MHLW definition
Examples of MHLW in a sentence
The Regulatory Approval milestones set forth in this Section 7.4.3 shall be payable only once for an Oncology Indication relating to [**] for each Regulatory Authority (i.e., either the FDA or the EMEA/EU Major Market Country or the MHLW in Japan) regardless of the Profile.
Upon the request of Affymax, Collaborator shall request the MHLW to allow one Affymax representative to attend, as a silent observer, all meetings between Collaborator and the MHLW, and Collaborator shall timely inform Affymax of any such meetings scheduled with the MHLW as soon as practically possible.
Collaborator may terminate this Agreement upon [ * ] advance written notice to Exelixis, if substantially all ongoing Clinical Trials of the Product are ordered or required to be terminated by the FDA or the MHLW.
The Parties acknowledge and understand that, in order for the Product to be Commercialized in the Licensed Territory, Bulk Hematide supplied to Collaborator by Affymax hereunder must be manufactured, handled and stored in compliance with the GMP required by MHLW.
Collaborator shall devote Diligent Efforts to the Development of the Product in the Field and in the Licensed Territory, consistent with the then-agreed Development Plan, and in accordance with this Agreement, including without limitation by using Diligent Efforts to perform its obligations under the Development Plan and in accordance with the regulations promulgated by the MHLW for the manufacture, testing and Commercialization of pharmaceutical products in the Licensed Territory.