“Global Health Purchasers” are non-profit organizations and public-sector purchasers in Target Countries.
“Target Countries” are Low and Lower-Middle Income Countries (as defined by the World Bank and if approved by the Global Access Committee)
4. Program-Related Investment Requirements
(b) Global Access Commitments
(i) Beginning on the date of this Global Health Agreement, the Company shall conduct the following activities to advance the Global Health Objectives during the Term:
(3) The volume of Program Products made available for the Global Health Purchasers under Section4(b)(i)(2) above shall meet the demands of the Global Health Purchasers, as confirmed by the Global Access Committee, up to 20% of the Company’s annual unit sales volume (unless adjusted jointly by a majority of the Board of Directors and Global Access Committee); it being understood, however, that the Company shall have the right to supply more at its sole discretion.
(4) Beginning in the year immediately following year in which any Program Product receives European or FDA approval/clearance, the Company shall allocate $50,000 per year to the Global Access Committee to work on training programs to be conducted by the Company or by partners approved by the Global Access Committee, such as the WHO, Gates Foundation and others, in Target Countries on the use of the Program Products with a target of training leading practitioners each year in the Target Countries, as defined by the Global Access Committee, as well as to work on access and promoting demand in the Target Countries.
(5) The Company shall work with global health authorities and partner organizations, including but not limited to the World Health Organization, the Clinton Health Access Initiative (CHAI), and the Bill & Melinda Gates Foundation (BMGF) and use commercially reasonable efforts to have the Program Products added to protocols and treatment guidelines.
(c) Global Health License
(iii) In the event that the Investor exercises its rights to the Global Health License under this Section 4(c) pursuant to a License Trigger Event, and the Program Products distributed under such Global Health License in the Target Countries subsequently appear for sale or distribution in commercial marketplaces of the Target Countries or non-Target Countries (“Grey Market Sales”), then the Company or any transferee may give notice to the Investor. Following receipt of such notice by the Investor, the Company or any transferee and the Investor will work together to identify how the Program Products intended for Global Health Purchasers arrived in the commercial marketplace. During such investigation, the Company or any transferee may request that the Investor suspend distribution and/or sales to certain organizations if those organizations are identified as being involved in Grey Market Sales, and the Investor will respond in a timely manner to any such request. Following such investigation, the Company or any transferee and the Investor agree to take any such corrective measures to prevent additional Grey Market Sales, including ceasing sales to the identified parties on a permanent basis.