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).
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.
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.
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”).
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).