Health Registrations. Horizon shall maintain the Health Registrations in full force and effect at all times during the term of this Agreement; provided, however, upon the reasonable request of Horizon, Mikart shall assist Horizon in connection therewith; provided further in exchange therefor Horizon will pay Mikart its standard fees therefor. Mikart hereby acknowledges and agrees that the Health Registrations are owned by, in the name of and for the benefit of Horizon and that Mikart has no rights in or to any of the Health Registrations, except to the extent it is expressly authorized to manufacture the Products for Horizon pursuant to this Agreement.
Health Registrations. OPTIMER shall be responsible for preparing and filing the application for HEALTH REGISTRATION to be submitted to the regulatory authorities in the TERRITORY. As of the EFFECTIVE DATE, OPTIMER shall use REASONABLE COMMERCIAL EFFORTS to submit a New Drug Application for the PRODUCT within twenty four (24) months following the EFFECTIVE DATE in the TERRITORY and to obtain HEALTH REGISTRATION approval in the TERRITORY. However, OPTIMER shall not be responsible for any delays caused by circumstances beyond its reasonable control, including guidance from the FDA to conduct a longer than expected clinical development program. In the event of any such delay, the time periods set forth above and in Section 16.1 will be extended for a reasonable period as agreed to in good faith by SHINYAKU and OPTIMER. If any delay is anticipated, OPTIMER will inform SHINYAKU of the reasons for the delay and the Steering Committee will discuss whether reasonable measures may be undertaken to minimize or eliminate the delay.
Health Registrations. Anthra shall be responsible for the preparation of the CMCs to be included in the applicable Health Registrations with the applicable Regulatory Authorities. Anthra shall provide Sicor with a copy of those sections of the CMC applicable to Sicor in order to facilitate its Manufacture of AD32 in accordance with this Agreement and the Health Registrations. In the event that Anthra subsequently modifies the Health Registration(s) (or the CMC), it shall promptly notify Sicor and provide Sicor with copies of the supplements or amendments filed.
Health Registrations. Mikart shall own the Health Registrations in its own name and shall maintain the same in full force and effect at all times during the Term of this Agreement.
Health Registrations. INNOVIVE shall be responsible for preparing and filing the application for HEALTH REGISTRATION to be submitted to the respective regulatory authorities in the TERRITORY. As of EFFECTIVE DATE, INNOVIVE shall make REASONABLE COMMERCIAL EFFORTS to submit NDA or a similar application for the PRODUCT within [*] following EFFECTIVE DATE in the United States and to obtain HEALTH REGISTRATION approval in any country in the TERRITORY, provided that INNOVIVE shall not be responsible for any delays caused by circumstances beyond its reasonable control, including but not limited to delays resulting from actions, inaction or regulatory guidance by the FDA or other authority. If any delay is anticipated, INNOVIVE shall inform SHINYAKU of the reasons for the delay and the PARTIES shall discuss whether reasonable measures may be undertaken to minimize or eliminate the delay.
Health Registrations. As of the Closing Date, Buyer or its Affiliates shall have the full corporate and regulatory authority to own, hold and use the Health Registrations.
Health Registrations. From and after the U.S. Restructuring Effective Date:
(i) WC and/or one or more of its Affiliates shall continue to hold and shall use commercially reasonable efforts to maintain in good order all Health Registrations related to the Product in the WC Exclusive Territory; and
(ii) WC and/or one or more of its Affiliates shall be solely and fully responsible for all costs and expenses of maintaining Health Registrations with respect to the Product in the WC Exclusive Territory, including all administrative costs and expenses and all country specific registration fees (including user fees); provided that all such costs and expenses in the USA relating to the time period prior to the U.S. Restructuring Effective Date shall be allocated among the Parties in accordance with the Collaboration Agreement (without giving effect to this Amendment).
Health Registrations. It is anticipated that in the White Space Territory, the sub-licensee shall be the holder of all Health Registrations related to the Product. To facilitate the sub-licensee’s efforts to obtain such Health Registrations, API shall have the right to provide to such sub-licensee a copy of the Drug Dossier, or the appropriate components thereof.
Health Registrations. Mikart shall maintain the Health Registrations in full force and effect at all times during the Term of this Agreement. Auriga hereby acknowledges and agrees that the Product and the Health Registrations are owned by, in the name of and for the benefit of Mikart, and that Auriga has no rights in or to the Product or any of the Health Registrations, except to the extent it is expressly authorized by Mikart to market and sell the Product pursuant to this Agreement.
Health Registrations. (a) RIBI shall be responsible, at its cost and expenses, for applying for and maintaining Health Registrations to conform to applicable law for the sale of the Product by SP Ltd. in the EU Countries and Australia. RIBI shall [*] obtain Health Registrations with Minimum Labeling and with Expanded Labeling in the EU Countries and Australia. RIBI's effort shall be [*].
(b) In the event SP Ltd. desires to obtain Health Registration for [*].
