Common use of Required Updates Clause in Contracts

Required Updates. Radius shall neither sell, nor distribute nor otherwise use, whether directly or indirectly, any Finished Product in any country outside of the United States of America, Canada, Australia, New Zealand, any country of the European Union, or Switzerland; provided, however, (i) any country other than such countries mentioned in the foregoing clause of this sentence may be designated in writing by Radius to be a Designated Country, and the Parties shall work together to complete all regulatory, technical, commercial, quality and/or certain other requirements (and any filings required to be made by Radius) necessary for any country to be a Designated Country; and (ii) Radius agrees to update ▇▇▇▇▇▇ on any such requirements of Norway, Liechtenstein, and Iceland (for clarity, other than cGMP of Norway, Liechtenstein, and Iceland, to the extent not Product-specific). Once such working together has been completed and such necessary requirements have been mutually agreed upon, such requirements applicable to the Manufacture of the Cartridges, the Pens, or the Finished Products, intended for use by Radius in Norway, Liechtenstein, Iceland or such Designated Country, ▇▇▇▇▇▇ shall cause ▇▇▇▇▇▇ Pharma to Manufacture the Cartridges, the Pens, or the Finished Products in accordance with such requirements, which shall become part of the Standard, and Radius may thereafter sell, distribute or otherwise use, whether directly or indirectly, such Finished Product in Norway, Liechtenstein, Iceland or such Designated Country. Radius shall provide ▇▇▇▇▇▇ Pharma with, included in any notice designating a country to be a Designated Country, the country specific legislation, rules and regulations and practices or requirements of the regulatory authorities and governmental bodies of such country which may affect the Manufacture and/or any Delivery Assistance, and shall inform ▇▇▇▇▇▇ of the effect of any thereof. After good faith discussions on any of the foregoing contained in the previous sentences and mutual agreement in respect of any thereof, ▇▇▇▇▇▇ shall thereafter comply with, and the definition of Applicable ▇▇▇▇▇▇ Law shall thereafter be deemed to include, such requirements. For avoidance of doubt, Radius shall not be restricted from distributing Product for use in clinical trials in any country except as may be prohibited by Applicable Law.

Appears in 2 contracts

Sources: Commercial Supply Agreement (Radius Health, Inc.), Commercial Supply Agreement (Radius Health, Inc.)