Regulatory Filings Protection

💡 Plain English Explanation

This clause protects regulatory filing information, including FDA submissions, IND/NDA applications, approval strategies, and agency correspondence. Regulatory intelligence is one of the most valuable assets in pharmaceutical development, often determining whether a drug reaches market and how quickly.

Regulatory filings contain detailed information about a company's development strategy, scientific rationale, manufacturing capabilities, and clinical approach. While some regulatory documents eventually become public, the strategic insights behind filing decisions and unpublished correspondence remain highly sensitive.

This clause addresses critical regulatory concerns:

• 1
  IND/NDA/BLA submissions. Complete applications, amendments, supplements, and supporting documentation filed with regulatory authorities worldwide.
• 2
  Regulatory strategy documents. Pre-submission meeting requests, approval pathway analyses, and strategic rationale for regulatory decisions.
• 3
  Agency correspondence. FDA meeting minutes, complete response letters, information requests, and informal communications with regulators.

⚠ Why This Clause Matters

For the Disclosing Party (Filing Company): Your regulatory strategy is a competitive roadmap. Complete Response Letters (CRLs), FDA meeting minutes, and approval pathway decisions reveal your vulnerabilities and strategic choices. This information could enable competitors to design around your regulatory approach or anticipate your market entry timeline.

For the Receiving Party (Potential Partner/Acquirer): You need to assess regulatory risk and timeline for due diligence purposes. Clear definitions help you understand what regulatory information you can access, share with advisors, and factor into valuation decisions.

Public Disclosure Complexity: Regulatory documents exist on a spectrum from fully public (approval letters) to strictly confidential (internal strategy memos). Some documents become public upon approval, others through FOIA requests, and many remain confidential indefinitely. The clause must navigate this complexity.

📄 Clause Versions

"Regulatory Information" means Confidential Information relating to regulatory submissions, approvals, and interactions with regulatory authorities, including without limitation:

(a) Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologics License Applications (BLAs), Abbreviated New Drug Applications (ANDAs), and equivalent submissions to non-U.S. regulatory authorities (collectively, "Regulatory Submissions");

(b) pre-submission meeting requests, briefing documents, meeting minutes, and correspondence with the FDA, EMA, PMDA, Health Canada, and other regulatory agencies;

(c) complete response letters, refuse-to-file letters, clinical holds, information requests, and other regulatory feedback;

(d) regulatory approval strategies, including pathway selection rationale (505(b)(1), 505(b)(2), biosimilar), expedited program strategies (Fast Track, Breakthrough Therapy, Priority Review, Accelerated Approval), and pediatric development plans;

(e) Chemistry, Manufacturing, and Controls (CMC) sections of regulatory submissions, including manufacturing process descriptions, specifications, and stability data;

(f) Risk Evaluation and Mitigation Strategies (REMS), post-marketing commitments, and post-approval study requirements; and

(g) internal regulatory strategy documents, timelines, and assessments prepared in anticipation of regulatory submissions.

The Receiving Party agrees that Regulatory Information shall be used solely for evaluating a potential business relationship and shall not be shared with regulatory consultants, regulatory agencies, or competitors.

Regulatory Information does not include:
(i) information contained in publicly available approval letters, product labels, or Summary Basis of Approval documents;
(ii) information disclosed through publicly accessible regulatory databases; or
(iii) information obtained through Freedom of Information Act (FOIA) requests that has been made available to the public.

For clarity, even where portions of Regulatory Submissions become publicly available, the Disclosing Party's internal strategy documents, regulatory correspondence, and proprietary analyses shall remain Confidential Information.

"Regulatory Information" means all information of any kind relating to regulatory matters, including without limitation:

(a) all Regulatory Submissions worldwide, including INDs, NDAs, BLAs, ANDAs, MAAs, CTAs, and all amendments, supplements, annual reports, and supporting documentation;

(b) all regulatory correspondence, including formal and informal communications with FDA, EMA, PMDA, NMPA, Health Canada, TGA, and any other regulatory authority worldwide;

(c) all meeting-related materials, including pre-submission meeting requests, briefing documents, questions for agencies, meeting minutes (official and unofficial), and follow-up correspondence;

(d) all regulatory feedback, including complete response letters, refuse-to-file letters, clinical holds, warning letters, Form 483 observations, information requests, and deficiency letters;

(e) all regulatory strategy documents, including regulatory pathway assessments, expedited program applications, orphan drug designations, pediatric study plans, and approval timeline projections;

(f) all CMC regulatory information, including manufacturing site registrations, Drug Master Files, process validation data, and specifications not publicly disclosed;

(g) all post-approval regulatory information, including REMS materials, post-marketing commitments, periodic safety update reports, and labeling negotiations;

(h) all regulatory intelligence, including competitive regulatory analyses, anticipated FDA guidance interpretations, and regulatory landscape assessments; and

(i) all internal documents prepared for or in connection with regulatory strategy, including board presentations, regulatory risk assessments, and go/no-go decision materials.

The Receiving Party shall:
(i) not contact any regulatory authority regarding the Disclosing Party's products, regulatory submissions, or regulatory status without prior written consent;
(ii) not submit any FOIA request or equivalent disclosure request regarding the Disclosing Party's regulatory submissions;
(iii) not share Regulatory Information with regulatory consultants or former regulatory agency employees without prior written consent;
(iv) not use Regulatory Information to inform the Receiving Party's own regulatory strategy for competing products; and
(v) maintain Regulatory Information in confidence for a period of ten (10) years following disclosure or until such information becomes publicly available through official regulatory agency publication, whichever is later.

The fact that certain regulatory documents may become publicly available upon product approval shall not affect the confidential status of regulatory strategy documents, internal analyses, or correspondence that is not included in such public disclosure.

"Regulatory Information" means only that information which:

(a) relates to regulatory submissions or regulatory agency communications made by the Disclosing Party; and

(b) is not available through public sources, including FDA databases, Drugs@FDA, the FDA Approval Package database, FOIA reading rooms, EMA public assessment reports, or equivalent public sources.

Regulatory Information includes only:
(i) complete copies of pending regulatory submissions not yet acted upon by regulatory agencies;
(ii) complete response letters and other non-public regulatory correspondence;
(iii) meeting minutes not available through FOIA or equivalent requests; and
(iv) internal regulatory strategy documents expressly designated as Confidential at the time of disclosure.

Regulatory Information expressly does not include:
(i) approved product labels, prescribing information, or package inserts;
(ii) Summary Basis of Approval or Summary Basis of Regulatory Action documents;
(iii) medical reviews, chemistry reviews, pharmacology reviews, or other review documents publicly available through FDA databases;
(iv) European Public Assessment Reports (EPARs) or equivalent public assessment reports;
(v) information available through FOIA requests, whether or not the Receiving Party has submitted such requests;
(vi) general regulatory pathway information or requirements applicable to the therapeutic area;
(vii) publicly announced regulatory milestones, approval dates, or submission timelines; or
(viii) information disclosed in SEC filings, press releases, or investor presentations.

The Receiving Party may:
(i) engage regulatory consultants to assist in evaluating Regulatory Information, subject to appropriate confidentiality obligations;
(ii) submit FOIA requests or equivalent disclosure requests regarding the Disclosing Party's regulatory submissions;
(iii) prepare internal analyses and summaries of Regulatory Information for due diligence purposes; and
(iv) retain copies of Regulatory Information in accordance with legal and compliance requirements.

Confidentiality obligations with respect to Regulatory Information shall terminate upon the earlier of:
(i) three (3) years from disclosure;
(ii) public availability through regulatory agency publication or FOIA disclosure; or
(iii) approval of the relevant product and publication of associated review documents.

💬 Key Considerations

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  Address FOIA implications. In the U.S., much regulatory information can be obtained through FOIA requests. Consider whether to restrict such requests or acknowledge their availability.
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  Cover global submissions. Most pharmaceutical products are developed globally. Ensure protection extends to EMA, PMDA, NMPA, and other regulatory authority submissions.
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  Plan for approval-triggered disclosure. Many regulatory documents become public upon approval. Structure your clause to maintain protection for strategic documents even after product approval.
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  Consider regulatory consultant access. Receivers often need regulatory expertise to evaluate opportunities. Address whether and how regulatory consultants can access information.
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  Protect agency meeting strategies. Pre-submission meeting strategies and anticipated questions reveal development vulnerabilities. Ensure specific protection for these sensitive materials.