Gilead-MPP Licence Overview December 2017 LEGAL May contain MPP - - PowerPoint PPT Presentation

Gilead-MPP Licence Overview

December 2017

May contain MPP and/or MPP licensee confidential information. Not for circulation

History of Gilead-MPP collaboration Gilead and MPP signed licence agreement in 2011 for Tenofovir Disoproxil Fumarate (TDF); Cobicistat (Cobi) and Elvitegravir (EVG), with a covenant not to sue for Emtricitabine (FTC) The Agreement has been modified several times, incorporating Tenofovir Alafenamide (TAF) in 2015 and Bictegravir (BIC) in 2017, to the portfolio of licensed products, together with a territorial expansion across all compounds Current Territory

• For TAF-TDF-BIC-Cobi 116 countries
• For EVG 109
• Covenant not to sue for FTC in 116 countries

LEGAL

May contain MPP and/or MPP licensee confidential information. Not for circulation

Scope of the Licence

• MPP has the right to issue non-exclusive licences to any qualified entity in India,

China and South Africa

• Licensee will have the right to make, offer for sale, sale, import and export API

and/or Products for use in the applicable Territory

• Licensee may grant sublicenses to its Affiliates located in India/China/South Africa

upon prior written notice to Gilead and MPP. Upon Gilead’s or MPP’s request, Licensee shall provide Gilead and/or MPP with the written copies of the applicable sublicense agreement with such Affiliate(s)

• Any Licensee distributor agreement to be consistent with the terms of the Licence

Territory

• Gilead drugs licensed to the MPP, to be manufactured in India, China and South

Africa for its use in 109 (EVG) and 116 countries (rest of the compounds) representing 87.8% PLHIV in the developing world

• Allows for sale outside the Territory where
• Compulsory licence is issued
• There are no patents in force or patent has been held invalid or unenforceable

beyond the possibility of any further appeal in the country of manufacture (India/China/South Africa) and the country of sale

LEGAL

May contain MPP and/or MPP licensee confidential information. Not for circulation

Quality requirements

• Licensee agrees that it shall manufacture API and Product in a manner consistent

with (i) the applicable Indian manufacturing standards; (ii) either World Health Organization (“WHO”) pre qualification standards, standards of the European Medicines Agency (“EMA”), or United States Food and Drug Administration (“FDA”) tentative approval standards (“Minimum Quality Standards”); and (iii) on a country- by-country basis, any applicable national, regional or local standards as may be required by the specific country where Product is sold

• Timelines for WHO pre-qualification or FDA conditional approval:

– For the API Drug Master File (DMF), no later than the 2nd anniversary of such API included in the WHO Guidelines – For the TAF, BIC, Cobi, EVG Product and Combination Products and TDF Quad, no later than the 3rd anniversary of such Product being included in WHO Guidelines Royalties

• Royalty bearing licence, payable only until expiration of patent “containing a valid

claim” in country of manufacture or sale:

• 5% of Net Sales for BIC, TAF, EVG, Cobi
• 3% of Net Sales for TDF

LEGAL

May contain MPP and/or MPP licensee confidential information. Not for circulation

Packaging requirements

• Obligation to bear mark and packaging distinctive from Gilead
• Labelling of all Products shall expressly state that the Product is manufactured under

a licence from the Medicines Patent Pool and Gilead Termination by Licensees

• On a product-by-product basis
• Right to terminate the sublicence without cause, with 30 days notice

Data exclusivity waiver

• Agreements to waive data exclusivity rights; prevention of further data exclusivity

rights Other relevant provisions

• Gilead to provide Technology transfer to Indian and South African Licensees
• No restrictions on ability of Licensees to challenge patents
• Licensees to be free to combine the Compound with any other/others APIs
• Product liability insurance obligation on Licensees

LEGAL

MPP’s Expression of Interest and Sub- licensing process

• MPP has an expression of interest process (EOI) for sub-licensing IP it obtains from originators
• EOIs are to be submitted online on our website: https://medicinespatentpool.org/what-we-do/expression-of-interest/
• At the end of this webinar, the EOI system will be opened. EOIs can be submitted for licence to:
• Bictegravir, TAF, TDF, emtricitabine, cobicistat, elvitegravir (Gilead)
• Dolutegravir adult (ViiV Healthcare)
• Lopinavir and ritonavir adult (Abbvie)
• Daclatasvir (BMS)
• Two currently open calls for proposal on development oriented licences: sutezolid (TB) and ravidasvir (HCV)
• Objective: EOI is your proposal to use licensed IP to improve access to medicine
• The EOI process assesses:
• Capacity, capability, readiness and willingness to
• Develop, register for approval, manufacture and distribute
• Appropriate APIs and formulations enabled by our licences and required in licensed countries (following guidelines)
• The process:
• Rigorous, objective, standardized, quantified
• Panel of evaluators
• Decision makers are blinded

SUB-LICENSING PROCESS1

• Applicants encouraged to provide as much detail as possible for accurate assessment of their EOI
• All information kept strictly confidential
• Schedule:
• EOI system opens: 13 Dec 2017
• New applicants: need to register – generate a login/password
• Trouble? Write to eoi@medicinespatentpool.org
• Q&As about using the EOI portal: 13-22 Dec 2017 and 8-31 Jan 2018 (eoi@medicinespatentpool.org)
• EOI submission deadline: 31 Jan 2018
• Q&As on EOI responses by MPP: submission date through end of evaluation
• Communication with offer for licences (tentative): 30 April 2018
• Sign & send scanned form agreements back: within 15 calendar days of offer
• Hard copies soon after
• Failure to sign within deadline may result in lapse of offer to license
• Please ensure your legal has reviewed and cleared the licence agreement before you apply
• Q&A on licence agreement: Dec 13-19 and 8-31 Jan 2018 (eoi@medicinespatentpool.org)

SUB-LICENSING PROCESS2

THE EOI PORTAL

May contain MPP and/or MPP licensee confidential information. Not for circulation

GETTING STARTED

• Link: : http://eoi.medicinespatentpool.org
• New applicants must create a login/password:
• Step 1: Click ‘Sign Up’
• Step 2: Complete account creation questionnaire with required credentials
• Step 3: Click ‘Submit to MPP’. Once login request is approved, you will receive a notification by email

May contain MPP and/or MPP licensee confidential information. Not for circulation

STEP 4: SELECT “CREATE A NEW EOI”

May contain MPP and/or MPP licensee confidential information. Not for circulation

STEP 5: SELECT FROM AVAILABLE OPEN EOIS

• To create a new EOI application, applicant can select from a list of available licences
• Applicant must fully fill in requested information including uploading necessary documents
• Can save form as draft until complete
• When application is complete, click ‘submit to MPP’

May contain MPP and/or MPP licensee confidential information. Not for circulation

• After EOI application is submitted, MPP may request further

information/clarification from the applicant

• If this occurs, applicant will receive notification via email as well as a notification
• n the EOI portal dashboard
• Please respond in a thorough and timely manner

NEXT STEPS

May contain MPP and/or MPP licensee confidential information. Not for circulation

Please submit any questions on how to use the EOI portal to: eoi@medicinespatentpool.org

QUESTIONS?