Initial Supply Sample Clauses
Initial Supply. (a) Ardelyx will initially be responsible for supplying Lead Licensed Compound and Lead Licensed Products for use in the Development under this Agreement until such time as AstraZeneca assumes responsibility for such supply hereunder (the “Initial Supply”). The Initial Supply shall include, unless otherwise determined by the DCC, those quantities of Lead Licensed Product and Lead Licensed Compound and those activities described on Exhibit J. Ardelyx agrees to use Commercially Reasonable Efforts to deliver the Initial Supply and perform [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. the activities set forth in Exhibit J in such a manner and within such timelines as are required under the Initial Development Plan. For the purposes of the Initial Supply, Ardelyx will source the Lead Licensed Compounds and Lead Licensed Products from its current suppliers identified on Exhibit F, unless other suppliers are approved by the DCC.
(b) The Parties agree and acknowledge that a separate manufacturing and supply agreement (“MSA”) is required to be entered into between the Parties to further govern the supply obligations undertaken by Ardelyx hereunder. The Parties shall also enter into a separate Quality Assurance Agreement (“QAA”) that shall define the manufacturing and supply quality responsibilities of the Parties for the Lead Licensed Compound and the Lead Licensed Product. The QAA shall further include provisions obligating Ardelyx to report to AstraZeneca any regulatory compliance issues with its suppliers as well as any critical quality non-conformances relating to the Lead Licensed Compound or Lead Licensed Product. The MSA and the QAA shall be negotiated in good faith between the Parties and be executed as promptly as possible following the Effective Date. The Parties’ objective is that the MSA and the QAA shall be entered into as soon as reasonably practicable and within sixty (60) days of the Effective Date and shall include, amongst other appropriate and detailed provisions, the provisions set out in Exhibit K.
(c) The Transfer Price for any Licensed Products or Licensed Compounds supplied by Ardelyx will be a Development Expense, and will be reimbursed by AstraZeneca in compliance with the provisions of Section 4.3, regardless of whether AstraZeneca or Ardelyx has been assigned the responsibility fo...
Initial Supply.
a) First Year of Employment - three (3) pairs of trousers - three (3) shirts - two (2) pair of overalls, where applicable - smocks, where applicable - such other items as may be approved by the Board.
b) Second Year of Employment - two (2) pairs of trousers plus replacement if needed - two (2) shirts plus replacement if needed.
c) Third Year of Employment - one (1) pair of trousers plus replacement if needed - one (1) shirt plus replacement if needed.
Initial Supply. Portola shall procure the Collaboration Compounds and Products for use in the Development of Collaboration Compounds and Products (including procuring adequate clinical supply for the conduct of the first Phase II Clinical Trial) until the later of the (x) Transition Date, (y) in the event Biogen Idec decides to [*], and (z) such later date as the Parties may mutually agree, with such Manufacturing activities to be conducted by Portola as set forth in the Development Plan (the “Portola Manufacturing Activities”). All Materials (and all other research materials related to Collaboration Compounds) which are owned by or otherwise in the possession or control of Portola as of the Effective Date shall be contributed to the collaboration for use pursuant to this Agreement [*]. All expenses incurred by or on behalf of Portola in connection with Portola Manufacturing Activities after the Execution Date that would otherwise fit within the definition of “Development Expenses,” shall be Development Expenses.
Initial Supply. Any capitalized terms used but not separately defined in this Exhibit J shall have the meaning ascribed to them in the main body of the Agreement. The Initial Supply from Ardelyx to AstraZeneca, or to Ardelyx internally where Ardelyx has been assigned (either by the DCC or under the terms of the Agreement) the lead responsibility for the conduct of the Clinical Trial for which the supply is intended, shall include those GMP quantities of Lead Licensed Compound or Lead Licensed Product, and those development activities, in either case, approved by the DCC. As of the Effective Date of the Agreement, the DCC has not been convened. Therefore, the Parties have agreed that the following provisions shall govern the Manufacture and delivery of the Initial Supplies necessary to conduct the Initial Studies and the IBS-C Study, as well as those additional Initial Supplies discussed below.
Initial Supply. Upon completion of the probationary period, the Board will supply the following clothing to each respective employee:
a) First Year of Employment - three (3) pairs of trousers - three (3) shirts - two (2) pair of overalls, where applicable - smocks, where applicable - snow suits, where applicable - such other items as may be approved by the Board
b) Second Year of Employment - two (2) pairs of trousers plus replacement if needed - two (2) shirts plus replacement if needed
c) Third Year of Employment - one (1) pair of trousers plus replacement if needed - one (1) shirt plus replacement if needed
Initial Supply. Selecta will supply SEL-110 to Spark until [***] in accordance with the terms of this Section 5.6 and Exhibit F (Initial Supply Order). Exhibit F (Initial Supply Order) sets forth (i) the quantity of SEL-110 ordered by Spark for delivery on or before the specific date set forth on Exhibit F (Initial Supply Order), (ii) whether such SEL-110 is process development material that is not Manufactured in accordance with cGMP (“Non-cGMP Initial Supply”) or is cGMP-grade material that is Manufactured in accordance with cGMP (“cGMP Initial Supply”) and (iii) whether such SEL-110 will be Manufactured with the [***] manufacturing process or the [***] manufacturing process. Spark may cancel or reduce the quantity of SEL-110 set forth on Exhibit F (Initial Supply Order) by providing notice to Selecta at least [***] in advance of when such SEL-110 would otherwise be delivered; provided, however, Spark may not cancel or reduce the quantity of cGMP Initial Supply set forth on Exhibit F (Initial Supply Order) by more than [***]. Selecta will (subject [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions to any reduction elected by Spark in accordance with the immediately preceding sentence) deliver the quantities of SEL-110 set forth on Exhibit F (Initial Supply Order) that conform to the specifications set forth on Exhibit C (SEL-110), EXW (Incoterms 2010) Selecta’s facility in the United States, in accordance with Spark’s reasonable delivery instructions on or before the specific date set forth on Exhibit F (Initial Supply Order) for such quantity of SEL-110. Non-cGMP Initial Supply will be supplied at a price of $[***] if the [***] manufacturing process is used or at a price of $[***] if the [***] manufacturing process is used. Non-cGMP Initial Supply will be purchased [***] with the exception of any Non-cGMP Initial Supply that Selecta supplies [***]. cGMP Initial Supply will be supplied [***]. cGMP Initial Supply will be purchased by batch. Following delivery of SEL-110 to Spark under this Section 5.6, Selecta will invoice Spark for such Licensed Particles and Spark will pay such invoice within [***].
Initial Supply. Subject to the terms and conditions contained in this Agreement, until the Manufacturing Transition Date, GSK agrees to purchase solely from Antigenics MA or it Affiliates (or a Third Party manufacturer approved by GSK, such approval not to be unreasonably withheld or delayed), and Antigenics MA or its Affiliates (or a Third Party manufacturer approved by GSK, such approval not to be unreasonably withheld or delayed) agrees to supply GSK and its Sublicensees with one hundred percent (100%) of their initial requirements of QS-21 (subject to the Manufacturing Capacity) for use solely in the development, marketing and sale of QS-21 Vaccines in the Territory. In the event that GSK’s requirements for QS-21 exceed the Manufacturing Capacity, the Parties will work together to increase the Manufacturing [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Initial Supply. Angiotech hereby agrees to supply Histogenics with 1000 kits containing CT3 to be used by Histogenics for pre-clinical and clinical studies. These kits shall be supplied to Histogenics at ****.
Initial Supply. Within [***] days of the Effective Date, Archemix will make available for pickup by Ophthotech’s designated carrier, at no additional cost to Ophthotech, [***] of [***] manufactured at Sirna from GMP [***] (the “Sirna Materials”). Ophthotech shall provide Archemix with written notice when it has a GMP-compliant facility available for receipt of the Sirna Materials. Title, possession, risk of loss and all [***] costs and expenses (including the costs of Ophthotech’s designated carrier) shall [***] by [***] [***] the Sirna Materials [***] Ophthotech’s designated carrier.
Initial Supply. OST shall purchase from Advaxis existing finished drug Licensed Product (the “Initial Supply”).