DMAH definition
Examples of DMAH in a sentence
This right of Distributor to audit and inspect the data, documentation, and work product of the Company, its subcontractors, the DMAH and Company Agent may be exercised at any time during the Term upon reasonable notice (subject to each Party’s record retention policies then in effect), or such longer period as shall be required by Applicable Law.
MAH will, as MANUFACTURER’s DMAH for the PRODUCTS, present the perspective of MANUFACTURER to the Japanese Authorities in advance to alleviate the risks of field safety corrective action (or recall) or sales restrictions.
MANUFACTURER is desiring to designate MAH as its Designated Marketing Authorization Holder (Sen-nin Seizou Hanbai Gyosha) (hereinafter referred to as “DMAH”) under PAL, a Pre-market Approval Holder under article 19-2 of PAL MAH, which stands for “MARKETING AUTHORIZATION HOLDER” (Seizou Hanbai Gyosha), is a Marketing Authorization Holder (Seizou Hanbai Gyosha) and is authorized to act as a DMAH under PAL.
Company and the DMAH have sole authority to issue a recall or require corrective action with respect to Products in the Territory (collectively, the “Recall”) including those required by Applicable Law or a regulatory authority in the Territory.
In the case of any Recall, Company and DMAH shall be responsible to plan and lead the Recall with input from the Distributor, and Distributor shall be responsible for executing the plan within the Territory including communications with customers, performing all field activities in the Territory and, if necessary, the physical return of the Product from the Territory.
Subject to the terms and conditions of the Quality Agreement and this Agreement, MAH will have the right to represent the MANUFACTURER as its DMAH before the Japanese Authorities regarding the PRODUCTS.
The MAH will forthwith inform the MANUFACTURER of the imminence or initiation of any action by Japanese Authorities and will monitor such action on behalf of the MANUFACTURER as its DMAH as required by applicable Japanese law.
The DMAH is responsible for disbursement of CMHC Funding and Cost-Matched Funding for each Project and to each Recipient.
Distributor shall collaborate with Company and DMAH directly in matters of vigilance and post-market surveillance.
As soon as reasonably practicable, Capricor shall use Commercially Reasonable Efforts to obtain the Manufacturing and Marketing Approval for the Product in the Territory at its own expense including appointing, at its discretion, a DMAH.