Injection Product definition
Examples of Injection Product in a sentence
The JDCC will then promptly meet to take action on the Injection Product Election.
To the extent required to support Regulatory Requirements of a Product for North America and for Europe if Acologix has the Injection Product Election, Acologix shall have reference rights to use the safety, Manufacturing and other data in such drug master file.
In addition, upon Acologix’ request Toray shall use Commercially Reasonable Efforts to provide Acologix with any data, documentation, information and materials generated or used by Toray in the Development of the Injection Product, to the extent any such materials are not already in Acologix’ possession, and to ensure orderly transition and uninterrupted Development of the Injection Product.
In the event that Toray has not secured an European Partner [***] from the time Toray assume the Injection Product Election, Acologix may make certain proposals to the JDCC for possible licensing arrangements in Europe involving Acologix, and Toray will confer with Acologix thereof in good faith with a view of accomplishing Commercialization in Europe as soon as reasonably possible.
In the event that Acologix provides written notice to Toray that it waives its right to assume Commercialization responsibility in Europe or if Acologix fails to timely provide notice of its desire to pursue such Injection Product Election, the Injection Product Election shall be that Toray will have responsibility to exclusively license a Third Party for Commercialization of Injection Products in Europe in accordance with Section 3.3 below.
In addition, as of the Effective Date, Toray has discussed with appropriate representatives of the EMEA its planned protocol for Phase III Trials of an Injection Product, Toray has fully disclosed such protocol to Acologix and Toray has no reason to believe that Phase III Trials performed in accordance with such protocol would be deemed insufficient by the EMEA to support an MAA for such Injection Product.
As a result of the deliberations of the JDCC after receipt of said notice from Acologix, the Injection Product Election shall be either that (i) Acologix will be assigned responsibility for Commercialization of Injection Products in Europe in accordance with Section 3.2 below, or (ii) Toray will have responsibility to exclusively license a Third Party for Commercialization of Injection Products in Europe in accordance with Section 3.3 below.
If Acologix is assigned responsibility by the JDCC for Commercialization of Injection Products in Europe as the Injection Product Election in accordance with Section 3.1.2, then Acologix shall proceed with such Commercialization at its sole discretion and expense in accordance with this Section 3.2.
The JDCC shall oversee the process of the Commercialization of Injection Products in Europe prior to obtaining Regulatory Approval in Europe for an Injection Product, in accordance with this Section 3.1 (such determination, the “Injection Product Election”).
Furthermore, in the event that the Injection Product Election is subject to determination hereunder, it is understood and agreed that the arbitrator shall select one of the two options set forth in Section 3.1.1 as his or her decision, and shall not have the authority to render any substantive decision other than to choose one of those options.