💡 Plain English Explanation

This clause protects clinical trial data, efficacy results, safety information, and adverse event reports exchanged between pharmaceutical companies, CROs, research institutions, and potential partners. Clinical data represents the culmination of years of research and hundreds of millions of dollars in investment.

Clinical trial information is uniquely sensitive because it directly impacts regulatory approval, market valuation, and competitive positioning. Premature disclosure of trial results, whether positive or negative, can affect stock prices, trigger regulatory scrutiny, and compromise the integrity of ongoing studies.

This clause addresses critical clinical data concerns:

⚠ Why This Clause Matters

For the Disclosing Party (Trial Sponsor): Clinical data leakage can derail partnerships, trigger SEC violations for public companies, and compromise competitive positioning. This clause ensures that interim results, unblinded data, and strategic insights remain protected during licensing negotiations, M&A due diligence, and partnership discussions.

For the Receiving Party (Potential Partner/Investor): You need to evaluate clinical programs for business decisions while managing legal exposure. Clear definitions help you understand what you can and cannot do with the data, including sharing with internal teams, advisors, and decision-makers.

Regulatory Intersection: Clinical trial data exists in a complex regulatory environment with mandatory disclosure requirements (ClinicalTrials.gov, EudraCT, regulatory submissions). The clause must carve out required disclosures while maintaining protection for non-public elements and proprietary analyses.

📄 Clause Versions

Balanced Version: Comprehensive protection for clinical data with appropriate carve-outs for regulatory requirements and published results. Suitable for partnership discussions and due diligence processes where both parties need clarity on data handling. 
"Clinical Data" means Confidential Information relating to clinical trials, clinical studies, and human research conducted by or on behalf of the Disclosing Party, including without limitation:

(a) clinical trial protocols, amendments, investigator brochures, and informed consent forms;

(b) efficacy data, including primary and secondary endpoint results, response rates, progression-free survival, overall survival, and other clinical outcome measures;

(c) safety data, including adverse events, serious adverse events (SAEs), adverse drug reactions, safety signals, and Data Safety Monitoring Board (DSMB) reports;

(d) patient-level data, case report forms, and individual patient narratives (in de-identified form);

(e) statistical analysis plans, interim analyses, and final study reports;

(f) regulatory correspondence, clinical study reports (CSRs), and data submitted to regulatory authorities; and

(g) trial design rationale, endpoint selection strategy, patient population considerations, and development timelines.

The Receiving Party agrees that Clinical Data shall be used solely for evaluating a potential business relationship and shall not be disclosed to any third party, including healthcare professionals, investors, or analysts, without prior written consent.

Nothing in this Agreement shall prevent either party from:
(i) making disclosures required by applicable law or regulation, including mandatory safety reporting to regulatory authorities;
(ii) registering clinical trials on public registries as required by law; or
(iii) publishing clinical trial results in accordance with applicable disclosure requirements, provided that such publication does not include information beyond what is legally required.

Clinical Data that has been published on ClinicalTrials.gov, in peer-reviewed journals, or in regulatory documents available to the public shall no longer be considered Confidential Information to the extent of such publication.
Disclosing Party Favor: Maximum protection for clinical program data, including strategic insights and competitive analyses. Extended protection periods and restrictions on derivative analyses. Ideal when sharing late-stage clinical data or during M&A due diligence. 
"Clinical Data" means all information of any kind relating to clinical research, clinical trials, and human studies conducted, planned, or contemplated by or on behalf of the Disclosing Party, including without limitation:

(a) all clinical trial protocols, protocol synopses, protocol amendments, investigator brochures, pharmacy manuals, and study-related training materials;

(b) all efficacy data, including raw data, analyzed data, primary endpoints, secondary endpoints, exploratory endpoints, biomarker data, pharmacodynamic data, patient-reported outcomes, quality of life assessments, and any interim, preliminary, or final results;

(c) all safety data, including adverse events of any severity, serious adverse events, suspected unexpected serious adverse reactions (SUSARs), adverse drug reactions, safety signals, aggregate safety analyses, DSMB reports, DSMB recommendations, and any safety-related communications with regulatory authorities;

(d) all patient-level data, individual case safety reports, case report forms, source data verification reports, and patient narratives, whether identified, coded, or de-identified;

(e) all statistical information, including statistical analysis plans, sample size calculations, randomization schemes, interim analyses, futility analyses, adaptive design parameters, and final statistical analyses;

(f) all clinical study reports (CSRs), integrated summaries of safety (ISS), integrated summaries of efficacy (ISE), and any documents prepared for regulatory submission;

(g) all regulatory correspondence, FDA meeting minutes, EMA scientific advice, regulatory feedback, and approval strategies;

(h) all clinical development plans, trial design rationale, comparator selection strategy, endpoint selection strategy, patient population strategy, and competitive positioning analyses; and

(i) all interpretations, analyses, compilations, or reports prepared by or for the Receiving Party based on any of the foregoing.

The Receiving Party shall:
(i) limit access to Clinical Data to those employees and advisors with a strict need to know for purposes of evaluating the potential transaction;
(ii) not share Clinical Data with healthcare professionals, key opinion leaders, or clinical advisors without prior written consent;
(iii) not use Clinical Data to inform the Receiving Party's own clinical development programs;
(iv) not conduct independent analyses, meta-analyses, or reinterpretations of Clinical Data;
(v) not make investment decisions based on Clinical Data for any purpose other than evaluating the proposed transaction; and
(vi) not disclose the existence of Clinical Data or the fact that clinical trials have achieved certain results to any third party.

Clinical Data shall remain Confidential Information for a period of ten (10) years following disclosure, or until FDA approval of the relevant product, whichever is later. Publication of summary results shall not terminate confidentiality obligations with respect to underlying patient-level data, statistical analyses, or strategic interpretations not included in such publication.
Receiving Party Favor: Narrower definition focused on genuinely non-public data with clear carve-outs for publicly required disclosures. Permits internal analysis and sharing with advisors. Suitable for investors and partners with established due diligence processes. 
"Clinical Data" means only that information relating to clinical trials which:

(a) is disclosed in writing and clearly marked as "Confidential Clinical Data"; and

(b) is not available from public sources, including ClinicalTrials.gov, regulatory agency databases, published literature, investor presentations, or SEC filings.

Clinical Data includes only the following categories:
(i) patient-level data and case report forms not available through public disclosure;
(ii) detailed statistical analyses beyond what is published or submitted to registries;
(iii) complete clinical study reports to the extent not publicly available; and
(iv) regulatory correspondence not publicly disclosed.

Clinical Data expressly does not include:
(i) top-line results that have been publicly announced;
(ii) information disclosed on ClinicalTrials.gov or equivalent registries;
(iii) information contained in SEC filings, investor presentations, or press releases;
(iv) information published in peer-reviewed journals or presented at scientific conferences;
(v) information disclosed in FDA approval letters, European Public Assessment Reports (EPARs), or other publicly available regulatory documents;
(vi) general information about clinical trial design, endpoints, or patient populations that is standard in the industry; or
(vii) safety information that the Disclosing Party is required to disclose under applicable law.

The Receiving Party may:
(i) share Clinical Data with its employees, officers, directors, and professional advisors who need to know such information for purposes of evaluating the proposed transaction;
(ii) prepare internal analyses and summaries of Clinical Data for decision-making purposes;
(iii) retain copies of Clinical Data in accordance with its document retention policies and legal hold requirements; and
(iv) disclose Clinical Data as required by law, regulation, or legal process.

Confidentiality obligations with respect to Clinical Data shall terminate upon the earlier of:
(i) three (3) years from the date of disclosure;
(ii) public disclosure of such information by the Disclosing Party; or
(iii) termination of the evaluation period without a definitive agreement.

💬 Key Considerations