DESCRIPTION AND DELIVERABLES Sample Clauses

DESCRIPTION AND DELIVERABLES. The objective of this Agreement is to GMP manufacture, the warehousing, the analytical release testing and the stability storage and testing of the RHB-104 CTM resupply. 2.1 API, excipients and packaging components reception and storage 2.1 a) API sourcing 2.1 b) GMP Materials (excipients and packaging components) storage and handling-
DESCRIPTION AND DELIVERABLES. 2.1- [****] study
DESCRIPTION AND DELIVERABLES. 2.1- [****] study The Drug-Drug compatibility study will be limited to [****] and [****] since [****] these molecules have [****] (i.e. [****] and [****] respectively) and thus it is highly probable that they will [****] the [****] moleculewhich is very [****] in an [****] environment. The [****] and [****] will be [****] under [****] and [****] conditions and stored in [****] and [****] containers under the following conditions of temperature and humidity: The mixture will be and for their (and) at each time points [****] [****] [****] [****] [****] [****] [****]
DESCRIPTION AND DELIVERABLES. In this agreement, Corealis will be executing the development of a manufacturing process, GMP manufacture, packaging and warehousing and analytical release and stability testing of the RHB-104 CTM for the Client. 2.1- API, excipients and packaging components reception and storage 2.1 a) API sourcing Materials will be provided in sufficient quantity by the Client fully released as per USP and EP pharmacopeia. · GMP Clarithromycin API; · GMP Rifabutin API; · GMP Clofazimine API; · All GMP inactive ingredients and packaging components. Cost: 0$ 2.1 b) GMP material storage and handling- Corealis will handle the reception, ID testing, shipping and storage of GMP APIs and other components in its cGMP warehouse. Minimal documentation required which will consist of BSE statement, cGMP certificate, certificate of analysis and MSDS. All material handling operations and storage conditions will respect the ICH GMP requirements. Cost: [****]$* * The cost includes: · the reception of one lot of each of the three GMP APIs and [****] lots of excipients and packaging components (i.e., documentation review, material registration in Corealis inventory, and material sampling following GMP requirements) as well as their ID testing (The cost is based on the hypothesis that all GMP material will be received in one single shipment at [****]$/ shipment and [****] GMP materials will be sampled and analyzed at [****]$/ lot of GMP material received. Any additional shipment or reception of GMP material will be considered as Extra Work at [****]$/ shipment or reception. Any additional sampling and ID testing of GMP material received will be considered Extra Work at [****]$/ lot of GMP material received.) · the GMP warehousing of the APIs and the drug product until completion of the study. If the material needs to be stored for a longer period of time then the storage cost will be [****]. The cost does not include: · the cost of the APIs as it will be determined pending the sourcing activities, Date: September 28th, 2012 · the time of Corealis professionals and related cost in supporting the Client in the API manufacturers qualification and any eventual costs related to the sourcing of the APIs (e.g., shipping and custom fees, time and expenses in negotiating contracts, direct and indirect costs of API sourcing). Any third Party cost and fees will be charged to Client at cost and will be considered as Extra Work. · the purchase cost of the reference materials to be used as a standards a...

Related to DESCRIPTION AND DELIVERABLES

  • Tasks and Deliverables A description of and the schedule for each task and deliverable, illustrated by a ▇▇▇▇▇ chart. Start and completion dates for each task, milestone, and deliverable shall be indicated. Must include deliverables specified in SOW-RFP as well as other deliverables that may be proposed by Contractor.

  • Services and Deliverables The Services and the required Deliverables for the Services are specified below. Service Type Output Measure Quantity per annum Number of Service Users Funding amount per annum (excl. GST) $ $ $ Description of Services Funding amount one-off (excl. GST) $ Service Type Output Measure Quantity per annum Number of Service Users Funding amount (excl. GST) $ $ $ Description of Services Funding amount one-off (excl. GST) $

  • LOCATION AND DESCRIPTION The subject property is a 3 bedroom serviced apartment (corner unit) bearing a postal address Unit No. ▇▇-▇▇-▇▇, ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇. ▇, ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇. The property will be sold on an “as is where is” basis, subject to a reserve price of RM449,000.00 (RINGGIT MALAYSIA FOUR HUNDRED FORTY NINE THOUSAND ONLY), subject to the Conditions of Sale and by way of an Assignment from the Assignee subject to consent being obtained by the successful bidder (“the Purchaser”) from the relevant authorities, if any, including all terms, conditions, stipulations and covenants which were and may be imposed by the relevant authority. Apportionment on any arrears of quit rent, assessment rate and maintenance charges ONLY which is lawfully due i.e which is unpaid for up to maximum 6 years preceding the successful auction date in respect of the property up to the date of sale shall be paid by the Bank upon receipt of full auction proceeds and any such sums due and payable after the date of sale shall be borne by the Purchaser. Successful Bidder is urge to submit their claim to the Bank within sixty (60) days from the date of payment of balance purchase money (or any extended period allowed by the Bank); any subsequent claims made thereunder will not be entertained by the Bank and the same shall be borne by the Purchaser solely. The Assignee/Lender shall not be liable to make payment or to deduct from the proceeds of sale any outstanding utilities/bills relating to the property namely water, electricity, telephone, gas or sewerage charges, administration charges and other utilities. All other fees, costs and charges relating to the transfer and assignment of the property including any revival cost for abandoned project (if any) shall also be borne solely by the successful Purchaser. Intending Purchaser shall make his own inquiries in respect thereof and the Purchaser shall be deemed to have full knowledge of the same.

  • Execution and Delivery The Guaranteeing Subsidiary agrees that the Guarantee shall remain in full force and effect notwithstanding the absence of the endorsement of any notation of such Guarantee on the Notes.

  • Execution and Delivery of Agreement Each of the parties shall be entitled to rely on delivery by fax transmission of an executed copy of this agreement by the other party, and acceptance of such fax copies shall create a valid and binding agreement between the parties.