“Compassionate Use” means the use of Licensed Product outside of a clinical trial in a country where it has not been approved for commercialization and in accordance with applicable laws or regulations that allow such use to treat a patient with a serious or life-threatening disease or condition who has no comparable or satisfactory alternative treatment options.
2. LICENSE GRANT
(q) Each Sublicensee that will Manufacture the Licensed Compound and Licensed Product for use and sale in the Territory will (i) do so in strict conformity with the applicable conditions specified in this License Agreement and their Sublicense Agreement, and (ii) use commercially reasonable efforts in accordance with the applicable Sublicense Access Plan to provide a sufficient supply thereof to meet the needs in the countries of the Territory. Without limiting the foregoing and to the extent applicable, each Sublicense Agreement with a Sublicensee that Manufactures Licensed Product shall require the Sublicensee to Manufacture the Licensed Product: (a) in a manner consistent with and in accordance with standards validated by a World Health Organization prequalification (WHO PQ) or by any applicable Stringent Regulatory Authority (if the manufacturing site has already been approved by a Stringent Regulatory Authority) or, if neither WHO PQ or an SRA has assessed and confirmed compliance with such manufacturing standards, by a Third Party audit (including relative to GMP) to confirm adherence with WHO PQ and/or SRA standards, such third party to be agreed by both Parties; and (b) any applicable industry standards for responsible Manufacture of antibiotics.
2.13 Compassionate Use
The Parties agree that after the Effective Date of this License Agreement, Shionogi shall retain all rights to initiate and conduct a Compassionate Use or comparable early access program using Licensed Product Manufactured by Shionogi in all countries in the Territory. Once Licensed Product manufactured by a Sublicensee (including Licensed Product from the initial validation batch) can be used for such purposes under applicable laws and regulations, the conduct of Compassionate Use or comparable early access programs shall be transitioned to GARDP and/or applicable Sublicensee(s) for the Territory; provided that Shionogi may, in coordination with GARDP, choose to continue to conduct Compassionate Use or comparable early access programs for one or more countries in the Territory. Notwithstanding the foregoing, Shionogi and GARDP may agree on a case-by-case basis on an alternative approach for one or more countries in the Territory taking into account relevant criteria, such as the sustainable availability of sufficient quantities of Licensed Product for the applicable country(ies) (Manufactured by Shionogi), the agreement of Sublicensees to conduct such activities, and relevant regulatory considerations.
(d) Each Sublicense Agreement will contain an obligation for the Sublicensee to use commercially reasonable efforts in accordance with the applicable Sublicense Access Plan to provide an adequate supply of the Licensed Product to meet the therapeutic needs in the countries of the Territory covered by their Sublicense.
Schedule F: Provisions for Sublicense Agreement
4. Sublicensor Commitment [OPTIONAL]. So long as Sublicensee is complying with its diligence obligations, Sublicensor hereby agrees not to seek another market access partner for the country(ies) covered by this Agreement. For the avoidance of doubt, nothing herein shall restrict Licensor or its agents’ development, manufacture, registration, or commercialization of the Licensed Product in the Territory.