Common use of Regulatory Activities Clause in Contracts

Regulatory Activities. (i) As between the Parties, Receptos shall have the sole responsibility, at Receptos’ sole expense, for preparing, obtaining, and maintaining INDs and other related submissions or approvals (e.g., from any Institutional Review Board, Independent Ethics Committee or analogous authority), and for conducting communications with the Regulatory Authorities, in connection with any human clinical trial involving ABT-308 in the Lead Indication to be conducted or being conducted pursuant to the Development Plan and Budget. *** AbbVie agrees to provide reasonable regulatory assistance to Receptos, upon Receptos’ reasonable request and Receptos’ reasonable expense, regarding any modifications to any existing IND or other regulatory submissions that may be necessary or advisable in respect of the activities under the Development Plan and Budget. (ii) Receptos shall provide AbbVie with *** opportunity to review and comment on all filings and documents with Regulatory Authorities (including INDs and Regulatory Authority meeting requests) made pursuant to the Development Plan and Budget and this Agreement. Receptos shall, and shall cause its Affiliates to*** any reasonable comments of AbbVie. (iii) Receptos shall notify AbbVie promptly (but in no event later than *** hours) following its determination that any event, incident, or circumstance has occurred that may reasonably be expected to result in the need for a withdrawal of ABT-308, and shall include in such notice the reasoning behind such determination, and any supporting facts. AbbVie shall have the right to make the final determination whether to voluntarily implement any such withdrawal; provided that prior to any implementation thereof, AbbVie shall consult with Receptos and shall consider Receptos’ comments in good faith. If a withdrawal is mandated by a Regulatory Authority, Receptos shall initiate such withdrawal in compliance with Applicable Law. For all withdrawals undertaken pursuant to this Section 2.2.1(iii), Receptos shall be solely responsible for the execution and all costs thereof; provided, however, that if any such withdrawal is a result of any material breach of this Agreement by AbbVie or any of its Affiliates (including a material breach of any representation or warranty), then AbbVie shall be solely responsible for all costs thereof. (iv) During the Term, Receptos represents and warrants that no Drug Approval Application for a Licensed Compound will be filed with any Regulatory Agency anywhere in the Territory.

Regulatory Activities. (ia) As between the Parties, Receptos Adapt shall have the sole responsibility, at Receptos’ sole expense, be responsible for preparing, obtaining, and maintaining INDs Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals and other related submissions or approvals (e.g., from any Institutional Review Board, Independent Ethics Committee or analogous authority)submissions, and for conducting communications with the Regulatory Authorities, for Products (which shall include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities), in connection each case in accordance with any human clinical trial involving ABT-308 the terms of this Agreement and otherwise in Adapt’s sole discretion. All Regulatory Approvals applied for or received after the Effective Date relating to Products shall be owned by and held in the Lead Indication to be conducted or being conducted pursuant to name of, Adapt. At Adapt’s request, Lightlake shall transfer ownership of the Development Plan and Budget. *** AbbVie agrees to provide reasonable regulatory assistance to Receptos, upon Receptos’ reasonable request and Receptos’ reasonable expense, regarding any modifications to any existing IND or other regulatory submissions that may be necessary or advisable in respect of the activities under initial Product to Adapt at no cost and shall take such action as is necessary to confirm such transfer with the Development Plan and BudgetFDA. (iib) Receptos shall provide AbbVie with *** opportunity to review and comment on all filings and documents with Regulatory Authorities (including INDs and Regulatory Authority meeting requests) made pursuant to the Development Plan and Budget and this Agreement. Receptos shall, and shall cause its Affiliates to*** any reasonable comments of AbbVie. (iii) Receptos Adapt shall notify AbbVie Lightlake promptly (but in no event later than *** forty-eight (48) hours) following its determination that any event, incident, or circumstance has occurred that may reasonably be expected to result in the need for a recall, market suspension, or market withdrawal of ABT-308a Product, and shall include in such notice the reasoning behind such determination, and any supporting facts. AbbVie Adapt (or its Sublicensee) shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal; provided that prior to any implementation thereof, AbbVie shall consult with Receptos and shall consider Receptos’ comments in good faith. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority, Receptos Adapt (or its Sublicensee) shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions, or market withdrawals undertaken pursuant to this Section 2.2.1(iii)undertaken, Receptos Adapt (or its Sublicensee) shall be solely responsible for the execution and all costs thereof; provided, however, that if any such withdrawal is a result of any material breach of this Agreement by AbbVie or any of its Affiliates (including a material breach of any representation or warranty), then AbbVie shall be solely responsible for all costs thereof. (iv) During the Term, Receptos represents and warrants that no Drug Approval Application for a Licensed Compound will be filed . IRS Employer Identification No. 40-0000000 Confidential treatment requested with any Regulatory Agency anywhere in the Territory.respect to certain portions hereof denoted with “*** REDACTED ***”