Second Source Facility Sample Clauses
Second Source Facility. Within […***…] months after Client provides notice to Patheon requesting that Patheon commence qualification and validation of an additional manufacturing facility, Patheon shall, at Client’s expense, qualify and validate, and thereafter keep qualified and validated, an additional manufacturing facility at Patheon’s manufacturing site located at ▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇ ▇▇▇ (a “Second Source Facility”), in addition to the existing Manufacturing Site, for the manufacture of Product to ensure a second source of supply of Product to Client. The Second Source Facility must be a second facility operated by Patheon with quality and reliability in manufacturing comparable to the Manufacturing Site and shall comply with all obligations and limitations of this Agreement to the same extent as Manufacturing Site. Without limiting the generality of the foregoing, such Second Source Facility must be approved by the FDA, EMA and other relevant Regulatory Authorities such that the Product manufactured by the Second Source Facility may be commercialized by Client under the applicable Regulatory Approvals for Product.
Second Source Facility. No later than [...***...] and thereafter during the Term, ▇▇▇▇▇▇ ▇▇▇▇▇ shall have qualified and keep qualified an additional manufacturing facility (a "Second Source Facility"), in addition to the facility located in Gaillac, France, for the production of API to ensure a second source of supply of API to Cypress. The Second Source Facility must be a second facility operated by ▇▇▇▇▇▇ ▇▇▇▇▇ or any licensee or subcontractor of ▇▇▇▇▇▇ ▇▇▇▇▇ with quality and reliability in manufacturing comparable to ▇▇▇▇▇▇ ▇▇▇▇▇'▇ first facility, and such Second Source Facility must be approved by the FDA or other relevant regulatory authorities for the countries of the Licensed Territory such that the Licensed Products containing API manufactured by the Second Source Facility may be lawfully sold by Cypress.
Second Source Facility. Within eighteen (18) months after the filing of the first application for Regulatory Approval in the Territory, NovaDel will qualify and thereafter keep qualified an additional Manufacturing facility (a “Second Source Facility”), in addition to, and at least one hundred and fifty (150) kilometers away from, the existing Manufacturing facility, for the production of Licensed Product to ensure a second source of supply of Licensed Product to BioAlliance. The Second Source Facility must be a second facility operated by NovaDel or any licensee or subcontractor of NovaDel with quality and reliability in Manufacturing comparable to NovaDel’s first facility, and such Second Source Facility must be approved by the EMEA and other relevant Regulatory Authorities in the Territory such that the Licensed Product Manufactured by the Second Source Facility may be commercialized by BioAlliance under the applicable Regulatory Approvals for Licensed Product. *** Portion for which confidential treatment requested.
Second Source Facility. Buffer Stock. Not later than [***] months following the first Launch of a Product and thereafter during the term of the Agreement, ALMIRALL shall have qualified and shall maintain the qualification of at least one additional manufacturing site to assure a secondary and back-up source of supply of FOREST's requirements of Bulk Active LAS 34273. Such secondary facility shall comply with all applicable laws and regulatory requirements and have quality and reliability standards sufficient to permit its lawful use as a source of supply for LAS 34273 under this Agreement. Beginning on the date which is approximately [***] prior to the first Launch of a Product, ALMIRALL shall maintain buffer stock of LAS 34273 Bulk Active Ingredient which shall represent at least [***] (the "Minimum Buffer Stock") of FOREST's anticipated requirements of the LAS 34273 Bulk Active Ingredient. In addition, ALMIRALL shall use Commercially Reasonable Efforts to maintain or cause Third Party suppliers to maintain reasonable buffer stocks of the Device (at FOREST's cost to the extent borne by ALMIRALL) and Formoterol Bulk Active Ingredient for the Territory. Information about buffer stock levels will be periodically provided to the JMSC.
Second Source Facility. Material omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Exchange Act of 1934. Material filed separately with the Securities and Exchange Commission. If Immtech: (a) discontinues or permanently ceases to manufacture the Product (unless otherwise agreed to in advance by BioAlliance); or (b) otherwise breaches its supply obligations hereunder or is otherwise unable or unwilling to supply BioAlliance with Product which conforms to the Specifications for a period in excess of one hundred twenty (120) consecutive days (“Event”), then effective upon written notice by BioAlliance that an Event has occurred, Immtech will work with BioAlliance or its sublicensees to identify a Third Party to manufacture the Product in order to satisfy BioAlliance’s and its Affiliates’ and sublicensees’ requirements of the Product. Immtech will enter into an agreement with a Third Party manufacturer acceptable to Immtech and will grant such Third Party manufacturer a license for the Immtech Technology as necessary for the Third Party Manufacturer to manufacture and supply the Product to BioAlliance, and its Affiliates and sublicensees. In addition, Immtech shall provide such technical assistance to such Third Party manufacturer as reasonably required, at Immtech’s expense, to the extent of any out-of-pocket expenses incurred by Immtech in connection with providing such technical assistance.