Pharma and biotech | Leela Works

Pharma and biotech

Holding IP and regulatory obligations across the agreement package.

A programme is a licence, a research collaboration, a clinical trial agreement per site and a quality agreement, and the IP and regulatory obligations have to be consistent across all of them. Leela reviews each draft to your positions, reads the agreements together, and keeps the issues list per programme, so a results-ownership clause in a site agreement that contradicts the licence, or a regulatory reporting obligation that two agreements allocate to different parties, is found before signature.

Leela Received. I am reviewing the markup against your positions and the executed licence. 8:31 AM

Reviewed against the licence: 2 conflicts, 10 other issues

Dear Charisma

Two of the site's changes conflict with the Halvard licence, and there are 10 other issues.

The site's markup at clause 9.2 provides that inventions arising from the study are jointly owned by the institution and the sponsor. The licence at clause 7.1 obliges Meridian to own or control all improvements to the licensed compound and to grant Halvard a licence to them, which a joint ownership position at the site would prevent. I have restored sponsor ownership with the institution's non-exclusive research licence, which is your standard, and quoted licence clause 7.1 in the margin. The publication clause at 11.3 as marked up allows publication 30 days after submission to the sponsor; the licence at 12.4 requires a 60-day review period with a right to delay 90 days for patent filing. I have restored 60 and 90.

Of the other issues, the indemnity at 13.1 is within the fallback, the insurance limits at 14.2 are below the standard and are redlined, and the data protection clause at 15 allocates the controller role to the site in a way that contradicts the protocol; that one is open for you and the regulatory team.

Leela

W Halvard CTA site 12 - issues list.docx66 KBW Halvard CTA site 12 - redline.docx206 KB

IP and results

Ownership of inventions, data and results in every site and research agreement, read against the licence that sits over them. A joint ownership clause at a site is found because the licence is in the same matter.

Regulatory and quality obligations

Reporting, pharmacovigilance and the quality agreement's responsibilities, allocated once and checked for consistency across every agreement in the programme.

Publication, confidentiality and data

Review periods, patent delays, controller and processor roles, held to the positions the licence and the protocol require.

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