Back-Up Supplier. If Angiotech, through exercise of reasonable business judgment, determines that it is reasonable and prudent to obtain a back-up supplier to prevent a Supply Disruption, then Athersys shall use its Commercially Reasonable Efforts to identify, engage and qualify at least one back-up supplier for the Clinical Development Candidate(s) or Cell Therapy Product(s). If a Third-Party is or will be the principal manufacturer of the Clinical Development Candidate(s) or Cell Therapy Product(s), such back-up supplier may be Athersys or its Table of Contents Affiliate or Angiotech or its Affiliate. In a manner similar to that described in Section 9.7 regarding a Supply Disruption, Athersys shall transfer or license to each such back-up supplier such Athersys Intellectual Property as is necessary or useful to permit such back-up supplier to implement and practice processes related to manufacture and supply of Clinical Development Candidate(s) or Cell Therapy Product(s), and/or to maintain its status as a qualified manufacturing entity under any and all applicable laws and regulations with respect to such processes or Clinical Development Candidate(s) or Cell Therapy Product(s). If Athersys decides to designate and qualify a back-up supplier, Athersys agrees to consult with Angiotech in identifying and selecting an appropriate Third Party as back-up supplier, and the Parties shall work together to establish each selected Third Party back-up supplier as expeditiously as reasonably possible, so as to minimize the period of absence of supply of Clinical Development Candidate(s) and/or Cell Therapy Product(s), as the case may be.
Back-Up Supplier. 14.1 Except as contemplated by Section14.2, LTS shall be the sole and exclusive supplier of the Products for sale in the Territory during the term of this Agreement. Notwithstanding anything to the contrary, and without limitation of BDSI’s rights under Section 14.2, BDSI may in its discretion and at its own cost and responsibility qualify an alternative, back-up to LTS, source of supply (“Back-up Supplier”) for Products in the Territory during the term of this Agreement; for purposes of clarification, but not limitation, BDSI, any Affiliate thereof, any BDSI Licensee, Aveva, or any other Third Party may constitute a Back-up Supplier.
14.2 The qualification of the Back-up Supplier shall not be construed to give BDSI any right to order Products from the Back-up Supplier for sale in the Territory during the term of the Agreement except as provided in this Section 14.2. However, BDSI shall have the right, notwithstanding anything to the contrary (including but not limited to the exclusive supply provisions of Section 4.1), to (i) order and purchase Products from a Back-up Supplier (including, for purposes of clause (b) below, Aveva), and/or have a Back-up Supplier (including, for purposes of clause (b) below, Aveva) manufacture and supply Products on behalf of BDSI, or (ii) manufacture Products for its own benefit (such right, the “BDSI Back-up Right”) in case a Back-up Trigger has occurred. BDSI shall pay all royalties owed to LTS under this Agreement with respect to any Products procured from any Back-up Supplier and provide LTS in a timely manner with documents showing all quantities ordered from any Back-up Supplier. BDSI’s failure to comply with the foregoing sentence shall be deemed a material breach of this Agreement. In such a case LTS shall, subject to the provisions of Section 19.3 and BDSI’s opportunity to cure thereunder, be entitled to terminate this Agreement and all license obligations hereunder.
14.3 In the situation where LTS is not able to supply Product, or LTS anticipates that it will be unable to supply Product to BDSI in satisfaction of BDSI’s Orders or Forecasts, LTS shall:
(a) inform BDSI in a timely manner about such situation and the details causing such situation; and
(b) provide BDSI with a reasonable estimate of the length and extent of production interruption or other issue affecting LTS’ satisfaction of BDSI’s Product demand. LTS shall inform BDSI immediately when it is again able, after any particular effectiveness of BDSI’s Ba...
Back-Up Supplier. In the event that DPT is unable to meet COMPANY’s supply requirements, COMPANY shall have the immediate right to have a third-party supplier act as Back-Up Supplier (“Back-Up Supplier”). In such an event, DPT shall use commercially reasonable efforts to enable Back-Up Supplier to manufacture and package the Products, provided that Back-Up Supplier agrees to enter into an acceptable agreement of confidentiality with DPT and DPT is reimbursed its reasonable costs and expenses associated with such assistance. Subject to the foregoing, DPT shall provide to Back-Up Supplier the Specifications and any other information reasonably necessary for the manufacturing and packaging of the Products (“Technical Information”). Any disclosure or use of Technical Information will be subject to the confidentiality restrictions set forth in this Agreement. ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
Back-Up Supplier. Notwithstanding Article 2.2, SAG may elect to qualify a back-up supplier ("Back-Up Supplier") reasonably acceptable to RTU for any Authorized Generic, Additional Formulation or the supply of Drug Substance and Drug Product which acceptance shall not be unreasonably withheld, conditioned or delayed in the event that RTU is unable, or determines that it will be unable, to produce Drug Substance or Drug Product in accordance with SAG's Orders or Specifications, Authorized Generic or Additional Formulation. For such purpose, RTU shall grant to such Back-Up Supplier a non-exclusive, royalty-free, license under the patent rights and know-how owned by RTU to manufacture Drug Substance and Drug Product, Authorized Generic or Additional Formulation solely as the Back-Up Supplier pursuant to the terms of this Agreement. Further, RTU shall promptly provide, at such times and locations as may reasonably be requested by SAG, and at SAG's expense at reasonable consulting rates, cooperation to enable the Back-Up Supplier to establish such manufacturing capability. Notwithstanding anything to the contrary in this Agreement, if RTU recovers the ability to produce Drug Substance and Drug Product in accordance with SAG's Orders or Specifications, Authorized Generic or Additional Formulation and at the same terms as the Back-Up Supplier, RTU shall promptly notify SAG and SAG shall cause the Back-Up Supplier to cease manufacturing and supplying Drug Substance and Drug Product, Authorized Generic or Additional Formulation within thirty (30) business days, and SAG shall not purchase from the Back-Up Supplier after such thirtieth business day any Drug Substance or Drug Product, Authorized Generic or Additional Formulation. RTU shall indemnify SAG or its designee for any loss, including but not limited to loss of profit, arising from SAG's cancellation of the supply from the Back-Up Supplier.
Back-Up Supplier. Licenses
Back-Up Supplier. At Lumara's request, and at Lumara's cost to the extent requested, Antares will qualify at least one back-up supplier for each critical component of the Device, as determined to be appropriate as part of the Device Development Plan. Notwithstanding the foregoing, Antares shall at Antares' cost develop, implement and maintain a redundancy plan reasonably acceptable to Lumara for molds, tooling and assemblies required for manufacturing the Devices, as more specifically set forth in Exhibit G.
Back-Up Supplier. At Lilly’s request, Antares will qualify at least one back-up supplier for each critical component of the Device as determined to be appropriate as part of the Device Development Plan. Lilly shall bear the cost associated with a second set of tooling for such back-up supplier, and other qualification costs associated therewith.
Back-Up Supplier. Sucampo shall use Commercially Reasonable Efforts to provide Takeda, within ninety (90) days after the Effective Date, with a written list of Third Party contract manufacturer(s) (other than for Secondary Packaging) identified by Sucampo to act as potential Back-Up Suppliers. The Parties will discuss the strategy to qualify the Back-Up Supplier in the meetings of the JSC and JWG. Not later than […***…], Sucampo shall identify one or more Third Party contract manufacturers reasonably acceptable to Takeda to act as a secondary source for the Manufacture and supply of the Licensed Product. Not later than twelve (12) months after […***…], Sucampo shall use Commercially Reasonable Efforts to obtain all Regulatory Approvals required for the Back-Up Supplier to Manufacture and supply the License Product for use in Development and Commercialization of such Licensed Product as provided under this Agreement. Sucampo will be responsible for all costs associated with qualifying the Back-Up Suppliers, including costs for materials, start up, validation and test batches, stability testing and equipment. Upon written request by Takeda from time to time, Sucampo shall provide a reasonably detailed written report of Sucampo's efforts and progress to qualify the Back-Up Suppliers as required hereunder. Sucampo shall ensure that the Back-Up Supplier has the capacity to Manufacture and supply the Licensed Product in sufficient quantities to meet Takeda's binding forecast in any given quarter in the event of an interruption to the primary source of supply. Sucampo, at their cost, shall prepare and submit to the applicable Regulatory Authorities all information and filings, and take such other actions reasonably required, to obtain and maintain the Regulatory Approvals required for the Back-Up Supplier to Manufacture and supply the Licensed Product for Development and Commercialization activities under and during the Term of this Agreement. For the avoidance of doubt, Takeda shall continue to purchase the Licensed Product directly from Sucampo in the event that it is necessary for Sucampo to use the Back-Up Supplier to Manufacture, and supply to Takeda, the Licensed Product. Under no circumstances shall Sucampo willfully withhold supply of the Compound or the Licensed Product from Takeda during the Term of this Agreement, including, but not limited to, during a dispute with Takeda.
Back-Up Supplier. The occurrence of the any of the events set forth in subsections (i) - (v) below, Section 3.4(b)(iv) or (v), Section 4.9 (b) or Section 10.3 shall each be considered a “Failure Event”; provided, however, that, with respect to the occurrence of an event set forth in subsections (i) through (iv) below, LTS shall have a period of the greater of [**] months or [**] consecutive Purchase Orders following written notice from NuPathe of such Failure Event (the “Cure Period”) to Cure the Failure Event. If LTS is unable to Cure the Failure Event within the Cure Period (to the extent applicable) and NuPathe, in its sole discretion, does not agree to any additional Cure Period, in addition to any other rights and remedies available to NuPathe under this Agreement, at law or in equity, NuPathe’s obligation to purchase Drug Product under this Agreement shall become non-exclusive and NuPathe shall have the right to have the Drug Product manufactured by a third party of NuPathe’s choosing (the “Back-Up Supplier”). In the event that NuPathe exercises such rights (the “Back-Up Rights”), the amount of Drug Product that NuPathe is obligated to obtain from LTS pursuant to this Agreement shall be reduced by the greater of [**]% or any LTS shortfall resulting from the Failure Event. Notwithstanding the foregoing, the occurrence of three or more Failure Events set forth in subsection (i) — (v) below in any consecutive twelve month period shall automatically trigger NuPathe’s Back-Up Rights without regard to whether such Failure Event(s) are Cured within any applicable Cure Period. The exercise of NuPathe’s Back-Up Rights shall not relieve LTS of its obligations under this Agreement.
(i) Failure to Supply. LTS fails to supply at least [**]% of the Drug Product specified in a Firm Order.
(ii) Anticipated Failure to Supply. LTS provides written notice to NuPathe of an Anticipated Failure to Supply.
(iii) Egregious Delivery Delay. LTS fails to deliver Drug Product within thirty (30) days of its Scheduled Delivery Date under the terms set forth in Section 2.10(e) or delivers Drug Product having a residual shelf life of less than [**] months under the terms set forth in Section 2.10(g).
Back-Up Supplier
