Stressgen Input Clause Samples

The 'Stressgen Input' clause defines the requirements and specifications for the information or data that must be provided to the party responsible for conducting stress testing or analysis. Typically, this clause outlines the format, timing, and content of the input data, ensuring that it is accurate, complete, and delivered in a timely manner to facilitate effective stress testing. By clearly setting out these requirements, the clause helps prevent misunderstandings and delays, ensuring that the stress testing process can proceed smoothly and yield reliable results.
Stressgen Input. Review of [* *] • Approval to [* *] stage [*] = CONFIDENTIAL TREATMENT REQUEST(ED).
Stressgen Input. Review of individual development reports
Stressgen Input. 6.4.2.1 List of [* *] 6.4.2.2 List of [* *] 6.4.2.3 List of [* *] specifications 6.4.2.4 Test methods for above 6.4.2.5 List of [* *] 6.4.2.6 List of assays to be performed during transfer stage 6.4.2.7 [* *] Methods and related assays, [* *]
Stressgen Input. Report on [* *]. • [* *] report. • Container closure system descriptions for bulk Drug Substance and Drug Product. • Data on stability of Drug Substance and Drug Product. [*] = CONFIDENTIAL TREATMENT REQUEST(ED). • Samples of Drug Substance and Drug Product
Stressgen Input. [* *] Description • [* *] Batch Records • [* *] Development Report including updated info for [* *] • Samples of HspE7 and process intermediates. • Cell Paste used previously to produce acceptable HspE7 batches for comparison
Stressgen Input. 6.1.2.1 Fermentation process description 6.1.2.2 Fermentation batch record 6.1.2.3 [* *] report 6.1.2.4 [* *] vials 6.1.2.5 [* *] stability and characterization reports 6.1.2.6 [* *] method 6.1.2.7 Samples of [* *]

Related to Stressgen Input

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Collaboration activities 4.1 The Collaboration Suppliers will perform the Collaboration Activities and all other obligations of this Agreement in accordance with the Detailed Collaboration Plan. 4.2 The Collaboration Suppliers will provide all additional cooperation and assistance as is reasonably required by the Buyer to ensure the continuous delivery of the services under the Call-Off Contract. 4.3 The Collaboration Suppliers will ensure that their respective subcontractors provide all cooperation and assistance as set out in the Detailed Collaboration Plan.

  • Field The term “

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).