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 and (B) 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 Control in which the acquirer is a competitor of Biogen set forth on Schedule 5.1 or a Third Party toll manufacturer that Manufactures a competing fumarate product or (iii) there is a S...
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. 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. 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. 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. 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. 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. (a) Determination of Manufacturing Party and Distributing Party. At any time but [ * ] after commencement of a [ * ] Clinical Trial of Licensed Product, [ * ] shall determine which of the Parties shall be the Manufacturing Party for Commercial Supplies and which shall be the Distributing Party, provided that the same Party shall not be both the Manufacturing Party for Commercial Supplies and the Distributing Party of a Licensed Product; provided further that the Manufacturing Party for Clinical Supplies of a Licensed Product may be the Distributing Party of that Licensed Product so long as it is not the Manufacturing Party for Commercial Supplies of that Licensed Product. Notwithstanding the foregoing, if a Change of [ * ] designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission. Control of a Party occurs prior to the decision specified in the preceding sentence, then the Party that did not undergo the Change of Control [ * ].
Commercial Supplies. Topotarget and Spectrum currently contemplate that Spectrum will contract with [***] (“[***]”) for the commercial supply of Belinostat active pharmaceutical ingredient (“API”) for Products, and [***] (“[***]”) for the commercial supply of finished Products. The Parties acknowledge that Topotarget has transferred to [***] and [***] the Information, including the specifications for the Product, Controlled by Topotarget that is necessary to enable [***] and [***] to replicate the process employed by or on behalf of Topotarget to manufacture, test, and release API and finished Products, as applicable. Spectrum agrees to reasonably and in good faith consult with Topotarget with respect to Spectrum’s negotiation of agreements with such Third Parties. In the event that Spectrum wishes to use any other Third Party manufacturer to produce Products (or components thereof), Spectrum shall reasonably and in good faith consult with Topotarget with respect to such other Third Party manufacturer and any agreement between Spectrum and such Third Party for the supply of Products (or components thereof), and Topotarget shall perform a technology transfer to such Third Party manufacturer in accordance with Section 5.6(e) below. In any event, Spectrum agrees that it promptly shall provide to Topotarget copies of any agreement, or the like (including any amendments thereto), executed by Spectrum or any of its Affiliates with any Third Party for the supply of Products (or components thereof (including API and Bulk Product). Spectrum will obtain permission from such Third Parties for disclosure to Topotarget. In addition, Topotarget and Spectrum will together enter into a letter of understanding with [***] to reflect the terms and conditions of this Section 5.6. Such letters of understanding will not be required for any other Third Party manufacturers proposed to be used by Spectrum for supply of Products (including API and Bulk Product) if Spectrum’s agreement with such other Third Party manufacturers are consistent with the terms and conditions of this Section 5.6 and protect Topotarget’s Confidential Information and Intellectual Property on terms at least as protective as the terms of this Agreement. For avoidance of doubt, Spectrum shall be the sole source of interface with Third Party manufacturers for the Products and, except as provided below or in other provisions of this Section 5.6, Topotarget shall not place any direct orders for API and/or Bulk Product with a Third P...
