Inspection by Eisai. Arena agrees that Eisai and its respective agents (but no more than a total of three persons per inspection) shall have the right, pursuant to a reasonable confidentiality agreement with Arena, no more than once per Calendar Year (unless any such inspection reveals a material compliance issue, in which event Eisai and its respective agents shall have the right to conduct such additional inspections during such Calendar Year as necessary to verify that such issue has been remedied), upon reasonable prior notice to Arena and during business hours, and in a manner that does not unreasonably disrupt Arena’s manufacturing operations, to inspect the portion of the Facility where Finished Product is manufactured or stored as well as the manufacturing of the Finished Products, including inspection of (a) the raw materials used in the manufacture of the Finished Products, (b) the holding facilities for such raw materials, (c) the equipment used in the manufacture of the Finished Products, and (d) all material records reasonably relating to such manufacturing at the Facility, to the extent they relate to the Finished Products (which records may be copied by Eisai or its agent, at Eisai’s expense). Following such inspection, Eisai shall discuss its observations and conclusions with Arena and if Eisai believes that any corrective actions are necessary for Arena to comply with the terms and conditions of this Article 6, then within 15 days after such discussion, Eisai shall prepare a schedule that sets forth the corrective actions that Eisai reasonably believes in good faith are required, and Arena will consider such actions in good faith and use Commercially Reasonable Efforts to implement such corrective actions that Arena reasonably and in good faith determines to be required.
Appears in 3 contracts
Samples: Marketing and Supply Agreement (Arena Pharmaceuticals Inc), Marketing and Supply Agreement (Arena Pharmaceuticals Inc), Marketing and Supply Agreement (Arena Pharmaceuticals Inc)
Inspection by Eisai. Arena agrees that Eisai and each Designated Distributor (and its and their respective agents (but no more than a total of three persons per inspection) shall separately have the right, pursuant to a reasonable confidentiality agreement with Arena, no more than once per Calendar Year (unless any such inspection reveals a material compliance issue, in which event Eisai and each Designated Distributor (and its and their respective agents agents) shall have the right to conduct such additional inspections during such Calendar Year as necessary to verify that such issue has been remedied), upon reasonable prior notice to Arena and during business hours, and in a manner that does not unreasonably disrupt Arena’s manufacturing operations, to inspect the portion of the Facility where Finished Product is manufactured or stored as well as the manufacturing of the Finished Products, including inspection of (a) the raw materials used in the manufacture of the Finished ProductsProducts including Eisai Materials, (b) the holding facilities for such raw materials, (c) the equipment used in the manufacture of the Finished Products, and (d) all material records reasonably relating to such manufacturing at the Facility, to the extent they relate to the Finished Products (which records may be copied by Eisai Eisai, the Designated Distributor or its or their agent, at Eisai’s their expense). Following such inspection, Eisai or the applicable Designated Distributor shall discuss its observations and conclusions with Arena and if Eisai or the applicable Designated Distributor believes that any corrective actions are necessary for Arena to comply with the terms and conditions of this Article 6Agreement, then within 15 days after such discussion, Eisai shall prepare a schedule that sets forth the corrective actions that Eisai reasonably believes in good faith are required, and Arena will consider such actions in good faith and use Commercially Reasonable Efforts to implement such corrective actions that Arena reasonably and in good faith determines to be required.
Appears in 2 contracts
Samples: Supply Agreement (Arena Pharmaceuticals Inc), Supply Agreement (Arena Pharmaceuticals Inc)