Solesta Sample Clauses

Solesta. Q-Med will prepare the PMA Application in a timely manner for the first Solesta Product in the U.S. (the “Solesta PMA”) and will consider in good faith all comments provided by QMS with respect thereto. Q-Med shall appoint QMS, and QMS agrees to be appointed, as Q-Med’s local agent for purposes of the PMA Application. Final labeling with respect to such Solesta Product shall be subject to the consent of QMS, which shall not be unreasonably withheld, delayed or conditioned. In all events, QMS shall permit and enable Q-Med to participate in all communications with the FDA with respect to the Solesta PMA. Upon its issuance, Q-Med shall assign the Solesta Product PMA to QMS.
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Solesta. (i) Pre-Clinical Studies. In connection with the further development activities conducted pursuant to Article III or as may be required for approval of the Solesta Product in the U.S., Q-Med, itself or through Third Parties, shall conduct all pre-clinical development activities concerning the biocompatible gel composition containing polymerized and cross-linked hyaluronic acid, derived from a non-animal source, and dextranomer microspheres used as a Licensed Product (or as an ingredient thereof) that are necessary for achieving Regulatory Approval of such Licensed Product in the U.S. for any indication in the Licensed Field. Q-Med will bear all Development Costs for all such current pre-clinical studies required to be conducted by the FDA relating to the approval of the first Solesta Product in the U.S. Should FDA require additional pre-clinical studies to be performed, the parties shall share the costs for such additional pre-clinical studies.
Sample 1

Related to Solesta

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