MAA Approval. 6.1.1 As between the Parties, subject to the terms and conditions of the this Agreement, including without limitation Section 6.1.2 and the Quality and Regulatory Agreement, and Applicable Laws, (a) Iridex shall be responsible to prepare and file all MAA and secure all MAA Approvals for Products from all Regulatory Agencies necessary to market Products in (A) the Territory, except for Japan, (B) the United States and (C) outside the Territory, and (b) Topcon shall be responsible to prepare and file all MAA and secure all MAA Approvals for Products from all Regulatory Agencies necessary to market Products in Japan; provided, that, with respect to all countries and regions in the Territory other than Japan and the United States, the responsibilities shall be allocated based on good faith discussion among the Parties and reflected in the Quality and Regulatory Agreement (Iridex, with respect to all countries and regions in the Territory other than Japan, and Topcon, with respect to Japan, shall be referred to as “MAA Responsible Party”). Iridex shall own all right, title and interest in and to any and all MAA and MAA Approvals for Products in the Territory other than Japan, and Topcon shall own all right, title and interest in and to any and all MAA and MAA Approvals for Products in Japan. For clarity, and notwithstanding anything to the contrary herein, Iridex shall own all right, title and interest in and to any and all MAA and MAA Approvals for Products outside the Territory.
MAA Approval. Representative agrees that Company shall own and retain all right, title and interest in and to any and all MAA Approvals in the Territory.
MAA Approval. [*] within thirty (30) days of the first MAA approval for Product in the European Union or any country thereof.
MAA Approval. (i) Promptly after the Fourth Amendment Effective Date, and in any event no later than July 31st, the Parties shall take all actions necessary to transfer ownership of the MAA Approval for Staccato loxapine (ADASUVE) from Alexza to Xxxxxx. Such transfer shall be free of charge for Xxxxxx except with regard to regulatory fees. Upon positive European Commission decision of the transfer of ownership of the MAA Approval, Xxxxxx shall at all times be responsible, at its cost, for conducting the development and regulatory activities associated with maintaining MAA Approval (including any additional clinical or non-clinical studies that may be requested by the EMA, unless conducting such studies would be inconsistent with Xxxxxx’x exercise of Commercially Reasonable Efforts, and making Regulatory Filings and paying fees for Regulatory Filings, and including all scientific services requested by the EMA), except as otherwise set forth in the Fourth Amendment or as agreed by the Parties in writing; provided [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. that Xxxxxx’x responsibility for annual fees for maintaining the MAA Approval (for clarity, including pharmacoviligance costs) will commence on September 1, 2015. With respect to any additional variations to the MAA Approval, Alexza will be responsible for all costs incurred through September 1, 2015 for modifications planned or ongoing as of the Fourth Amendment Effective Date or proposed thereafter by Alexza, and Xxxxxx will be responsible for all costs incurred after September 1, 2015 for modifications proposed by Xxxxxx or required by Regulatory Authorities in the Territory. Any regulatory approvals granted in the European Union will be owned by Xxxxxx, and Xxxxxx shall be designated as the “marketing authorization holder” pursuant to the applicable EMA regulations. Alexza shall use Commercially Reasonable Efforts to cooperate and provide assistance in the conduct of any clinical and regulatory post-approval programs requested by Xxxxxx in response to requests by or efforts to satisfy the requirements of the EMA.
MAA Approval. Pioneer will file and register all XXXx and/or required registrations and seek all MAA and all necessary registration and government and Regulatory Approvals in the Territory. NBY shall furnish Pioneer with such assistance and cooperation as may be reasonably necessary in connection with securing of such government or Regulatory Approval. Pioneer will keep NBY reasonably informed with respect to such matters (including meeting at least twice a year in person or by teleconference to discuss such matters). NBY will reimburse Pioneer with the actual registration cost, provided, however such amount shall not exceed $[***] and such reimbursement shall be in the form of a credit towards Pioneer’s future purchase of the Product. NBY will provide reasonable amount of Products, free of change, for the purpose of sample testing and MAA approval if required by local authorities and regulations. After Pioneer’s receipt of MAA Approvals in the Territory, if there is any material change(s) to NBY’s marketing approvals in U.S., NBY will promptly inform Pioneer of such change(s) and Pioneer, in its reasonable judgment, may file any additional Regulatory Approval Applications with Regulatory Authorities in the Territory.
MAA Approval. NBY will have the right and responsibility to file and register all XXXx and seek all MAA Approvals in the Territory, and will own all right, title and interest in and to any and all XXXx and MAA Approvals in the Territory. NBY will keep Pioneer reasonably informed with respect to such matters (including meeting with Pioneer at least twice a year in person or by teleconference to discuss such matters) and Pioneer agrees to execute such documents, render such assistance, and take such other action as NBY may reasonably request, at NBY’s expense, to apply for, register, perfect, confirm, and protect NBY’s rights in the MAA Approvals. After NBY’s receipt of MAA Approvals in the Territory, if there is any material change(s) to NBY’s marketing approvals in U.S., NBY will promptly inform Pioneer of such change(s) and NBY, in its reasonable judgment, may file any additional Marketing Approval Applications with SFDA. ***Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission. CONFIDENTIAL TREATMENT REQUESTED BY NOVABAY PHARMACEUTICALS, INC.
