Common use of Applications for Regulatory Approval Clause in Contracts

Applications for Regulatory Approval. Pharmaceutical Partners and RMS will discuss and together determine the regulatory strategy/activities to be undertaken with the FDA and other relevant Regulatory Authorities in the Major Markets in connection with the development of any RMS Product pursuant to the Agreement. RMS agrees to work in good faith with the Pharmaceutical Partners to identify the regulatory strategy/activities to be undertaken with relevant Regulatory Authorities in other countries where the Pharmaceutical Partners are intending to commercialize the Pharmaceutical Partners Product beyond those countries in the Major Markets.

Appears in 2 contracts

Sources: Companion Diagnostics Agreement (Epizyme, Inc.), Companion Diagnostics Agreement (Epizyme, Inc.)

Applications for Regulatory Approval. Pharmaceutical Partners and RMS will discuss and together determine the regulatory strategy/activities to be undertaken with the FDA and other relevant Regulatory Authorities in the Major Markets in connection with the development of any RMS Product pursuant to the Agreement. RMS Rβ–‡β–‡ agrees to work in good faith with the Pharmaceutical Partners to identify the regulatory strategy/activities to be undertaken with relevant Regulatory Authorities in other countries where the Pharmaceutical Partners are intending to commercialize the Pharmaceutical Partners Product beyond those countries in the Major Markets.

Appears in 1 contract

Sources: Companion Diagnostics Agreement (Epizyme, Inc.)