CMC Activities Sample Clauses

CMC Activities. ANXXXXXX xhall be solely responsible for performing, at its sole cost, all activities required to support the chemistry, manufacturing and control requirements for the ANDA (“CMC”) as required to support the NDA or ANDA in the Territory. ANXXXXXX xhall perform all activities, prepare all materials and information, and provide any and all equipment, as required for CMC to support the NDA or ANDA.
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CMC Activities. XOMA shall be responsible for the performance of CMC Activities for Bulk Drug Substance, including associated regulatory activities, in accordance with the Manufacturing Plan. Prior to XOMA’s exercise of the Cardiometabolic Indications Option and thereafter if XOMA does not exercise such option, Servier shall reimburse XOMA for all documented costs incurred by XOMA in performing such activities in accordance with the Manufacturing Plan and the budget contained therein, as provided in Article 3. If XOMA exercises the Cardiometabolic Indications Option, XOMA shall reimburse certain of these costs as provided in Section 8.5, and the Parties shall thereafter share such costs for the Cardiometabolic Field as provided in Section 3.4(d).
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CMC Activities. (a) The first sentence of Section 4.2 of the Agreement shall be deleted in its entirety and replaced with the following: “NN shall pay ZGEN the milestone fees set forth in Sections 4.2(a) through 4.2(d) and 4.2(i), subject to utilization of any credits provided in Sections 4.5(b) and 5.5.”
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CMC Activities. NN shall use commercially reasonable efforts to perform the process development, implementation, qualification, validation, and process scale-up to clinical and commercial scale and any other activities required to develop and commercialize a Licensed Product, including, without limitation, production of the drug product (“Drug Product”) at anticipated commercial scale of, at least, [ * ] liters (“Commercial Scale Production”) and [ * ] stability studies of a new formulation of the Licensed Products produced at a lab scale under research (non-GMP) conditions (“New Formulation Stability Study”).
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CMC Activities. As of the Effective Date and during the first [***] years this Agreement is in effect, ISIS will support ATL's efforts to timely file an IND application for each Collaboration Compound with respect to the CMC activities described in Exhibit 9.1 for Collaboration Compounds for which ISIS supplied API.
Sample 1
CMC Activities. Notwithstanding anything herein to the contrary (but subject to the last two sentences of this Section 4.4), with respect to CMC responsibilities, (i) Loxo shall be responsible for ongoing CMC Activities related to the capsule or liquid formulation of a Licensed Product pursuant to the applicable Development Plan, (ii) Bayer shall be responsible for CMC Activities related to a tablet formulation of any LOXO-101 Product pursuant to the applicable Development Plan and, (iii) following the transition of Manufacturing and CMC Activities to Bayer as set forth in Section 10.1, Bayer shall be solely responsible for CMC Activities for Licensed Compounds and Licensed Products pursuant to the applicable Development Plan. For clarity, the provisions of Section 3.6.3 with respect to Loxo’s final decision-making authority shall not apply to CMC Activities following the transition of such activities to Bayer as set forth in Section 10.1. [***] Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Confidential treatment has been requested with respect to this information. [***]
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CMC Activities. As part of winding-down the Studies and the manufacturing activities related thereto, Merck will discontinue all activities related to drug substance-, formulation- and analytical development of all Compounds and Follow-on Compounds. Discontinuing formulation development includes Merck’s short term stability studies after 9-months stability data become available from Alphalytik. Upon Idera´s request, and subject to Idera´s willingness to take on all subsequent costs and duties associated with such stability studies, Merck is willing to provide reasonable assistance to Idera to enable continuation of the ongoing stability studies beyond the 9-month timepoint. Idera will inform Merck within [**] days after the Effective Date if it wants to assume the responsibility of conducting the stability studies beyond 9 months. In any event, Merck shall not be liable to Idera for any failure of Idera to enter into a contract with Alphalytik. Furthermore, Merck´s assistance will be limited to reasonable efforts to establish contact and mediate a handover within [**] months following the Effective Date, but shall not include any continuation of technical activities such as laboratory work.
Sample 1
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Related to CMC Activities

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Specific Activities Please give detailed information about the specific activities of the Project promoter and the Partner(s), with budget allocations

  • Regulatory Activities Beginning on the Effective Date and to the extent UGNX remains the Lead Development Party with respect to a particular territory, subject to and in accordance with the terms and conditions of this Agreement and the requirements of Applicable Laws, UGNX, shall: (a) use Commercially Reasonable Efforts to file (or have filed) all Regulatory Filings with respect to the Licensed Products in the Field in order to obtain Marketing Approvals in each country in the Territory and the European Territory (or to obtain the European Centralized Approval in the European Core Territory) and in order to obtain Pricing and/or Reimbursement Approvals in the Profit Share Territory; (b) respond in a timely fashion to requests for data and information from Regulatory Authorities with respect to the Licensed Products in the Field in the Territory and the European Territory; and (c) meet with officials of the Regulatory Authorities at such times as may be requested by such Regulatory Authorities with respect to the Core Development Activities (“Regulatory Activities”), provided that KHK will have primary responsibility for obtaining, and UGNX shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals for the Licensed Products in the Field in the European Territory. For the avoidance of doubt, UGNX will be responsible for obtaining, and KHK will provide all assistance reasonably requested by UGNX, in relation to Pricing and/or Reimbursement Approvals, if any, for the Licensed Products in the Field in the Profit Share Territory as part of the UGNX Core Development Activities, it being understood that the costs incurred by UGNX in connection with such activities will be shared equally (50/50). All such Regulatory Activities will be conducted in a manner consistent with the Core Development Plan and coordinated by the JSC in accordance with Article 3. Without limiting the applicability of the foregoing and the remainder of this Article 5, UGNX shall interface with the applicable Regulatory Authority(ies) and, through the JDC, shall keep KHK reasonably informed of all material events and developments occurring in the course of the Regulatory Activities, including scheduled UGNX regulatory strategy discussions and meetings with Regulatory Authorities in the Territory and the European Territory relating to the Licensed Products in the Field.

  • PROJECT ACTIVITIES Grantee must perform the project activities set forth on Exhibit A (the “Project”), attached hereto and incorporated in this Grant by this reference, for the period beginning on the Effective Date and ending June 30, 2021 (the “Performance Period”).

  • Extracurricular Activities Effective July 1, 2009, stipends for participation in extracurricular activities which are authorized by the appointing authority shall be: Pathfinders/Mountaineering: Inland $950/year Sailing $400/year Art Club Advisor $300/year Drama Club Advisor $300/year Cross Country Skiing $150/year Interscholastic Coaches: Boys’ Basketball $1000/year Girls’ Basketball (if class D) $1000/year Asst. Boys’ Basketball $750/year Asst. Girls’ Basketball (if class D) $750/year Interscholastic Sport: Scorekeeper/Timekeeper $10/game Club Sport Coaches: Soccer $400/year Track $400/year Cross County Running $400/year Girls’ Basketball (if not class D) $400/year Sports Activity Director $400/year Athletic Director $200/year Committee:

  • Marketing Activities The Borrower will not, and will not permit any of its Subsidiaries to, engage in marketing activities for any Hydrocarbons or enter into any contracts related thereto other than (i) contracts for the sale of Hydrocarbons scheduled or reasonably estimated to be produced from their proved Oil and Gas Properties during the period of such contract, (ii) contracts for the sale of Hydrocarbons scheduled or reasonably estimated to be produced from proved Oil and Gas Properties of third parties during the period of such contract associated with the Oil and Gas Properties of the Borrower and its Subsidiaries that the Borrower or one of its Subsidiaries has the right to market pursuant to joint operating agreements, unitization agreements or other similar contracts that are usual and customary in the oil and gas business and (iii) other contracts for the purchase and/or sale of Hydrocarbons of third parties (A) which have generally offsetting provisions (i.e. corresponding pricing mechanics, delivery dates and points and volumes) such that no “position” is taken and (B) for which appropriate credit support has been taken to alleviate the material credit risks of the counterparty thereto.

  • Activities Except with the prior written consent of the Board, Executive will not during his employment with the Company undertake or engage in any other employment, occupation or business enterprise, other than ones in which Executive is a passive investor. Executive may engage in civic and not-for-profit activities so long as such activities do not materially interfere with the performance of his duties hereunder.

  • EXTRA-CURRICULAR ACTIVITIES 1. In this agreement, extra-curricular programs and activities include all those that are beyond the provincially prescribed and locally determined curricula of the school.

  • Typical activities (i) Assist in the management of a large functional unit with a diverse or complex set of functions and significant resources.

  • 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).

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