SlideServe
Télécharger Obtenir Pro
Menu
Accueil Pro
Préférences
ApparenceLight Aide et commentaires
© SlideServe · v2026

Streamlining Material Transfer and Clinical Trial Agreements: A Template Initiative

linnea avatar
linnea
12 diapositives · 307 Views · Oct 20, 2014

This presentation from the IOM Forum outlines efforts to standardize Material Transfer Agreements (MTA) and Clinical Trial Agreements (CTA) to facilitate negotiations between industry and academia. The objectives include providing templates that serve as starting points for discussions, benchmarking tools, and a standard process for the transfer of research materials. Key considerations include ownership of intellectual property (IP), publication rights, and indemnification terms. The initiative aims for simplicity and brevity in agreements, benefiting both companies and universities.

#streamlining material transfer and clinical trial agreements: a template initiative #streamlining material transfer and clinical trial agreements: a template initiative ppt #powerpoint #presentation
Streamlining Material Transfer and Clinical Trial Agreements: A Template Initiative - slide 1
01 / 12Streamlining Material Transfer and Clinical Trial Agreements: A Template Initiative
1 / 17

Télécharger la présentation

Streamlining Material Transfer and Clinical Trial Agreements: A Template Initiative
Une image / un lien ci-dessous est fourni (tel quel) pour télécharger la présentation

Politique de téléchargement : le contenu du site vous est fourni TEL QUEL pour votre information et votre usage personnel ; il ne peut être vendu, concédé sous licence ni partagé sur d’autres sites sans l’accord de son auteur.Le contenu vous est fourni TEL QUEL, pour votre information et votre usage personnel uniquement. Téléchargez la présentation en cliquant sur ce lien. Lors du téléchargement, si vous ne parvenez pas à télécharger une présentation, l’éditeur a peut-être supprimé le fichier de son serveur.Pendant le téléchargement, si vous ne parvenez pas à obtenir une présentation, le fichier a peut-être été supprimé par l’éditeur.

F I N

Plus de contenu associé

Transcription de la présentation

  1. The IOM Template Project:Material Transfer Agreements and Clinical Trial Agreements Presentation to the IOM Forum on Drug Discovery, Development and Translation April 27, 2009 Jim Snipes Covington & Burling, San Francisco jsnipes@cov.com

  2. Objectives • Generate standard forms of agreement to streamline industry-university negotiations • starting-point for discussions • benchmarking tool • Template for material transfer agreement (MTA) • transfer from company to university • research not sponsored by the company • Template for clinical trial agreement (CTA) • sponsor-initiated • Phase 2 or Phase 3 • multi-center trial

  3. Process • Companies and universities shared standard forms of MTA/CTA • Covington & Burling retained to review forms, prepare initial drafts of templates • Working group from academia and industry convened

  4. Ground rules • Aim for the middle ground • 80% rule – target the typical transaction • Shoot for brevity and simplicity • No obligation to adopt or endorse

  5. Material Transfer Agreement Template • Ownership of IP • “Inventor owns” structure • Recipient to grant Transferor broad license to use know-how nonexclusive license to use patentable inventions to exploit materials option to negotiate exclusive license under patentable inventions

  6. MTA Template • Publication • Recipient may publish results of research and identifying information regarding materials • Transferor has pre-publication right of review • Publication subject to delay for filing of patent applications

  7. MTA Template • Indemnification • materials provided “as is” – no indemnity from Transferor • Recipient to indemnify Transferor for losses from conduct of research or use of materials

  8. Clinical Trial Agreement Template • Ownership of IP • Inventor owns, except that Sponsor owns all patentable inventions related to study drug • Sponsor to grant Institution broad research license to inventions related to study drug • Institution to grant Sponsor option to negotiate exclusive license to Institution-owned inventions developed in the trial

  9. CTA Template • Ownership of data and records • Sponsor to own all case report forms, databases and study reports prepared under the protocol • Institution to own primary medical records, other source documents • restrictions on disclosure of data from study deliverables

  10. CTA Template • Publication • Institution may publish summary of the study results and supporting data • Single-center publication to be deferred until publication of summary of results from all centers • Sponsor has right of pre-publication review

  11. CTA Template • Indemnification/Subject Injury • Sponsor to bear medical expenses of subjects incurred in connection with the trial • Sponsor to indemnify Institution for losses from use of study drug or procedures under protocol • Institution to indemnify Sponsor for losses from failure to follow protocol or negligence

  12. Comments from the Panel Diane Archer, University of California Richard Neff, Schering-Plough Adam Rifkind, University of Pennsylvania Gil Smith, Duke University