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Spin-off Contract Assignment and Consent Review

Consent to assignment review that places each contract on its side of the separation, counts each deadline back from the separation date, and leaves each plan's signature to counsel.

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The problem

Thousands of contracts to sort before the new company opens its doors

When a device maker separates a business, every contract of the entities and sites in the separation has to be read for one question: can it go to the new company, and how. The wording varies. Some may be assigned as they are, some need only notice, some need written consent, and some give no right to assign at all.

Contracts that serve both businesses have no default: someone must propose a split, a mirror agreement or transition services, and the other side must agree. The terms that change the plan hide in exhibits and schedules, such as a distributor that holds the local registration or a quality agreement that names the old legal manufacturer. And the clocks to ask for consent run backward from a date that has not happened yet.

Built forSeparation counselContracts managersParalegalsSeparation program leads

The Problem Today

Every contract is read by hand for consent terms, while the clocks to ask start months before the separation date.

3 hours
to abstract one contract in full by hand, a booth estimate our estimate
30 days
to tell FDA of a change of owner of a registered establishment published

Read and decided one at a time

  • Contracts
  • Amendments
  • Consent
  • Notice
  • Shared contracts stallNo default for contracts that serve both businesses
  • Device terms hideRegistrations and quality agreements sit in exhibits

The Solution

  1. Each clause read and citedAssignment, change of control, consent, notice and termination, to the page
  2. Placed on its sideStays, goes to the new company, or shared, from the products it covers
  3. Clocks counted backEach last day to ask and send-by date counted back from the separation date
  4. Checked, then signedLarge contracts and a random sample checked; counsel reads and signs

Built-in controls

  • No letter goes before counsel signs the plan
  • No one checks work they did themselves
  • Typed reasons are read word for word by counsel

What You Get

A signed plan for each contract family, each clause cited, so the new company's contracts are routed before its first day.

15,000
hours of abstraction for 10,000 contracts, half done by agents our estimate
  • Shared contracts routedSplit, mirror agreement or transition services, with reasons
  • Requests drafted and trackedApproved wording, each clause cited, replies opened by a person
  • Evidence for each signatureWho signed what, when, why and in which session
One family read, one plan signed

Consent to assignment for a diagnostics spin-off, 169 days before Day 1

A device maker is separating its diagnostics business, lab analyzers and assays, into a new company. About 10,000 contracts are in scope. Today the purchasing group and health system agreements are read.

demoThe device maker, the new company, the purchasing group, its members, the people and each value are sample data.

  1. 01Before the read

    Nine families are placed; the 600 GPO and IDN agreements are next

    Contracts manager

    The separation line splits the screen: contracts that stay with the maker on the left, those going to the new diagnostics company on the right, shared ones on the line. Nine of ten families are read, 2,626 of 2,840 diagnostics contracts placed and 377 needing consent so far. Day 1 is 169 days away, and the 600 GPO and IDN agreements are next.

  2. 02After the read

    386 stay, 148 sit on the line, 66 go, and consent needed reaches 438

    Contracts manager

    He starts the read and watches each agreement land by the products, sites and entities it covers, sized by annual value and tinted by its assignment term. Filtered to consent needed, the chips that matter stand out, each with its last day to ask counted back from Day 1. All 2,840 diagnostics contracts are now placed.

  3. 03After the read

    A $603M master agreement covers both businesses and needs consent first

    Contracts manager

    The purchasing group's master agreement governs seven category agreements, two of them diagnostics. Section 19.2 bars assignment without written consent, asked at least 90 days ahead, so the request goes 30 days before that last day. Section 19.4's affiliate route ends when the new company stops being an affiliate on Day 1, so the route proposer rules it out and proposes a mirror.

  4. 04After the read

    The draft asks consent for two category agreements and a mirror master

    Contracts manager

    The letter drafter writes the request in counsel's approved wording, version 4, to the group's vice president of contract services, as section 22.1 directs. It asks consent to assign the core lab and hematology agreements and to sign a mirror master agreement on the same terms from Day 1, citing each clause it relies on. A draft goes nowhere until counsel signs the plan.

  5. 05Check

    68 reads to confirm against the page: 8 large, 1 unsure and 59 at random

    Paralegal

    The paralegal's check for this family follows the rule counsel signed: every contract above $25M a year, every read below 85% confidence, and 59 at random from the rest. If all 59 are right, the error rate in the rest is under 5% with 95% confidence. One wrong read doubles the random set; a second sends the family to full review.

  6. 06Sign-off

    Counsel reads the largest contract herself, passage by passage, before signing

    Separation counsel

    Separation counsel opens the hospital lab family's plan, whose reads the paralegal already checked: 63 of 1,180. She must open its largest contract, a $34M lab supply agreement, and keep each highlighted passage on screen for its full reading time before she may sign. Assignment, change of control, termination and the exhibit sit beside the agents' read.

  7. 07Sign-off

    Signed: 112 consent requests and 120 shared routes in one plan

    Separation counsel

    She signs in her own name, with her password. The 120 shared contracts move off the line to their sides on their signed routes: 22 mirror, 90 split, 8 transition services. The 112 signed consent requests are ready for the contracts manager to send. Reopening the plan would clear her signature and mark its letters unsigned.

  8. 08Runway

    72 requests must go by the first send-by date, 19 days from today

    Separation counsel

    The deadlines view counts the runway back from Day 1, with today at D−169. Bars show consent requests by send-by date in the families read so far, and a dot marks a distributor's registration transfer clock, 120 days before Day 1. Each send-by is the contract's last day to ask, less the 30-day buffer counsel set.

600 GPO and IDN agreements, and a proposed route for each of the 148 shared

The route proposer rules out any route that fails on Day 1 and says why. Each route waits for the contracts manager and counsel.

Stay with the maker386
Shared, on the line148
Go to the new company66
Agreements read600
Shared: a mirror agreement for the new company31
Shared: split, the diagnostics part assigned97
Shared: kept under transition services20
Shared contracts with a proposed route148

demoSample data, from the working solution.

Around the plan

Readiness, shared routes and the contracts behind consent to assignment

What the program office, counsel and the contracts team read between one family and the next.

Day 1 readinessTen families with read, check, plan and letters: 4 of 10 plans signed, 135 consent requests sent and 55 granted, each family with an owner and a clock.
Shared contractsThe family's 148 contracts that serve both businesses, each with its diagnostics part, its term and the proposed split, mirror or transition services.
Transition and linksContracts the maker keeps for the new company under transition services, and the registration and quality agreement links other teams must act on.
10,000 in scopeSearch by number, counterparty or title; filter by family, side and term; see the reads waiting for the paralegal and their clock.
Audit trailReads, routes, drafts and signatures, each with its time, person, reason, signature meaning and session. An evidence file downloads.
RulesDay 1, the reading time, the send buffer and the check rule, with who signs each change. A signed change applies to plans not yet signed.

demoSample data, from the working solution.

Device terms outside the assignment clause that change a contract's route

A distributor holds the local registration

Its agreement sets how fast the registration must transfer, so its clock joins the deadlines.

A quality agreement names the old manufacturer

It cannot simply be assigned; the new company signs its own before its first day.

A placed analyzer whose title must move

Placement agreements carry title and service terms that decide what goes with the business.

An affiliate route that ends at the split

Assignment to an affiliate looks easy until the new company stops being one.

Who prepares, who checks and who signs each family's plan

The paralegal never checks a route she changed, and counsel signs only after opening what she must.

Contracts manager
Sees
The separation line, the routes and the draft letters
Signs
Prepares each family's plan and sends signed requests
Paralegal
Sees
Sampled reads beside the contract page
Signs
Confirms each read or sends it back with her reason
Separation counsel
Sees
The largest contracts, changed routes and reads sent back
Signs
Each family's plan and the legal settings
Separation program office lead
Sees
Readiness across all ten families
Signs
The read order and the operational settings
New company designate
Sees
The contracts coming over and their status, read only
Signs
Nothing; exports her list
Who reads the contracts

Seven agents read and place each contract, and none of them decides a route

Each read carries its document, section, page and confidence.

Contract finder

Pulls each contract of the separating entities and sites, groups amendments with their base agreement and counts by family.

  • Never drops a contract; anything unmatched goes to the contracts manager
Clause reader

Reads assignment, change of control, consent, notice and termination clauses with section, page and confidence.

  • Leaves a term blank when no clause states it
Device terms reader

Reads category exhibits, member letters, registration holders, quality agreements, placed-equipment title and business associate agreements.

  • Never decides a regulatory transfer
  • Never reads the complaint handling section of a quality agreement
Side placer

Places each contract left, on the line or right from the products, sites and entities it covers, citing the exhibit.

  • Never places a contract on a product the perimeter does not name
Route proposer

Proposes assign, notice, consent, split, mirror, transition services or novation, and counts each deadline back from the separation date.

  • Never decides
  • Never relaxes a deadline
Letter drafter

Drafts consent requests, notices and mirror term sheets in approved wording, citing each clause.

  • Never sends or signs
  • Never offers terms beyond the template
Reply tracker

Logs replies, sends reminders on the cadence and watches the clocks.

  • Never records consent as granted

Routes, signatures and each word to a counterparty belong to people

The agents place, count and draft. A named person owns each decision listed here.

No agent decides a routeThe route proposer proposes. The contracts manager accepts or changes it, and a changed route that loosens waits for counsel to read the reason.
Nothing reaches a counterparty unsignedLetters go only after counsel signs the family's plan, and the contracts manager sends them.
A reply is read by a personThe reply tracker logs and reminds. A person opens each reply and records consent, or conditions for counsel to decide.
Regulatory transfers belong to regulatory affairsRegistration and quality agreement links are handed to the teams that own them.
Complaint and vigilance records are not readThe agents skip the complaint handling sections of quality agreements and never open complaint or adverse event files.

What separation counsel ask about consent to assignment review

What is a consent to assignment review?

A consent to assignment review reads each contract in a separation for whether it may be assigned to the new company as it is, needs notice, needs written consent, or cannot be assigned. Here agents read and place each contract, and counsel signs each family's plan.

How are contracts that serve both businesses handled?

The route proposer proposes a split, a mirror agreement or transition services for each one and rules out any route that would fail on the separation date, with the reason. The contracts manager accepts or changes it, and counsel signs.

How are consent deadlines worked out?

Each contract's notice period is counted back from the separation date to its last day to ask, and the send-by date sits a set buffer before that. The route proposer never relaxes a deadline.

How do we know the agents read the clauses right?

A paralegal confirms a sample against the contract page: the large contracts, every low-confidence read and a random set. A wrong read doubles the random set, and a second sends the whole family to full review.

Does it draft the consent request letter?

Yes, in counsel's approved wording, citing each clause it relies on. It never sends one; letters go only after counsel signs the plan.

What about registrations and quality agreements?

The device terms reader finds them in exhibits and schedules, and the links go to regulatory affairs and quality, who own the transfer. A quality agreement naming the old manufacturer is replaced, not assigned.

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Hand us one contract family
and your separation date.

We will place each contract on its side and count every consent deadline back from that date.

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