Pfenex Responsibilities Clause Samples

The "Pfenex Responsibilities" clause defines the specific duties and obligations that Pfenex must fulfill under the agreement. This may include tasks such as providing certain products or services, meeting quality standards, supplying documentation, or adhering to timelines. By clearly outlining what is expected from Pfenex, the clause ensures accountability and helps prevent misunderstandings regarding each party's roles, thereby facilitating smooth collaboration and project execution.
Pfenex Responsibilities. Pfenex shall perform its responsibilities as set forth in the Development Plan, including (i) completion, at its expense, of the Pharmacokinetic Study, and (ii) using Commercially Reasonable Efforts to perform the Manufacturing Process Development work as described in the Development Plan. Pfenex shall, upon the request of Hospira, provide Hospira with all records, documents, data and other information related to the development with respect to Product, including any Manufacturing Process Development work or Pre-Clinical Study conducted by or on behalf of Pfenex with respect to Product either before or after the date hereof, in each case as is reasonably requested by Hospira to conduct its obligations or exercise its rights hereunder. Pfenex shall conduct its activities in performance of the Development Program in a good scientific manner and using cGxP of the applicable jurisdiction where its obligations under the Development Program are being conducted to the extent cGxPs are applicable to its activities, to achieve the objectives of the Development Program efficiently and expeditiously, in compliance with all Applicable Laws. Pfenex shall cooperate and provide Hospira with reasonable assistance in connection with the performance by Hospira of its obligations under Section 3.1(b).
View SourceView Similar (3)
Pfenex Responsibilities. Promptly after the filing of the Regulatory Documentation with the FDA, but in any case within thirty (30) days of such filing, Pfenex shall deliver to Alvogen a copy of such Regulatory Documentation, provided that Alvogen and any Sublicensee may only use such Regulatory Documentation and the Know-How incorporated therein pursuant to the Product License, including the right to use such Regulatory Documentation for compiling Regulatory Materials.
View SourceView Similar (2)
Pfenex Responsibilities. Pfenex (itself or, subject to Section 3.3, through its Affiliates or Third Parties) shall use Diligent Efforts to (a) provide Product necessary for the conduct of the E.U. BE Study, and (b) conduct any analytical testing activities requirement to support the initial MAA filing for the Product (to be filed through a centralized process as defined in Section 3.2.1.1, part I, Annex I to Directive 2001/83/EC, as amended) for the Territory, as set forth in the development plan and associated timelines attached hereto as Exhibit 3.1 (as may be [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. updated by the Executive Steering Committee, the “Development Plan”) and such activities shall be conducted in accordance with applicable cGxP and Applicable Law with the goal of supporting the preparation and filing of an MAA for the Product and obtaining MAA Approval for the Product. Promptly after the filing of the Regulatory Documentation with the FDA, but in any case within thirty (30) days of such filing, Pfenex shall deliver to Alvogen a copy of such Regulatory Documentation, provided that Alvogen and any Sublicensee may only use such Regulatory Documentation and the Know-How incorporated therein pursuant to the Product License, including the right to use such Regulatory Documentation for compiling Regulatory Materials.
View Source
Pfenex Responsibilities. Pfenex (itself or, subject to Section 3.3, through its Affiliates or Third Parties) shall use Diligent Efforts to: (a) conduct the development activities for Product in the Territory set forth in the development plan and associated timelines attached hereto as Exhibit 3.1(a) (as may be updated by the Executive Steering Committee, the “Development Plan”) and such activities shall be conducted in accordance with applicable cGxP and Applicable Law with the goal of supporting the preparation and filing of an NDA for the Product and obtaining NDA Approval for the Product; (b) prepare, file with the FDA and defend the NDA for Product and obtain NDA Approval for Product. In connection with the filing and review of such NDA, Pfenex shall apply for and use Diligent Efforts to obtain a waiver (or reduction) with respect to the PDUFA Fee, as provided in 21 U.S.C. 379h(d); provided, however, if despite such Diligent Efforts, the FDA notifies Pfenex that any PDUFA Fee is payable, then the Parties shall share the cost of such PDUFA Fee equally (i.e., on a 50:50 basis). Accordingly, Alvogen shall remit its share of the PDUFA Fee to Pfenex within five (5) Business Days of receipt of an invoice therefor from Pfenex; and (c) Upon receipt of NDA Approval for Product, Pfenex shall file a notice with the FDA (and copying Alvogen) under 21 CFR 314.72 transferring the NDA Approval to Alvogen (the “Transfer Notice”).
View Source
Pfenex Responsibilities. Pfenex shall, promptly but no later than ten (10) days following submission to the FDA, which Pfenex anticipates will be no later than [***], provide NT Pharma with appropriate sections of the NDA for Product and, upon the request of NT Pharma, provide NT Pharma with such additional records, documents, data and other information in its possession or control related to the development of Product, as may be reasonably requested by NT Pharma to perform its obligations or exercise its rights under this Agreement, provided, however, that Pfenex shall not be required to provide any manufacturing records or laboratory notebooks unless that information is necessary for NT Pharma to obtain Regulatory Approval in the Territory. Such records, documents, data and other information provided by Pfenex shall remain the sole property of Pfenex, shall be deemed to be the Confidential Information of Pfenex, shall not be used by NT Pharma for any purpose other than the development and commercialization of Product in the Territory in accordance with this Agreement and shall be provided to NT Pharma in such form as maintained by or on behalf of Pfenex in the ordinary course of business, and Pfenex shall not be obligated to provide any translations. Pfenex shall also provide necessary training and advice to NT Pharma to enable it to understand the records, documents, data and other information so provided by Pfenex, including providing necessary on-site technical guidance and support, provided that NT Pharma shall reimburse Pfenex for its reasonable out-of-pocket costs incurred in providing such training and advice. Until such time as NT Pharma submits a MAA to the SFDA for Product in Mainland China, if Pfenex fails to provide in a timely fashion any material information or documentation in its possession or control that is reasonably requested in writing by NT Pharma, NT Pharma reserves the right to terminate the Agreement and receive a payment in the amount of Two Million Five Hundred Thousand Dollars ($2,500,000.00) in accordance with Section 10.2(b)(v). Pfenex shall keep NT Pharma reasonably informed as to Pfenex’s progress with respect to its development activities relating to Product through quarterly updates to the Executive Steering Committee at its meetings. Pfenex shall cooperate and provide NT Pharma with reasonable assistance in connection with the performance by NT Pharma of its obligations under Section 3.1(a).
View Source

Related to Pfenex Responsibilities

  • IRO Responsibilities The IRO shall: 1. perform each Claims Review in accordance with the specific requirements of the CIA;

  • Specific Responsibilities Without limiting the responsibilities of the Manager, the Manager will: 1. Maintain office facilities (which may be in the offices of the Manager or a corporate affiliate but shall be in such location as the Trust reasonably determines). 2. Furnish statistical and research data, clerical services and stationery and office supplies. 3. Compile data for, prepare for execution by the Fund and file all the Fund’s federal and state tax returns and required tax filings other than those required by this Agreement to be made by the Fund’s custodian and transfer agent. 4. Prepare compliance filings pursuant to state securities laws with the advice of the Trust’s counsel. 5. Prepare the Trust’s Annual and Semi-Annual Reports to Shareholders and amendments to its Registration Statements (on Form N-1A or any replacement therefor). 6. Compile data for, prepare and file timely Notices to the SEC required pursuant to Rule 24f-2 under the 1940 Act. 7. Determine the daily pricing of the portfolio securities and computation of the net asset value and the net income of Fund in accordance with the Prospectus, resolutions of the Trust’s Board of Trustees, and the procedures set forth in EXHIBIT A: NET ASSET VALUE CALCULATIONS. 8. Keep and maintain the financial accounts and records of the Fund and provide the Trust with certain reports, as needed or requested by the Fund. 9. Provide officers for the Trust as requested by the Trust’s Board of Trustees. 10. Perform fund accounting services for the Fund as set forth in EXHIBIT B: FUND ACCOUNTING FUNCTIONS. 11. Generally assist in all aspects of the operations of the Fund.

  • Our Responsibilities A. We will provide the Services in accordance with our then-current systems, standards, and procedures. Nothing requires us to provide you with any special programming; any system, program, or procedure implementation; or any special hardware or software. B. We will provide reports online for each fiscal day’s activity by 10:00 AM ET the next calendar day. Such reports will include an accounting for each currency with supporting detail of transaction activity, Daily Proceeds, reserves and funds transfers for transaction settlement services. Reports will be available for download on the online reporting tool for a period of 14 months from the date of issue. Reports may be upgraded, enhanced and/or modified by us at any time. C. We will initiate payment to you for the amount of each accepted Card transaction only after we receive payment. D. We have the right to honor and rely on the request(s) or instruction(s) of any person we reasonably believe to be your representative or Agent. In the event we receive returned mail intended for you, we may, but are not required to, procure a replacement address according to our standard operating procedures. E. We are only responsible for processing credits and adjustments for Card transactions that we originally processed. You authorize us to audit all Card transactions and deposits. We have the right to withhold amounts from you if we discover inaccuracies. F. We may report information about your account, late payments, missed payments, or defaults to credit bureaus. G. We may suspend or cease providing any Services to you in response to a Member Bank, Network, or Association request. We will use reasonable efforts to notify you if we suspend or cease any Services. H. We are responsible for the security of Cardholder data we store or transmit on your behalf only while it is in our possession and control.

  • Vendor Responsibilities Note: NO EXCEPTIONS OR REVISIONS WILL BE CONSIDERED IN C-M, O-S, V-W. Indemnification

  • Client’s Responsibilities The Client’s responsibilities include the following: a. Enrolling. The Client must complete the Informed Consent for Collection and Storage (attached as Schedule 1) The Client must complete or facilitate the Gestational Carrier’s and if applicable, Egg Donor’s completion of the Health History Questionnaire and the Informed Consent to Testing of the Maternal Sample provided by ViaCord. For ▇▇▇▇ ▇▇▇▇▇▇▇ collected in New York State, where possible, the Child’s biological father should also complete a Health History Questionnaire. Generally, for Newborn Stem Cells to be used in treatment, the healthcare provider will need information about the Gestational Carrier and if applicable, Egg Donor. The Health History Questionnaire(s) provides much of the required information.Complete and accurate information is critical to Release and use of Newborn Stem Cells. If You do not provide a completed Health History Questionnaire(s) from the Gestational Carrier and if applicable, Egg Donor, VPL may be unable to Release the Newborn Stem Cells. In addition, if any information provided in the ViaCord Services Agreement or any of the Health History Questionnaire(s) is incomplete or incorrect, it is the Client’s responsibility to notify ViaCord and correct that information immediately.