Proposal to incorporate Additional Antigens Sample Clauses

Proposal to incorporate Additional Antigens. The Parties each acknowledge and agree that, although the primary objective of the Development Programme is to Develop a Product comprising only Programme Antigens, the effectiveness of a potential Product for the prevention of Neisseria meningitidis serogroup B may be enhanced by the incorporation of one or more Additional Antigens. Subject to Clause 5.8, sanofi pasteur may propose any such addition (and any corresponding amendments to the Development Plan) during the Early Development Phase or the Late Development Phase provided that sanofi pasteur is able to demonstrate that the proposed Additional Antigen satisfies the Inclusion Criteria. Any such proposal by sanofi pasteur shall be in writing and shall include all information required to determine whether the Additional Antigen satisfies the Inclusion Criteria and shall either be submitted to Emergent or, if sanofi pasteur is not prepared to disclose such information to Emergent, sanofi pasteur shall confirm that such information is available for review by an independent expert in accordance with Clause 5.7.2. Emergent shall within thirty (30) days from the date of such submission notify sanofi pasteur whether it agrees to the inclusion of such Additional Antigen or alternatively that it wishes the matter to be referred to an independent expert in accordance with Clause 5.7.2. If Emergent fails to provide such notice within such thirty (30) day period, Emergent shall be deemed to have consented to the incorporation of such Antigen into the Product or potential Product.
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Related to Proposal to incorporate Additional Antigens

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