notify each other immediately by an e-mail, of any information concerning the quality and/or malfunction of the Bromelain SP. The parties will investigate all complaints, and shall respond in accordance with mutually agreed SOP's. Both parties shall comply with requirements of all regulatory authorities in dealing with complaints. MediWound shall have the right to determine whether any adverse event should be reported to any applicable regulatory authority. All quality assurance and/or quality complaints shall be handled in accordance with this section above. 5.8.2 In the event that CBC has any reason to believe that the Bromelain SP or one or more Products should be recalled or withdrawn from distribution, CBC shall immediately notify MediWound in writing. In such event MediWound shall, at MediWound's sole discretion, determine whether to recall or withdraw the Product from the market. 5.8.3 If a recall of the Product is due to CBC or the Bromelain SP, then the recall shall be conducted by MediWound at CBC's expense, and CBC shall replace such Bromelain SP at no charge to MediWound or shall provide MediWound with a credit or refund of same, at MediWound's election. 5.9 Storage CBC shall store, in accordance with the applicable CBC SOP, free of charge, Bromelain SP batches at its premises in appropriate storage conditions, for up to ninety (90) days from the day of the Acceptance Sample Notice for the respective batch or longer if CBC was unable to deliver such batch to MediWound earlier following the Acceptance Sample Notice. The Bromelain SP shelf life and designated packaging shall be in accordance with CBC SOP and subject to the supportive results of a proper stability study. 5.10 Retention of Samples CBC shall retain samples of Bromelain SP stored at their original package from each batch for the duration of the Products'