Facility Licenses; Storage Clause Samples

Facility Licenses; Storage. Arena shall obtain and maintain for the Facility, at its sole cost, all permits, licenses and approvals (including facilities licenses) needed for Arena to be able to manufacture and supply Product in compliance with the warranty set forth in Section 12.1 (the “Facility Licenses”), in a timely manner such that Arena is able to meet its manufacturing and supply obligations under this Agreement. Arena shall keep Eisai regularly informed about the status of all such Facility Licenses and shall provide Eisai copies thereof upon request. Arena shall ensure that the Facility complies with GMP and all other Applicable Laws (including environmental laws) with regard to its manufacturing and supply of Product. Arena shall use Commercially Reasonable Efforts to resolve as soon as possible any issues that arise in its seeking or maintaining Facility Licenses, including completely addressing and rectifying any deviations or other issues raised in any Warning Letter from the FDA or any similar warning or objection by any other Regulatory Authority. Arena shall have the right to subcontract with Third Parties for storage services and storage facilities for Products manufactured for supply to Eisai hereunder, and Arena shall be responsible for all such subcontractors as provided in Section 2.4.

Facility Licenses; Storage. (a) Arena shall maintain for the facility(ies) at which Arena manufactures Finished Product for supply to Roivant (each, a “Facility”), at Arena’s sole cost, all permits, licenses and approvals (including facilities licenses) needed for Arena to be able to manufacture and supply Finished Product in compliance with the Product Warranty (the “Facility Licenses”), in a timely manner such that Arena is able to meet its manufacturing and supply obligations under this Agreement. Arena shall keep Roivant regularly informed about the status of Facility Licenses for each Facility and shall provide Roivant copies thereof upon reasonable request. Arena shall ensure that each Facility complies with Applicable Laws (including environmental laws) with regard to its manufacturing and supply of Finished Product. Arena shall use Commercially Reasonable Efforts to resolve as soon as possible any issues that arise in seeking or maintaining Facility Licenses for any Facility, including completely addressing and rectifying any deviations or other issues raised in any Warning Letter from the FDA or any similar warning or objection by any other Regulatory Authority. Arena shall have the right to subcontract with Third Parties for storage services and storage facilities for Finished Products manufactured for supply to Roivant hereunder, subject to Roivant’s approval of each such Third Party which approval will not be unreasonably withheld, delayed or conditioned and Arena shall be responsible for all such subcontractors as provided in Section 15.4(b). (b) Arena shall ensure that each Third Party manufacturer maintains for the facility(ies) at such Third Party manufactures Compounds or Finished Product hereunder, at Arena’s and/or such Third Party’s cost, all permits, licenses and approvals (including facilities licenses) needed for such Third Party to be able to manufacture and supply Compound or Finished Product, as applicable, in compliance with the Specifications or Product Warranty, in a timely manner such that Arena is able to meet its manufacturing and supply obligations under this Agreement. Arena shall keep Roivant regularly informed about the status of such permits, licenses and approvals (including facilities licenses) for each such Third Party facility. Arena shall ensure that each such Third Party facility complies with Applicable Laws (including environmental laws) with regard to its manufacturing and supply of Compound or Finished Product. Arena shall ensure that su...