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Clinical Stage Partnering Terms and Agreements in Pharma and Biotech, 2nd Edition

CurrentPartnering, April 2010, Pages: 510


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The Clinical Stage Partnering Terms and Agreements in Pharma and Biotech report provides comprehensive understanding and unprecedented access to the clinical stage agreements entered into by the worlds leading biopharma companies.

The report provides a detailed understand and analysis of how and why companies enter clinical stage partnering deals. In addition a review of deal terms including upfront, milestone and royalty rates is provided. Understanding the flexibility of a prospective partner’s negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered – contract documents provide this insight where press releases and databases do not.

This report contains over 1500 links to online copies of actual clinical stage contract documents as submitted to the Securities Exchange Commission by biopharma companies and their partners. Contract documents provide the answers to numerous questions about a prospective partner’s flexibility on a wide range of important issues, many of which will have a significant impact on each party’s ability to derive value from the deal.

The initial chapters of this report provide an orientation of clinical stage dealmaking and business activities.

Chapter 1 provides an introduction to the report, whilst chapter 2 provides an analysis of the trends in clinical stage partnering as well as a discussion on the merits and attributes of dealmaking at each stage of clinical development. In addition, the chapter provides review of deal terms including upfront, milestone and royalty rates, as identified in our deal tracking database.

Chapter 3 provides an overview of the structure of clinical stage partnering deal contracts. The chapter includes numerous case studies to enable understanding of both pure deals and multicomponent clinical stage partnering deals.

Chapters 4, 5 and 6 provide a review of the leading phase I, II and III clinical stage partnering deals since 2000, respectively. Deals are listed by headline value, signed by bigpharma, most active bigpharma, and most active of all biopharma companies. Where the deal has an agreement contract published at the SEC a link provides online access to the contract.

Chapter 7 provides a comprehensive listing of the top 50 bigpharma companies with a brief summary followed by a comprehensive listing of clinical stage contract documents available in the public domain. Each deal title links via Weblink to an online version of the actual contract document, providing easy access to each contract document on demand.

Chapters 8, 9 and 10 provide a comprehensive listing of all phase I, II and III clinical stage agreement contracts since 2003 available in the public domain, respectively. Each chapter is organized by company AZ, therapeutic area, and deal type. Each deal title links via Weblink to an online version of the actual contract document, providing easy access to each contract document on demand.

The report also includes numerous tables and figures that illustrate the trends and activities in clinical stage dealmaking since 2000.

In conclusion, this report provides everything a prospective dealmaker needs to know about clinical stage partnering, enabling thorough learning, education and due diligence prior and during the clinical stage dealmaking process.

Clinical Stage Partnering Terms and Agreements in Pharma and Biotech provides the reader with the following key benefits:

- In-depth understanding of clinical stage partnering deal trends since 2000
- Analysis of the structure of clinical stage partnering agreements with numerous real life case studies
- Partnering deal terms including average upfront, milestone and royalty payments
- Comprehensive access to over 1500 actual clinical stage partnering contracts entered into by the world’s biopharma companies
- Detailed access to actual clinical stage partnering contracts enter into by the leading fifty bigpharma companies
- Insight into the terms included in a clinical stage partnering agreement, together with real world clause examples
- Understand the key deal terms companies have agreed in previous deals
- Undertake due diligence to assess suitability of your proposed deal terms for partner companies

Clinical Stage Partnering Terms and Agreements in Pharma and Biotech is intended to provide the reader with an in-depth understanding of the clinical stage partnering trends and structure of deals entered into by leading biopharma companies worldwide.

Clinical Stage Partnering Terms and Agreements in Pharma and Biotech includes:

- Trends in clinical stage partnering dealmaking in the biopharma industry since 2000
- Analysis of clinical stage partnering deal structure
- Case studies of real-life clinical stage partnering deals
- Partnering deal terms including average upfront, milestone and royalty payments
- Access to over 1500 clinical stage partnering contract documents
- The leading clinical stage partnering deals by value since 2000
- Most active clinical stage partnering dealmakers since 2000
- The leading clinical stage partnering resources

In Clinical Stage Partnering Terms and Agreements in Pharma and Biotech, the available contracts are listed by:

- Company A-Z
- Headline value
- Stage of development at signing (phase I, phase II and phase III)
- Therapeutic area
- Deal type

Each deal title links via Weblink to an online version of the actual contract document, providing easy access to each contract document on demand.

The Clinical Stage Partnering Terms and Agreements in Pharma and Biotech report provides comprehensive access to available contract documents for over 1500 clinical stage partnering deals.

Analyzing actual contract agreements allows assessment of the following:

- What are the precise rights granted or optioned?
- What is actually granted by the agreement to the partner company?
- What exclusivity is granted?
- What is the payment structure for the deal?
- How do milestone align with clinical stage development phases?
- How are sales and payments audited?
- What is the deal term?
- How are the key terms of the agreement defined?
- How are IPRs handled and owned?
- Who is responsible for commercialization?
- Who is responsible for development, supply, and manufacture?
- How is confidentiality and publication managed?
- How are disputes to be resolved?
- Under what conditions can the deal be terminated?
- What happens when there is a change of ownership?
- What sublicensing and subcontracting provisions have been agreed?
- Which boilerplate clauses does the company insist upon?
- Which boilerplate clauses appear to differ from partner to partner or deal type to deal type?
- Which jurisdiction does the company insist upon for agreement law?


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