Successful Partnering Alliance Management

1
Successful Partnering- Alliance Management

• Steven Axon
• Head of Alliance Management

2
Merck Serono portfolio as of October 2007
Submitted
Phase III
Phase II
Phase I
Osteopontin Neurological Disorders
Atacicept Multiple Sclerosis
Rebif New Formulation in CIS (REFLEX)
Rebif New Formulation Relapsing forms of
MS EMEA approved FDA approval pending
Adecatumumab (MT201) EpCAM-expressing tumors
Erbitux (cetuximab) Breast cancer
Oral cladribine tablets Relapsing forms of MS
Erbitux (cetuximab) Colorectal cancer (CRC),
1st line therapy EMEA Submission filed
Aurora Kinase Inhibitor AS703569 Solid tumors and
hematological malignancies
Matuzumab (EMD 72000) EGFR-expressing tumors
NSCLC
Safinamide Early stage Parkinsons
Matuzumab (EMD 72000) EGFR-expressing tumors
gastric cancer
Safinamide Mid-to-late stage Parkinsons
Recombinant Growth Hormone HARS FDA approval
pending
Atacicept Hematological malignancies
Erbitux (cetuximab) (Adj Colon Cancer)
Tucotuzumab celmoleukin (EMD 273066/huKS-IL2),
EpCAM-expressing tumors ovarian cancer
NHS-IL2-LT Solid tumors
Erbitux (cetuximab) (SCCHN)
DI17E6 Solid tumors
Tucotuzumab celmoleukin (EMD 273066/huKS-IL2),
EpCAM-expressing tumors Small cell lung cancer
(SCLC)
Erbitux (cetuximab) (NSCLC)

• Neurodegenerative Diseases
• Oncology
• Autoimmune Inflammatory Diseases
• Fertility
• Endocrinology
• CM Care local products

Eg 5 inhibitor Solid tumors and hematological
malignancies
Erbitux (cetuximab) (Gastric Cancer)
EMD 273063 (hu14.18-IL2),immunocytokine
GD2-expressing tumors melanoma
Cilengitide Glioblastoma
AS602868 (IKK 2 inhibitor) Hematological
malignancies
Stimuvax MUC1-expressing tumors (NSCLC)
EMD 273063 (hu14.18-IL2),immunocytokine
GD2-expressing tumors Pediatric neuroblastoma
Survivac Cancer Vaccine Survivin-expressing
tumors Solid tumors
Atacicept Lupus
Atacicept Rheumatoid Arthritis
Anti-CD 3 (NI-0401) Crohn's disease / Renal
transplantation
Sapropterin Mild-to-Moderate Phenylketonuria (PKU)
Anastrozole OI and improvement of follicular
development
Fibroblast Growth Factor 18 Osteoarthritis
Hyperglycosylated FSH Infertility (OI / ART)
ARX 201 Growth hormone deficiencies
EMD 387008 Type 2 Diabetes
FC EPO Anaemia associated with chronic renal
failure
DPPIV-Inhib. Type 2 Diabetes
Merck Serono received FDA Special Protocol
Assessment.
3
Merck Serono is heavily reliant on partnerships
with well over half of its pipeline partnered-
Partnered programs
4
Complex deal structures lead to significant
challenges in managing the partnership

• Merck Serono is extremely reliant on partnering
  and it is critical that we focus on actively
  managing these partnerships.
• The deal structures for these partnerships vary
  in complexity from
• Simple in-licensing agreements (acquisition of
  global rights)
• Co-development arrangements
• Co-development arrangements with commercial
  territory splits
• Full co-development and co-commercialization
  arrangements in a territory
• Strategic option agreements including variations
  of all of the above
• The more complex the agreement, the more
  challenging it is to manage the collaboration and
  align objectives to successfully deliver the
  project.

5
Example of organizational structure in the frame
of an internal program
Merck Serono/Partner

• Project Team
• Internal Program
• Merck Serono
• 1 Sponsor
• 1 Global Project Team Leader
• Merck Serono Team Members
• - 1 Marketing
• 1 Clinical Development
• 1 Clinical Trial Manager
• 1 Research (PD) / Biomarkers
• 1 Regulatory
• 1 Nonclinical
• 1 Quality, Molecule Leader
• 1 Project Leader (P996)
• Ad hoc
• 1 Finance

Merck Serono only
Commercial Team
Research Team
Backup Compounds Team
Regulatory Affairs Working Group
Pharmaceutical Development Team
Clinical Team
Non-clinical Team
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Example of organizational structure in the frame
of a licence agreement
Patent Committee Merck Serono Partner - IP
Counsel - Legal

• Steering Committee
• Merck Serono Partner
• 3 Senior Management - 3 Senior Management

Merck Serono/Partner
Merck Serono only

• Project Team
• Merck Serono
• 1 Sponsor
• 1 Global Project Team Leader
• 1 Alliance Manager
• Merck Serono Team Members
• - 1 Marketing
• 1 Clinical Development
• 1 Clinical Trial Manager
• 1 Research (PD) / Biomarkers
• 1 Regulatory
• 1 Nonclinical
• 1 Quality, Molecule Leader
• 1 Project Leader (P996)
• Ad hoc
• 1 Finance
• 1 Intellectual Property

External Communications Workgroup Merck
Serono Partner - Communications - Communications
Research Team
Backup Compounds Team (P996)
Regulatory Affairs Working Group
Pharmaceutical Development Team
Clinical Team
Non-clinical Team
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Example of organizational structure in the frame
of a co-development, co-commercialization
agreement

• Steering Committee
• Merck Serono Partner
• 3 Senior Management - 3 Senior Management

Merck Serono/Partner
Business Development Merck Serono Alliance
Manager Partner Head of Business Development
Merck Serono only

• Joint Project Team
• Merck Serono Partner
• 1 Sponsor - 1 Sponsor
• 1 Global Project Team Leader
• 1 Alliance Manager - 1 Project Contact
• Merck Serono Team Members Partner Team Members
• 3 Study Directors - 1 Study Director
• 2 Medical Directors - 1 Medical Director
• 1 Safety - 1 Preclinical
• 1 Molecule Leader - 1 Modeling and simulation
• 1 Regulatory - 1 Research
• 2 Marketing - 1 Research collaborations
• 1 Pre-clinical
• 1 Bioanalytical
• Merck Serono adhoc Members Partner adhoc
  members
• 4 Clinical Trial Leaders - 1 Preclinical

IP workgroup Merck Serono Patent
Council Partner Patent Council
Finance workgroup Merck Serono GPD Financial
Controller Partner Financial Controller
Clinical Development Team
Clinical Pharmacology Team
Pre clinical Team
Manufacturing Team
Bio- analytical Team
Research Team
8
Example of organizational structure in the frame
of a strategic option agreement
Merck Serono/Partner
Merck Serono only
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Alliance Management at Merck Serono

• Alliance Management at Merck Serono
• Each collaboration at Merck Serono has a
  dedicated Alliance Manager.
• Merck Serono has 9 alliance professionals
  dedicated to over 50 RD collaborations. The
  Alliance Manager is a unique contact for all
  contractual and non-project related issues with
  our collaboration partners.
• Alliance management is not project management,
  but supports project leaders on business and
  contractual issues so that they can focus their
  time and energy on managing the project.

Merck Serono has established a dedicated Alliance
Management team to help manage this complexity
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Role of the Alliance Manager

• Manage the transition from BD to the project team
  
• Participates in contract review to ensure JSC,
  governance, communications, decision making,
  dispute resolution, etc are well addressed.
• Transitions to the project to the JSC project
  team
• Manage the contractual framework of the
  collaboration
• Monitor compliance of both parties and assists
  JSC members and project members with contract
  issues and interpretation
• Negotiate certain contractual amendments (with
  legal)
• Monitor and manage the health of the relationship
  
• Proactive management to ensure a successful
  partnership
• Ongoing governance, facilitation of JSC meetings
• Act as internal voice/advocate of the partner
• Management of all contract issues, milestone
  tracking and payments
• Manage change in the relationship
• Manage restructuring of the alliance or change in
  deal terms
• Identify opportunities to expand existing
  alliance (acquisition, follow on deals)
• Manage termination of partnership, including
  project close down process

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Merck Serono Alliance Management Team

• Research Discovery Programs
• Ulrich Betz
• John De Lamarter
• Gerd Bartoszyk
• Michel Dreano
• Elmar vom Baur

• Global Product Devt Programs
• Steven Axon
• Andrew Barber
• Harm-Jan Borgeld
• Valentine France-Lanord