The Contractor will continue to develop of NUZYRA® for the treatment of pulmonary Anthrax with the objective of obtaining approval through the FDA Animal Rule.

“Phase 1” means, in reference to a clinical study (or trial) of a Licensed Product, that as described in US federal regulation 21 C.F.R. § 312.21(a).

General. Subject to [Section 4.7], Licensee shall, at its sole cost and expense, conduct development activities (including Clinical Trials) for the Compound and Products in the Field in the Territory to support MAA filing and Regulatory Approval in the Territory, pursuant to this Agreement and the Development Plan. Licensee shall keep Verrica reasonably informed, through the JSC, of the status, progress, and results of all development activities for the Compound and the Products in the Field in the Territory. Licensee shall not perform any activity that Verrica reasonably believes in good faith and following consultation with Licensee through the JSC would have a material adverse effect on the development, registration, manufacturing or commercialization of the Product outside the Field or outside the Territory.

License(s) pursuant to Research Evaluation Agreement, dated December 10, 2003, by and between Lonza Biologics PLC and Trubion Pharmaceuticals, Inc.

. Prior to the Option Effective Date, [[Agenus:Organization]] shall be solely responsible for the Development (and Manufacture, or having Manufactured, for the purposes thereof) of the Licensed Antibodies and the Licensed Products; provided, that [[Agenus:Organization]] shall use Commercially Reasonable Efforts to Develop the Licensed Antibodies and the Licensed Products and Manufacture or have Manufactured necessary quantities thereof in accordance with: # the [[Agenus:Organization]] Development Plan, as may be amended from time to time by mutual agreement of the Parties or to the extent required by Applicable Law or any relevant Regulatory Authority; # the Clinical Trial Criteria; and # the reasonable directions of the JSC. Subject to [Section 2.2.5], all such Development and associated Manufacturing shall be at ​. The [[Agenus:Organization]] Development Plan shall remain in effect unless and until amended as provided herein. From the Effective Date until the Option Effective Date, the JSC shall review and discuss potential amendments to the [[Agenus:Organization]] Development Plan at least ​. In addition, the Parties will agree upon an amendment to the [[Agenus:Organization]] Development Plan in order to ensure that such plan is designed to enable [[Agenus:Organization]] to, during the Option Period, provide Gilead with the Data Package with respect to the first completed Phase 1b Clinical Trial of an Initial Licensed Product which meets the Clinical Trial Criteria.

The Research and Development (R&D) effort will progress in specific phases that cover a base period of performance Contract Line Item (CLIN) 0001 followed by two option period segments (CLINs 0002 and 0003) as specified in this contract. The base period (CLIN0001) will pursue the preclinical efficacy studies and other activities required under the New Drug Application submission as well as manufacturing activities to supply the clinical program. T h e two option period segments (CLINs 0002 and 0003) will pursue the further characterization of the in vitro profile of [[Unknown Identifier]] against target pathogens of interest and conduct clinical studies to support use of [[Unknown Identifier]] in a pneumonic indication. Work performed during the period of performance constitutes an independent, non-severable discrete work segment that cannot be subdivided for separate performance and is necessary to support the R&D tasks related to the assay. The non-severable, discrete work segment constitutes an entire job (discrete requirement) which shall contain multiple R&D activities that when reviewed in total shall satisfy a defined end-product. The non-severable work segment will be fully funded from an appropriation source that is current at the time the work under such segment will be authorized to begin.

Alexion shall have the sole right and responsibility to conduct Development activities with respect to the Licensed Compound and the Licensed Products in the Field in the Territory in its sole discretion, except as necessary for Eidos to conduct the ATTRibute-CM Clinical Trial, the ATTRibute-PN Clinical Trial or any Additional Clinical Trial in the Territory following a ​ in accordance with [Section 4.2(b)].

Biologics License Application or BLA means a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2) to the FDA, including any supplements, addendums, or amendments thereto. For the avoidance of doubt, the term Biologics License Application or BLA shall include any Abbreviated Biologics License Application.

Develop and have Developed the Compound and Licensed Product in the Territory but only as part of a global Phase 3 Clinical Trial that EverInsight elects to participate in pursuant to Section 4.4(b); and

Enrollment of the first patient in the first Phase II (or its non-U.S. equivalent) clinical trial of a Licensed Product by June 30, 2022.