Common use of Amendments to Development Plan Clause in Contracts

Amendments to Development Plan. In the event that Dermavant desires to amend the Development Plan in any material respect, it shall notify NovaQuest in reasonable detail of the proposed amendment (the “Proposed Amendment Notice”). During the [***] period following NovaQuest’s receipt of a Proposed Amendment Notice, NovaQuest shall notify Dermavant that the amendment described in such Proposed Amendment Notice either (i) does not constitute a material amendment to the Development Plan, in which case Dermavant shall be free to amend the Development Plan as described in the Proposed Amendment Notice or (ii) constitutes a material amendment to the Development Plan, in which case Dermavant shall not amend the Development Plan without NovaQuest’s prior written consent, which consent shall not be unreasonably withheld, conditioned or delayed; provided, however, that NovaQuest’s consent for an amendment shall not be required if such amendment is being made pursuant to the recommendation or direction of the FDA that is either conveyed in writing or conveyed orally and subsequently confirmed in writing (e.g., documented in FDA meeting minutes); and provided, further, that if Dermavant amends the Development Plan in a manner that is inconsistent with this Section 3.1(a)(ii) (Amendments to Development Plan), such amendment shall be deemed to constitute a termination due to a reason other than for a Technical Failure of the applicable Indication (for clarity, such termination is solely with respect to the Indication that is affected by the Proposed Amendment Notice). For the purposes of this Section 3.1(a)(ii) (Amendments to Development Plan), a “material” amendment to the Development Plan shall be an amendment that, either alone or together with one or more other amendments, would reasonably be expected to (I) delay the receipt of Marketing Approval of either Indication in the U.S. by more than [***] from the projected approval date set forth in the Development Plan (as amended), or (II) result in a Material Adverse Effect.

Amendments to Development Plan. In the event that Dermavant Xxxxxxxxx desires to amend the Development Plan in any material respect, it shall notify NovaQuest in reasonable detail of the proposed amendment (the “Proposed Amendment Notice”). During the [***] period following NovaQuest’s receipt of a Proposed Amendment Notice, NovaQuest shall notify Dermavant that the amendment described in such Proposed Amendment Notice either (i) does not constitute a material amendment to the Development Plan, in which case Dermavant shall be free to amend the Development Plan as described in the Proposed Amendment Notice or (ii) constitutes a material amendment to the Development Plan, in which case Dermavant shall not amend the Development Plan without NovaQuest’s prior written consent, which consent shall not be unreasonably withheld, conditioned or delayed; provided, however, that NovaQuest’s consent for an amendment shall not be required if such amendment is being made pursuant to the recommendation or direction of the FDA that is either conveyed in writing or conveyed orally and subsequently confirmed in writing (e.g., documented in FDA meeting minutes); and provided, further, that if Dermavant amends the Development Plan in a manner that is inconsistent with this Section 3.1(a)(ii) (Amendments to Development Plan), such amendment shall be deemed to constitute a termination due to a reason other than for a Technical Failure of the applicable Indication (for clarity, such termination is solely with respect to the Indication that is affected by the Proposed Amendment Notice). For the purposes of this Section 3.1(a)(ii) (Amendments to Development Plan), a “material” amendment to the Development Plan shall be an amendment that, either alone or together with one or more other amendments, would reasonably be expected to (I) delay the receipt of Marketing Approval of either Indication in the U.S. by more than [***] from the projected approval date set forth in the Development Plan (as amended), or (II) result in a Material Adverse Effect.