Autoinjector Sample Clauses

Autoinjector. 3.2.1 Within 90 days after the Effective Date, POZEN will prepare the development plan for the Autoinjector Presentation (the “Autoinjector Development Plan”) and will submit such plan for review and approval by the CMC at the next meeting. The outline of the Autoinjector Development Plan with the target timeline for the submission of the Autoinjector SNDA is attached as Exhibit B.
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Related to Autoinjector

  • Manufacturing Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that AquaBounty and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials or bulk quantities of other components of AquaBounty Products, then Intrexon shall provide to AquaBounty or a contract manufacturer selected by AquaBounty and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of AquaBounty Products for use in the Field and (b) reasonably necessary to enable AquaBounty or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of AquaBounty Products. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any AquaBounty Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty to switch manufacturers.

  • Recycling (a) To the extent the Master Fund is authorized to retain or recall for reinvestment proceeds received by the Master Fund from the Underlying Funds, the Fund may retain or recall such amounts as the General Partner, in its sole discretion, deems necessary or desirable to facilitate such reinvestment (which may include the payment of fees or expenses of the Master Fund, as well as investment in Underlying Funds).

  • Virus Management Transfer Agent shall maintain a malware protection program designed to deter malware infections, detect the presence of malware within the Transfer Agent environment.

  • Fuel Upon redelivery of the Aircraft to Lessor, an adjustment will be made in respect of fuel on board on the Previous Delivery Date and the Expiry Date at the price then prevailing at the Redelivery Location.

  • Stability During the Term, Seller shall conduct the commercial stability program pursuant to Regulatory Requirements applicable as of the Effective Date at its own expense. Should additional stability studies be required, the Parties shall agree, in good faith, upon the protocol, and associated charges, based on the then current charge rates for the staff services, with invoicing for such additional services to occur when the lot is placed on stability.

  • Wash all machine-washable bedding, drapes, and clothing, on the hottest water temperature and dry on the highest heat setting. Items that cannot be washed must be taken to a dry cleaner who MUST be informed of the issue. You must safely discard ALL items that cannot be decontaminated.

  • Cleaning 4.6.1 To keep the Property clean, tidy and free from rubbish;

  • HEATING, VENTILATING AND AIR CONDITIONING The Tenant will operate and regulate those portions of the heating, ventilating, and air conditioning equipment within and serving the Leased Premises so as to maintain such reasonable conditions of temperature and humidity within the Leased Premises as are determined by the Landlord and its Architect and engineers so that no direct or indirect appropriation of the heating, ventilating and air conditioning from the other portions of the Building occurs. The Tenant shall comply with such stipulations and with all Rules and Regulations of the Landlord pertaining to the operation and regulation of such equipment. The Tenant shall immediately notify the Landlord in the event that any repairs are required to the heating, ventilating and air conditioning equipment serving the Leased Premises and shall reimburse the Landlord as part of its Proportionate Share of Operating Costs for the cost of any maintenance, repairs or replacements made by the Landlord in respect of the heating, ventilating and air conditioning equipment serving the Leased Premises. The Landlord acknowledges that the Tenant shall not be responsible for the cost of capital repairs and capital replacements in respect of the heating, ventilating and air conditioning equipment serving the Leased Premises provided that such capital repairs and capital replacements are not necessitated by the Tenant's incorrect or negligent use of equipment. The Tenant shall not under any circumstances go onto the roof of the Building or make any maintenance repairs or replacements to the heating, ventilating and air conditioning systems in the Building without the prior written consent of the Landlord. If the Tenant fails to comply with such stipulations and Rules and Regulations, the Landlord shall be entitled to take such steps as it deems advisable to correct such defaults (including, without limitation, entering upon the Leased Premises and assuming control of such equipment) without liability to the Tenant, and the Tenant will pay to the Landlord forthwith upon demand as Additional Rent all costs and expenses incurred by the Landlord in so doing. The Landlord represents and warrants to the Tenant that the heating, ventilating and air conditioning equipment serving the Leased Premises and required to be installed by the Landlord pursuant to Schedule "C" is and will be at the Commencement Date in good working order and condition.

  • Transportation Management Tenant shall fully comply with all present or future programs intended to manage parking, transportation or traffic in and around the Building, and in connection therewith, Tenant shall take responsible action for the transportation planning and management of all employees located at the Premises by working directly with Landlord, any governmental transportation management organization or any other transportation-related committees or entities.

  • Plant An electrical generating alternative energy resource facility developed by Producer for which IID shall provide transmission service, as specified in Exhibit(s) II, Transmission Service, and in any subsequent Plant Amendments.

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