Common use of Clinical Supply Clause in Contracts

Clinical Supply. Angioblast shall use commercially reasonable efforts to supply to Cephalon the [***] for use in Development of Products for use in the Field in the Territory in accordance with this Section 7.3. (a) Angioblast shall supply Cephalon with such quantities of the [***] as are reasonably required by Cephalon in order to conduct Development of the Products for use in the Field in the Territory in accordance with the then-current Development Plan. (b) Such supply shall be at [***] to Cephalon; however, Cephalon shall be responsible for all costs of shipping, handling, transit, taxes (including VAT), packaging, storage and the like in connection with the transport of [***] from the facilities where Angioblast manufactures or has manufactured the same to the location designated by Cephalon. Accordingly, Cephalon shall choose the carrier and be responsible for all payments thereto. It being understood that Angioblast shall not be responsible for any loss or damage of [***] in carriage, use or otherwise not caused by Angioblast or a Person acting by or on behalf of Angioblast; however, in the event of such loss or damage, the Parties shall promptly discuss how to address such situation, including Cephalon reimbursing Angioblast’s costs associated with replacing such lost or damaged [***] and any expedite fees associated therewith. (c) The Parties shall establish reasonable procedures for Cephalon to forecast and submit to Angioblast, and for Angioblast to fill, orders for [***] for use for Development. Such procedures shall include reasonable schedules for delivery of [***] ordered by Cephalon pursuant to this Section 7.3 consistent with the Development Plan then in effect. Notwithstanding the foregoing, Angioblast shall not be obligated to supply any quantities of the Product in excess of the Product necessary for Cephalon to conduct the Development activities assigned to it under the Development Plan. Cephalon agrees that [***] supplied pursuant to this Section 7.3 shall be used solely for purposes of performing Development of the Products for use in the Field in the Territory in accordance with the Development Plan and, unless otherwise agreed by the Parties, for no other purpose. Accordingly, Cephalon acknowledges that Angioblast shall have the right to package or otherwise xxxx such [***] in a manner that distinguishes them from those intended for Commercialization. (d) [***] supplied to Cephalon pursuant to this Section 7.3 shall be manufactured in compliance with all applicable GMP and the Specifications therefor and other requirements therefor established by the applicable Regulatory Authorities.

Clinical Supply. Angioblast (a) On DSP’s request, Neurocrine shall use commercially reasonable efforts to supply to Cephalon the provide DSP with DSP’s requirements for (i) Indiplon API, (ii) [...***...] for use in Development of Products for use in the Field in the Territory in accordance with this Section 7.3. (a) Angioblast shall supply Cephalon with such quantities of the IR Product [...***...] as are reasonably required and (iii) [...***...] IR Product [...***...] (collectively, “Clinical Drug Product”) for use by Cephalon DSP in order to conduct clinical studies in and outside the Territory under DSP Development Program at a cost [...***...]. Payment of the Products for use price of the Clinical Drug Product shall be made in US Dollars by telegraphic transfer to a bank account designated by Neurocrine, within forty-five (45) days after the Field in date of receipt of the Territory in accordance with the then-current Development PlanClinical Drug Product by DSP. (b) Such supply shall As soon as practicable after the Effective Date, DSP will provide Neurocrine with non-binding forecast of DSP’s purchase orders for Clinical Drug Product which may be at placed for the initial [...***] to Cephalon; however...], Cephalon shall be responsible and thereafter, DSP will provide Neurocrine with non-binding forecast of DSP’s purchase order for all costs of shipping, handling, transit, taxes (including VAT), packaging, storage and the like in connection with the transport of Clinical Drug Product [...***] from the facilities where Angioblast manufactures or has manufactured the same ...]. The purchase orders for Clinical Drug Product shall be placed to the location designated by Cephalon. Accordingly, Cephalon shall choose the carrier and be responsible for all payments thereto. It being understood that Angioblast shall not be responsible for any loss or damage of allow no less than [...***...] lead time prior to the shipment dates specified in carriagethe said purchase orders, and Neurocrine will use or otherwise not caused by Angioblast or a Person acting by or on behalf of Angioblast; however, best reasonable efforts to comply with the purchase orders provided however that in the event Neurocrine does not have sufficient stock of such loss or damageClinical Drug Product, the Parties lead time for the Clinical Drug Product shall promptly discuss how be determined by mutual agreement of Neurocrine and DSP through good faith discussions. The purchase orders for the Clinical Drug Product shall be in any event non-cancelable. The risk of loss and damage for, and the title in, Clinical Drug Product supplied hereunder shall pass to address such situation, including Cephalon reimbursing Angioblast’s costs associated with replacing such lost DSP upon delivery of the Clinical Drug Product to the carrier designated by DSP. Shipment shall be FCA an international airport or damaged [***] and any expedite fees associated therewithport designated by Neurocrine as defined in INCOTERMS 2000 as amended. (c) The Parties Neurocrine through its contract manufacturers shall establish reasonable procedures for Cephalon to forecast and submit to Angioblast, and for Angioblast to fill, orders for [***] for use for Development. Such procedures shall include reasonable schedules for delivery of [***] ordered by Cephalon pursuant to this Section 7.3 consistent with the Development Plan then in effect. Notwithstanding the foregoing, Angioblast shall not be obligated to supply any quantities of the manufacture Clinical Drug Product in excess of the Product necessary for Cephalon to conduct the Development activities assigned to it under the Development Plan. Cephalon agrees that [***] supplied pursuant to this Section 7.3 shall be used solely for purposes of performing Development of the Products for use in the Field in the Territory compliance with any and all applicable laws and regulations and in accordance with such appropriate quality, specifications and test methods, formula and manufacturing process as specified by mutual agreement of Neurocrine and DSP, which may not be changed by Neurocrine without prior written consent of DSP, except as may be required by any Regulatory Authorities. DSP shall not use Clinical Drug Product which to DSP’s knowledge does not meet the Development Plan andthen-prevailing quality, unless otherwise agreed by the Partiesspecifications and test methods, for no other purpose. Accordingly, Cephalon acknowledges that Angioblast shall have the right to package or otherwise xxxx such [***] in a manner that distinguishes them from those intended for Commercializationformula and manufacturing process. (d) [***] DSP shall carry out quality testing to confirm that the Clinical Drug Product conforms to the specifications and shall use the testing method specified by mutual agreement of Neurocrine and DSP. In case that any quantity of Clinical Drug Product supplied by Neurocrine hereunder does not, at the time of delivery, conform to Cephalon pursuant the then-prevailing specifications, Neurocrine shall at its own cost replace such quantity of the Clinical Drug Product with material of the quality specified in such specifications, and DSP shall at Neurocrine’s option and expense return to Neurocrine or dispose of such quantity of the Clinical Drug Product which failed to meet such specifications; provided, however, that DSP shall have notified Neurocrine, within forty-five (45) days from receipt of the said Clinical Drug Product of the failure of such quantity to meet the specifications and in any event before DSP has utilized the Clinical Drug Product for any purpose. In case that DSP notifies Neurocrine within the forty-five (45)-day period that the Clinical Drug Product does not conform to the specifications, Neurocrine may have the relevant Clinical Drug Product tested by an appropriate independent institute acceptable to DSP in order to determine finally whether or not the Clinical Drug Product conforms to the specifications. The results of such test carried out by the institute shall be binding upon the Parties. The expense of the test shall be borne by Neurocrine, except that DSP shall bear the expense if the result of the test indicates that the relevant Clinical Drug Product conforms to the specifications. ALL OTHER EXPRESS AND IMPLIED WARRANTIES INCLUDING WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE SPECIFICALLY DISCLAIMED BY NEUROCRINE AND EXCLUDED FROM THE TERMS OF SALE OF THE CLINICAL DRUG PRODUCT. (e) Unless otherwise agreed upon between the Parties, DSP shall use the Clinical Drug Product supplied under this Section 7.3 shall be manufactured in compliance with all applicable GMP 6.2 for the sole purpose of Development and the Specifications therefor testing, including formulation studies of Indiplon and other requirements therefor established by the applicable Regulatory AuthoritiesProducts.

Clinical Supply. Angioblast shall use commercially reasonable efforts to supply to Cephalon the the[***] for use in Development of Products for use in the Field in the Territory in accordance with this Section 7.37.2. ** Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. (a) Angioblast shall supply Cephalon with such quantities of the [***] as are reasonably required by Cephalon in order to conduct Development of the Products for use in the Field in the Territory in accordance with the then-current Development Plan. (b) Such supply shall be at [***] to Cephalon; however, Cephalon shall be responsible for all costs of shipping, handling, transit, taxes (including VAT), packaging, storage and the like in connection with the transport of [***] from the facilities where Angioblast manufactures or has manufactured the same to the location designated by Cephalon. Accordingly, Cephalon shall choose the carrier and be responsible for all payments thereto. It being understood that Angioblast shall not be responsible for any loss or damage of [***] in carriage, use or otherwise not caused by Angioblast or a Person acting by or on behalf of Angioblast; however, in the event of such loss or damage, the Parties shall promptly discuss how to address such situation, including Cephalon reimbursing Angioblast’s costs associated with replacing such lost or damaged [***] and any expedite fees associated therewith. (c) The Parties shall establish reasonable procedures for Cephalon to forecast and submit to Angioblast, and for Angioblast to fill, orders for [***] for use for Development. Such procedures shall include reasonable schedules for delivery of [***] ordered by Cephalon pursuant to this Section 7.3 7.2 consistent with the Development Plan then in effect. Notwithstanding the foregoing, Angioblast shall not be obligated to supply any quantities of the Product in excess of the Product necessary for Cephalon to conduct the Development activities assigned to it under the Development Plan. Cephalon agrees that [***] supplied pursuant to this Section 7.3 7.2 shall be used solely for purposes of performing Development of the Products for use in the Field in the Territory in accordance with the Development Plan and, unless otherwise agreed by the Parties, for no other purpose. Accordingly, Cephalon acknowledges that Angioblast shall have the right to package or otherwise xxxx such [***] in a manner that distinguishes them from those intended for Commercialization. (d) [***] supplied to Cephalon pursuant to this Section 7.3 7.2 shall be manufactured in compliance with all applicable GMP and the Specifications therefor and other requirements therefor established by the applicable Regulatory Authorities.

Clinical Supply. Angioblast shall use commercially reasonable efforts to supply to Cephalon the [***] BMT MPCs, Cardiovascular Products and CNS Products for use in Development of Products for use in the Field in the Territory in accordance with this Section 7.3. (a) Angioblast shall supply Cephalon with such quantities of the [***] BMT MPCs, Cardiovascular Products and CNS Products as are reasonably required by Cephalon in order to conduct Development of the Products for use in the Field in the Territory in accordance with the then-current Development Plan. (b) Such supply shall be at [***] no charge to Cephalon; however, Cephalon shall be responsible for all costs of shipping, handling, transit, taxes (including VAT), packaging, storage and the like in connection with the transport of [***] BMT MPCs, Cardiovascular Products and CNS Products from the facilities where Angioblast manufactures or has manufactured the same to the location designated by Cephalon. Accordingly, Cephalon shall choose the carrier and be responsible for all payments thereto. It being understood that Angioblast shall not be responsible for any loss or damage of [***] BMT MPCs, Cardiovascular Products and CNS Products in carriage, use or otherwise not caused by Angioblast or a Person acting by or on behalf of Angioblast; however, in the event of such loss or damage, the Parties shall promptly discuss how to address such situation, including Cephalon reimbursing Angioblast’s costs associated with replacing such lost or damaged [***] BMT MPCs, Cardiovascular Products and CNS Products and any expedite fees associated therewith. (c) The Parties shall establish reasonable procedures for Cephalon to forecast and submit to Angioblast, and for Angioblast to fill, orders for [***] BMT MPCs, Cardiovascular Products and CNS Products for use for Development. Such procedures shall include reasonable schedules for delivery of [***] BMT MPCs, Cardiovascular Products and CNS Products ordered by Cephalon pursuant to this Section 7.3 consistent with the Development Plan then in effect. Notwithstanding the foregoing, Angioblast shall not be obligated to supply any quantities of the Product in excess of the Product necessary for Cephalon to conduct the Development activities assigned to it under the Development Plan. Cephalon agrees that [***] BMT MPCs, Cardiovascular Products and CNS Products supplied pursuant to this Section 7.3 shall be used solely for purposes of performing Development of the Products for use in the Field in the Territory in accordance with the Development Plan and, unless otherwise agreed by the Parties, for no other purpose. Accordingly, Cephalon acknowledges that Angioblast shall have the right to package or otherwise xxxx such [***] BMT MPCs, Cardiovascular Products and CNS Products in a manner that distinguishes them from those intended for Commercialization. (d) [***] BMT MPCs, Cardiovascular Products and CNS Products supplied to Cephalon pursuant to this Section 7.3 shall be manufactured in compliance with all applicable GMP and the Specifications therefor and other requirements therefor established by the applicable Regulatory Authorities.