a free guide to out-licensing in generic pharma (by asa cox)
TRANSCRIPT
A GUIDE: OUT-LICENSING in GENERIC PHARMA
Introduction
Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategyStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post deal
Very Important to Remember
VITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust
Asa CoxFounder - Genericlicensing.com
Who
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What
Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategyStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post deal
VITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust
Asa CoxFounder – [email protected]
● Out-licensing is vital to the generic industry
● Companies of all sizes need new products to grow
● It is the most efficient mechanism to grow a portfolio quickly
● The premier route for internationalising a business
● Potential for supply to multiple countries with one client
● Needs strategic thinking and professional management
“The future depends on what we do in the present” Ghandi
Introduction
Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategyStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post deal
VITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust
Asa CoxFounder – [email protected]
● What are the technical abilities of the development team?
● What formulation technologies are available to work with?
● What are the manufacturing constraints? (handling, dose form, machinery)
● What are the production capacities available?
● What international quality approvals are in place or planned?
● What regulatory expertise is in-house?
“Coming together is a beginning. Keeping together is progress. Working together is success” Henry Ford
Internal Capability
Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategyStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post deal
VITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust
Asa CoxFounder – [email protected]
● Identify the products that are in demand- Sales data (e.g IMS)- Client 'wish lists' - Future patent expiries- Niche technologies
● Select the attractive markets- Newly regulated markets (CEE, MENA)- Improving healthcare standards (Asia, Russia, Latin America)- Established generic markets. Higher volume, lower price.
● Discover the timelines target customers work to- X years before patent expiry- Y products within Z years- ASAP
“Wise men put their trust in ideas and not in circumstances” Ralph Waldo Emerson
Market Research
Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategyStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post deal
VITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust
Asa CoxFounder – [email protected]
● Determine the business strategy - Best utilisation of manufacturing assets
- Focus on select technologies, therapy area or product type- Lower risk, lower profit or higher risk, higher profit- Financial and human resource requirements
● Outline timetable and milestones- Balance risk, reward and probability- Identify perfect client and likely product requirements
● Combine needs of local, regional and international demand
● Consider supply chain & customer performance expectations
“A spoonful of honey will attract more bee's than a gallon of vinegar” Benjamin Franklin
Product Selection
Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategyStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post deal
VITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust
Asa CoxFounder – [email protected]
● Select which attributes of the company will help differentiate- Price- Quality- Service- Manufacturing- Technology- Management
● Create a plan that will create maximum awareness amongst clients- Online engagement (LinkedIn, Twitter, Blogs etc)- Direct email/post/fax/phone- Partnering events and exhibitions- Advertising & sponsorship of relevant publications & websites- Networking- Agent, Broker, Trader
“Creativity is the natural extension of our enthusiasm” Earl Nightingale
Marketing Strategy
Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategyStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post deal
VITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust
Asa CoxFounder – [email protected]
● Define criteria for target clients- Multi-country or local- Market share or project value focused- Preferred supplier program or deal-to-deal
● Establish sales objective- Highest possible sales value- Highest possible product volume- Establish relationship with key clients- One major deal or many deals with bigger network
● Sales proposition- Lowest cost- Best timeline- Best legal position- Best regulatory position
“Asking is the beginning of receiving. Make sure you don't go to the ocean with a teaspoon” Jim Rohn
Sales Strategy
Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategyStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post dea
VITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust
Asa CoxFounder – [email protected]
● Provide all the essential information- Formulation- Strengths- Development status- Regulatory plan- License fee structure- Product cost structure- Deal terms (exclusivity, duration, key clauses)
● Establish credibility- Professional company presentation & website- Customer referrals (if non-confidential)- Outline company strategy and future plans
“The length of time it takes to reach your goal depends on the intensity of your desire” Michelle Ustaskeski
Client Engagement
Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategyStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post deal
VITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust
Asa CoxFounder – [email protected]
● Don't insist the customer gives you information first
● Give the customer 'draft' commercial information to work with
● Give batch size prices so the customer can make calculations
● Show an understanding of customer markets in proposals
● Provide timely and well detailed responses
● Get a clear decision making plan from the client
“Always do your best. What you plant now, you will harvest later” Og Mandino
Commercial Essentials
Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategyStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post deal
VITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust
Asa CoxFounder – [email protected]
● Detailed HoT saves a lot of time in wasted contract negotiation
● Outline all:- Commercial terms- Key roles & responsibilities- Major clauses expected
● Create a formal signature document
● Liaise with legal team for contract continuity
“Life is a succession of lessons which must be lived to be understood” Helen Keller
Heads of Terms
Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategyStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post deal
VITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust Contract Negotiations
Asa CoxFounder – [email protected]
● It is OK to suggest using a client template- Especially if a big client with separate legal process- A poor or unprofessional contract will reflect poorly
● Start with a balanced contract- Credibility & trust could be damaged with a very one sided draft
● Always attempt to find common ground & easy concessions
● Identify critical items and explain the reasoning for a strong position
● Attempt to understand cultural negotiation tactics
● Where possible; meet face-to-face for final negotiations
“Eyes & ears are your gateway to the world. Keep them wide open ” M.K Soni
Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategyStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post deal
VITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust
Asa CoxFounder – [email protected]
● Establish a detailed action plan- Regulatory- Logistics- Financial- Manufacturing- Legal
● Maintain contact at all times through implementation- Licensing contact should maintain lead connection with client- Responsibility for project through to delivery of product- Clear channel of communication for problem resolution
● Find another product to discuss- Use the momentum to begin discussion quickly- Successful negotiation provides opportunity for another contract
“Opportunities are like sunrises – if you wait too long, you miss them” William Arthur Ward
Post Deal
Very Important to Remember
Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategyStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Close deal
VITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust
Asa CoxFounder – [email protected]
● Don't make the client chase- Always communicate within agreed timelines- Reliable response times help build confidence
● Bad news is better than silence- Clients need information to make decisions- Disappointing a client is better than frustrating them- Openness and honesty is very well respected
● Make it easy to find your information- Clients will have hundreds of emails daily- Updated discussion documents or summary tables useful- Creates a positive impression for the company
“Communication is the real work of leadership” Nitin Nohria
Communication
Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategyStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Close deal
VITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust
Asa CoxFounder – [email protected]
● Know your client- Type of deals to they normally do- Strong existing partner base or open to new suppliers- Seeking to add more markets or existing market share- First in, last out strategy or launch with the masses
● Know your product- Supply chain costs likely to support price decrease- Manufacturing challenges- Opportunity for IP or market differentiation
● Know your competitors - How many - Launch timetable - Likely cost position - Relationships with target clients
“The victorious strategist only seeks battle after the victory has been won. ” Sun Tzu
Market Intelligence
Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategyStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Close deal
VITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust
Asa CoxFounder – [email protected]
● Always continue to grow client contacts- May need options if key client pulls out- All part of establishing company within market
● Seek to develop deep connections within major clients- Regulatory, purchasing, supply chain, legal etc- Helps with problem solving during new projects- People may move to alternative clients
● Smaller clients may offer information- About target clients- About competitor products
● A strong network online enables quick and effective communication:- Solicit feedback on new product ideas- Gain access to client connections
“What we hope to do with ease, we must first do with diligence” Samuel Johnson
Building a Network
Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategyStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Close deal
VITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust
Asa CoxFounder – [email protected]
● Business is about people- Clients need to believe you will deliver- License partners are strategically important- Buyers have targets, objectives and bonuses to consider too!
● All projects will have problems- Bad situations do not break strong relationships- Demonstrate you value the trust of the client
● You will always have competitors- Focus on building reliability as a key business foundation- Key clients look to give more projects to trusted partners
“Losers make promises they often break. Winners make commitments they always keep” Denis Waitely
Building Trust
Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategyStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Close deal
VITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust
Asa CoxFounder – [email protected]
● Carefully select products to develop
● Understand the market from a client perspective
● Have clear sales and marketing strategy
● Make it easy for the client to do a deal with you (not just price!)
● Commit to: communication, quality information & openness
● Secure the future of your business through a trusted network
“The secret of success is to be ready for an opportunity when it comes” Benjamin Disraeli
Summary
● How to reach licensing clients worldwide
● Strategic Generic Product Portfolio Selection
● How to be seen by major clients online
● International business development services
● Out-licensing consultancy services
Contact: [email protected] skype: asa_cox tel: +44 (0)845 453 1376
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