Global Access Commitments. In furtherance of the Charitable Purpose and Global Access, the Company agrees to the following (collectively “Global Access Commitments”):
Global Access Commitments. As a condition to the Foundation making the Foundation Investment and in furtherance of the Foundation’s charitable purposes, including the Global Access Objectives, the Company agrees to the following commitments (the “Global Access Commitments”):
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:
(1) The Company shall use commercially reasonable efforts to obtain FDA approvals and clearances, as appropriate for the Program Products.
(2) The Company shall make Program Products available to non-profit organizations and public-sector purchasers in Target Countries (“Global Health Purchasers”) at a price of no more than 30% above the Company’s COGS, in Low- Income Countries and in Low-Middle-Income Countries, if approved by the Global Access Committee (as defined below); provided, however, that any non-profit organization and public-sector purchaser located in Brazil, India, South Africa and Mexico shall need to be approved by the Global Access Committee before qualifying as a “Global Health Purchaser” within the terms of this Global Health Agreement.
(3) The volume of Program Products made available for the Global Health Purchasers under Section 4(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 & Xxxxxxx Xxxxx Foundation (BMGF) and use commercially reasonable efforts to have the Program Products added to protocols and treatment guidelines.
(ii) The Global Access Commitments set forth in this Section 4 shall continue for the Term and shall be fully enforceable by th...
Global Access Commitments. The following paragraphs ensure satisfaction of the Global Access Objectives and represent the Company’s “Global Access Commitments.” Subject to the provisions of this Letter Agreement, the Company will not grant to a third-party any rights to or enter into any arrangements with respect to, the Platform Technology that would prohibit, prevent or otherwise significantly restrict the Company (or any acquirer of the Platform Technology) from fulfilling these Global Access Commitments.
Global Access Commitments. As a condition to the Foundation making the Foundation Investment at the initial closing and committing to invest a subsequent tranche, subject to the terms and conditions of the Investment Documents, and to ensure satisfaction of the Charitable Purpose, the Company agrees to the following “Global Access Commitments”. Unless the Parties and [*****] agree otherwise, if the Parties would agree on a Project which relates to an [*****] non-exclusive pathogen under the Option Agreement, the Global Access Commitments hereunder would be subject to the rights granted to [*****] under the Option Agreement.
Global Access Commitments. In furtherance of the Charitable Purpose, Icosavax agrees to the following “Global Access Commitments”:
Global Access Commitments. The Company shall engage in the following activities in order to advance the Global Health Objectives (the “Global Access Commitments”).
(i) The Company acknowledges the importance of these Global Access Commitments and that their purpose is to ensure that innovative and affordable drugs to treat disease are made available for use in public health programs and private purchase in (i) melioidosis-endemic and melioidosis-at-risk countries and (ii) tuberculosis-endemic and tuberculosis-at-risk countries listed in Exhibit 1 (the “Target Countries”), as agreed to by the Company and Adjuvant.
(ii) The Company shall use its reasonably diligent endeavors to make the Global Access Products accessible to most people in need in the Target Countries, to the extent such access can be achieved on terms that are commercially reasonable for the Company. For the avoidance of doubt, the Company agrees that the maximum price of Global Access Products in the Target Countries will be capped at cost of sales plus 25%. In no event shall the Company be obligated to sell the Global Access Products at a loss.
(iii) In addition to the Investment, the Company shall also actively seek funding from government grants and other granting sources to advance the development of the Global Access Products. Furthermore, the Company shall also use its reasonably diligent endeavors to enter into good faith negotiations with the Gates Medical Research Institute.
(iv) The Company shall develop regulatory strategies for the Global Access Products that in the opinion of the Company and Adjuvant, acting reasonably advances the Global Health Objectives, and it shall pursue the necessary product registrations for its Global Access Products in the Target Countries.
(v) The Company shall make the Global Access Products available to both public and private purchasers in the Target Countries at a reasonable volume that is sufficient to meet the demands of non-profit organization and public-sector purchasers in accordance with a tiered pricing framework that is commercially reasonable for the Company, in the opinion of the Company and Adjuvant, acting reasonably, and that reflects the needs, including price sensitivity, of low-income patients in the Target Countries. The tiered pricing framework shall include pricing based on the type of buyer (public or private) and the geographic location of such buyer.
(vi) The Global Access Commitments set forth in this Section 2 shall continue with respect to each Glob...
Global Access Commitments. The Parties acknowledge and agree that (i) the Parties intend that funding for the Initial Program (and, if applicable, the Replacement Program) will be supported in part by a grant under the Gates Foundation Agreement, [***] (such commitments the “Global Access Commitments”). Novartis’s diligence obligations under Sections 4.2, 5.2 and 6.2 of this Agreement will at all times be subject to Novartis’s Global Access Commitments, as applicable, and nothing in this Agreement shall be deemed to require Novartis to undertake any action that is inconsistent with the Global Access Commitments.
Global Access Commitments. (i) The Company shall take the following steps in order to advance the Global Health Objective (the “Global Access Commitments”):
(1) establish a joint steering committee (the “JSC”), within 90 days of the Closing Date, comprised of up to [***] relevant global health experts (as mutually agreed between Adjuvant and the Company), up to [***] senior Company employees, and up to [***] Adjuvant team members to advise on the clinical development, [***];
(2) pursue the necessary international and local product registrations (e.g., WHO PQ, CE xxxx, TFDA2 registration) for the Global Access Products in Target LMICs, in order to submit [***] registration dossiers for the Global Access Products [***] in Target LMICs;
(3) make the Global Access Products available [***];
(4) create a [***]; and
(5) commit to [***].
(ii) The Global Access Commitments will remain in effect for ten (10) years following the Closing Date (the “Global Access Term”). The Global Access Commitments shall remain in place upon a change of control of the Company, provided, however, that the potential acquirer (the “Acquirer”) shall be granted the following rights with respect to the Global Access Commitments:
(1) the right to [***];
(2) the right to [***];
(3) the right to[***]; and
(4) the right to [***].
Global Access Commitments. The following paragraphs are intended to ensure satisfaction of the Charitable Purposes. In consideration of the Foundation Investment, the Company agrees to the following (collectively “Global Access Commitments”) effective as of the Closing Date (as defined in the SPA):
