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 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). This appointment is subject to the Parties negotiating in good faith and entering into a commercial supply agreement pursuant to which Biogen would engage Alkermes on a toll manufacturing basis to Manufacture Commercial Supplies and Biogen would purchase such Commercial Supplies in accordance with the terms and conditions included in Exhibit E and such other commercially reasonable and customary terms and conditions, satisfactory in form and substance to the Parties and their legal advisors, as are necessary or appropriate for transactions of this type and that will allow Biogen to be supplied with Product in a manner appropriate to meet its obligations and exercise its rights under this Agreement, subject to both Parties’ compliance with the terms and conditions of such commercial supply agreement. In connection with such commercial supply agreement, the Parties will also negotiate in good faith and execute a technical and quality agreement, which will be appended to the commercial supply agreement and which will specify certain quality assurance and quality control requirements relating to the Manufacture of such Commercial Supplies. If, following the use of good faith efforts, the Parties are unable to reach agreement on the terms of a commercial supply agreement within a period of six (6) months from the commencement of negotiations, then Biogen shall have the right (in its sole discretion) to Manufacture or have Manufactured Commercial Supplies. 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 th...
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. 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. 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. 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. 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. Upon termination of this Agreement, except in the event that Jazz has terminated this Agreement pursuant to Section 17.3 or 17.4 and if a Terminated Licensed Product is being marketed in any terminated country on the effective date of termination, Jazz shall manufacture and supply to Werewolf the marketed Terminated Licensed Product for a period of up to [**] from the effective date of termination of this Agreement, at a price of [**] percent ([**]%) of the Cost of Goods with respect thereto.
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. Within [***] the JMC will discuss and agree upon a commercial supply strategy for the Licensed Compound and Licensed Products in the Territory (the “Commercialization Supply Strategy”). Under the Commercialization Supply Strategy, Gossamer U.S. shall have the sole right and authority to Manufacture (or to have Manufactured) commercial supplies of Licensed Compounds and Licensed Products for sale in the U.S. Territory for [***] in accordance with the Commercialization Supply Strategy and the Commercialization Supply Strategy will describe the responsible Party for the Manufacture of commercial supplies of Licensed Compounds and Licensed Products for any other Additional Indications in the U.S. Territory. Subject to [***], Chiesi SpA shall have the sole right and authority to Manufacture (or to have Manufactured) commercial supplies of Licensed Compounds and Licensed Products for sale in the ROW Territory. Upon Chiesi’s request, the Parties shall enter into a commercial supply agreement for the supply of such Licensed Compounds and Licensed Products from Gossamer to Chiesi SpA for Commercial use in the ROW Territory and, as applicable, to Chiesi U.S. for Commercial use in the U.S. Territory (the “Commercial Supply Agreement”). The Commercial Supply Agreement shall be consistent with the applicable terms of this Agreement and otherwise include commercially reasonable terms for such a supply arrangement. The costs of supplies of Licensed Compounds or Licensed Products for Commercialization in the U.S. Territory shall be deemed as Allowable Expenses, and the costs of supplies of Licensed Compounds or Licensed Products for Commercialization in the ROW Territory shall be borne by Chiesi SpA and as set forth in the Commercial Supply Agreement.
