Technical Complaint means any complaint that questions the purity, identity, potency or quality of the Product, its packaging or labeling or the compliance of any batch of the Product with Applicable Laws and Regulations and current Good Manufacturing Practices; any complaint that concerns any incident that causes the Product or its labeling to be mistaken for, or applied to, another article; any bacteriological contamination or significant chemical, physical or other change or deterioration in the Product; any failure of one or more batches of the Product to meet the specifications therefore in the NDA; or any complaint or evidence of tampering with the Product.
If the KING Product Technical Complaint cannot be categorized as a B Complaint (meaning no actual or potential harm to patient), then the KING Product Technical Complaint will be categorized as an A Complaint.
Technical Complaint - Complaints of a technical nature are complaints that are not of a medical nature, e.g. complaints regarding the syringe, syringe cap, needles, etc.
If the NOVAVAX Product Technical Complaint cannot be categorized as a B Complaint (meaning no actual or potential harm to patient), then the NOVAVAX Product Technical Complaint will be categorized as an A Complaint.
Amgen will use Commercially Reasonable Efforts to address any such Product Technical Complaint with respect to Ivory in the Collaboration Scope.
If GSK (including any GSK sales representative Detailing Ivory) becomes aware of any Product Technical Complaint (as defined below), GSK will submit a written report of such complaint to Amgen within one (1) business day of GSK so becoming aware (along with a sample of the Ivory product involved in the complaint, as soon as (and if) available).