Variance Costs. Standard Cost of Goods include cost elements which are set at so-called standard costs. They serve as a norm on how much typically a Product costs. Deviations from such standard costs are captured in variances · Inventory re/devaluation shall mean the gain or loss as a result of the inventory value adjustment due to changes in the standard costs. · Non-Product related Production costs shall contain technical operations corporate headquarter overhead costs, non Product allocated QA costs, validation costs, directly expensed IT Programme costs, and other costs that cannot be attributed to specific Products. · Warehousing & distribution costs are costs related to warehousing and distribution activities for finished goods to be shipped to 3rd parties. · Write-offs are captured for the destruction of Products that cannot be used anymore due to expiration of shelf-life, spoilage in the Production process, and transportation mishaps. · Third Party royalties are manufacturing and/or supply royalties paid to Third Parties The following expenses are not included in Production costs: a) Inventory carrying costs; b) Regulatory affairs costs; c) Pilot plant costs, research batches and other similar costs prior to turnover to manufacturing (excluding commercial goods produced by a research facility); d) Costs incurred by manufacturing for special Programmes to establish and certify new Production processes, batch sizes and Product line improvements, and new vendor certification of equipment and primary materials components; e) Manufacturing start-up costs and initial one-time extraordinary manufacturing costs incurred prior to plant operation and achievement of a normal Production activity level; including the costs of training, testing, qualification/validation of new equipment and facilities and initial, trial batches; f) Significant idle capacity is eliminated from factory overhead and Product cost; g) Finished goods warehousing, shipping and other distribution costs; h) Product liability and/or business interruption insurance expenses; and i) Intercompany profit. 1. Infrastructure: laboratories and office space, including the costs of buildings, rental, fixtures and utilities) at the PTC’s facilities in New Jersey, USA (the “PTC Facilities”) and provision of the services of the PTC FTEs to the extent set out in the Application. 2. Access to existing equipment and laboratory benches within the PTC Facilities.
Appears in 5 contracts
Samples: Agreement for the Provision of Funding, Agreement for the Provision of Funding (PTC Therapeutics, Inc.), Agreement for the Provision of Funding (PTC Therapeutics, Inc.)
Variance Costs. Standard Cost of Goods include cost elements which are set at so-called standard costs. They serve as a norm on how much typically a Product product costs. Deviations from such standard costs are captured in variances · variances. • Inventory re/devaluation shall mean the gain or loss as a result of the inventory value adjustment due to changes in the standard costs. · • Non-Product product related Production production costs shall contain technical operations corporate headquarter Technical Operations Corporate Headquarter overhead costs, non Product non-product allocated QA costs, validation costs, directly expensed IT Programme project costs, and other costs that cannot be attributed to specific Productsproducts. · • Warehousing & distribution Distribution costs are costs related to warehousing and distribution activities for finished goods Finished Goods to be shipped to 3rd parties. · • Write-offs are captured for the destruction of Products products that cannot be used anymore due to expiration of shelf-life, spoilage in the Production production process, and transportation mishaps. · • Third Party royalties are for manufacturing or marketing, and/or supply royalties paid to Third Parties third parties ◦ Product liability and/or business interruption insurance expenses, and ◦ Patent maintenance costs The following expenses are not included in Production production costs:
a) Inventory carrying costs;Carrying Costs
b) Regulatory affairs costs;Affairs Costs
c) Pilot plant costs, research batches and other similar costs prior to turnover to manufacturing (excluding commercial goods produced by a research facility);
d) Costs incurred by manufacturing for special Programmes to establish and certify new Production processes, batch sizes and Product line improvements, and new vendor certification of equipment and primary materials components;
e) Manufacturing start-up costs and initial one-time extraordinary manufacturing costs incurred prior to plant operation and achievement of a normal Production activity level; including the costs of training, testing, qualification/validation of new equipment and facilities and initial, trial batches;
f) Significant idle capacity is eliminated from factory overhead and Product product cost;.
gd) Finished goods warehousingIntracompany profit. "Direct Costs" means any costs and expenses incurred or allowed from time to time in accordance with this Agreement by or for the account of the Trust or the Company (as appropriate) in prosecuting, shipping maintaining, enforcing or defending any of the Exploitation IPRs, marketing the Exploitation IPRs and negotiating, concluding or enforcing agreements for the licensing or other Exploitation of the Exploitation IPRs (including by way of acquisition of equity in a company), including without limitation:(a) all reasonable legal, accounting and other distribution costsprofessional fees and charges;(b) official filing, prosecution, maintenance and renewal fees;(c) travelling and other out-of-pocket expenditure; and (d) Cost of Goods;
h) Product liability and/or business interruption insurance expenses; and
i) Intercompany profit.
1. Infrastructure: laboratories and office space, including the costs of buildings, rental, fixtures and utilities) at the PTC’s facilities in New Jersey, USA (the “PTC Facilities”) and provision of the services of the PTC FTEs to the extent set out in the Application.
2. Access to existing equipment and laboratory benches within the PTC Facilities.
Appears in 1 contract
Samples: Equity and Revenue Sharing Agreement (Summit Therapeutics PLC)