New Regulatory Requirements. Either party shall promptly notify the other party new Regulatory Requirements of which it obtains actual knowledge and which are relevant to the Services under this Agreement and which are required by the FDA, other applicable Regulatory Authority, or other applicable laws or governmental regulations and the parties shall confer with each other with respect to the best means to comply with such requirements.
New Regulatory Requirements. Each party shall promptly notify the other of new regulatory requirements of which it becomes aware which are relevant to the manufacture of BMIPP under this Agreement and which are required by the FDA and other applicable governmental entities and the parties shall confer with each other with respect to the best means to implement and comply with such requirements.
New Regulatory Requirements. Each Party shall promptly notify the other of new regulatory requirements of which it becomes aware which are relevant to the manufacture of Sources under this Agreement and which are required by the European Authority, United States Authority or other applicable governmental entities and the Parties shall confer with each other with respect to the best means to comply with such requirements. QSA shall be responsible for implementing and complying with any new or revised regulatory requirements arising after the Effective Date relating to QSA's performance of this Agreement.
New Regulatory Requirements. Each party shall promptly notify the other of new regulatory requirements of which it becomes aware which are relevant to the manufacture of Azedra under this Agreement and which are required by the FDA and other applicable governmental entities. The parties shall confer with each other with respect to the best means to implement and comply with such requirements. If after a NDA submission is made to the FDA or EMEA, any Facility investment above ****** in aggregate required to maintain cGMP or FDA compliance, and the need for such investment is not due to the negligence or fault of Nordion, such investment shall be treated as a scope change pursuant to Section 3.3, shall be the subject of a Change in Scope Form (Schedule G) and paid for by Molecular Insight Pharmaceuticals.
New Regulatory Requirements. Each Party shall promptly notify the other of new or amended regulatory requirements of which it becomes aware which are relevant to the manufacture of Labelled Drug under this Agreement and which are required by the FDA, other applicable governmental entity in the United States or Canada, or other applicable laws or governmental regulations and shall confer with each other with respect to the best means to comply with such requirements.
New Regulatory Requirements. Each Party shall promptly notify the other of new regulatory requirements of which it becomes aware which are relevant to the manufacture of the Product under this Agreement and which are required by the Regulatory Authorities, as applicable. The Parties shall confer with each other with respect to the best means to implement and comply with such requirements. Any reasonable costs for modifications or additions to the facility required as a result of new regulatory requirements shall be borne by POINT to the extent such modifications or additions directly relate to the manufacture of the Product; provided that the scope, and cost thereof shall have been preapproved in writing by POINT.
New Regulatory Requirements. In the event that the Government of Canada enacts any Regulations during the life of this Agreement that conflict with any provision of this Agreement, the parties agree to meet, discuss and determine the necessary modification(s) to this Agreement, which will be reduced to writing and will become effective as of the date of such conflicting Regulations.
New Regulatory Requirements. Inex and Enzon will use Commercially Reasonable Efforts to make such changes as reasonably necessary to the Master Production Record, the Specifications or procedures, processes, materials, facilities, equipment or any matter utilized by Inex under this Agreement or contained or referenced in Inex's NDA or DMF controlled by Inex to meet new Regulatory Requirements and guidelines in the Territory. Upon agreement by the Parties to proceed with such changes, Enzon shall be responsible for ***, and Inex ***, of all costs incurred by the Parties, including Development FTE costs, in respect of any changes made by either Party pursuant to this Section 8.2.
New Regulatory Requirements. Each party shall promptly notify the other of new regulatory requirements of which it becomes aware which are relevant to the manufacture of Altropane under this Agreement and which are required by the FDA and other applicable governmental entities and the parties shall confer with each other with respect to the best means to comply with such requirements.
New Regulatory Requirements. Each party shall promptly notify the other of new regulatory requirements of which it becomes aware which are relevant to the manufacture of NAV5001 under this Agreement and which are required by the FDA and other applicable governmental entities. The parties shall confer with each other with respect to the best means to implement and comply with such requirements. If after the Effective Date any Facility investment above [*] in aggregate is required during any calendar year to comply with any new regulatory requirement or cGMP mandated by applicable law or a Regulatory Authority, such investment in excess of [*] shall be treated as a scope change pursuant to Section 3.4 (Schedule G) and paid for by Navidea.
