Post-Marketing Studies. With respect to any Post Marketing Studies required by a jurisdiction where Aldurazyme does not have Regulatory Approval as of the Effective Date, Genzyme shall, at its sole expense and in its sole discretion, have the responsibility for conducting any such Post-Marketing Studies that are not funded by BioMarin/Genzyme LLC pursuant to the terms of the Amended and Restated Collaboration Agreement.
Post-Marketing Studies. The Parties anticipate that it will be desirable to conduct post-marketing studies of the Products in the Field (including phase IV studies) in order to maximize the potential market for Products in or outside the Territory (“Post-Marketing Studies”). The Parties shall discuss all proposed Post-Marketing Studies at the JSC. In relation to the Territory, in the event Partner wishes to conduct a Post-Marketing Study of the Product in the Field, Partner shall first prepare a protocol for any such Post-Marketing Study and present it to the JSC for comment. Partner shall be responsible for planning and overseeing the performance of any such Post-Marketing Studies in the Territory (at its sole expense), subject to the oversight of the JSC, and shall update the JSC on the progress of such studies. In relation to the countries outside Territory other than in the XXXX Territory, Optimer shall first prepare a protocol for any such Post-Marketing Study and present it to the JSC for comment. Optimer or its licensee, as applicable, shall be responsible for planning and overseeing the performance of any such Post-Marketing Studies outside the Territory other than in the XXXX Territory (at its sole expense), and shall update the JSC on the progress of such studies. Notwithstanding the foregoing, if, following the presentation by a Party to the JSC of the protocol for such a Post-Marketing Study, the other Party promptly provides written notice to the Party proposing to perform the Post-Marketing Study that it reasonably believes, as supported by documentation, that such proposed Post-Marketing Study is reasonably likely to have a material adverse effect on such other Party’s or its licensees’ Regulatory Approval for or commercialization of any product containing the Compound, then such Post-Marketing Study may not be performed, unless the Parties agree in writing that such Post-Marketing Study may proceed following good faith discussions by the Parties. For clarity, Post-Marketing Studies shall include (i) in the case of Partner, any clinical experimental investigations (“Shiyo-Seiseki-Chosa”) and special investigations (“Tokutei-Shiyo-Seiseki-Chosa”) of MHLW’s ordinance (No.145, 1960), respectively, under the Pharmaceutical Affairs Law of Japan and any other mandatory post-marketing studies required by MHLW as the phase IV commitment for the Regulatory Approval of the Product in the Field in the Territory, and (ii) in the case of Optimer, any Post-Marketing Studies requ...
Post-Marketing Studies. If the Regulatory Authority requires that a Post-Marketing Study for the Licensed Product be conducted in the Licensed Territory, or if the Parties mutually agree that a Post-Marketing Study for the Licensed Product in the Licensed Territory is necessary (such agreement not to be unreasonably withheld, conditioned, or delayed), Zai shall be responsible for conducting such Post-Marketing Study for the Licensed Product in the Licensed Territory, including [***].
Post-Marketing Studies. Focal, at its sole cost and expense, shall be responsible for conducting all post marketing studies of the Systems required by Regulatory Authorities as a condition to the issuance, continuation or maintenance of a Regulatory Approval, or in connection with any other related regulatory matter.
Post-Marketing Studies. If a Post-Marketing Study in the Takeda Territory is required by the applicable Regulatory Authority or the Parties agree that such a Post- Marketing Study is necessary or reasonably useful, Takeda shall be responsible for such Post- Marketing Study in the Takeda Territory. Unless required by the Regulatory Authority or otherwise agreed by the Parties, Takeda may in its sole discretion determine whether a Post- Marketing Study in the Takeda Territory is necessary and if deemed necessary, shall be responsible for such Post-Marketing Studies within the Takeda Territory. Upon reasonable request of either Party, the other Party shall, at the requesting Party’s reasonable expense for the other Party’s support, beyond an initial [***] of such other Party’s personnel time which initial time shall be [***], provide the requesting Party reasonably necessary or useful technical assistance in the form of responding to questions and providing available and then- existing Information (e.g., post-marketing reports, if available) to support the conduct of such studies in regards to the Manufacturing, nonclinical or clinical area that may be required to meet post-approval commitments in the Takeda Territory or Novavax Territory, as applicable. For clarity, unless otherwise agreed by the Parties, neither Party has an obligation to the other Party to recreate or regenerate any Information in any particular format or including any particular data or other content, but the requesting Party may reasonably request that such other Party, at such other Party’s option, either (A) reformat or reorganize an existing set of Information or (B) provide the requesting Party the relevant underlying data so as to permit the requesting Party to reformat or reorganize such existing Information, in each case so as to satisfy the requirements of the relevant Regulatory Authority(ies).
Post-Marketing Studies. ATS may, in its sole discretion and at its expense, pursue authorship and publication of post-marketing or white paper studies to increase market awareness of the Products. GBI will assist ATS by providing marketing materials and manufacturing information reasonably necessary to support such studies. ATS shall provide GBI with sufficient opportunity to review any such proposed publications and ATS shall agree not to publish GBI Confidential Information or publish any information that will affect GBI's ability to seek patent protection.
Post-Marketing Studies. If, at any time, additional pre-clinical, clinical or regulatory studies are required to be conducted in any country of the Territory by Regulatory Authorities or otherwise to maintain the marketing authorization or any Governmental Permit for the Agreement Product in such country, Sequus shall be obligated to conduct such studies.
Post-Marketing Studies. CL may, in its sole discretion and at its expense, pursue authorship and publication of post-marketing or white paper studies to increase market awareness of the Products. HJL will assist CL by providing marketing and other materials and manufacturing information reasonably necessary to support such studies. CL shall provide HJL with sufficient opportunity to review any such proposed publications and CL shall agree not to publish HJL Confidential Information or publish any information that will affect HJL’s ability to seek patent protection on the Product or related technology or know-how. HJL shall inform CL promptly in the event that HJL becomes aware of (i) post-market clinical studies being conducted involving the Product, or (ii) literature or unpublished reports of data from any clinical or non-clinical laboratory studies involving the Product.
Post-Marketing Studies. For clarity, if a Party desires to conduct a Post-Marketing Study that has not been approved by the Parties for inclusion under the applicable Development Plan under Section 4.2.5(e) above, such Party may perform such Post-Marketing Study, at its own expense. Further, the Party conducting such Post-Marketing Study outside such Development Plan shall not be required to share the Data (other than safety Data, in accordance with [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. the Pharmacovigilance Agreement or as otherwise required by a governmental or a regulatory authority or applicable Laws) resulting from such Post-Marketing Study.
Post-Marketing Studies. ATS may, in its sole discretion and at its expense, pursue authorship and publication of post-marketing or white paper studies to increase market ***** Denotes confidential information that has been omitted from the exhibit and filed separately, accompanied by a confidential treatment request, with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934.
