Type II Variation definition

Type II Variation means the supplemental application as defined and required by the EMA for significant changes to the manufacturing process described in the marketing authorization and which will be submitted to the EMA for the licensure of a manufacturing process at the applicable facility.
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Type II Variation means a variation of the type referred to in Article 3.1(b) of Regulation (EC) No. 541/95.
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Type II Variation shall have the definition as set forth in Commission Regulation (EC) No 1234/2008.
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Examples of Type II Variation in a sentence

  • Clinical: In Europe: § ** ** § ** ** § ** ** § Successful EMA approval of a Type II Variation €2M § ** ** ** § ** ** § ** ** Each milestone payment is to be paid only one time regardless of how many times a Licensed Product achieves such milestone, and no payment is to be due for any milestone that is not achieved.

  • If a Force Majeure Event has caused a delay in Alimera’s filing of a Type II Variation for uveitis pursuant to this Section 2.2.2, then Alimera shall notify pSivida promptly of such delay and use Commercially Reasonable Efforts to overcome such Force Majeure Event.

  • In the event that any European Union regulatory authority requires two (2) clinical trials for Approval in three (3) or more of the Major European Markets, then the Parties shall meet and negotiate in good faith a revised timeline for the Type II Variation filings.

  • In the event that any European Union regulatory authority requires two (2) clinical trials for Approval in three (3) or more of the Major European Markets, then the Parties shall meet and negotiate in good faith a revised timeline for the Type II Variation filings, including a revised timeframe for the Second Milestone Payment set forth in Section 5.5.

  • Alimera (itself or through any of its Affiliates, sublicensees and subcontractors) shall file a Type II Variation for uveitis with the appropriate regulatory authorities in at least three (3) of the Major European Markets within [***] of the Amendment Effective Date and shall provide to pSivida validation letters evidencing such appropriate regulatory authorities’ acceptances of such Type II Variation filings.