Designated Facility. Cardinal shall manufacture the Drug Products for the worldwide market in the Facility or an Alternate Facility. Notwithstanding the foregoing, the parties hereto agree that the requirement to validate an Alternate Facility and the allocation of costs and expenses related thereto shall be borne as follows: (a) Cardinal shall validate an Alternate Facility for fluid bed drying (with capacity reasonably comparable to the capacity for fluid bed drying at the Facility) in accordance with the Specifications as soon as practicable after the effective date of this Agreement. The cost of validating the Alternate Facility for fluid bed drying shall be borne equally by the parties hereto. (b) Cardinal shall validate an Alternate Facility at which the Drug Products are able to be readily manufactured and packaged in accordance with the Specifications (other than the fluid bed drying pursuant to Section 3.4(a) above): (i) if Cardinal, on its own accord and for reasons unrelated to business decisions made by Adams, chooses to validate such Alternate Facility, in which ca▇▇ ▇▇rdinal agrees to and shall bear the cost of such validation, (ii) if the forecasts under Section 4.1 hereof demonstrate additional capacity at the Facility (located in Fort Worth) is required for Cardinal to fulfill its obligations to Adams under this Agreement, or if Adams requires increased production capacity or desires such Al▇▇▇▇▇te Facility for business reasons determined by Adams in its sole discretion, such that the Facility would not ▇▇ ▇▇le to accommodate Adams's requirements or Cardinal's obligations to Adams for the ▇▇▇▇ ▇roducts or for such other business reasons of ▇▇ams, in which case Adams agrees to and shall bear the cost of such validation; or (iii) if the parties, for reasons other than as provided in clauses (i) and (ii) of this Section 3.4, mutually agree to arrange for Cardinal or a Cardinal Affiliate to validate such Alternate Facility, in which case the parties agree, in good faith, to negotiate the fair allocation of all costs associated with such validation, and (c) at Adams's sole cost and expense, Adams shall have the right, in its sol▇ ▇▇▇▇▇etion, to validate a fac▇▇▇▇▇ of its own at which the Drug Products are able to be readily manufactured and packaged in accordance with the Specifications.
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Sources: Supply Agreement (Adams Respiratory Therapeutics, Inc.), Asset Purchase Agreement (Adams Laboratories, Inc.), Asset Purchase Agreement (Adams Respiratory Therapeutics, Inc.)
Designated Facility. Cardinal shall manufacture the Drug Products for the worldwide market in the Facility or an Alternate Facility. Notwithstanding the foregoing, the parties hereto agree that the requirement to validate an Alternate Facility and the allocation of costs and expenses related thereto shall be borne as follows:
(a) Cardinal shall validate an Alternate Facility for fluid bed drying (with capacity reasonably comparable to the capacity for fluid bed drying at the Facility) in accordance with the Specifications as soon as practicable after the effective date of this Agreement. The cost of validating the Alternate Facility for fluid bed drying shall be borne equally by the parties hereto.
(b) Cardinal shall validate an Alternate Facility at which the Drug Products are able to be readily manufactured and packaged in accordance with the Specifications (other than the fluid bed drying pursuant to Section 3.4(a) above):
(i) if Cardinal, on its own accord and for reasons unrelated to business decisions made by Adams▇▇▇▇▇, chooses to validate such Alternate Facility, in which ca▇▇ ▇▇rdinal case Cardinal agrees to and shall bear the cost of such validation,
(ii) if the forecasts under Section 4.1 hereof demonstrate additional capacity at the Facility (located in Fort Worth) is required for Cardinal to fulfill its obligations to Adams ▇▇▇▇▇ under this Agreement, or if Adams ▇▇▇▇▇ requires increased production capacity or desires such Al▇▇▇▇▇te Alternate Facility for business reasons determined by Adams ▇▇▇▇▇ in its sole discretion, such that the Facility would not ▇▇ be able to accommodate ▇▇le to accommodate Adams's ▇▇▇'▇ requirements or Cardinal's obligations to Adams for the ▇▇▇▇▇ ▇roducts for the Drug Products or for such other business reasons of ▇▇ams▇▇▇, in which case Adams ▇▇▇▇▇ agrees to and shall bear the cost of such validation; or
(iii) if the parties, for reasons other than as provided in clauses (i) and (ii) of this Section 3.4, mutually agree to arrange for Cardinal or a Cardinal Affiliate to validate such Alternate Facility, in which case the parties agree, in good faith, to negotiate the fair allocation of all costs associated with such validation, and
(c) at Adams's ▇▇▇▇▇'▇ sole cost and expense, Adams ▇▇▇▇▇ shall have the right, in its sol▇ ▇▇▇▇▇etionsole discretion, to validate a fac▇▇▇▇▇ facility of its own at which the Drug Products are able to be readily manufactured and packaged in accordance with the Specifications.
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