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A FREE guide to out-licensing in generic pharma (by Asa Cox)

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  • 1. A GUIDE: OUT-LICENSING in GENERIC PHARMA
  • 2. What WhoIntroductionStep 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategyStep 6: Client engagementStep 7: Commercial essentials Asa CoxStep 8: Heads of terms Founder - Genericlicensing.comStep 9: Contract negotiationStep 10: Post deal asa.cox@genericlicensing.comVery Important to Remember Find me on:VITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust
  • 3. Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategy “ The future depends on what we do in the present” GhandiStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post dealVITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust Introduction ● 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 managementAsa CoxFounder – Genericlicensing.comasa.cox@genericlicensing.com
  • 4. Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategy “ Coming together is a beginning. Keeping together is progress. Working together is success ” Henry FordStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post dealVITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust Internal Capability ● 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?Asa CoxFounder – Genericlicensing.comasa.cox@genericlicensing.com
  • 5. Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategy “Wise men put their trust in ideas and not in circumstances” Ralph Waldo EmersonStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post dealVITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust Market Research ● 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 - ASAPAsa CoxFounder – Genericlicensing.comasa.cox@genericlicensing.com
  • 6. Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategy “A spoonful of honey will attract more bees than a gallon of vinegar ” Benjamin FranklinStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post dealVITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust Product Selection ● 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 expectationsAsa CoxFounder – Genericlicensing.comasa.cox@genericlicensing.com
  • 7. Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategy “Creativity is the natural extension of our enthusiasm” Earl NightingaleStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post dealVITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust Marketing Strategy ● 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, TraderAsa CoxFounder – Genericlicensing.comasa.cox@genericlicensing.com
  • 8. Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategy “Asking is the beginning of receiving. Make sure you dont go to the ocean with a teaspoon” Jim RohnStep 5: Sales strategyStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post dealVITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust Sales Strategy ● 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 positionAsa CoxFounder – Genericlicensing.comasa.cox@genericlicensing.com
  • 9. Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategy “ The length of time it takes to reach your goal depends on the intensity of your desire” Michelle UstaskeskiStep 5: Sales strategyStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post deaVITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust Client Engagement ● 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 plansAsa CoxFounder – Genericlicensing.comasa.cox@genericlicensing.com
  • 10. Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategy “Always do your best. What you plant now, you will harvest later ” Og MandinoStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post dealVITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust Commercial Essentials ● Dont 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 clientAsa CoxFounder – Genericlicensing.comasa.cox@genericlicensing.com
  • 11. Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategy “Life is a succession of lessons which must be lived to be understood” Helen KellerStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post dealVITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust Heads of Terms ● 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 continuityAsa CoxFounder – Genericlicensing.comasa.cox@genericlicensing.com
  • 12. Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategy “Eyes & ears are your gateway to the world. Keep them wide open ” M.K SoniStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post dealVITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust Contract Negotiations ● 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 negotiationsAsa CoxFounder – Genericlicensing.comasa.cox@genericlicensing.com
  • 13. Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategy “Opportunities are like sunrises – if you wait too long, you miss them” William Arthur WardStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Post dealVITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust Post Deal ● 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 contractAsa CoxFounder – Genericlicensing.comasa.cox@genericlicensing.com
  • 14. VeryImportant toRemember
  • 15. Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategy “Communication is the real work of leadership” Nitin NohriaStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Close dealVITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust Communication ● Dont 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 companyAsa CoxFounder – Genericlicensing.comasa.cox@genericlicensing.com
  • 16. Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategy “ The victorious strategist only seeks battle after the victory has been won. ” Sun TzuStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Close dealVITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust Market Intelligence ● 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 clientsAsa CoxFounder – Genericlicensing.comasa.cox@genericlicensing.com
  • 17. Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategy “What we hope to do with ease, we must first do with diligence” Samuel JohnsonStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Close dealVITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust Building a Network ● 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 connectionsAsa CoxFounder – Genericlicensing.comasa.cox@genericlicensing.com
  • 18. Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategy “Losers make promises they often break. Winners make commitments they always keep” Denis WaitelyStep 5: Sales strategyStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Close dealVITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust Building Trust ● 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 partnersAsa CoxFounder – Genericlicensing.comasa.cox@genericlicensing.com
  • 19. Step 1: Internal capabilityStep 2: Market researchStep 3: Product selectionStep 4: Marketing strategyStep 5: Sales strategy “ The secret of success is to be ready for an opportunity when it comes” Benjamin DisraeliStep 6: Client engagementStep 7: Commercial essentialsStep 8: Heads of termsStep 9: Contract negotiationStep 10: Close dealVITR: 1 CommunicationVITR: 2 Market intelligenceVITR: 3 Building a networkVITR: 4 Building trust Summary ● 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 networkAsa CoxFounder – Genericlicensing.comasa.cox@genericlicensing.com
  • 20. Interested in Knowing More ● How to reach licensing clients worldwideMore Strategic Generic Product Portfolio SelectionFREE ●resources ● How to be seen by major clients online ● International business development services ● Out-licensing consultancy services Contact: asa.cox@genericlicensing.com skype: asa_cox tel: +44 (0)845 453 1376