“Distribution Through the Public Sector” means Distribution, disposition or use of CAMB in the Territory for use in the Field by a Public Sector Agency.
“Public Sector Agency” means any Governmental Authority (but specifically excludes any military or para-military organization, branch, department or agency of any Governmental Authority) or entity organized under applicable tax laws as a non-profit or public benefit organization or entity, including, without limitation, ministries of health, governmental organizations such as the World Health Organization or UNICEF, non-governmental organizations operating for the provision of health care within the public health area such as Médecins sans Frontières or recipients of funding from the Global Fund to Fight Aids, Tuberculosis andMalaria. Public Sector Agencies specifically exclude any non-state or government-supported hospitals and clinics which wish to purchase CAMB for their own use.
“Territory” means all countries of the world excluding Japan, Australia, New Zealand, Russia, CIS countries, China, and all countries in North America and any country in, or that joins the European Union.
3. REGULATORY APPROVALS, MANUFACTURE AND DISTRIBUTION
3.1 Allocation of Responsibilities. Beginning with the completion of the R&D Plan, DNDi will have sole responsibility for seeking and obtaining Regulatory Approvals for CAMB, and for the Distribution Through the Public Sector of CAMB in the Territory for use in the Field. DNDi may use a third party for Regulatory Approval activities, provided that the terms of the agreements with such third party conform to the terms of the present Agreement. BDSI shall have sole responsibility for the manufacture and supply to DNDi of CAMB for DNDi’s Distribution.
3.3 Manufacture and Supply. During the Term and subject to the provisions of Section 4.1, BDSI will be responsible for the exclusive, subject to section 3.3 (a), manufacture and supply of CAMB to DNDi for Distribution in the Territory and for all costs associated therewith. Prices at which BDSI will sell CAMB to DNDi are set out in section 5.3 below.
(a) Should BDSI be unable to meet DNDi’s Distribution needs as evidenced by failure to meet *** of DNDi’s forecast needs for *** consecutive quarters, DNDi shall be able to engage a secondary supplier to meet any BDSI shortfall in DNDi’s supply needs with the assistance of BDSI. However, in every instance, DNDi shall purchase the full quantity of CAMB available from BDSI prior to engaging a secondary manufacturer. Should DNDi engage a secondary supplier due to BDSI shortfall of DNDi’s Distribution needs, DNDi will revert back to BDSI as the exclusive supplier of DNDi’s needs once BDSI is able to show manufacturing capacity equivalent to *** of DNDi’s forecast needs for any upcoming quarter.
(b) Should BDSI determine, in its sole discretion, that parallel importing, or diversion by or through any mechanism, that Distribution Through the Public Sector is adversely impacting the sales of CAMB sold by BDSI, the parties will meet, discuss and DNDi will assist BDSI in developing and implementing mechanisms to stop any parallel importing, diversion or other mechanism adversely impacting BDSI’s sales of CAMB.
4.1 Licenses to DNDi. Subject to all of the terms and conditions of this Agreement, BDSI hereby grants DNDi: […]
(b) an non-exclusive, royalty-free, irrevocable and fully paid-in, sublicensable (as permitted under Section 4.3) license to use BDSI Background IP and Collaboration IPR for the purpose of seeking Regulatory Approvals and undertaking Distribution Through the Public Sector in the Territory for use in the Field; provided, however that if, for any reason, BDSI is unable to supply CAMB ordered by DNDi or its nominee for Distribution Through the Public Sector, for use in the Field, in the Territory, this exclusive license shall be automatically extended to include the right for DNDi to manufacture CAMB, or to have CAMB manufactured by any Third Party, for the sole purpose of its Distribution Through the Public Sector in the Territory for use in the Field, subject to section 3.3.
4.5 Limitation to Territory. DNDi and its Affiliates, sublicensees, and distributors shall not Distribute CAMB outside the Territory or for use outside the Field, or conduct any Distribution except for Distribution Through the Public Sector. DNDi and its Affiliates, sublicensees, and distributors shall refer to BDSI any inquiries or orders for CAMB that they receive, where DNDi believes the use will be outside of the Field, or from outside the Territory or from any Third Party other than Public Sector Agencies. DNDi shall additionally take all reasonable steps ((as further described in section 3.3 (b), and such as by example, but not limitation, changes in packaging and trade dress, use of tamper resistant materials and the like), necessary and work with and assist BDSI in preventing the redistribution, parallel importation or diversion of DNDi’s supply of CAMB.