability checker reports 97% confidence, which tells Omar how the agent rated its own reading. It decides nothing.
A finding to decide. Two numbers, the sum, the sources, the effect and the clause. The clause is the sample's text.
4
Omar applies it, and the payment moves to $18.40M
The statement recalculates, and the next finding opens. Quillmere charged $3.60M of global brand campaign to the profit pool, and the Joint Steering Committee approved $2.0M for 2026, so $1.60M leaves the pool and Northwind's half is $0.80M. Here the recommendation is to ask Quillmere, because the figure belongs to the partner. Asking puts the agreement figure in the statement, marked pending, and drafts a question with the evidence attached.
Applied, then the next finding. The net payment reads $18.40M, with the change from the draft shown beside it.
5
Every step is on the record
The Activity tab lists each event in order, with who and when: Quillmere's upload, the calculator's run, the checker's proposals and Omar's decision. Internal audit has read-only access to statements, calculation trails and this record.
Who did what, and when. Each statement carries its own audit trail.
14 · The hardest statement
Building the Larkspur statement: 1,206 general ledger lines, $129.22M and six findings in both directions
In shortLarkspur's report and Northwind's extract arrived that morning. Five agents read ten documents, map the lines, test each one and calculate. The draft says Northwind pays $129.22M, with six findings: three that raise what Northwind pays and three that lower it.
1
Five agents build from ten documents
The list on the left holds the extracts, Larkspur's reports, the shared CRM, the agreement and its amendments, the 2026 committee letter, the opt-out notice and the supply agreement. The agreement reader finds 14 terms in force from three documents. The ledger mapper places 1,206 general ledger lines in 11 agreement categories and ties them to the trial balance, the list of every account's total. A statement cannot be built on lines that do not tie.
Building a statement. Each agent's step and result in order, with a person at the end.
2
Every line opens a calculation trail
The draft shows U.S. pre-tax profit of $463.21M, split 50/50. Open sales and marketing, and the trail appears: cost centers CC-4410 to CC-4460, the field force at the 2026 FTE rate, and on the right the committee letter that sets the rate at $286,440. The calculator uses fixed logic, so the same inputs always give the same statement.
The calculation trail. From the statement line to the cost centers and the letter behind the rate.
3
An opted-out study still in the shared pool
Larkspur opted out of a new indication, Study VLT-318, effective April 2, 2026. Its $4.80M of Q3 cost stays with Northwind and leaves the shared pool, which falls from $100.80M to $96.00M, so Larkspur's 55% charge falls by $2.64M. The finding works against Northwind, and it is reported the same way. An honest statement has to survive the partner's audit.
An opted-out study. Six findings on the left, with the project records, the notice and the clause cited.
4
A price nobody signed
Larkspur costed 826,400 units at $41.20. The signed 2026 supply price is $38.90, and the $41.20 amendment is still a draft. Using the signed price lowers cost of goods by $1.90M, and Northwind's half is $0.95M. The recommendation is to ask Larkspur, since partner data is never edited.
An unsigned supply price. The partner's figure, the signed one and the draft amendment noted on the right.
5
Sales visits above the shared CRM
Larkspur claims 31,400 details, its sales representatives' product visits. The shared customer relationship management system records 29,850, and in this sample agreement only recorded visits count. 1,550 × $452 is $0.70M less to reimburse. U.S. profit rises by the same amount and Larkspur takes half of that rise, so Northwind pays $0.35M less.
Details above the CRM count. A partner's report checked against a shared record.
15 · ASC 808 memo and partner replies
A drafted ASC 808 classification memo and a cited reply to a partner's returns reserve question
In shortThe memo writer classifies each flow in the final statement under the company's own policy and leaves the signature to the assistant controller. The reply writer drafts answers with the clause attached and never sends one. Both save reading time and leave the judgment with a person.
1
Each flow on its line, with the reason beside it
U.S. profit share and co-promotion costs owed to Larkspur go to cost of products sold, $245.80M. The ex-U.S. share is collaboration revenue, shown apart from product revenue, $82.10M. The development true-up reduces R&D expense, $34.48M. Product supplied under the supply agreement is treated as a distinct good to a customer, under ASC 606. This is one sample company's policy. Part A explains why another company may reasonably present these flows differently, and FASB's example makes the same point.3
The classification memo. The summary it cites is the sample company's policy note. Read ASC 808 and ASU 2018-18 themselves for the rule.
2
A partner's question, answered with the clause
Ingrid Holm at Quillmere wants to deduct a $1.2M increase in the Canada returns reserve, the amount set aside for product customers may send back, from Q2 Net Sales. The reply writer drafts the answer: section 1.14(c) allows a reserve only to the extent it rests on the historical return rate, trued up each year, so please send the calculation. Omar reads it and decides whether to send, escalate to the committee or mark it resolved.
A partner question. The thread, its evidence and a draft sent only by a person.
16 · The rest of the quarter
The whole quarter updated: an agreed statement, the list by due date, terms side by side and the dashboard
In shortWith Larkspur built, the map shows Northwind paying a net $104.1M across four alliances. The other screens hold what a controller, an alliance manager and an auditor each need: an agreed statement with its signatures, every statement by stage and due date, every agreement's terms in one grid, and the close's trend.
The quarter, updated. All arrows solid, and seven findings still waiting for a person.
An agreed statement. Sakuradai's Japan statement, with no adjustments. The stage rail shows each step done, and the signatures are recorded.
Every statement. By quarter, stage, net payment, open findings and due date.
Terms side by side. Ten money terms across four sample agreements, each opening its clause. A manager can see at a glance where two partners differ.
The close dashboard. Sample data. The 19 days is a forecast for this quarter on the sample, and a design target for a live deployment.
Approvals and checks. Who signs, above what amount, and which checks run. Each change lands on the audit trail.
17 · Who proposes, who signs
Seven agents propose and calculate; the accounting lead decides and the controller signs
In shortEach agent has one job and a line it does not cross. Nothing reaches a statement without a person's decision. Partner data is never edited, replies are sent by a person and the arithmetic uses no language model.
Agent
Its job
What it never does
Agreement reader
Extracts the money terms from agreements, amendments and committee letters, each with its clause
Treat a draft or unsigned amendment as in force, or infer a rate nobody wrote down
Ledger mapper
Maps general ledger lines to each agreement's categories
Build a statement whose totals do not tie to the trial balance
Allowability checker
Tests each mapped line against the definition in force and proposes adjustments with amount and clause
Apply an adjustment, or report only one direction
Partner data checker
Recomputes rate method, supply price, CRM details and budgets
Change partner data. Differences become questions
Statement calculator
Shares, reimbursements, true-ups and net payment, with a trail
Use a language model in the arithmetic
Partner reply writer
Drafts cited replies to partner questions
Concede or settle an amount, or send
Accounting memo writer
Drafts the quarterly ASC 808 memo from the final statement
Sign. It flags any new type of flow for the controller
The four-eyes rule on a sample $1,000,000 threshold
The four-eyes rule means a second person signs what the first decided. Omar applies, asks the partner or keeps as drafted on each finding. A statement with any single adjustment above the threshold goes to Dr. Maya Chen, the assistant controller, for signature. In the sample the threshold is $1,000,000, with $500,000 and $2,500,000 as other choices.
Statements go out with an electronic signature recording its meaning, name and time. A partner sees only its own statements and questions. Set the signer list so that nobody signs what they decided. These controls support your own work on internal control over financial reporting. Your own assessment and your auditor decide whether they are effective.
Agreements, general ledger lines and partner reports go in; a signed statement comes out
From your company
Collaboration agreements and amendments
Committee letters, minutes and opt-out notices
General ledger extracts by product and territory
Prior statements and signed memos
From each partner
Profit and cost reports, through a partner portal
Shared CRM records of sales visits
Supply agreements and prices
Agents read, fixed logic calculates, people decideEvery number tied to its source line and its clause
The accounting lead decides each finding
The controller signs above the threshold
Outputs
The who-pays-whom view of every alliance
Quarterly statements, every line cited
Findings with clause and record, decided by a person
Partner question threads with cited replies
ASC 808 classification memo and journal entries
What changes for the team
A statement already built at the start of review
Terms in force, dated and cited
Partner figures recomputed every quarter
The systems an alliance close already runs on
The solution works with what you already have: your ERP for general ledger and project records, your contract repository, a partner portal or secure upload, your shared CRM, a published exchange rate source and your electronic signature tool. Enterprise needs are built in: roles and separation of duties, maker-checker on each adjustment (one person decides, another approves), an exportable audit trail, read-only access for internal audit, and scale to as many alliances as you run. Botminds is SOC 2 Type II audited, and its information security is managed to ISO 27001.
Design targets for a live deployment, as labeled in the solution
19 days
from quarter end to final statement, inside the sample's 45-day contract limit.
Design target · measured in the live solution
100%
of final statements inside the limit, with the full calculation trail.
Design target · measured in the live solution
The $15.9M and the other amounts above are the fictional sample's. They are no forecast for your alliances. Part C shows how to measure your own.
Part C · Are you ready to automate?
Automating alliance accounting: what errors cost, what it returns and how to test it
You build alliance statements, or lead the people who do, or sign what they produce. This part is written for you: what errors and delay cost today, what automation could return, whether your team is ready, and what to ask any vendor of collaboration accounting software, including us.
18 · What errors and delay cost
What a wrong profit-share statement costs you in true-ups, audits, reporting risk and partner trust
In shortNobody publishes how often alliance statements are wrong, so start with your own. The published figures below frame the stakes: how large these payments can be, how far back an audit can reach, and what a public company must tell investors if controls fail.
$1.68B
owed to alliance partners at one large company's 2025 year end. Small percentages of a balance like this are large sums.21
Bristol-Myers Squibb 10-K for 2025
5 years
the audit look-back in one filed agreement, once a year. A second filed agreement allows the preceding three, and many redact the number.10,6
Otsuka and Acucela, 2008 · read yours
3 years
of annual results restated at one biotech over its accounting for collaboration and license agreements, with a material weakness reported.27
CytomX 10-K/A for 2021 · revenue timing
What we could not find published. We found no public figure for the hours a statement takes, the days teams take to reach a final statement, the error rate on statements, how much partner audits recover or how often alliances reach arbitration. Treat any such number in a sales document, including ours, as a claim to test.
Re-checking one closed quarter to find your own alliance leakage
Cost
Where it hides
How to find your number in a week
Rates out of date
Cost center charges at a planning rate; committee letters filed elsewhere
Compare the FTE and detail rate in each cost line to the latest signed letter, for one quarter
Costs outside the definition
Allocated overheads, shared events, spend above the approved budget
Trace your 20 largest cost lines to the definition and the budget minutes
Opt-outs and scope changes
Project codes left in the shared pool after a notice
List every notice and test each project code against its date
Royalty tiers
An accrual at a flat rate through the year
Recompute the year to date on each tiered royalty, by quarter
Partner figures
Exchange rate method, supply price, visit counts
Recompute one partner's latest report from the source rates and signed prices
Team hours
Evenings at the end of each close, and audit preparation
Ask each person for a rough split on your last two closes
Past true-ups
Adjustments to prior quarters in later statements
Add up the last eight quarters' prior-period changes by cause
A small error rate on large flows can outweigh every saving in team time
Illustrative: yearly error value at different error rates, on $640M of yearly alliance flows. Replace with your own
0.5% of flows misstated$3.2M
1.5% of flows misstated$9.6M
3% of flows misstated$19.2M
For scale: 2,000 team hours at $120$240K
Illustrative · replace with your own numbers
Show the numbers
Item
Value
0.5% of flows misstated
$3.2M
1.5% of flows misstated
$9.6M
3% of flows misstated
$19.2M
For scale: 2,000 team hours at $120
$240K
Five costs no alliance calculator counts, from audit findings to lost know-how
The control findingAn error in a public company's collaboration numbers can become a deficiency or a material weakness.32,27
The steering committeeA money dispute goes to the same people who decide development plans and budgets.
The reopened quartersAn error found late can reopen every quarter inside your audit look-back.6,10
The confirmation requestYour auditor may ask your partner to confirm the net amount, as Nektar's auditor did.26
The one person who knowsWhen the spreadsheet's author leaves, the reasons behind its choices often leave too.
19 · Your return
What collaboration accounting automation returns: errors found earlier, hours back and days off the close
In shortPut in your own numbers. The calculator separates money you would have overpaid from team time, because a correction in your partner's favor is money you owe anyway and no saving. Nearly every default is an assumption. The share misstated decides the answer most, and you learn it only by re-checking a closed quarter.
Overpayments, build hours, audit preparation and partner questions: where an alliance team gains
Overpayments
Overpayments caught before the money goes out
Partner figures, unsupported costs and stale rates caught while they are still cheap to fix.
Reading, mapping and keying move to the software; review stays with people.
statements × hours saved × hourly cost
Audit preparation
Each number already opens its evidence
The clause, the source line and the decision are already linked when an auditor asks.
audits a year × hours saved × hourly cost
Partner questions
Replies start with the clause
Fewer rounds of email on what a term means, and a shared record of evidence.
questions × hours saved × hourly cost
Accounting memo
Classification drafted from the statement
Each flow's line and basis start from the final numbers and last quarter's signed memo.
memos × hours saved × hourly cost
Close days
Earlier certainty on the quarter's numbers
Fewer estimates and fewer later adjustments to prior periods.
size of the last eight quarters' true-ups, before and after
Your alliance flows, share misstated and hours per statement
No public source gives these inputs. Each default is an assumption that describes no real company. Replace it.
Your alliancesMoney misstatedHours and cost
Illustrative yearly value
Misstated flows in first drafts$0
Newly caught errors, both directions$0
Of those, money you would have overpaid$0
Team hours freed0
Value of team hours freed$0
After your yearly cost$0
Formulas: misstated = flows × share misstated. Newly caught = misstated × share you miss today. Overpaid = newly caught × share you overpay. Hours = statements × 4 quarters × hours saved. Result = overpaid + hours value − cost. Corrections in your partner's favor are money you owe anyway, so they do not count as return. They reduce audit risk.
Most of the sample close's time gain comes from mapping, definitions and partner checks
Estimated elapsed days for one fictional quarter, by hand and as a design goal. No public benchmark exists
By hand, estimateWith the solution, design goal
Waiting for the extract and reports6 d5 d
Mapping lines to categories8 d1 d
Applying definitions, rates and tiers7 d1 d
Checking the partner's figures6 d1 d
Review, sign-off and memo6 d4 d
Partner questions and agreement10 d7 d
Illustrative · replace with your own numbers
Show the numbers
By hand, estimate
With the solution, design goal
Waiting for the extract and reports
6 d
5 d
Mapping lines to categories
8 d
1 d
Applying definitions, rates and tiers
7 d
1 d
Checking the partner's figures
6 d
1 d
Review, sign-off and memo
6 d
4 d
Partner questions and agreement
10 d
7 d
Start here20 · Readiness check
How ready your alliance accounting team is: agreements, general ledger data, partners and sign-off
In shortPick the answer closest to your team today. Eight questions score 0 to 2, and the last is for reflection. The meter adds up your score as you go, and each question says why it matters and what a strong answer sounds like.
1
Alliances and flows
How many active agreements produce a statement, and how much moves through them each year?
Why it mattersFlows turn small percentages into a business case. One simple royalty report rarely justifies new software.
A strong answer"Four alliances with shared profit, over $500 million a year on the statements."
2
The agreement file
Can you find every amendment, committee letter and opt-out notice for an alliance within an hour?
Why it mattersA term in force is only as good as the file behind it. Filed agreements leave rates and overruns to committees.8,7
A strong answer"One repository, each document dated and marked signed or draft."
3
General ledger structure
Do cost centers, projects and accounts let you pull an alliance's lines by product and territory?
Why it mattersLines that cannot be placed stop a build. Tying to the trial balance needs clean codes.
A strong answer"A profit center per product and territory, and a project code per study."
4
Partner reports
Do you get partner figures in a steady format, and do you recompute them?
Why it mattersA partner's exchange rate, price and counts sit outside your own controls.
A strong answer"A template or portal, and we recompute rate method and supply price each quarter."
5
Your baseline
Do you know your days to final statement, hours per statement and past true-ups?
Why it mattersNo public benchmark exists, so a pilot can only be judged against your own numbers.
A strong answer"Eight quarters of days and true-ups by cause, and a rough hours split."
6
Accounting policy
Is your ASC 808 or IFRS 11 policy written down, with each flow's line and reason?
Why it mattersASC 808 leaves classification to analogy or a consistent policy.3 Software can only apply a policy you have written.
A strong answer"A memo per alliance, signed each quarter, reviewed by our auditor."
7
Who signs a large adjustment
Are the maker, the checker and the threshold defined, and separated?
Why it mattersA controller's review only counts if another person made the decision being signed.32
A strong answer"Named approvers, a dollar threshold, and evidence kept per statement."
8
Partner and owner backing
Would your partners accept a shared portal or new evidence format, and does someone own this project?
Why it mattersA partner's consent often has to pass a joint finance committee, and your own team needs a sponsor.
A strong answer"The assistant controller owns it, and we raised it at the last finance committee."
9
The number behind the number · for reflection
If your partner's auditor picked one line from last year's largest statement tomorrow, what would have to be true for you to show the source line, the clause in force that day and the person who decided, in under a minute?
Why it mattersYour answer lists the gaps. Each gap is a candidate job for software: reading, matching, tracing or writing down.
A strong answerA short, specific list, for example: "every term dated, every line tied, every decision with a name and a clause."
A low score means building the terms register first
0–6
Explore
Build the baseline first: gather every amendment and letter, write one dated page of terms in force for each alliance, re-check one closed quarter and name an owner. Start with your largest alliance.
7–11
Ready to pilot
Run a measured pilot on one closed quarter with your hardest agreement, with known errors planted in copies. Compare catches, false findings and hours with your current process, and keep your people deciding.
12–16
Ready to implement
Plan every alliance: terms as dated reference data, signers and thresholds, general ledger feeds, a partner portal, the classification memo and the record your auditor will ask for.
21 · Questions for any vendor
What to ask a collaboration accounting software vendor about definitions, arithmetic, evidence and partners
In shortAsk every vendor the same questions, us included. The answers show how the tool works: how it knows which term is in force, what does the sums, what evidence you keep and how you would measure it on your own quarter.
Ask
A good answer
A warning sign
Definitions and terms in force
How do you know which FTE rate applies this quarter?
It reads the letter, shows its date and signature, and cites it
Someone keys it into a settings page
What happens with a draft amendment in the file?
It is shown as a draft and never used
The latest file wins
Can you handle a Net Sales definition with our own bad debt and reserve wording?
Yes, per agreement, each deduction tied to its clause
One standard deduction list for every alliance
Numbers and arithmetic
What does the sums: a model or a formula?
Fixed logic. The same inputs give the same statement, every time
A model writes the answer
Can I open any number and see its source line and clause?
Yes, in one click, down to the general ledger line
A summary explanation with no link
Do totals tie to the trial balance before a statement builds?
Yes, and unplaced lines stop the build
Unmapped lines go to "other"
Partners
Do you change a partner's figures?
Never. A difference becomes a question with evidence
It corrects them silently
Do you report corrections that favor our partner?
Yes, both directions, the same way
It only looks for recoveries
What can a partner see?
Only its own statements and questions, by role
Shared folders
Controls, records and proof
Can one person decide a finding and sign the statement?
No. Test it in the signer settings, in front of them
Any user can be set as signer
Can you rebuild last year's statement with the terms in force then?
Yes, with the rate and clause dated at the time
It only shows the current terms
Does the memo choose our accounting policy?
It drafts from your written policy and flags new flows for a person
"The AI determines the ASC 808 treatment"
What credentials do you hold?
A current independent audit report you can read under NDA, with a named scope
"Certified for SOX, the Sarbanes-Oxley Act": no product can hold that
Will you measure on my closed quarter with errors I planted?
Yes, catch rate by error type and false findings on clean lines
A demo on the vendor's data, and a percentage
22 · How to start
Pilot alliance statement checks on a quarter you already closed, then decide on three numbers
In shortMeasure first, then test on your own closed quarter with errors you planted, then run a live close in parallel, then decide with three numbers. None of these steps commits you to a vendor.
Write down your baseline: days to final, hours per statement and eight quarters of prior-period true-ups by cause.
Re-check one closed quarter by hand on one alliance, for rates, opt-outs and tiers. The result tells you whether a business case exists.
Pick your hardest agreement and gather its amendments, letters, general ledger extracts and partner reports. Copy them and plant known errors of each kind.
Run in parallel on a live close, with your people deciding and your normal process still producing the statement.
Decide with three numbers: catch rate by error type, false findings on clean lines, and hours per statement.
A 16-week pilot covers a closed quarter, a live close and a decision on three numbers
Plan the parallel run around your own quarter end
Your teamVendor
Baseline; choose the alliance; gather files
Plant known errors in copies
Load agreements, general ledger lines, partner reports
Set up signers, thresholds and checks
Run the closed quarter; check 300 values by hand
Parallel run on a live close
Decide on three numbers
Week 0481216
Illustrative · replace with your own numbers
Show the numbers
Activity
From
To
Baseline; choose the alliance; gather files
0
3
Plant known errors in copies
2
4
Load agreements, general ledger lines, partner reports
3
6
Set up signers, thresholds and checks
4
7
Run the closed quarter; check 300 values by hand
6
10
Parallel run on a live close
10
15
Decide on three numbers
15
16
Catch rate, false findings and hours per statement
Measure
How
Why
Catch rate by error type
Planted errors caught ÷ planted, per type, with the number planted
A single percentage can hide a weak check on opt-outs
False findings
Findings on clean lines, in reviewer minutes
Each false finding costs time and credibility with a partner
Reading accuracy
300 random terms and values checked by hand against the source
If none of 300 is wrong, the true error rate is very likely under 1%
Hours per statement
Same people, same alliance, before and after
The saving only counts if a person still reads what they sign
Days to final statement
Days from quarter end to final, against the agreement's deadline
Some of the delay sits with your partner, so measure both sides
Repeatability
Run the same quarter twice; the statements must match line for line
An auditor will ask whether the same input gives the same output
The full working-session questions: 12 questions in four groups
Bring alliance accounting, the controller, the alliance manager, commercial finance, legal and IT into one room. Each question says why it matters, what a strong answer looks like, and the warning sign.
A
Agreements and the terms in force
A1
Who decides when a committee letter changes the money?
Why it mattersCommittees often set rates and approve overruns.8,5
Strong answer · warning sign
A named person, same day.
Finance hears at quarter end.
A2
What are the deadlines for estimates, finals and payment on each alliance?
Why it mattersThey differ by agreement and set your pace.6,10
Strong answer · warning sign
A table by alliance, with clauses.
Everyone assumes 45 days.
A3
How far back can each partner audit, and what shifts the cost?
Why it mattersIt sets how long you keep evidence and how many quarters an error can reopen.6,10
Strong answer · warning sign
Known by alliance, records kept to match.
"We have never been audited."
B
General ledger data and mapping
B1
Does the actual FTE charge use a planning rate or the contract rate?
Why it mattersThe gap multiplies by each employee.
Strong answer · warning sign
A documented adjustment each quarter.
Nobody knows the difference.
B2
How are shared costs split between products?
Why it mattersAttributable cost is often the first thing a partner challenges.
Strong answer · warning sign
A written basis, applied every quarter.
A fresh estimate each time.
B3
Do project codes follow opt-outs and scope changes?
Why it mattersCosts after an opt-out date may leave the pool.5
Strong answer · warning sign
Codes closed or flagged on the effective date.
Reviewed at audit.
C
Accounting policy and internal control
C1
Where does each flow go in the accounts, and why?
Why it mattersASC 808 leaves the classification to a consistent policy.3
Strong answer · warning sign
A memo by alliance, with reasons.
Same line since signing, reason lost.
C2
Is a partner a customer for anything?
Why it mattersA distinct good or service to a customer falls under ASC 606 or IFRS 15.3,18
Strong answer · warning sign
Reviewed whenever responsibilities change.
Decided once in 2019.
C3
Which control covers the statement, and who tests it?
Why it mattersManagement assesses controls each year if the company is public.32
Strong answer · warning sign
A named control with evidence per statement.
Not sure it is on the list.
D
2026 changes and partners
D1
Does any alliance product carry a negotiated Medicare price?
Why it mattersNet Sales wording may predate it.33,34
Strong answer · warning sign
Reviewed with legal and the partner.
Left to the booking party.
D2
Who will build the new expense tables?
Why it mattersASU 2024-03 and IFRS 18 reach alliance lines from 2027.19,20
Strong answer · warning sign
Named, with a split by nature.
Not yet discussed.
D3
How does your partner want to see evidence?
Why it mattersA shared record shortens the argument.
Strong answer · warning sign
Agreed at the finance committee.
Email attachments, as always.
23 · Questions people ask
Alliance accounting questions, from what ASC 808 is to how profit share is presented
In shortShort answers to what people search. Each one stands alone. For your own accounting, read the current standard and ask your auditor.
What is alliance profit-share accounting?
It is the quarterly work of settling a collaboration between two companies: both parties' sales and costs by territory, each share, cost reimbursements, development true-ups and one net payment, under the definitions in their agreement. It also covers how each company presents those flows in its accounts. In the U.S. the accounting topic is ASC 808.
What is ASC 808?
ASC 808 is the U.S. GAAP topic on collaborative arrangements, meaning contractual arrangements involving a joint operating activity where participants take an active part and face significant risks and rewards. It addresses presentation and disclosure, and it does not give full recognition and measurement rules. ASU 2018-18, issued in November 2018, added guidance on when a partner is a customer under ASC 606.
How are collaboration payments classified under ASC 808?
If a distinct good or service goes to a partner acting as a customer, ASC 606 applies to that unit. Other payments are classified by analogy to other guidance or under a reasonable, rational and consistently applied policy. They may not be presented together with revenue from contracts with customers.
Is profit share revenue or cost of sales?
It depends on which side you are on and your policy. A company that books the sales as principal often shows the partner's share in cost of sales, as Bristol-Myers Squibb does for its Pfizer alliance. A company receiving a share may show it as collaboration revenue, as Regeneron does. FASB's own example shows one such policy on each side.
What is the difference between ASC 808 and IFRS 11?
ASC 808 applies to collaborative arrangements defined by joint operating activity and shared risks and rewards. IFRS 11 starts from joint control, meaning decisions need the unanimous consent of the parties sharing control. Under IFRS 11 an arrangement with no separate vehicle is a joint operation, and each party records its own assets, liabilities, revenue and expenses. Presentation can differ materially between the two.
What are Allowable Expenses in a collaboration agreement?
Allowable Expenses are the costs an agreement lets a partner charge to the shared profit calculation, such as cost of goods, distribution, approved sales and marketing, medical affairs and certain insurance. The wording is set by each contract, often with a budget limit. A cost outside the definition stays with the company that spent it.
What is an FTE rate in a collaboration agreement?
An FTE rate is an agreed yearly cost for one full-time employee working on the alliance, used in place of each person's actual pay. Filed agreements commonly change it each year through a price index or a committee decision. Charging a company's internal planning rate in its place is one way the number drifts.
How far back can a collaboration partner audit?
The agreement decides. Filed examples include once a year over five years in one agreement, and the preceding three years in another, while many filings redact the number. Read your own audit clause, including who pays if the audit finds an error above a set percentage.
How do you calculate a tiered royalty when a threshold is crossed mid-year?
Where the agreement applies tiers to cumulative annual sales, split the quarter's sales at the threshold. Apply the lower rate to the part below it and the higher rate to the part above. Accruing the whole quarter at the old rate understates the royalty for that quarter.
Can AI do ASC 808 accounting?
Software can read agreements, map lines, recompute partner figures, draft memos and link every number to its source. Fixed logic should do the arithmetic, and people should choose the accounting policy and decide each adjustment. Management remains responsible for internal control over financial reporting, whatever tool it uses.
Does the Medicare negotiated price affect alliance profit share?
It can, where a shared product has a negotiated price, because the price feeds the sales from which profit is calculated. CMS negotiates with one Primary Manufacturer, and partners that market under an agreement can be Secondary Manufacturers. Check how your Net Sales definition treats it, since many agreements predate the program.
24 · Summary and glossary
Alliance profit-share accounting on one page: the method, the standards, readiness and terms
Print this page
In shortThe whole guide on one screen: the method, the standards as of November 2026, the readiness scale and the terms.
The method
Keep every agreement, amendment, letter and notice, dated and marked signed or draft.
List the terms in force for the quarter, each with its clause.
Map general ledger lines to the agreement's categories and tie them to the trial balance.
Test each line against the definition, and recompute the partner's figures.
Calculate shares, reimbursements, true-ups and one net payment with fixed logic.
A person decides each adjustment; a second person signs above a threshold.
Send, answer questions with the clause attached and keep the record for the audit look-back.
Readiness: score 0–2 on eight questions: 0–6 explore · 7–11 pilot · 12–16 implement.
As of November 2026: ASC 808 as amended by ASU 2018-18 · IFRS 11 unchanged in substance · first negotiated Medicare prices in effect since January 1, 2026; CMS-4215-P still proposed · ASU 2024-03 for annual periods beginning after December 15, 2026 · IFRS 18 from January 1, 2027 · FDA's AI draft and draft EU GMP Annex 22 do not reach this work.
14 terms
Collaborative arrangement
A contract for a joint operating activity with active participants and shared risks and rewards.
Booking party
The partner that records a sale in a territory.
Principal
The party that controls a sale and reports it gross.
Net Sales
Gross sales less the deductions the agreement lists.
Allowable Expenses
Costs the agreement lets a partner charge to the shared pool.
Pre-tax profit
Net Sales less Allowable Expenses, before the split.
FTE rate
The agreed yearly cost of one full-time employee.
Detail
A sales representative's product visit with a prescriber.
True-up
The payment that brings actual spending back to the agreed share.
Opt-out
A partner's election to leave a study or indication, under the agreement's terms.
Royalty tier
A rate that applies to sales above a set cumulative amount.
Unit of account
The distinct good or service an accounting test applies to.
Joint operation
Under IFRS 11, jointly controlled, with rights to assets and obligations for liabilities.
Material weakness
A control gap with a reasonable possibility of an unprevented material misstatement.
25 · Sources
Sources
Accessed November 2026. Accounting and regulatory status statements are as of November 2026. Filed agreements are read as filed, with redactions.
PwC Viewpoint, "Consolidation and equity method of accounting guide", section 8.3, Joint venture versus collaborative arrangement, published September 15, 2025. viewpoint.pwc.com
IFRS Foundation, IFRS 11 Joint Arrangements, issued May 2011, paragraphs 4, 5, 7, 14 to 16, 20, 24 and B16, as served in its 2026 issued standards. ifrs.org
FASB, "Accounting Standards Update No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606", November 2018. storage.fasb.org
Deloitte, "Heads Up: FASB Proposes Guidance on Collaborative Arrangements", Volume 25, Issue 5, April 30, 2018, on the April 26, 2018 proposal. iasplus.com
BioNTech and Genmab, License and Collaboration Agreement, May 19, 2015, filed with BioNTech's Form F-1, 2019, sections 1.98, 7.2, 7.4, 7.8 to 7.10 and 14. sec.gov
Solvay Pharmaceuticals and CV Therapeutics, Co-Promotion Agreement, December 6, 2004, as filed, sections 1.14, 1.24, 4.2, 5.4 and 5.5. sec.gov
Corgentech and Bristol-Myers Squibb, agreement filed with Corgentech's Form S-1, 2003, sections 1.75, 2.7, 3.3, 5.4, 6.5, 6.15 and 6.17. sec.gov
Bayer Pharmaceuticals and Onyx Pharmaceuticals, U.S. Co-Promotion Agreement, March 6, 2006, as filed, sections 4.3, 8.3 to 8.6 and 9. sec.gov
Amgen, letter agreement on FTE rates to AstraZeneca Collaboration Ventures, December 1, 2023, as filed. sec.gov
Otsuka Pharmaceutical and Acucela, Co-Development and Commercialization Agreement, September 4, 2008, as filed, sections 1.29, 1.45, 6.4, 6.6, 6.7.2 and 6.9. sec.gov
Amgen and BeiGene, First Amendment to Collaboration Agreement, April 20, 2022, as filed, section 7.9. sec.gov
Astellas and FibroGen, Supplement to Anemia License and Collaboration Agreement, November 12, 2009, as filed. sec.gov
Bristol-Myers Squibb and Pfizer, Amended and Restated Co-Development and Co-Promotion Agreement (Apixaban), August 23, 2007, as filed. sec.gov
Deloitte, "Life Sciences Industry Accounting Guide", March 2026, sections 1.2.1.2 and 1.2.1.3; developments through March 6, 2026. deloitte.com
EY, "Technical Line: How the new revenue standard affects life sciences entities", No. 2017-22, updated July 10, 2020, section on collaborative arrangements. ey.com
Deloitte IFRS Global Office, "IFRS industry insights: Joint arrangements in the life sciences industry", March 2013. iasplus.com
FASB, Chair Report, April 1 to June 30, 2026, Appendix: technical agenda and other projects, revised June 30, 2026, the newest list we could read. Check FASB's agenda page for later changes. storage.fasb.org
IFRS Foundation, IFRS 15 Revenue from Contracts with Customers, paragraph 6, as served in its 2026 issued standards. ifrs.org
FASB, "Accounting Standards Update No. 2024-03, Income Statement: Disaggregation of Income Statement Expenses", November 2024. storage.fasb.org
IFRS Foundation, IFRS 18 Presentation and Disclosure in Financial Statements, standard page, read November 3, 2026. ifrs.org
Bristol-Myers Squibb, Form 10-K for 2025, Alliances note. sec.gov
Pfizer, Form 10-K for 2025, Note 1, Basis of Presentation and Significant Accounting Policies, collaborative arrangements. sec.gov
Regeneron Pharmaceuticals, Form 10-K for 2025, note on Collaboration, License, and Other Agreements. sec.gov
Sanofi, Q3 2025 aide-memoire, September 24, 2025. sanofi.com
J.P. Morgan with DealForma, "Q4 2025 Biopharma Licensing and Venture Report", data through December 15, 2025, page 7. jpmorgan.com
Nektar Therapeutics, Form 10-K for 2022, report of Ernst & Young LLP, critical audit matter on cost sharing. sec.gov
CytomX Therapeutics, Form 10-K/A for 2021, explanatory note. sec.gov
Alnylam Pharmaceuticals, response to the SEC staff's letter of November 25, 2015, Comment 1. sec.gov
Blueprint Medicines, response of January 14, 2021 to the SEC staff's letter of December 2, 2020. sec.gov
Exelixis, Form 10-K for fiscal 2016, Item 1, Cobimetinib Collaboration. sec.gov
Exelixis, Form 10-Q for the third quarter of 2017, Note 2, Collaboration Agreements. sec.gov
SEC, Release 33-8810, Commission Guidance Regarding Management's Report on Internal Control Over Financial Reporting, June 2007. sec.gov
CMS, fact sheet, negotiated prices for initial price applicability year 2026; list prices are 2023 figures for a 30-day supply. cms.gov
CMS, Medicare Drug Price Negotiation Program final guidance, initial price applicability year 2027 and manufacturer effectuation of the maximum fair price in 2026 and 2027, October 2, 2024, section 40. cms.gov
CMS, fact sheet on the proposed rule CMS-4215-P, issued June 16, 2026 (91 FR 36236), for initial price applicability year 2029 and beyond; OIRA's record for RIN 0938-AV90, read November 3, 2026, lists the final rule received September 9, 2026, pending review. cms.gov · reginfo.gov
COSO, "Achieving Effective Internal Control Over Generative AI (GenAI)", released February 23, 2026 (date per KPMG, Defining Issues, April 2026). coso.org · kpmg.com
FDA, draft guidance, Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products, January 2025. fda.gov
European Commission, EudraLex Volume 4, read November 3, 2026: Annex 11 at its January 2011 revision and no Annex 22. health.ec.europa.eu
Explore the solution, or bring one closed quarter, its collaboration agreement and amendments, and the partner's report, and we will run them with you, every number beside its source line and its clause.
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