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. 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. 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. 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. 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. (a) RIBI shall be responsible, at its cost and expense, for applying for and maintaining Health Registrations to conform to U.S. law for the sale of the Product by Schering in the Territory. RIBI shall [*] obtain Health Registrations with Minimum Labeling within the Territory and with Expanded Labeling within the Territory. RIBI's efforts shall be [*].
Health Registrations. The manufacture, marketing, sale and distribution of the Products for sale in the Territory at all times during the two (2) year period prior to the Closing has been conducted in material compliance with the Health Registrations, and Merck is (and has been at all times during the two (2) year period prior to the Closing) in material compliance with all the Health Registrations. To the Knowledge of Merck, the Health Registrations contain all of the available (i.e., in Merck’s possession as Recorded Information) material information concerning side effects, injury, toxicity or sensitivity reaction, or unexpected incidents, whether or not Serious or Unexpected, relating to the Products in the Territory received by Merck, Inspire and their Affiliates and required by applicable Law to be reported to the FDA and included as part of such Health Registration (“Adverse Experience”), during the time from the original filing of the Health Registrations through the Closing Date. To the Knowledge of Merck, Health Registrations do not contain any false or materially misleading information. None of Merck or any of its Affiliates has received any written notice from any Governmental Authority that there are any circumstances currently existing which might reasonably be expected to lead to any loss or refusal to renew any Health Registration, and to the Knowledge of Merck, no such circumstances currently exist. Neither Merck nor any of its Affiliates has committed fraud in relation to the filing or acquisition of any Health Registration or used unfair methods of competition in connection with such filing or acquisition, in each case, in non-compliance with applicable Law. CONFIDENTIAL TREATMENT REQUESTED Portions of this exhibit indicated by “[***]” have been omitted, and such omitted portions have been filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
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. NESTLE shall be responsible for obtaining and maintaining all governmental approvals to sell Licensed Products in the markets that NESTLE decides to enter and shall assume all related costs. MEDJET will cooperate with NESTLE in seeking regulatory approval of Licensed Products.
Health Registrations. (a) Promptly following the Effective Date, Sequus shall transfer, or cause to be transferred, all right, title and interest in and to all existing filings, applications, marketing authorizations, centralized registrations, approvals, health
