Medical Device Reports. “MDRs”). Any adverse effect reported by a patient, whether critical or chronic, which may be associated with a potential Product malfunction shall be immediately reported by Distributor according to the FDA MDR requirements then in effect.
Medical Device Reports. The parties will promptly alert each other to any reports of facts that may be grounds for the filing of Medical Device Reports, as defined by the FDA, with respect to the Product.
Medical Device Reports. If the Supplier files a Medical Device Report for the product, or any similar product, the Supplier provides to the Customer, the Supplier shall promptly notify the Customer. The Supplier and the Customer shall cooperate in the exchange of information required to effectively manage the Supplier’s medical device report in the Customer’s Medical Device Event files.
Medical Device Reports. Each party will immediately (within two business days) notify the other party in writing of any event or complaint that gives rise or could give rise to the need to file a Medical Device Report (hereinafter, an "MDR") within the meaning of the Federal Food, Drug and Cosmetic Act, as amended (the "Act"), with respect to any Product or the manufacture, distribution or use thereof in accordance with the MDR regulation, 21 C.F.R. Part 803. ABI, as the manufacturer of the Products, shall be responsible for preparing and shall file any MDR if such filing is required by applicable law. If, as a result of any corrective action or any final, non-appealable or non-appealed governmental or court action, an MDR is required to be issued for any Product sold hereunder, ABI shall bear the costs and expenses of and shall be responsible for all corrective actions associated with such MDR if such MDR is not the direct result of any breach of SYNOVA's duties under this Agreement or of SYNOVA's negligence or willful misconduct, in which event, SYNOVA shall bear the costs and expenses of such MDR. Because it manufactures the Products, ABI shall be responsible for submitting MDRs in accordance with applicable laws and regulations.
Medical Device Reports. The Parties agree to cooperate in good faith with respect to responding to or making any Medical Device Reports (“MDR’s”) pertaining to the Products. Synergetics ** This information has been omitted pursuant to a request for confidential treatment and has been filed separately with the Securities and Exchange Commission. and Alcon shall actively cooperate in investigating the circumstances underlying the MDR and in responding to FDA or other governmental agency inquiries. Synergetics shall file any necessary manufacturer MDR’s for all complaints that are found to meet the definition of MDR reportable events (as defined in 21 CFR, Part 803).
Medical Device Reports. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
19.1 ANIKA shall be responsible for notifying all applicable regulatory authorities of reportable events (including without limitation complaints) involving the Licensed Product for which ANIKA receives written notification, as required by applicable laws.
19.2 MITEK shall notify ANIKA of potentially reportable events promptly but in no event later than twenty-four (24) hours after the event. In addition, all such notices by MITEK shall be consistent with the requirements of law in the applicable jurisdictions.
19.3 ANIKA and MITEK will work together to investigate reportable events and complaints, including gathering information from customers and end users.
Medical Device Reports. The Parties agree to cooperate in good faith with respect to responding to or making any Medical Device Reports (“MDRs”) pertaining to the Existing Products. Synergetics and CODMAN shall actively cooperate in investigating the circumstances underlying the Medical Device Report and in responding to FDA inquiries. Synergetics shall file any necessary manufacturer MDRs for all complaints that are found to meet the definition of MDR reportable events (as defined in 21 CFR, Part 803); provided that (i) with respect to Disposable Products (other than the Xxxxxxxx-Xxxxx Forceps), CODMAN shall file any necessary manufacturer MDRs for all complaints that are found to meet the definition of MDR reportable events (as defined in 21 CFR, Part 803) and (ii) with respect to Xxxxxxxx-Xxxxx Forceps, (A) CODMAN will provide timely notification to Synergetics of any product complaints it receives, (B) Synergetics will be responsible to investigate all complaints received and to make MDR reporting determinations and filings as required under Part 803, (C) Synergetics will provide to CODMAN a copy of the completed investigation files as well as copies of any MDRs submitted within 60 days of receipt of the complaint information.”
7. A new Section 3.09 (Samples) shall be added to the Distribution Agreement as follows:
Medical Device Reports. Each Party will immediately (within two (2) business days) notify the other Party in writing of any event or complaint that gives rise or could give rise to the need to file a Medical Device Report (an “MDR”) within the meaning of the Federal Food, Drug and Cosmetic Act, as amended (the “Act”), with respect to any Celera Product or the manufacture, distribution or use thereof in accordance with the MDR regulation, 21 C.F.R. Part 803. Each such written notice will be Confidential Information. Celera will be responsible for making the decision if an MDR or Medical Device Incident report is necessary. Celera will be responsible for filing the MDR reports within the United States. Celera will be responsible for any Medical Device Incident reports to be filed for the European Union or any other regulating country that requires such medical incidence reports. If, as a result of any corrective action or any final, non-appealable or non-appealed governmental or court action, an MDR is required to be issued for any Celera Product sold hereunder, Celera will bear the costs and expenses of and will be responsible for all corrective actions associated with such MDR if such MDR is not the direct result of: (a) any breach by AMI of its duties under this Agreement; or (b) AMI’s negligence or willful misconduct. If such MDR is the result of Subsection 6.8(a) or 6.8(b), AMI will bear the costs and expenses of such MDR. If the Parties are equally at fault for such MDR correction, or should Distribution Agreement 44 it prove impossible to assign fault to either Party, then the costs and expenses of and responsibility for all corrective actions associated with the MDR will be reasonably agreed upon and allocated between the Parties by mutual agreement of the Parties prior to implementation of said corrective actions. If the Parties cannot agree on the allocation of fault for an MDR within ten (10) days after jointly considering the matter and if time is of the essence, then either Party may take reasonable corrective action and will be entitled to receive one-half ( 1/2) of the costs it actually and reasonably incurs in connection with the corrective action from the other Party; and the other Party will reimburse the Party that takes corrective action within thirty (30) days after receipt of a written statement with respect to such corrective action and the costs thereof.
Medical Device Reports. BioPad or Synova, as the case may be, will immediately (within two (2) business days) notify the other party in writing of any event or complaint that gives rise or could give rise to the need to file a Medical Device Report (hereinafter, an "MDR") within the meaning of the U.S. Federal Food, Drug and Cosmetic Act, as amended (the "ACT"), with respect to any Licensed Product or the manufacture, distribution or use thereof in accordance with the MDR regulation, 21 C.F.R. Part 803, as amended. Synova shall be responsible for preparing and shall file any MDR that is required by law. If, as a result of any corrective action or any final, non-appealable or non-appealed governmental or court action, an MDR is required to be issued for any Licensed Product sold hereunder, Synova shall bear the costs and expenses of and shall be responsible for all corrective actions associated with such MDR.
Medical Device Reports. The parties agree to cooperate in good faith with respect to responding to or making any Medical Device Reports (“MDR’s”) pertaining to the Existing Products. Synergetics and CODMAN shall actively cooperate in investigating the circumstances underlying in the Medical Device Report and in responding to FDA inquiries. With respect to Disposable Products, Codman shall file any necessary manufacturer MDR’s for all complaints that are found to meet the definition of MDR reportable events (as defined in 21 CFR, Part 803). Otherwise, Synergetics shall file any necessary manufacturer MDR’s for all complaints that are found to meet the definition of MDR reportable events (as defined in 21 CFR, Part 803).
