Commercial Supplies. Pursuant to this Agreement, Biogen has the right to Manufacture or have Manufactured Commercial Supplies. Biogen has considered in good faith, and hereby appoints, Alkermes as the toll manufacturer for such Commercial Supplies for Commercialization in the Territory at a site outside of the United States, and Biogen and its Affiliates and Sublicensees will purchase Commercial Supplies exclusively from Alkermes; provided that, (A) with respect to the Alkermes 8700 Product only and subject to the Manufacturing transition plan referenced in this Section 5.1.2, Biogen’s appointment of Alkermes as toll manufacturer, Alkermes’ obligation to Manufacture, and the obligations of Biogen and its Affiliates and Sublicensees to purchase Clinical Supplies and Commercial Supplies exclusively from Alkermes will each expire on the Exclusive Manufacturing End Date, (B) with respect to Bulk Form Only Product, Biogen shall have the right to Manufacture or engage a Third Party to Manufacture the finished form to be derived from such Bulk Form; and (C) for Products other than the Alkermes 8700 Product, Biogen may qualify to Manufacture, or engage and qualify a Third Party to Manufacture, Commercial Supplies as a back-up manufacturer so long as such Third Party Manufacturer does not Manufacture more than [**] percent ([**]%) of Commercial Supplies in the aggregate in any Calendar Year, except in the event of a Force Majeure Delay or a Serious Failure to Supply. Upon Biogen’s written request, Alkermes and Biogen shall work in good faith to (a) enter into a technology transfer plan pursuant to which Alkermes will undertake a Technology Transfer in accordance with Section 3.2.3(iv) of the Agreement, including the reimbursement provisions therein, as promptly as reasonably practicable and, in any event, to be completed no later than [**] after Biogen’s written request to transition manufacturing and enter into a technology transfer plan, and (b) enter into a Manufacturing transition plan ([**]) to ensure the orderly transition after the Exclusive Manufacturing End Date to Biogen or its designee of Manufacturing responsibility for Clinical Supplies and Commercial Supplies of the Alkermes 8700 Product in an effort to prevent any interruption in the supply of such product. Notwithstanding anything to the contrary set forth in this Section 5.1.2, if (i) Alkermes foregoes its exclusive right to Manufacture or have Manufactured Commercial Supplies, (ii) Alkermes undergoes a Change of Contr...
Commercial Supplies. If a Returnable Product is marketed in any country of Territory on the date of the notice of termination of this Agreement, upon the request of Eleven, Roche shall manufacture and supply such Returnable Product to Eleven for a period of eighteen (18) months from the effective date of the termination of this Agreement (unless such obligation is earlier terminated by Eleven) at a price of one hundred twenty-five percent (125%) of Roche’s fully burdened manufacturing cost. Eleven shall use Commercially Reasonable Efforts to take over the manufacturing as soon as possible after the effective date of termination.
Commercial Supplies. Biogen shall be responsible for establishing a commercial manufacturing process, and supplying Commercial Supplies of Antegren, or applicable, other Licensed Product at the scale and in the amounts required to meet worldwide demand for Licensed Product subject to oversight of the JSC with respect to plans and forecasts. Within ninety (90) days after initiation of a Phase III Clinical Trial of Licensed Product, the Parties will enter into a "Commercial Manufacturing and Supply Agreement" in a form to be mutually agreed upon by the Parties. The executed Commercial Supply Agreement shall contain terms and provisions identical or not less favorable than the applicable provisions of this Agreement. The termination provisions in the Commercial Supply Agreement shall be identical to those provisions related to continuation of supply after termination contained in Article 14. The purchase price to be paid by Elan for Commercial Supplies provided by Biogen under the Commercial Manufacturing and Supply Agreement shall be the applicable Transfer Price as defined under this Agreement, provided, however, that the purchase price of any unit of Commercial Supplies to be distributed as Samples shall be *** . The Transfer Price shall be calculated on a quarterly basis, or on a such other basis as the JCT shall determine. The Transfer Price shall be paid within thirty (30) days after such Commercial Supplies are delivered to Elan or its designee. CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS (*) DENOTE SUCH OMISSIONS.
Commercial Supplies. Commercial Supplies of the Covered Products shall be governed by the Commercial Supply Agreement, the terms of which shall be consistent with Sections 3.5 (d) and (e) of the TTA and Schedule 3 hereto, which are binding for both Parties.
Commercial Supplies. The Parties shall in good faith negotiate the terms of one (1) or more supply agreements and corresponding quality agreement(s) pursuant to which the Party assigned a given Manufacturing activity under the Global Manufacturing Plan and Budget shall supply Optioned Molecules and Optioned Products to the other Party for Commercial activities and such terms shall be set forth in a commercial supply agreement to be entered into between the Parties on terms to be negotiated in good faith (the “Commercial Supply Agreement”). The supplying Party may charge a xxxx-up equal to the lowest of (i) […***…] percent […***…], (ii) such Party’s markup used […***…] or (iii) such xxxxxx xxxx-up agreed by the Parties in the applicable Clinical Supply Agreement.
Commercial Supplies. In the case of termination by BPM according to Section 21.2.1 or Section 21.2.2 or by Roche under Section 21.2.4, if a Reversion Product is marketed in any country of Territory on the date of the notice of termination of this Agreement, upon the request of BPM, Roche shall manufacture and supply such Reversion Product to BPM for a period that shall not exceed […***…] from the effective date of the termination of this Agreement at […***…]. BPM shall use Commercially Reasonable Efforts to take over the manufacturing as soon as reasonably possible after the effective date of termination.
Commercial Supplies. Advancis shall be responsible for establishing a commercial manufacturing process and for manufacturing or causing to be manufactured Commercial Supplies of the Products, at the scale and in the amounts required to carry out the then-current Commercialization Plan. Advancis shall negotiate and enter into one or more manufacturing and supply agreements with one or more third party contract manufacturers for the manufacture, supply and quality control of such Commercial Supplies of the Products as soon as practicable after execution and delivery of this Agreement. Advancis’s choice of such third party contract manufacturer(s), and the terms and conditions of such manufacturing and supply agreement(s) shall be subject to reasonable prior review by the Development and Manufacturing Subcommittee (which includes the the reasonable input of Par). If a vote of the Development and Manufacturing Subcommittee disapproves of the third party contract manufacturer(s) or the proposed manufacturing and supply agreement for such Commercial Supplies, such dispute shall be referred to the Executive Committee for review and discussion; provided that all decision-making authority with respect thereto shall remain with Advancis, which may enter into any such manufacturing and supply agreement over the objections of the Development and Manufacturing Subcommittee and/or the Executive Committee.
Commercial Supplies. ALTUS shall be responsible for establishing and shall use Commercially Reasonable and Diligent Efforts to establish a commercial manufacturing process for, and making available, commercial supplies of the Licensed Product at the scale and in the amounts required to [*************] for the Licensed Product in the Field in the Territory. FALK shall have the [**************] its requirements for commercial xxxplies of the Licensed Product from ALTUS. If FALK takes advantage of such [********], the purchase price shall be xxxal to [****] of the German Ex-Factory Price for the Licensed Product; provided, however, that if ALTUS' aggregate fully-burdened manufacturing costs for such Licensed Product exceeds [*****] of the German Ex-Factory Price, [************************************************************ ******************************************************************************* ******************************************************************************* *******]. ALTUS shall keep full, true and accurate books of account containing all particulars that may be necessary for the purpose of evidencing its fully burdened manufacturing costs as a basis for the purchase price to be paid by FALK for Licensed Product. Such books and records shall be kept at AXXXX' principal place of business. FALK or its authorized independent accountant shall have the right tx [************] of such books and records of ALTUS that are necessary to report on the purchase price for the commercial supplies of the Licensed Product for the period or periods requested by FALK and the correctness of any purchase price payment made by FALK xx XLTUS. With regard to further details of such [*****], the pxxxxsions in Section 13.4 hereinafter shall apply mutatis mutandis. As soon as practicable after completion of a Phase III Enabling Clinical Trial for the Licensed Product, ALTUS will enter into a manufacturing and supply agreement with a Third Party contract manufacturer(s) covering the manufacture, supply and quality control with respect to the Licensed Product. ALTUS shall also ensure that [****************] for the manufacture and supply of the Licensed Product. FALK will be responsible for paying [*********************************************************************** ***********************]. The terms of the supply of commercial supplies by ALTUS, in particular regarding all packaging, handling, shipping, delivery, insurance, tariffs, taxes and the like pertaining to delivery of t...
Commercial Supplies. In the case of termination by Roche according to Sections 20.3, 20.4 or 22.5 or by PEGA1 under Section 20.3 or 20.5, if a Product is marketed or filed for Regulatory Approval in any country of Territory on the date of the notice of termination of this Agreement, upon the request of Roche, PEGA1 shall manufacture and supply such Product to Roche for a period that shall not exceed [####] from the effective date of the termination of this Agreement and Roche shall reimburse PEGA1 for this material at PEGA1’s fully burdened manufacturing cost. PEGA1 shall use Commercially Reasonable Efforts to transfer the manufacturing and supply processes and technologies to Roche or a Third Party defined by Roche as soon as possible after the effective date of termination at PEGA1 ‘s cost and provide Roche corresponding support until such processes and technologies have been fully established at Roche or at the Third Party defined by Roche.
Commercial Supplies. Xxxxxxx shall have the sole right and authority to Manufacture (or to have Manufactured) commercial supplies of Licensed Compounds and Licensed Products. The costs of commercial supplies of Licensed Compounds or Licensed Products for Commercialization in the U.S. shall be [...***...] as Allowable Expenses, and the costs of commercial supplies of Licensed Compounds or Licensed Products for Commercialization in the OUS Territory shall be borne by [...***...].
