Definition of Plasma. The term “Plasma” as used in this Agreement shall refer to the production of normal source plasma to be derived from automated plasmapheresis procedures conducted at the US Food and Drug Administration (“FDA”) and at European Authorities approved and IQPP-certified Plasma (when applicable) donor centers identified on Exhibit A attached hereto (the “Centers”), which Centers shall be operated by SUPPLIER and/or third parties and shall be subject to GWWO’s approval, all of which Plasma, collected or purchased and released by SUPPLIER shall comply with the specifications set forth herein, specifically those specifications set forth in the quality agreement attached hereto as Exhibit B (hereafter, the “Quality Agreement”). The Parties shall enter into the Quality Agreement as soon as possible and in any event within 20 days of the Effective Date. As used herein, the term “European Authorities” refers to and includes the European Medicines Agency, the MHRA, GHA and other constituent organizations with and through which the European Medicines Agency regulates plasma and plasma donor centers. Plasma shall further include various types of specialty plasma collected by SUPPLIER, including tetanus plasma, anti-D plasma, anti-HBs plasma, and rabies plasma.
Definition of Plasma. The term “Plasma” as used in this Agreement shall refer to the production of normal source plasma (as defined by the U.S. Food and Drug Administration (“FDA”) in 21 C.F.R. 640.40) to be derived from automated plasmapheresis procedures conducted at Seller’s FDA-approved and IQPP-certified Plasma donor centers (the “Centers”), which Centers shall be operated by Seller , all of which Plasma, collected and released by Seller shall comply with the specifications set forth herein, specifically those specifications set forth in the Source Plasma Specifications and Contract Manufacturing Agreement (hereafter, the “Specifications”), attached hereto as Exhibit A and otherwise in compliance with all Applicable Laws. As used herein, “Applicable Laws” means all applicable federal, state and local laws, regulations, rules, requirements and directives, including applicable current Good Manufacturing Practices (“cGMPS”), including all specifications and procedures for plasma sourcing, plasma testing, and in process testing and all applicable FDA laws, requirements, regulations, guidelines, licenses and directives, now in effect and as may be amended from time to time during the term of this Agreement.
Definition of Plasma. The term “
