Ongoing Trial definition
Examples of Ongoing Trial in a sentence
Within [***] days after the Effective Date, Novartis will provide Pharming with a high-level budget setting forth on a quarterly basis Novartis’ good faith estimate of its expected Development Costs in performing the Ongoing Trial and the Extension Study in accordance with the then existing Ongoing Trial Protocol and Extension Study Protocol until the Final Trial Transfer Date (the “Initial Trial Budget”).
Without limiting any obligations of Novartis under this Agreement with respect to the transfer of Manufacturing Technology contemplated by Section 6.7, the Parties acknowledge and agree that Novartis’ obligations under this Agreement with respect to the supply of Licensed Product, including for the Ongoing Trial and Extension Study, will be satisfied by the Existing Clinical Supply.
On an ongoing basis, and no more than [* * *], Pfizer shall reimburse GMI [* * *] such Additional Ongoing Trial Costs and payment shall be due from Pfizer within [* * *] after receipt of an invoice and an explanation of the Additional Ongoing Clinical Trial Costs included in the invoice.
Novartis and its Affiliates will have no liability with respect to any Pharming Activities, and will not be responsible for any adverse effect Pharming Activities may have on the Ongoing Trial, the Extension Study, the Licensed Compound or Licensed Product, or the activities of Novartis under this Agreement.
Pharming may propose amendments to the Ongoing Trial Protocol through the JCT, which shall consider any such proposed amendment in good faith.
The Parties will discuss and finalize the methods and procedure to exchange safety information (AE and SAE) related to the Ongoing Trial at reasonable timing after the Effective Date and shall include such procedures in the Transition Plan.
Serono may terminate this Agreement it its entirety, for any reason or no reason: (a) [***] upon written notice to Micromet following receipt by Serono of the Final Study Report for either Ongoing Trial, and (b) upon [***] prior written notice to Micromet at any time thereafter.
Within thirty (30) Business Days after each Calendar Quarter, Plexxikon shall deliver an invoice detailing Ongoing Trial Costs for such Calendar Quarter.
Merck (or one of its ***) shall be responsible for and act as the sole point of contact for communications with Regulatory Authorities in connection with the Development, Commercialization, and manufacturing of Licensed Products after the end of the communications relating to the Ongoing Trial that were initiated by Lpath before the Development Transfer Date.
Plexxikon shall use Commercially Reasonable Efforts to perform the Ongoing Trial until transitioned to Licensee in accordance with the Transition Plan, including by exercising its rights under the Unassigned Agreements applicable to the Ongoing Trial in accordance with Section 3.1.4(b) (Unassigned Agreements).