Dedicated Equipment. 2.7.1 Xxxx shall procure the Dedicated Equipment at Dyax’s sole cost, plus applicable Xxxx markup to cover handling costs, in accordance with the Product Specifications. Xxxx shall use commercially reasonable efforts to determine whether the Dedicated Equipment conforms to the applicable Product Specifications and will work in the Facility for purpose stated in the relevant Work Order. 2.7.2 Xxxx may use the Dedicated Equipment only for performing its obligations under this Agreement. Xxxx shall use the Dedicated Equipment only in accordance with any written instructions prescribed by Dyax or the manufacturer of the Dedicated Equipment, and shall perform such routine maintenance and calibration for the Dedicated Equipment as is reasonably required by such written instructions for an annual maintenance charge to Dyax. All costs for any extraordinary or non-routine maintenance that may be required will be approved in advance by Dyax, and the appropriate relevant Work Order will be revised to reflect any additional maintenance costs that may be required during the Term. Except (i) in connection with such routine maintenance, (ii) as required by the Services, or (iii) as directed in writing by Dyax, Xxxx shall not make any alterations, additions or improvements to the Dedicated Equipment. All alterations, additions or improvements made to the Dedicated Equipment will be at Dyax’s sole cost and expense. 2.7.3 Dyax shall own and continue to own all right, title and interest in and to any Dedicated Equipment. Dyax assumes any risk of loss, damage, theft or destruction of the Dedicated Equipment while that Dedicated Equipment is in Xxxx’x possession or on Xxxx’x premises. Upon termination or expiration of this Agreement, Dyax shall have the right and obligation to, upon reasonable notice, reclaim possession of such Dedicated Equipment at its sole expense (including all costs of disconnection, removal, physical transfer and any subsequent reinstallation and requalification costs). Xxxx shall reasonably cooperate with Dyax to remove and return such Dedicated Equipment to Dyax in accordance with Dyax’s written instructions and shall invoice Dyax for (i) direct costs incurred and (ii) any damage other than reasonable wear and tear to the Facility incurred as a result of the use and removal of the Dedicated Equipment. Notwithstanding the above, upon termination or expiration of this Agreement, Dyax may offer to sell to Xxxx, or Xxxx may offer to purchase from Dyax, the Dedicated Equipment at its then depreciated cost or fair market value, whichever is less. Neither Xxxx nor Dyax shall be obligated to make or accept such offers. In the event that Dyax has not removed the Dedicated Equipment within [*****] after reasonable notice, the Dedicated Equipment shall be deemed to be abandoned and Xxxx may dispose of it or use it as it sees fit.
Appears in 2 contracts
Samples: Manufacturing Services Agreement (Dyax Corp), Manufacturing Services Agreement (Dyax Corp)
Dedicated Equipment. 2.7.1 Xxxx shall procure At present, the Dedicated Equipment at Dyax’s sole cost, plus applicable Xxxx markup parties do not anticipate the need for any specialized equipment to cover handling costs, manufacture the Product in accordance with cGMP and the Product Specifications. Xxxx shall use commercially reasonable efforts to determine whether However, if in the future such need arises, Pfizer will advise AMAG of any specialized or dedicated equipment (“Dedicated Equipment”) that is required and the estimated costs associated with the purchase, installation and validation of the Dedicated Equipment conforms to Equipment. Pfizer will pay the applicable Product Specifications and will work in the Facility for purpose stated in the relevant Work Order.
2.7.2 Xxxx may use the Dedicated Equipment only for performing its obligations under this Agreement. Xxxx shall use the Dedicated Equipment only in accordance with any written instructions prescribed by Dyax or the manufacturer cost of the Dedicated Equipment, subject to AMAG’s prior written approval of such costs, which approval will not be unreasonably withheld or conditioned. Upon such approval, Pfizer will then purchase, install and shall perform such routine maintenance validate the equipment and calibration xxxx AMAG for the Dedicated Equipment as is reasonably required by such written instructions for an annual maintenance charge associated costs. AMAG will make payment to Dyax. All costs for any extraordinary or non-routine maintenance that may be required will be approved in advance by Dyax, and the appropriate relevant Work Order will be revised to reflect any additional maintenance costs that may be required during the Term. Except (i) in connection with such routine maintenance, (ii) as required by the Services, or (iii) as directed in writing by Dyax, Xxxx shall not make any alterations, additions or improvements to the Dedicated Equipment. All alterations, additions or improvements made to the Dedicated Equipment will be at Dyax’s sole cost and expense.
2.7.3 Dyax shall own and continue to own all right, title and interest in and to any Dedicated Equipment. Dyax assumes any risk of loss, damage, theft or destruction of the Dedicated Equipment while that Dedicated Equipment is in Xxxx’x possession or on Xxxx’x premises. Upon termination or expiration of this Agreement, Dyax shall have the right and obligation to, upon reasonable notice, reclaim possession of such Dedicated Equipment at its sole expense (including all costs of disconnection, removal, physical transfer and any subsequent reinstallation and requalification costs). Xxxx shall reasonably cooperate with Dyax to remove and return such Dedicated Equipment to Dyax in accordance with Dyax’s written instructions and shall invoice Dyax for (i) direct costs incurred and (ii) any damage other Pfizer no later than reasonable wear and tear to the Facility incurred as a result of the use and removal of the Dedicated Equipment. Notwithstanding the above, upon termination or expiration of this Agreement, Dyax may offer to sell to Xxxx, or Xxxx may offer to purchase from Dyax, the Dedicated Equipment at its then depreciated cost or fair market value, whichever is less. Neither Xxxx nor Dyax shall be obligated to make or accept such offers. In the event that Dyax has not removed the Dedicated Equipment within […*****…] after reasonable notice, receipt of Pfizer’s invoice. Title to the Dedicated Equipment shall be deemed to be abandoned and Xxxx may remain in AMAG’s name. Pfizer shall (and shall cause its Affiliates to) (i) label the Technical Transfer & Supply Agreement (signature version) CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED. Dedicated Equipment as the property of AMAG, (ii) use the Dedicated Equipment solely for the manufacture of the Product for and on behalf of AMAG, (iii) keep the Dedicated Equipment free of liens, claims and encumbrances, (iv) operate the Dedicated Equipment in accordance with the manufacturer’s instructions, and (v) maintain the Dedicated Equipment in good working condition and in compliance with cGMP and Applicable Laws. Upon the expiry or earlier termination of this Agreement, Pfizer will return or otherwise dispose of it or use it as it sees fitDedicated Equipment in accordance with Section 10.5(b).
Appears in 1 contract
Samples: Technical Transfer and Supply Agreement (Amag Pharmaceuticals Inc.)
Dedicated Equipment. 2.7.1 Xxxx Seattle Genetics shall procure pay the cost of additional equipment purchased by Abbott (“Dedicated Equipment”), which is required for Abbott to manufacture Bulk Drug Substance for Seattle Genetics (subject to the approval conditions stated below). Abbott shall advise Seattle Genetics of any Dedicated Equipment required and the estimated costs associated with the purchase, installation and validation of such Dedicated Equipment. Abbott must receive written approval (letter, e-mail or facsimile) by an authorized Seattle Genetics representative prior to the purchase of any such Dedicated Equipment. Such Dedicated Equipment shall be used exclusively for manufacturing of Bulk Drug Substance hereunder, unless otherwise permitted in advance by Seattle Genetics in writing. [***]. Abbott shall xxxx Seattle Genetics for the reasonable installation and equipment validation costs after Abbott installs the Dedicated Equipment. Seattle Genetics shall be responsible for any licensing fees, milestones, or royalties associated with Dedicated Equipment. This Section 8.11 shall not apply to any replacement equipment purchased by Abbott because of obsolescence (technical or otherwise). Dedicated Equipment, as estimated on or around the Effective Date, is outlined in Exhibit X. Xxxxxx shall own any Dedicated Equipment. In the event this Agreement is terminated, Abbott and Seattle Genetics shall in good faith agree on the commercially reasonable procedures and costs related to the transfer of title to and possession of Dedicated Equipment at Dyax’s sole costto Seattle Genetics. Seattle Genetics agrees and acknowledges that upon termination of this Agreement, plus applicable Xxxx markup to cover handling costs, unless otherwise agreed in accordance with the Product Specifications. Xxxx this Section, Seattle Genetics shall use commercially reasonable efforts to determine whether the own such Dedicated Equipment conforms to the applicable Product Specifications and will work in the Facility for purpose stated in the relevant Work Order.
2.7.2 Xxxx may use the shall remove its Dedicated Equipment only for performing its obligations under this from Xxxxxx’x property within thirty (30) days after the termination of the Agreement. Xxxx shall use the Upon such termination, if Abbott wishes to retain any such Dedicated Equipment only (in accordance Xxxxxx’x sole discretion), and Seattle Genetics approves of such retention in writing, Abbott shall [***]. In addition to Exhibit F, Abbott shall submit quarterly to Seattle Genetics, an updated estimate of Dedicated Equipment costs for the entire Project. Risk of loss of all Dedicated Equipment shall be retained by Seattle Genetics; provided, however, that Abbott shall be responsible for replacing any Dedicated Equipment that is destroyed due to Xxxxxx’x negligence, willful misconduct, unauthorized use or unauthorized use with any written instructions prescribed by Dyax or the manufacturer of other products. All Dedicated Equipment shall remain at Xxxxxx’x manufacturing facilities. Abbott shall be responsible for maintaining and servicing the Dedicated Equipment. Seattle Genetics, and however, shall perform such routine maintenance and calibration be responsible for the Dedicated Equipment as is reasonably required by such written instructions for an annual maintenance charge to Dyax. All costs for any extraordinary or cost of non-routine maintenance that may be required will be approved in advance by Dyax, and the appropriate relevant Work Order will be revised to reflect any additional maintenance costs that may be required during the Term. Except (i) in connection with such routine maintenance, (ii) as required by the Services, or (iii) as directed in writing by Dyax, Xxxx shall not make any alterations, additions or improvements to the Dedicated Equipment. All alterations, additions or improvements made to the Dedicated Equipment will be at Dyax’s sole cost and expense.
2.7.3 Dyax shall own and continue to own all right, title and interest in and to any Dedicated Equipment. Dyax assumes any risk of loss, damage, theft or destruction servicing of the Dedicated Equipment while that Dedicated Equipment is in Xxxx’x possession or on Xxxx’x premises. Upon termination or expiration of this Agreement(such as major repairs and material parts replacement), Dyax shall have the right and obligation to, upon reasonable notice, reclaim possession of such Dedicated Equipment at its sole expense (including all costs of disconnection, removal, physical transfer and any subsequent reinstallation and requalification costs). Xxxx shall reasonably cooperate with Dyax to remove and return such Dedicated Equipment to Dyax in accordance with Dyax’s written instructions and shall invoice Dyax for (i) direct costs incurred and (ii) any damage other than reasonable wear and tear except to the Facility incurred as a result of the use and removal of the Dedicated Equipment. Notwithstanding the aboveextent caused by Xxxxxx’x negligence, upon termination or expiration of this Agreementwillful misconduct, Dyax may offer to sell to Xxxx, or Xxxx may offer to purchase from Dyax, the Dedicated Equipment at its then depreciated cost or fair market value, whichever is less. Neither Xxxx nor Dyax shall be obligated to make or accept such offers. In the event that Dyax has not removed the Dedicated Equipment within [*****] after reasonable notice, Certain information on this page has been omitted and filed separately with the Dedicated Equipment Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. unauthorized use or use with other products in which case Abbott shall be deemed responsible. Abbott shall notify Seattle Genetics prior to the performance of any non-routine maintenance or servicing, and Seattle Genetics shall reimburse Abbott at cost for such maintenance or servicing costs that Seattle Genetics has authorized to be abandoned incurred and Xxxx may dispose of for which it or use it as it sees fitis responsible.
Appears in 1 contract
Samples: Development and Supply Agreement (Seattle Genetics Inc /Wa)
Dedicated Equipment. 2.7.1 Xxxx shall procure the Dedicated Equipment at Dyax’s sole cost, plus applicable Xxxx markup to cover handling costs, in accordance with the Product Specifications. Xxxx shall use commercially reasonable efforts to determine whether the Dedicated Equipment conforms to the applicable Product Specifications and will work in the Facility for purpose stated in the relevant Work Order.
2.7.2 Xxxx may use the Dedicated Equipment only for performing its obligations under this Agreement. Xxxx shall use the Dedicated Equipment only in accordance with any written instructions prescribed by Dyax The Parties have agreed that certain specialized or the manufacturer of the dedicated equipment (“Dedicated Equipment, and ”) is required to manufacture Product for Xxxxxxx as set forth on Schedule 5.5. The Parties have further agreed that Pfizer shall perform such routine maintenance and calibration for the Dedicated Equipment as is reasonably required by such written instructions for an annual maintenance charge to Dyax. All costs for any extraordinary or non-routine maintenance that may be required will be approved in advance by Dyax, and the appropriate relevant Work Order will be revised to reflect any additional maintenance costs that may be required during the Term. Except (i) in connection with such routine maintenance, (ii) as required by the Services, or (iii) as directed in writing by Dyax, Xxxx shall not make any alterations, additions or improvements to the Dedicated Equipment. All alterations, additions or improvements made to the Dedicated Equipment will be at Dyax’s sole cost and expense.
2.7.3 Dyax shall own and continue to own all right, title and interest in and to any Dedicated Equipment. Dyax assumes any risk of loss, damage, theft or destruction advise Xxxxxxx of the Dedicated Equipment while that Dedicated Equipment is in Xxxx’x possession or on Xxxx’x premises. Upon termination or expiration of this Agreementrequired and the estimated costs associated with the purchase, Dyax shall have the right installation and obligation to, upon reasonable notice, reclaim possession of such Dedicated Equipment at its sole expense (including all costs of disconnection, removal, physical transfer and any subsequent reinstallation and requalification costs). Xxxx shall reasonably cooperate with Dyax to remove and return such Dedicated Equipment to Dyax in accordance with Dyax’s written instructions and shall invoice Dyax for (i) direct costs incurred and (ii) any damage other than reasonable wear and tear to the Facility incurred as a result of the use and removal validation of the Dedicated Equipment. Notwithstanding the above, upon termination or expiration of this Agreement, Dyax may offer to sell to Xxxx, or Xxxx may offer to purchase from Dyax, the Dedicated Equipment at its then depreciated cost or fair market value, whichever is less. Neither Xxxx nor Dyax shall be obligated to make or accept such offers. In the event that Dyax has not removed the Dedicated Equipment within [****], subject to Xxxxxxx’x prior written approval of such costs, which approval will not be unreasonably withheld or conditioned. Upon such approval, Pfizer will then purchase, install and validate the equipment and xxxx Xxxxxxx for the associated costs in accordance with the terms agreed in the Statement of Work. [*] after reasonable notice, Title to the Dedicated Equipment shall be deemed and remain in Xxxxxxx’x name. Pfizer shall (and shall cause its Affiliates to) (i) label the Dedicated Equipment as the property of Xxxxxxx, (ii) use the Dedicated Equipment solely for the manufacture of the Product for and on behalf of Xxxxxxx, (iii) keep the Dedicated Equipment free of liens, claims and encumbrances, (iv) operate the Dedicated Equipment in accordance with the manufacturer’s instructions, (v) maintain the Dedicated Equipment in good working condition and in compliance with cGMP and Applicable Laws, provided that, for any repairs covered by a manufacturer’s warranty, Xxxxxxx shall authorize such repairs under such warranty solely to be abandoned the extent Pfizer grants access to the Facility for the performance of such repairs, and Xxxx may (vi) ensure the Dedicated Equipment is insured at all times in the amounts adequate to replace the Dedicated Equipment. Upon the expiry or earlier termination of this Agreement, Pfizer will return or otherwise dispose of it or use it as it sees fitDedicated Equipment at Xxxxxxx’x direction in accordance with Section 10.6(b).
Appears in 1 contract
Dedicated Equipment. 2.7.1 Xxxx Seattle Genetics shall procure pay the cost of additional equipment purchased by Abbott (“Dedicated Equipment”), which is required for Abbott to manufacture Bulk Drug Substance for Seattle Genetics (subject to the approval conditions stated below). Abbott shall advise Seattle Genetics of any Dedicated Equipment required and the estimated costs associated with the purchase, installation and validation of such Dedicated Equipment. Abbott must receive written approval (letter, e-mail or facsimile) by an authorized Seattle Genetics representative prior to the purchase of any such Dedicated Equipment. Such Dedicated Equipment shall be used exclusively for manufacturing of Bulk Drug Substance hereunder, unless otherwise permitted in advance by Seattle Genetics in writing. If Seattle Genetics authorizes the use of such Dedicated Equipment for other products, Abbott shall provide Seattle Genetics with a credit in the reasonable amount of prorated cost(s) of the Dedicated Equipment at Dyax’s sole cost, plus applicable Xxxx markup to cover handling costs, in accordance with the Product Specifications(based on relative time of usage for each product). Xxxx Abbott shall use commercially reasonable efforts to determine whether the Dedicated Equipment conforms to the applicable Product Specifications and will work in the Facility for purpose stated in the relevant Work Order.
2.7.2 Xxxx may use the Dedicated Equipment only for performing its obligations under this Agreement. Xxxx shall use the Dedicated Equipment only in accordance with any written instructions prescribed by Dyax or the manufacturer of the Dedicated Equipment, and shall perform such routine maintenance and calibration xxxx Seattle Genetics for the Dedicated Equipment as is reasonably required by such written instructions for an annual maintenance charge to Dyax. All reasonable installation and equipment validation costs for any extraordinary or non-routine maintenance that may be required will be approved in advance by Dyax, and the appropriate relevant Work Order will be revised to reflect any additional maintenance costs that may be required during the Term. Except (i) in connection with such routine maintenance, (ii) as required by the Services, or (iii) as directed in writing by Dyax, Xxxx shall not make any alterations, additions or improvements to after Abbott installs the Dedicated Equipment. All alterationsThis Section 8.8 shall not apply to any replacement equipment purchased by Abbott because of obsolescence (technical or otherwise). Dedicated Equipment, additions as estimated on or improvements made to around the Dedicated Equipment will be at Dyax’s sole cost and expense.
2.7.3 Dyax Effective Date, is outlined in Exhibit X. Xxxxxx shall own and continue to own all right, title and interest in and to any Dedicated Equipment. Dyax assumes any risk In the event this Agreement is terminated, Abbott and Seattle Genetics shall in good faith agree on the commercially reasonable procedures and costs related to the transfer of loss, damage, theft or destruction title to and possession of the Dedicated Equipment while to Seattle Genetics. Seattle Genetics agrees and acknowledges that Dedicated Equipment is in Xxxx’x possession or on Xxxx’x premises. Upon upon termination or expiration of this Agreement, Dyax unless otherwise agreed in accordance with this Section, Seattle Genetics shall have the right and obligation to, upon reasonable notice, reclaim possession of own such Dedicated Equipment at and shall remove its sole expense Dedicated Equipment from Xxxxxx’x property within thirty (including all costs 30) days after the termination of disconnectionthe Agreement. Upon such termination, removal, physical transfer and if Abbott wishes to retain any subsequent reinstallation and requalification costs). Xxxx shall reasonably cooperate with Dyax to remove and return such Dedicated Equipment to Dyax (in accordance with Dyax’s written instructions Xxxxxx’x sole discretion), and Seattle Genetics approves of such retention in writing, Abbott shall invoice Dyax reimburse Seattle Genetics for (i) direct costs incurred and (ii) any damage other than reasonable wear and tear to the Facility incurred as a result of the use and removal of the Dedicated Equipment. Notwithstanding the above, upon termination or expiration of this Agreement, Dyax may offer to sell to Xxxx, or Xxxx may offer to purchase from Dyax, the such retained Dedicated Equipment at its then depreciated cost or fair market current book value, whichever is less. Neither Xxxx nor Dyax shall be obligated to make or accept such offers. In the event that Dyax has not removed the addition to Exhibit F, Abbott shall submit quarterly to Seattle Genetics, an updated estimate of Dedicated Equipment within [*****] after reasonable noticecosts for the entire Project. Title to, the and risk of loss of, all Dedicated Equipment shall be deemed retained by Seattle Genetics; provided, however, that Abbott shall be responsible for replacing any Dedicated Equipment that is destroyed due to Xxxxxx’x negligence, willful misconduct, unauthorized use or unauthorized use with other products. All Dedicated Equipment shall remain at Xxxxxx’x manufacturing facilities. Abbott shall be responsible for maintaining and servicing the Dedicated Equipment. Seattle Genetics, however, shall be responsible for the cost of non-routine maintenance and servicing of the Dedicated Equipment (such as major repairs and material parts replacement), except to the extent caused by Xxxxxx’x negligence, willful misconduct, unauthorized use or use with other products in which case Abbott shall be responsible. Abbott shall notify Seattle Genetics prior to the performance of any non-routine maintenance or servicing, and Seattle Genetics shall reimburse Abbott at cost for such maintenance or servicing costs that Seattle Genetics has authorized to be abandoned incurred and Xxxx may dispose of for which it or use it as it sees fitis responsible.
Appears in 1 contract
Samples: Development and Supply Agreement (Seattle Genetics Inc /Wa)
Dedicated Equipment. 2.7.1 Xxxx Seattle Genetics shall procure pay the cost of additional equipment purchased by Abbott (“Dedicated Equipment”), which is required for Abbott to manufacture Bulk Drug Substance for Seattle Genetics (subject to the approval conditions stated below). Abbott shall advise Seattle Genetics of any Dedicated Equipment required and the estimated costs associated with the purchase, installation and validation of such Dedicated Equipment. Abbott must receive written approval (letter, e-mail or facsimile) by an authorized Seattle Genetics representative prior to the purchase of any such Dedicated Equipment. Such Dedicated Equipment shall be used exclusively for manufacturing of Bulk Drug Substance hereunder, unless otherwise permitted in advance by Seattle Genetics in writing. [*] Abbott shall xxxx Seattle Genetics for the reasonable installation and equipment validation costs after Abbott installs the Dedicated Equipment. This Section 8.8 shall not apply to any replacement equipment purchased by Abbott because of obsolescence (technical or otherwise). Dedicated Equipment, as estimated on or around the Effective Date, is outlined in Exhibit X. Xxxxxx shall own any Dedicated Equipment. In the event this Agreement is terminated, Abbott and Seattle Genetics shall in good faith agree on the commercially reasonable procedures and costs related to the transfer of title to and possession of Dedicated Equipment at Dyax’s sole costto Seattle Genetics. Seattle Genetics agrees and acknowledges that upon termination of this Agreement, plus applicable Xxxx markup to cover handling costs, unless otherwise agreed in accordance with the Product Specifications. Xxxx this Section, Seattle Genetics shall use commercially reasonable efforts to determine whether the own such Dedicated Equipment conforms to the applicable Product Specifications and will work in the Facility for purpose stated in the relevant Work Order.
2.7.2 Xxxx may use the shall remove its Dedicated Equipment only for performing its obligations under this from Xxxxxx’x property within thirty (30) days after the termination of the Agreement. Xxxx shall use the Upon such termination, if Abbott wishes to retain any such Dedicated Equipment only (in accordance Xxxxxx’x sole discretion), and Seattle Genetics approves of such retention in writing, Abbott shall [*]. In addition to Exhibit F, Abbott shall submit quarterly to Seattle Genetics, an updated estimate of Dedicated Equipment costs for the entire Project. Title to, and risk of loss of, all Dedicated Equipment shall be retained by Seattle Genetics; provided, however, that Abbott shall be responsible for replacing any Dedicated Equipment that is destroyed due to Xxxxxx’x negligence, willful misconduct, unauthorized use or unauthorized use with any written instructions prescribed by Dyax or the manufacturer of other products. All Dedicated Equipment shall remain at Xxxxxx’x manufacturing facilities. Abbott shall be responsible for maintaining and servicing the Dedicated Equipment. Seattle Genetics, and however, shall perform such routine maintenance and calibration be responsible for the Dedicated Equipment as is reasonably required by such written instructions for an annual maintenance charge to Dyax. All costs for any extraordinary or cost of non-routine maintenance that may be required will be approved in advance by Dyax, and the appropriate relevant Work Order will be revised to reflect any additional maintenance costs that may be required during the Term. Except (i) in connection with such routine maintenance, (ii) as required by the Services, or (iii) as directed in writing by Dyax, Xxxx shall not make any alterations, additions or improvements to the Dedicated Equipment. All alterations, additions or improvements made to the Dedicated Equipment will be at Dyax’s sole cost and expense.
2.7.3 Dyax shall own and continue to own all right, title and interest in and to any Dedicated Equipment. Dyax assumes any risk of loss, damage, theft or destruction servicing of the Dedicated Equipment while (such as major repairs and material parts replacement), except to the extent caused by Xxxxxx’x negligence, willful misconduct, unauthorized use or use with other products in which case Abbott shall be responsible. Abbott shall notify Seattle Genetics prior to the performance of any non-routine maintenance or servicing, and Seattle Genetics shall reimburse Abbott at cost for such maintenance or servicing costs that Dedicated Equipment is in Xxxx’x possession or on Xxxx’x premises. Upon termination or expiration of this Agreement, Dyax shall have the right and obligation to, upon reasonable notice, reclaim possession of such Dedicated Equipment at its sole expense (including all costs of disconnection, removal, physical transfer and any subsequent reinstallation and requalification costs). Xxxx shall reasonably cooperate with Dyax Seattle Genetics has authorized to remove and return such Dedicated Equipment to Dyax in accordance with Dyax’s written instructions and shall invoice Dyax for (i) direct costs be incurred and (ii) any damage other than reasonable wear and tear for which it is responsible. [*] Confidential treatment has been requested with respect to the Facility incurred as a result of the use and removal of the Dedicated Equipment. Notwithstanding the above, upon termination or expiration of this Agreement, Dyax may offer to sell to Xxxx, or Xxxx may offer to purchase from Dyax, the Dedicated Equipment at its then depreciated cost or fair market value, whichever is less. Neither Xxxx nor Dyax shall be obligated to make or accept such offers. In the event that Dyax has not removed the Dedicated Equipment within [*****] after reasonable notice, the Dedicated Equipment shall be deemed to be abandoned and Xxxx may dispose of it or use it as it sees fitomitted portions.
Appears in 1 contract
Samples: Development and Supply Agreement (Seattle Genetics Inc /Wa)
Dedicated Equipment. 2.7.1 Xxxx The Parties have agreed that certain specialized or dedicated equipment (“Dedicated Equipment”) is required to manufacture Product for Xxxxxxx as set forth on Schedule 5.5. The Parties have further agreed that Pfizer shall procure advise Xxxxxxx of [*] = 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 24b-2 of the Securities Exchange Act of 1934, as amended. the Dedicated Equipment at Dyax’s sole cost, plus applicable Xxxx markup to cover handling costs, in accordance required and the estimated costs associated with the Product Specifications. Xxxx shall use commercially reasonable efforts to determine whether the Dedicated Equipment conforms to the applicable Product Specifications purchase, installation and will work in the Facility for purpose stated in the relevant Work Order.
2.7.2 Xxxx may use the Dedicated Equipment only for performing its obligations under this Agreement. Xxxx shall use the Dedicated Equipment only in accordance with any written instructions prescribed by Dyax or the manufacturer of the Dedicated Equipment, and shall perform such routine maintenance and calibration for the Dedicated Equipment as is reasonably required by such written instructions for an annual maintenance charge to Dyax. All costs for any extraordinary or non-routine maintenance that may be required will be approved in advance by Dyax, and the appropriate relevant Work Order will be revised to reflect any additional maintenance costs that may be required during the Term. Except (i) in connection with such routine maintenance, (ii) as required by the Services, or (iii) as directed in writing by Dyax, Xxxx shall not make any alterations, additions or improvements to the Dedicated Equipment. All alterations, additions or improvements made to the Dedicated Equipment will be at Dyax’s sole cost and expense.
2.7.3 Dyax shall own and continue to own all right, title and interest in and to any Dedicated Equipment. Dyax assumes any risk of loss, damage, theft or destruction of the Dedicated Equipment while that Dedicated Equipment is in Xxxx’x possession or on Xxxx’x premises. Upon termination or expiration of this Agreement, Dyax shall have the right and obligation to, upon reasonable notice, reclaim possession of such Dedicated Equipment at its sole expense (including all costs of disconnection, removal, physical transfer and any subsequent reinstallation and requalification costs). Xxxx shall reasonably cooperate with Dyax to remove and return such Dedicated Equipment to Dyax in accordance with Dyax’s written instructions and shall invoice Dyax for (i) direct costs incurred and (ii) any damage other than reasonable wear and tear to the Facility incurred as a result of the use and removal validation of the Dedicated Equipment. Notwithstanding the above, upon termination or expiration of this Agreement, Dyax may offer to sell to Xxxx, or Xxxx may offer to purchase from Dyax, the Dedicated Equipment at its then depreciated cost or fair market value, whichever is less. Neither Xxxx nor Dyax shall be obligated to make or accept such offers. In the event that Dyax has not removed the Dedicated Equipment within [****], subject to Xxxxxxx’x prior written approval of such costs, which approval will not be unreasonably withheld or conditioned. Upon such approval, Pfizer will then purchase, install and validate the equipment and xxxx Xxxxxxx for the associated costs in accordance with the terms agreed in the Statement of Work. [*] after reasonable notice, Title to the Dedicated Equipment shall be deemed and remain in Xxxxxxx’x name. Pfizer shall (and shall cause its Affiliates to) (i) label the Dedicated Equipment as the property of Xxxxxxx, (ii) use the Dedicated Equipment solely for the manufacture of the Product for and on behalf of Xxxxxxx, (iii) keep the Dedicated Equipment free of liens, claims and encumbrances, (iv) operate the Dedicated Equipment in accordance with the manufacturer’s instructions, (v) maintain the Dedicated Equipment in good working condition and in compliance with cGMP and Applicable Laws, provided that, for any repairs covered by a manufacturer’s warranty, Xxxxxxx shall authorize such repairs under such warranty solely to be abandoned the extent Pfizer grants access to the Facility for the performance of such repairs, and Xxxx may (vi) ensure the Dedicated Equipment is insured at all times in the amounts adequate to replace the Dedicated Equipment. Upon the expiry or earlier termination of this Agreement, Pfizer will return or otherwise dispose of it or use it as it sees fitDedicated Equipment at Xxxxxxx’x direction in accordance with Section 10.6(b).
Appears in 1 contract
Dedicated Equipment. 2.7.1 Xxxx (a) During the entire Term, the Client may at times utilize Patheon to select and order Dedicated Equipment in addition to the equipment identified in Schedule F. In such case, the Client shall procure reimburse Patheon for all such reasonable costs agreed upon in writing and actually incurred by Patheon and shall pay to Patheon a fee equal to [ * ] percent ([ * ]%) of the actual purchase price of the equipment. In addition, the Parties shall update Schedule F to identify the additional Dedicated Equipment. Patheon agrees to accommodate, at Client’s cost, a reasonable amount of additional Dedicated Equipment, including, without limitation, at least one additional freezer. At the Client’s request and expense, Patheon shall be responsible for installing and qualifying at the Facility, any and all new or used equipment and tooling necessary for the manufacturing of the Product.
(b) Patheon shall obtain the Client’s prior written approval for all costs and expenses associated with installation and qualification of the Dedicated Equipment to be installed at Dyax’s the Facility (including without limitation labour and engineering costs) and the Client shall reimburse Patheon for all such reasonable costs actually incurred by Patheon within 30 days of the date of the relevant invoice issued by Patheon.
(c) The Dedicated Equipment shall at all times remain the sole cost, plus applicable Xxxx markup to cover handling costs, in accordance with property of the Product SpecificationsClient. Xxxx Patheon shall use commercially reasonable efforts to determine whether identify and track each item of Dedicated Equipment e.g., maintaining an inventory of the Dedicated Equipment conforms to the applicable Product Specifications and will work in the Facility for purpose stated in the relevant Work Order.
2.7.2 Xxxx may use the Dedicated Equipment only for performing its obligations under this Agreementnoting serial numbers when possible and/or physically marking items of dedicated equipment with labels or tags. Xxxx Patheon shall use the Dedicated Equipment only in accordance with any written instructions prescribed by Dyax or the manufacturer of the Dedicated Equipment, and shall perform such routine maintenance and calibration for the Dedicated Equipment as is reasonably required by such written instructions for an annual maintenance charge to Dyax. All costs for any extraordinary or non-routine maintenance that may be required will be approved in advance by Dyax, and the appropriate relevant Work Order will be revised to reflect any additional maintenance costs that may be required during the Term. Except (i) in connection with such routine maintenance, (ii) as required by the Services, or (iii) as directed in writing by Dyax, Xxxx shall not make any alterations, additions or improvements to the Dedicated Equipment. All alterations, additions or improvements made to the Dedicated Equipment will be at Dyax’s sole cost and expense.
2.7.3 Dyax shall own and continue to own all acquire no right, title and or interest in and to any Dedicated Equipment. Dyax assumes Patheon and its Affiliates shall not claim or file, and shall not allow any risk Third Party to claim or file, a security interest in any Dedicated Equipment.
(d) Patheon shall be responsible for the costs and expenses of loss, damage, theft or destruction routine maintenance and servicing of the Dedicated Equipment while that Dedicated Equipment is in Xxxx’x possession or on Xxxx’x premisesso long as all such equipment remains at the Facility. Upon termination or expiration The Client shall be responsible for the cost of this Agreement, Dyax shall have the right non-routine maintenance and obligation to, upon reasonable notice, reclaim possession of such Dedicated Equipment at its sole expense (including all costs of disconnection, removal, physical transfer and any subsequent reinstallation and requalification costs). Xxxx shall reasonably cooperate with Dyax to remove and return such Dedicated Equipment to Dyax in accordance with Dyax’s written instructions and shall invoice Dyax for (i) direct costs incurred and (ii) any damage other than reasonable wear and tear to the Facility incurred as a result of the use and removal servicing of the Dedicated EquipmentEquipment (such as major repairs and parts replacement). Notwithstanding Patheon shall notify the aboveClient prior to the performance of any non-routine maintenance or servicing, upon termination and the Client shall directly pay or expiration of this Agreement, Dyax promptly reimburse Patheon (as the case may offer be) for any such maintenance or servicing costs that the Client has authorized to sell to Xxxx, or Xxxx may offer to purchase from Dyax, the Dedicated Equipment at its then depreciated cost or fair market value, whichever be incurred and for which it is less. Neither Xxxx nor Dyax shall be obligated to make or accept such offers. In the event responsible.
(e) Patheon agrees that Dyax has not removed the Dedicated Equipment within [*****] after reasonable notice, the Dedicated Equipment shall only be deemed used by Patheon to be abandoned and Xxxx may dispose of it or use it as it sees fitprovide the Manufacturing Services.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Zymogenetics Inc)
Dedicated Equipment. 2.7.1 Xxxx ZymoGenetics shall procure pay the cost of additional equipment purchased by Xxxxxx (“Dedicated Equipment”), which is required for Xxxxxx to manufacture [ * ] designated portions of this document have been omitted pursuant to a request for confidential treatment filed separately with the Commission. Bulk Drug Substance for ZymoGenetics (subject to the approval conditions stated below). Xxxxxx shall advise ZymoGenetics of any Dedicated Equipment required and the estimated costs associated with the purchase, installation and validation of such Dedicated Equipment. Such DedicatedEquipment shall be used exclusively for manufacturing of Bulk Drug Substance hereunder, unless otherwise permitted in advance by ZymoGenetics in writing. [ * ] Xxxxxx shall xxxx ZymoGenetics for the reasonable installation and equipment validation costs after Xxxxxx installs the Dedicated Equipment. This Section 8.8 shall not apply to any replacement equipment purchased by Xxxxxx because of obsolescence (technical or otherwise). Dedicated Equipment, as estimated on or around the Effective Date, is outlined in Exhibit F. Any requirements that vary from Exhibit F herein shall be communicated to ZymoGenetics and approved in writing (letter, e-mail or facsimile) by an authorized ZymoGenetics representative prior to the purchase of any such Dedicated Equipment. ZymoGenetics shall own any Dedicated Equipment upon the date it makes full payment to Xxxxxx for said Dedicated Equipment. In the event this Agreement is terminated, Xxxxxx and ZymoGenetics shall in good faith agree on the commercially reasonable procedures and costs related to the return of the Dedicated Equipment at Dyax’s sole costto ZymoGenetics. Upon such termination, plus applicable Xxxx markup if Xxxxxx wishes to cover handling costs, in accordance with the Product Specifications. Xxxx shall use commercially reasonable efforts to determine whether the Dedicated Equipment conforms to the applicable Product Specifications and will work in the Facility for purpose stated in the relevant Work Order.
2.7.2 Xxxx may use the Dedicated Equipment only for performing its obligations under this Agreement. Xxxx shall use the Dedicated Equipment only in accordance with retain any written instructions prescribed by Dyax or the manufacturer of the such Dedicated Equipment, and ZymoGenetics approves of such retention in writing, Xxxxxx shall perform such routine maintenance and calibration [ * ] In addition to Exhibit F, Xxxxxx shall submit quarterly to ZymoGenetics, an updated estimate of Dedicated Equipment costs for the entire Project. Xxxxxx shall purchase such Dedicated Equipment as and promptly xxxx ZymoGenetics. Xxxxxx must receive written approval from ZymoGenetics prior to any such purchase if (a) the purchase is reasonably required by such written instructions for an annual maintenance charge amount greater than [ * ] of (b) if the aggregate of such purchases during a particular calendar quarter are for an amount greater than [ * ]. Title to, and risk of loss of, all Dedicated Equipment shall be retained by ZymoGenetics; provided, however, that Xxxxxx shall be responsible for replacing any ZymoGenetics Owned Dedicated Equipment that is destroyed due to DyaxXxxxxx’x negligence, willful misconduct, unauthorized use or unauthorized use with other products. All costs Dedicated Equipment shall remain at Xxxxxx’x manufacturing facilities. Xxxxxx shall be responsible for any extraordinary or maintaining and servicing the Dedicated Equipment. ZymoGenetics, however, shall be responsible for the cost of non-routine maintenance that may be required will be approved in advance by Dyax, and the appropriate relevant Work Order will be revised to reflect any additional maintenance costs that may be required during the Term. Except (i) in connection with such routine maintenance, (ii) as required by the Services, or (iii) as directed in writing by Dyax, Xxxx shall not make any alterations, additions or improvements to the Dedicated Equipment. All alterations, additions or improvements made to the Dedicated Equipment will be at Dyax’s sole cost and expense.
2.7.3 Dyax shall own and continue to own all right, title and interest in and to any Dedicated Equipment. Dyax assumes any risk of loss, damage, theft or destruction servicing of the Dedicated Equipment while (such as major repairs and material parts replacement), except to the extent caused by Xxxxxx’x negligence, willful misconduct, unauthorized use or use with other products in which case Xxxxxx shall be responsible. Xxxxxx shall notify ZymoGenetics prior to the performance of any non-routine maintenance or servicing, and ZymoGenetics shall reimburse Xxxxxx at cost for such maintenance or servicing costs that Dedicated Equipment is in Xxxx’x possession or on Xxxx’x premises. Upon termination or expiration of this Agreement, Dyax shall have the right and obligation to, upon reasonable notice, reclaim possession of such Dedicated Equipment at its sole expense (including all costs of disconnection, removal, physical transfer and any subsequent reinstallation and requalification costs). Xxxx shall reasonably cooperate with Dyax ZymoGenetics has authorized to remove and return such Dedicated Equipment to Dyax in accordance with Dyax’s written instructions and shall invoice Dyax for (i) direct costs be incurred and (ii) any damage other than reasonable wear and tear to the Facility incurred as a result of the use and removal of the Dedicated Equipment. Notwithstanding the above, upon termination or expiration of this Agreement, Dyax may offer to sell to Xxxx, or Xxxx may offer to purchase from Dyax, the Dedicated Equipment at its then depreciated cost or fair market value, whichever for which it is less. Neither Xxxx nor Dyax shall be obligated to make or accept such offers. In the event that Dyax has not removed the Dedicated Equipment within [*****] after reasonable notice, the Dedicated Equipment shall be deemed to be abandoned and Xxxx may dispose of it or use it as it sees fitresponsible.
Appears in 1 contract
Samples: Development and Supply Agreement