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Legal Instruction to Manufacture

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LEGAL INSTRUCTION TO MANUFACTURE

This Legal Instruction to Manufacture (the Instruction) is made and entered into as of by and between Client Name: with principal place of business at and Manufacturer Name: with principal place of business at .

RECITALS

WHEREAS, Client has developed certain designs, specifications, tooling information and confidential technical data relating to the Products described in this Instruction and desires to engage Manufacturer to manufacture such Products in accordance with the terms of this Instruction;

WHEREAS, Manufacturer represents that it has the facilities, personnel, equipment and expertise necessary to manufacture the Products to the specifications, schedules and quality standards required by Client;

WHEREAS, the parties desire to set forth their respective rights and obligations with respect to the manufacture, delivery, inspection, intellectual property, confidentiality and payment for the Products.

NOW, THEREFORE, in consideration of the mutual covenants contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:

1. DEFINITIONS

For purposes of this Instruction, the following terms shall have the following meanings:

"Products" means the items to be manufactured as described in the Specifications and Purchase Instructions provided by Client to Manufacturer.

"Specifications" means the technical drawings, bills of materials, tolerances, test procedures and any approved change orders delivered by Client and incorporated into this Instruction.

2. INSTRUCTION TO MANUFACTURE

Client hereby instructs Manufacturer to manufacture the Products strictly in accordance with the Specifications. Manufacturer shall manufacture the Products only upon receipt of written production orders or release documents issued by Client in the form specified in Section 4 (each, a Production Order).

3. SPECIFICATIONS, TOOLING AND CHANGE ORDERS

Manufacturer shall strictly comply with the Specifications provided by Client. Manufacturer shall not modify, deviate from, or alter the Specifications without Client's prior written approval, which may be given or withheld in Client's sole discretion. All tooling, molds, fixtures and prototypes supplied by Client shall remain Client property and shall be identified and returned upon termination unless otherwise agreed in writing.

4. PRODUCTION ORDERS; SCHEDULE; DELIVERY

Production Orders shall specify quantities, required delivery dates, shipping terms and any special packaging or marking requirements. Manufacturer shall adhere to the production and delivery schedule included in each Production Order and shall notify Client promptly in writing of any actual or anticipated delay.

5. INSPECTION, ACCEPTANCE AND REJECTION

Client and its designated representatives shall have the right to inspect, audit and test Products at Manufacturer's facility during normal business hours. Delivery is subject to final acceptance by Client at the delivery location following inspection and testing. Client may reject nonconforming Products and require repair, replacement or credit at Manufacturer's expense. Rejected Products shall be returned to Manufacturer at Manufacturer’s expense if so directed by Client.

6. QUALITY CONTROL AND WARRANTY

Manufacturer warrants that all Products supplied hereunder shall conform to the Specifications, be free from defects in material and workmanship and be merchantable and fit for their intended purpose. The warranty period shall be as specified in the applicable Production Order or, if not specified, for a period of twelve (12) months from delivery.

7. INTELLECTUAL PROPERTY; LICENSE

All intellectual property rights in the Specifications, designs, tooling and Client-provided materials shall remain the exclusive property of Client. Manufacturer is granted a limited, nonexclusive, nontransferable license to use Client's intellectual property solely to perform its obligations under this Instruction and for no other purpose. Any improvements, modifications or inventions developed by Manufacturer in direct connection with the manufacture of the Products shall be assigned to Client, and Manufacturer shall execute such instruments as may be reasonably required to effect assignment.

Check if Manufacturer is authorized to produce Products for resale under a separate written license agreement.

8. CONFIDENTIALITY

Manufacturer shall keep confidential and shall not disclose to any third party any Confidential Information received from Client, including but not limited to Specifications, tooling, processes, drawings and pricing, except as necessary to perform the manufacturing services and subject to written confidentiality obligations at least as protective as those contained herein. Confidential Information shall not include information that is or becomes publicly known through no breach by Manufacturer or that Manufacturer can demonstrate was independently developed.

9. PRICING, INVOICING AND PAYMENT

Prices for each Production Order shall be set forth in the applicable Production Order and shall include all labor, materials, tooling amortization (if applicable), packaging and customary testing unless otherwise specified. Manufacturer shall submit invoices in the form required by Client. Unless otherwise agreed in writing, Client shall pay properly submitted undisputed invoices within thirty (30) days of Client's receipt of invoice and accepted Products.

10. TAXES AND DUTIES

Unless otherwise stated in a Production Order, prices exclude applicable taxes, duties and other governmental charges. Each party shall be responsible for its own taxes, except that Manufacturer shall be responsible for taxes based on Manufacturer's income and Client shall be responsible for sales, use or value added taxes imposed on the sale of the Products.

11. TERMINATION

Either party may terminate this Instruction for material breach by the other party if such breach is not cured within thirty (30) days after written notice. Client may terminate for convenience upon thirty (30) days' written notice and shall pay Manufacturer for Products completed and reasonable costs incurred prior to termination, subject to Client's rights to offset for nonconforming work.

12. INDEMNIFICATION

Manufacturer shall indemnify, defend and hold Client and its officers, directors and affiliates harmless from and against any third-party claims, liabilities, damages, losses and expenses (including reasonable attorneys' fees) arising out of (a) Manufacturer's breach of this Instruction, (b) defects in the Products, or (c) Manufacturer's negligence or willful misconduct.

13. INSURANCE

Manufacturer shall maintain insurance coverages customary for the industry, including commercial general liability, product liability and workers' compensation, in amounts sufficient to protect Client from claims arising from Manufacturer's performance. Manufacturer shall provide certificates of insurance upon request.

14. COMPLIANCE WITH LAWS

Manufacturer shall comply with all applicable laws, rules, regulations and industry standards in performing its obligations under this Instruction, including export control and environmental laws. Manufacturer shall obtain and maintain all permits, licenses and approvals required to perform manufacturing services.

15. RECORDS AND AUDIT RIGHTS

Manufacturer shall maintain accurate books and records relating to the manufacture of Products and shall retain such records for a period of no less than five (5) years. Client shall have the right to audit such records upon reasonable notice during normal business hours to verify compliance with this Instruction.

16. NOTICES

Any notice, demand or communication required or permitted under this Instruction shall be in writing and shall be delivered by hand, commercial overnight carrier, or certified mail, return receipt requested, to the addresses set forth below or to such other address as a party may designate in writing.

17. AMENDMENTS; WAIVER

No amendment, modification or waiver of any provision of this Instruction shall be effective unless in writing and executed by both parties. The failure of either party to enforce any provision shall not constitute a waiver of future enforcement of that or any other provision.

18. GOVERNING LAW

This Instruction shall be governed by and construed in accordance with the laws of the State specified below without regard to conflict of law principles.

19. ENTIRE AGREEMENT; SEVERABILITY

This Instruction, together with any referenced Production Orders and attachments, constitutes the entire agreement between the parties with respect to its subject matter and supersedes all prior and contemporaneous agreements, understandings and communications. If any provision is held invalid or unenforceable, the remaining provisions shall continue in full force and effect.

20. COUNTERPARTS

This Instruction may be executed in counterparts, each of which shall be deemed an original, and all of which together shall constitute one and the same instrument.

EXECUTION

The persons signing below represent and warrant that they are duly authorized to execute this Instruction on behalf of their respective parties.

CLIENT

Printed Name:

By:

Date:

Title:

MANUFACTURER

Printed Name:

By:

Date:

Title:

Enter text✕

What the Legal Instruction to Manufacture Is

A Legal Instruction to Manufacture is a written directive that authorizes a manufacturer to produce goods to specified designs, materials, quantities, and quality standards. It defines technical specifications, acceptance criteria, intellectual property ownership or licenses, compliance and certification obligations, delivery schedules, and payment terms. In the United States this document can be exchanged and executed electronically under ESIGN (15 U.S.C. ch. 96) and state UETA laws where applicable, provided the parties demonstrate intent, consent, attribution, and reliable record retention.

Why a Clear Instruction Matters

A precise instruction reduces production risk, protects IP, and creates an enforceable baseline for quality, timelines, and payment. It also clarifies regulatory and safety responsibilities for manufacturers and buyers.

Why a Clear Instruction Matters

Who Typically Prepares and Signs This Instruction

The document is prepared by commercial parties that control design, procurement, or product development and is shared with contract manufacturers and suppliers.

  • Procurement managers and buyers in product companies who issue production orders and acceptance criteria.
  • Manufacturing or operations leads at contract manufacturers who confirm feasibility and capacity.
  • In-house legal or external counsel who draft IP, liability, and compliance provisions.

Clear role allocation speeds approval and reduces disputes during production and delivery.

Primary Signatory Roles

Head of Manufacturing

Responsible for technical acceptance, production scheduling, and compliance confirmations. Signs to acknowledge manufacturability, capacity commitments, and quality control requirements on behalf of the manufacturer; may delegate operational approvals under defined thresholds.

General Counsel

Reviews and signs contract-level protections such as IP assignments, indemnities, export controls, and dispute resolution clauses. Ensures the instruction aligns with broader master supply or manufacturing agreements.

Core Sections to Include in a Professional Instruction

A robust instruction organizes obligations so manufacturing, inspection, and legal duties are unambiguous. The following components are standard for enforceability and operational clarity.

Scope / Specs

Detailed drawings, bill of materials, tolerances, surface finishes, and reference standards. Include file versions and approval stamps to prevent ambiguity between revisions.

IP and Licensing

Explicit ownership, license grants, or work-for-hire language for tooling, designs, and improvements; address confidentiality and permitted subcontracting.

Quality & Inspection

Acceptance criteria, sampling plan, first article inspection requirements, corrective action processes, and consequences for nonconforming product.

Compliance & Certifications

List required certifications (FDA, FCC, CE, RoHS, safety standards) and testing responsibilities, including who pays for third-party testing and corrective measures.

Timing & Delivery

Production start date, lead times, milestones, delivery terms (INCOTERMS where appropriate), and penalties or remedies for late delivery.

Payment & Consideration

Unit pricing, setup/tooling costs, payment schedule, invoicing requirements, and holdback or escrow arrangements for disputed shipments.

Stepwise Process to Create and Issue the Instruction

Follow a consistent workflow to reduce rework and to ensure legal and operational completeness.

  • 01
    Draft the Instruction: Assemble specs, tolerances, and IP terms into a single document.
  • 02
    Attach Supporting Files: Include drawings, BOMs, and test plans as referenced exhibits.
  • 03
    Internal Review: Legal, procurement, and engineering confirm terms and risks.
  • 04
    Sign and Distribute: Execute electronically or on paper; send to all recipients with retained audit trail.

Typical Digital Workflow Settings for eSubmission

Configure these settings when preparing an instruction template for electronic distribution and signing.

Field Configuration
Document Upload PDF/A or DOCX source accepted
Signer Roles Assign manufacturer, buyer, and legal reviewer
Authentication Email + SMS code or advanced methods
Audit Trail Enable timestamp and IP recording

How Electronic Issuance and Acceptance Typically Flow

A clear, linear exchange reduces friction and preserves evidence of each step for compliance and dispute resolution.

  • Prepare Document: Consolidate specs and attachments into one package.
  • Place Fields: Add signature, date, and conditional fields as needed.
  • Send to Signers: Use role-based routing or bulk distribution.
  • Capture Audit Trail: Record timestamps, IPs, and authentication data.

Platform Capabilities to Support eSubmission

Integrations with document storage and ERP systems streamline routing and recordkeeping; ensure the vendor supports encryption, audit logging, and any required BAAs for healthcare data.

  • Authentication Options: Email, SMS OTP, KBA, or SSO
  • File Types: PDF, DOCX, and CAD via attachments
  • Integrations: ERP/CRM connectors like NetSuite and Salesforce

Security and Compliance Features to Verify

In-transit Encryption: TLS 1.2/1.3
At-rest Encryption: AES-256
Audit Trail: Detailed signing history
HIPAA Support: BAA available
Regulatory Certs: SOC 2 Type II
FDA Controls: 21 CFR Part 11 options

Practical Tips for Accurate and Enforceable Instructions

Adopt uniform templates and approval gates to lower operational risk and legal exposure across production runs.

Use version control
Include revision numbers and a change log in the instruction to prevent manufacturing from proceeding on obsolete specifications.
Require sign-off from engineering
Technical acceptance by a named engineer reduces disputes over tolerances and materials during inspections.
Attach test plans
Explicit test methods and acceptance criteria speed inspections and reduce rework cycles when quality issues arise.
Align IP clauses
Ensure IP assignments or licenses are consistent with any master manufacturing agreement to avoid ownership conflicts.

Common Preparation Mistakes to Avoid

  • Ambiguous specifications that omit tolerances or material grades, causing inconsistent production outcomes and disputes over compliance.
  • Failing to attach the exact revision of drawings and BOMs, which leads to unintended part variants and additional tooling costs.
  • Not specifying testing responsibilities or acceptance criteria, resulting in repeated failures and delayed shipments while parties negotiate responsibility.
  • Overlooking export control and customs classification details for cross-border manufacture, which can trigger seizures or fines.

Potential Legal and Operational Consequences

Contract Liability: Damages for late or defective delivery
IP Disputes: Infringement claims and injunctions
Regulatory Fines: Noncompliance penalties
Product Recalls: Recall costs and reputational harm
Customs Seizure: Improper classification or missing documentation
Payment Withholding: Buyer retains payment for nonconformity

Typical Dates to Specify and Monitor

Include clear milestone dates so parties can track approvals, production windows, and delivery expectations.

Effective Date:

When obligations start and warranties begin

Production Start Date:

Manufacturer begins tooling or production operations

First Article Inspection:

Date for initial sample approval before mass production

Mass Production Window:

Range of calendar dates for bulk manufacturing

Planned Delivery:

Target date or delivery timeframe for shipment

Key Milestones and Processing Stages

Track these stages sequentially from instruction issue to completed shipment to ensure accountability and traceability.

01

Draft and Technical Review

Engineering and procurement finalize specifications and acceptable tolerances.

02

Legal and Compliance Sign-off

Legal reviews IP, export controls, and indemnity language for risk allocation.

03

Prototype and FAI

Manufacturer produces and submits first article for buyer inspection and approval.

04

Production and Handover

Mass production, testing, and delivery with final acceptance documentation.

How This Instruction Differs from Related Documents

Compare the Instruction to Manufacture with close documents to choose the right form and level of legal detail.

Criteria Instruction to Manufacture Manufacturing Agreement
Purpose operational directive comprehensive commercial contract
Legal Binding yes for specified run yes, broader terms
Typical Signatories buyer + manufacturer buyer + manufacturer + legal
IP Assignment may be limited usually explicit and detailed

eSignature Vendor Pricing and Feature Snapshot

Select a signing platform that supports attachments, authenticated signatures, audit trails, and the compliance features your industry requires.

signNow DocuSign Adobe Sign PandaDoc HelloSign
Starting Price $8/user/mo $15/user/mo $14/user/mo $19/user/mo $15/user/mo
Free Trial 7-day trial Varies by vendor Varies by vendor Varies by vendor Varies by vendor
Bulk Send Yes Yes Yes Yes No
Audit Trail Yes Yes Yes Yes Yes
HIPAA Compliant Yes Yes Yes No No
Envelope Cap No envelope cap 100 envelopes/user/year Varies by plan Varies by plan Varies by plan

Representative Use Cases

These scenarios illustrate how organizations structure instructions to reduce production risk and enforce quality obligations.

Contract Manufacturer Use

A buyer issues a single consolidated instruction for multiple part revisions to a contract manufacturer to reduce interpretation errors

  • Immediate supplier confirmation required
  • Centralized attachments, clear acceptance criteria, and an electronic audit trail resolved earlier disputes and shortened time-to-production across repeat runs.

Prototype Approval Flow

Engineering sends a prototype instruction including FAI requirements and test criteria

  • Manufacturer returns first article data for approval
  • Formalizing the approval conditions and using authenticated electronic signatures accelerated prototype acceptance and reduced rework cycles.

Frequently Asked Questions and Troubleshooting

Answers to common questions about preparing, signing, and storing Legal Instructions to Manufacture in the United States.


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