Pharmaceutical Document Services
TERMS AND CONDITIONS

NTGC-PDS-TC | Revision 2026.09.5

These Pharmaceutical Document Services Terms and Conditions ("Terms") govern each quotation, estimate, statement of work, purchase order accepted by NTGC, and related engagement under which NT Graphics, INC., doing business as Newark Trade Graphic Communications ("NTGC"), provides pharmaceutical document typesetting, formatting, proofreading, quality control, artwork, file preparation, or related production services to the customer identified in the applicable Quote ("Client"). Each accepted quotation is referred to as a "Quote," and the services covered by it are the "Services."

1. Quotes, Scope, and Order of Terms

1.1 Quoted Services. Services, prices, assumptions, schedules, review passes, revision allowances, and final deliverables are limited to those expressly stated in the Quote. NTGC has no obligation to perform work outside that scope.

1.2 Changes in Scope. A change in Client Materials, specifications, quantity, trim size, page count, language, format, regulatory direction, timing, or other assumption may require revised pricing and a revised schedule. NTGC may suspend affected work until the Parties confirm the change in writing.

1.3 Client Purchase Orders. A purchase order is an administrative authorization for payment and does not add to or modify NTGC’s obligations. Additional or inconsistent terms printed on, linked to, or incorporated into a Client purchase order, supplier portal, acknowledgment, or other Client document are rejected and have no effect. A project-specific change to scope, price, schedule, or a non-editable deliverable is effective only through a written change authorization issued or expressly accepted by NTGC, and no such authorization may modify Section 3. NTGC’s performance, invoice, or acceptance of payment does not signify acceptance of a requirement to deliver Working Files.

1.4 Material Condition. The prohibition in Section 3 is a material and non-negotiable condition of every engagement. If Client requires Working Files, NTGC will not accept or continue the affected engagement.

2. Services and Deliverables

2.1 Services. Depending on the Quote, Services may include pharmaceutical labeling typesetting, document formatting, copy incorporation, reflow, proofreading, comparison, quality-control review, print-production preparation, and related services. Only Services expressly identified in the Quote are included.

2.2 Final Deliverables. Unless the Quote expressly identifies another non-editable output, the only final deliverable is a print-ready PDF file ("Final PDF"). Draft PDFs, proofs, comparison files, reports, annotations, markups, preflight results, and transmittal materials are review or production aids and are not additional final deliverables.

2.3 No Implied Deliverables. Client is entitled only to the Final PDF and any other non-editable deliverable expressly named in the Quote. A reference to typesetting, design, formatting, production, layout, artwork, file preparation, or source materials describes the Services and does not identify or imply delivery of the files used to perform them.

2.4 Technical Specifications. Client shall provide final output specifications, including page size, color requirements, bleed, marks, PDF standard, printer requirements, and accessibility requirements, before production begins. Requirements not stated in the Quote or supplied after work begins may constitute a change in scope.

3. Absolute Exclusion of Working and Native Files

3.1 No Delivery or Access. NTGC does not and will not provide, deliver, disclose, transfer, sell, assign, license, sublicense, release, deposit, escrow, loan, or permit Client or any third party to access Working Files. This policy applies during and after the engagement, regardless of project size, fees paid, urgency, intended use, length of relationship, or the identity of the requesting party.

3.2 Definition of Working Files. "Working Files" includes every native, editable, source, production, template, packaged, linked-asset, intermediate, archival, markup, database, preflight, automation, configuration, job-ticket, imposition, or other file used, generated, modified, or maintained by NTGC in connection with the Services. Examples include InDesign, Illustrator, Photoshop, Word, spreadsheet, database, script, font, style, master-page, library, package, and application-specific production files, except an unchanged original Client Material returned under Section 4.3.

3.3 No Purchase or Negotiated Exception. Working Files are not offered as a separately priced product or optional deliverable. NTGC will not quote a fee for their release and will not negotiate an assignment, license, buyout, handoff, escrow arrangement, conversion, or other method intended to make Working Files available. No payment, approval, project completion, termination, business transition, or course of dealing creates any right to them.

3.4 No Delivery to Others. The prohibition applies equally to delivery requested for Client’s parent, affiliate, successor, end customer, marketing agency, regulatory consultant, law firm, printer, translation provider, production vendor, or other representative. Client may not require NTGC to transmit Working Files directly or indirectly to another person.

3.5 Client Materials Within Working Files. Client’s ownership of Client Materials does not create a right to receive an NTGC Working File in which Client Materials appear or are embedded. Client must retain its own copies of all Client Materials submitted to NTGC.

3.6 Final PDF and Working Files. Delivery of a Final PDF does not include, require delivery of, or transfer ownership of the separate Working Files or NTGC Proprietary Materials.

3.7 Compulsory Legal Process. Nothing in these Terms requires NTGC to disobey applicable law or a valid and enforceable governmental demand, subpoena, or court order directed to NTGC. Any disclosure made solely because NTGC is legally compelled to make it is involuntary, will be limited to the material legally required, and does not constitute a contractual deliverable, voluntary release, license, assignment, waiver, course of dealing, or precedent. Client has no contractual right to invoke this provision as a means of obtaining Working Files.

4. Client Materials and Third-Party Materials

4.1 Client Materials. Client retains its rights in text, manuscripts, trademarks, logos, artwork, regulatory content, product information, and other materials supplied by or on behalf of Client ("Client Materials"). Client grants NTGC a nonexclusive license to use, reproduce, adapt, and modify Client Materials as reasonably necessary to perform the Services and produce the Final PDF.

4.2 Client Authority. Client represents that it has all rights and permissions necessary for NTGC to use the Client Materials as directed and that the materials and instructions do not infringe third-party rights or violate applicable law.

4.3 Original Client Materials. Upon written request and where reasonably practicable, NTGC may return an unchanged original physical or electronic item supplied by Client. NTGC has no obligation to provide any normalized, corrected, annotated, converted, linked, assembled, or otherwise modified version of that item, because such versions are Working Files.

4.4 Third-Party Materials. Fonts, software, plug-ins, stock assets, images, and other third-party materials remain subject to their own licenses. NTGC may embed or subset fonts in a Final PDF only as permitted by the applicable license. No font software or font file, including fonts obtained through Adobe Fonts or licensed from Linotype or another licensor, is transferred or sublicensed to Client.

5. Client Responsibilities

5.1 Final and Complete Source. Client shall provide a complete, internally approved manuscript and all required source materials, references, artwork, instructions, and specifications. Client shall clearly identify the controlling source and version.

5.2 Accuracy and Authorization. Client is responsible for the scientific, medical, legal, clinical, promotional, regulatory, and substantive accuracy and completeness of Client Materials, and for obtaining all required internal, legal, medical, regulatory, and brand approvals.

5.3 Consolidated Instructions. Client shall provide clear, complete, and consolidated comments through an authorized contact. NTGC may rely on instructions and approvals from that contact and is not responsible for conflicting, incomplete, or superseded directions.

5.4 Version Control. Client shall identify revisions and differences between drafts, revised manuscripts, FDA-approved content, and other source versions. NTGC is not responsible for undisclosed changes, incorrect source selection, or content omitted from the materials supplied.

5.5 Retention. Client shall retain copies of Client Materials, approvals, comments, Final PDFs, and regulatory records. NTGC is not Client’s records repository or regulatory archive.

6. Proofreading and Quality Control

6.1 Included Review. Proofreading, comparison, quality-control passes, and correction cycles are limited to those stated in the Quote. NTGC’s review is directed to typesetting, incorporation, consistency, and production quality within the agreed scope.

6.2 Nature of Review. NTGC may compare text and formatting against the Client-designated controlling source and apply agreed style and production standards. NTGC does not independently verify scientific conclusions, medical claims, legal sufficiency, promotional status, or regulatory strategy.

6.3 Client Review. Client shall review every proof and Final PDF in full, including text, tables, figures, references, footnotes, pagination, line breaks, symbols, special characters, images, color, links, and required labeling elements. NTGC’s review does not replace Client’s final approval.

6.4 Production Deviations. If Client timely identifies a reproducible error introduced solely by NTGC that causes the Final PDF to depart materially from the last Client-approved proof or controlling source, NTGC will correct the Final PDF within a reasonable time. This correction is Client’s exclusive remedy for that production deviation, subject to applicable law.

7. Proofs, Revisions, and Final Approval

7.1 Proof Status. Every proof or draft is supplied for review and is not approved for publication, printing, distribution, submission, or commercial use unless NTGC designates it as final and Client has approved it.

7.2 Revisions. Changes beyond the Quote’s allowances, changes to previously approved content, replacement manuscripts, translations, reflows, format changes, new regulatory direction, and corrections to Client Materials are additional services and may affect price and schedule.

7.3 Final Approval. Client’s written approval or instruction to release a Final PDF constitutes approval of that version. Client assumes responsibility for the approved content, except for a qualifying NTGC production deviation under Section 6.4.

7.4 Post-Approval Changes. NTGC is not responsible for changes made to a Final PDF by Client or a third party after delivery, including alteration, conversion, extraction, reformatting, editing, recompression, or other processing. NTGC does not review or approve those changes unless separately engaged to do so.

8. Scheduling, Rush Work, and Delays

8.1 Schedule Assumptions. Delivery dates depend on timely receipt of complete materials, consolidated comments, approvals, and responses. A delay or change by Client may extend the schedule, displace reserved production time, or require repricing.

8.2 Rush Services. Rush, expedited, FDA, or PDUFA-driven timing is available only when confirmed by NTGC in the Quote or a written change authorization. Rush acceptance may require additional fees, limited review cycles, fixed response deadlines, and after-hours work.

8.3 Late Changes. Changes received after typesetting, proofreading, or quality control begins may require reflow, repetition of review steps, or rescheduling and will be billed when outside the agreed scope.

8.4 Events Beyond Control. NTGC is not liable for delay caused by events reasonably beyond its control, including power, telecommunications, hosting, transportation, labor, public-health, governmental, or supplier disruptions. NTGC will use commercially reasonable efforts to resume affected Services.

9. Fees, Invoicing, Suspension, and Cancellation

9.1 Fees. Client shall pay the fees and approved additional charges stated in the Quote or applicable change authorization. Estimates based on incomplete or preliminary materials may be revised when final materials are received.

9.2 Invoices. Invoices are payable according to the Quote or invoice terms. Client shall promptly identify any good-faith billing dispute and pay all undisputed amounts when due.

9.3 Suspension. NTGC may suspend Services for overdue undisputed amounts, missing materials, unresolved scope changes, unsafe or unlawful instructions, or Client’s material breach. The schedule will be adjusted accordingly.

9.4 Cancellation. If Client cancels or places a project on hold, Client shall pay for Services performed, committed production time, noncancelable third-party costs, and authorized expenses through the effective date of cancellation or hold.

10. Regulatory and Content Responsibility

10.1 Production Role. NTGC provides typesetting, formatting, proofreading, quality control, and production services. NTGC is not a pharmaceutical manufacturer, sponsor, regulatory authority, law firm, medical reviewer, or scientific consultant.

10.2 No Regulatory Approval. NTGC’s Services and Final PDFs do not constitute FDA or other governmental approval, legal advice, medical approval, scientific validation, promotional review, or certification of compliance.

10.3 Client Responsibility. Client is solely responsible for content, labeling strategy, product claims, required disclosures, regulatory submissions, approvals, implementation dates, and compliance with applicable laws, regulations, guidance, and internal procedures.

10.4 No Acceptance Guarantee. NTGC does not warrant that a regulator, printer, platform, distributor, or other third party will accept a Final PDF unless the Quote expressly states objective technical acceptance criteria and the file fails those criteria because of NTGC’s production deviation.

11. Intellectual Property and Final PDFs

11.1 Client Materials. Client retains its rights in Client Materials. Nothing in these Terms transfers Client’s trademarks, regulatory content, or other preexisting Client intellectual property to NTGC.

11.2 NTGC Proprietary Materials. NTGC retains all rights in Working Files and in its templates, styles, master pages, scripts, automation, workflows, systems, tools, processes, production architecture, techniques, know-how, and generalized resources ("NTGC Proprietary Materials"). The Services are not commissioned as a work made for hire with respect to Working Files or NTGC Proprietary Materials.

11.3 Final PDF. NTGC imposes no contractual restriction under these Terms on Client’s use, reproduction, modification, submission, publication, printing, or distribution of the delivered Final PDF. Delivery of the Final PDF does not include or transfer ownership of separate Working Files, NTGC Proprietary Materials, or font software. Rights in Client Materials and third-party materials remain governed by applicable law and the applicable licenses.

11.4 No Implied Transfer. No ownership, license, access right, or delivery obligation concerning Working Files or NTGC Proprietary Materials arises from a Quote, payment, approval, Final PDF delivery, Client ownership of underlying content, repeated engagements, prior accommodation, oral statement, or any course of performance or dealing.

12. Confidentiality, Security, and Legal Process

12.1 Confidential Information. Each Party shall use reasonable care to protect the other Party’s nonpublic business, technical, regulatory, and proprietary information and shall use it only for the engagement. Access shall be limited to personnel and service providers who require it and are subject to appropriate confidentiality obligations.

12.2 Exclusions. Confidential information excludes information the recipient can demonstrate was lawfully known without restriction, becomes public without breach, is lawfully received without restriction from a third party, or is independently developed without use of the protected information.

12.3 Required Disclosure. A Party legally compelled to disclose confidential information may disclose only what is required and, where lawful, shall provide prompt notice and reasonable cooperation in seeking protective treatment. For clarity, this provision creates no right for Client to obtain Working Files and does not modify Section 3.

12.4 Sensitive Data. Client shall not provide protected health information, personally identifiable patient information, controlled data, or other specially regulated information unless NTGC has expressly agreed in advance to receive it and the Parties have implemented any required safeguards or agreement.

13. Limited Warranty and Disclaimers

13.1 Performance Standard. NTGC will perform the Services in a professional and workmanlike manner consistent with the agreed scope and customary commercial production practices.

13.2 Correction Remedy. Client shall report a claimed breach with reasonable detail promptly after discovery. If NTGC verifies the breach, NTGC’s obligation is to reperform the affected Service or correct the affected Final PDF within a reasonable time. If correction or reperformance is not commercially reasonable, NTGC may refund the portion of fees paid for the materially affected Service.

13.3 Disclaimer. EXCEPT FOR THE EXPRESS WARRANTY IN SECTION 13.1, AND TO THE MAXIMUM EXTENT PERMITTED BY LAW, NTGC DISCLAIMS ALL OTHER EXPRESS OR IMPLIED WARRANTIES, INCLUDING MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT BASED ON CLIENT MATERIALS, AND ANY WARRANTY OF REGULATORY ACCEPTANCE OR ERROR-FREE CONTENT.

14. Limitation of Liability and Client Indemnity

14.1 Liability Cap. TO THE MAXIMUM EXTENT PERMITTED BY LAW, NTGC’S AGGREGATE LIABILITY ARISING FROM OR RELATING TO A PROJECT WILL NOT EXCEED THE FEES ACTUALLY PAID TO NTGC FOR THE SPECIFIC SERVICES GIVING RISE TO THE CLAIM.

14.2 Excluded Damages. TO THE MAXIMUM EXTENT PERMITTED BY LAW, NTGC WILL NOT BE LIABLE FOR INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE, OR CONSEQUENTIAL DAMAGES, OR FOR LOST PROFITS, LOST REVENUE, LOSS OF GOODWILL, LOSS OF DATA, BUSINESS INTERRUPTION, RECALL COSTS, REGULATORY PENALTIES, OR CLAIMS BASED ON CLIENT’S OR A THIRD PARTY’S MODIFICATION OR USE OF A FINAL PDF.

14.3 Indemnity. Client shall defend, indemnify, and hold NTGC and its personnel harmless from third-party claims, damages, penalties, and reasonable costs to the extent arising from Client Materials, Client instructions, product claims, regulatory or legal noncompliance, unlicensed materials supplied by Client, or modification or use of a Final PDF after delivery, except to the extent caused by NTGC’s breach of these Terms, gross negligence, or willful misconduct.

15. File Retention and Records

15.1 NTGC Retention. NTGC may retain, archive, migrate, or destroy Working Files, proofs, correspondence, and Project records according to its business and records-retention practices. NTGC has no obligation to preserve Working Files for Client, maintain them in a usable software version, or provide retrieval, restoration, migration, or archival services.

15.2 Reorders and Future Revisions. NTGC may elect to use retained Working Files for a reorder or future revision performed by NTGC, but retention is not guaranteed. Availability of prior production materials does not change the prohibition on delivery or access.

15.3 Client Archive. Client is responsible for preserving its Client Materials, approved Final PDFs, approvals, and records required for regulatory, legal, production, or business purposes.

16. Acceptance and General Provisions

16.1 Acceptance. Client accepts these Terms by approving a Quote, issuing a purchase order, authorizing NTGC to begin, supplying materials for production, approving a proof, or otherwise instructing NTGC to perform Services.

16.2 Entire Agreement. The applicable Quote and these Terms constitute the agreement for the Services unless the Parties have a separately signed master services agreement expressly identified in the Quote. Section 3 governs every Quote accepted by NTGC regardless of general precedence language in another document. If a proposed or existing agreement would require delivery of Working Files, NTGC will not accept the affected engagement unless that requirement is removed in writing before work begins.

16.3 Priority. These Terms control over inconsistent Client terms. A Quote may supplement these Terms for project-specific scope, price, timing, and non-editable deliverables, but it may not create a right to Working Files. General precedence language in another document will not by itself modify Section 3.

16.4 No Waiver. A failure or delay in enforcing a provision is not a waiver. A waiver on one occasion does not waive the same or another provision on a later occasion. No NTGC employee, contractor, sales representative, project contact, officer, or other representative is authorized under these Terms to promise or approve delivery of Working Files; a request that makes their delivery a condition of engagement must be declined.

16.5 Assignment. Client may not assign an engagement without NTGC’s prior written consent. NTGC may use qualified employees and subcontractors to perform the Services and remains responsible for their work within the agreed scope.

16.6 Severability. If a provision is held unenforceable, it will be modified only to the minimum extent necessary, and the remaining provisions will continue in effect. The invalidity of a portion of Section 3 will not create an affirmative obligation to provide Working Files.

16.7 Governing Law and Forum. The agreement will be governed by the laws of the State of New Jersey, without regard to conflict-of-law principles. The state and federal courts located in Morris County, New Jersey, will have exclusive jurisdiction.

16.8 Electronic Communications. Electronic approvals, purchase orders, instructions, and signatures may be relied upon as writings. Headings are for convenience and do not limit the meaning of these Terms.

16.9 Future Versions. NTGC may issue revised terms for future engagements. A revised version applies only if furnished to Client and incorporated into a Quote accepted thereafter. These Terms for an accepted engagement may be amended only by a writing agreed to by both Parties. No later version or amendment creates a right to Working Files under the existing engagement.