Second Source Facility Sample Clauses

Second Source Facility. No later than [...***...] and thereafter during the Term, Xxxxxx Xxxxx shall have qualified and keep qualified an additional manufacturing facility (a "Second Source Facility"), in addition to the facility located in Gaillac, France, for the production of API to ensure a second source of supply of API to Cypress. The Second Source Facility must be a second facility operated by Xxxxxx Xxxxx or any licensee or subcontractor of Xxxxxx Xxxxx with quality and reliability in manufacturing comparable to Xxxxxx Xxxxx'x first facility, and such Second Source Facility must be approved by the FDA or other relevant regulatory authorities for the countries of the Licensed Territory such that the Licensed Products containing API manufactured by the Second Source Facility may be lawfully sold by Cypress.
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Second Source Facility. Buffer Stock. Not later than [***] months following the first Launch of a Product and thereafter during the term of the Agreement, ALMIRALL shall have qualified and shall maintain the qualification of at least one additional manufacturing site to assure a secondary and back-up source of supply of FOREST's requirements of Bulk Active LAS 34273. Such secondary facility shall comply with all applicable laws and regulatory requirements and have quality and reliability standards sufficient to permit its lawful use as a source of supply for LAS 34273 under this Agreement. Beginning on the date which is approximately [***] prior to the first Launch of a Product, ALMIRALL shall maintain buffer stock of LAS 34273 Bulk Active Ingredient which shall represent at least [***] (the "Minimum Buffer Stock") of FOREST's anticipated requirements of the LAS 34273 Bulk Active Ingredient. In addition, ALMIRALL shall use Commercially Reasonable Efforts to maintain or cause Third Party suppliers to maintain reasonable buffer stocks of the Device (at FOREST's cost to the extent borne by ALMIRALL) and Formoterol Bulk Active Ingredient for the Territory. Information about buffer stock levels will be periodically provided to the JMSC.
Second Source Facility. Within eighteen (18) months after the filing of the first application for Regulatory Approval in the Territory, NovaDel will qualify and thereafter keep qualified an additional Manufacturing facility (a “Second Source Facility”), in addition to, and at least one hundred and fifty (150) kilometers away from, the existing Manufacturing facility, for the production of Licensed Product to ensure a second source of supply of Licensed Product to BioAlliance. The Second Source Facility must be a second facility operated by NovaDel or any licensee or subcontractor of NovaDel with quality and reliability in Manufacturing comparable to NovaDel’s first facility, and such Second Source Facility must be approved by the EMEA and other relevant Regulatory Authorities in the Territory such that the Licensed Product Manufactured by the Second Source Facility may be commercialized by BioAlliance under the applicable Regulatory Approvals for Licensed Product. *** Portion for which confidential treatment requested.
Second Source Facility. Within […***…] months after Client provides notice to Patheon requesting that Patheon commence qualification and validation of an additional manufacturing facility, Patheon shall, at Client’s expense, qualify and validate, and thereafter keep qualified and validated, an additional manufacturing facility at Patheon’s manufacturing site located at 000 Xxxxxxxxx Xxxxx, Xxxxxx, Xxxxxxx, Xxxxxx X0X 0X0 (a “Second Source Facility”), in addition to the existing Manufacturing Site, for the manufacture of Product to ensure a second source of supply of Product to Client. The Second Source Facility must be a second facility operated by Patheon with quality and reliability in manufacturing comparable to the Manufacturing Site and shall comply with all obligations and limitations of this Agreement to the same extent as Manufacturing Site. Without limiting the generality of the foregoing, such Second Source Facility must be approved by the FDA, EMA and other relevant Regulatory Authorities such that the Product manufactured by the Second Source Facility may be commercialized by Client under the applicable Regulatory Approvals for Product.
Second Source Facility. Material omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Exchange Act of 1934. Material filed separately with the Securities and Exchange Commission. If Immtech: (a) discontinues or permanently ceases to manufacture the Product (unless otherwise agreed to in advance by BioAlliance); or (b) otherwise breaches its supply obligations hereunder or is otherwise unable or unwilling to supply BioAlliance with Product which conforms to the Specifications for a period in excess of one hundred twenty (120) consecutive days (“Event”), then effective upon written notice by BioAlliance that an Event has occurred, Immtech will work with BioAlliance or its sublicensees to identify a Third Party to manufacture the Product in order to satisfy BioAlliance’s and its Affiliates’ and sublicensees’ requirements of the Product. Immtech will enter into an agreement with a Third Party manufacturer acceptable to Immtech and will grant such Third Party manufacturer a license for the Immtech Technology as necessary for the Third Party Manufacturer to manufacture and supply the Product to BioAlliance, and its Affiliates and sublicensees. In addition, Immtech shall provide such technical assistance to such Third Party manufacturer as reasonably required, at Immtech’s expense, to the extent of any out-of-pocket expenses incurred by Immtech in connection with providing such technical assistance.

Related to Second Source Facility

  • Office Facilities During the Employment Period, the Company will furnish Executive, without charge, suitable office facilities for the purpose of performing his duties hereunder, which facilities shall include secretarial, telephone, clerical and support personnel and services and shall be similar to those furnished to employees of the Company having comparable positions.

  • Advance Facility (a) The Master Servicer is hereby authorized to enter into a financing or other facility (any such arrangement, an "Advance Facility") under which (1) the Master Servicer sells, assigns or pledges to another Person (an "Advancing Person") the Master Servicer's rights under this Agreement to be reimbursed for any Advances or Servicing Advances and/or (2) an Advancing Person agrees to fund some or all Advances and/or Servicing Advances required to be made by the Master Servicer pursuant to this Agreement. No consent of the Depositor, the Trustee, the Certificateholders or any other party shall be required before the Master Servicer may enter into an Advance Facility. Notwithstanding the existence of any Advance Facility under which an Advancing Person agrees to fund Advances and/or Servicing Advances on the Master Servicer's behalf, the Master Servicer shall remain obligated pursuant to this Agreement to make Advances and Servicing Advances pursuant to and as required by this Agreement. If the Master Servicer enters into an Advance Facility, and for so long as an Advancing Person remains entitled to receive reimbursement for any Advances including Nonrecoverable Advances ("Advance Reimbursement Amounts") and/or Servicing Advances including Nonrecoverable Advances ("Servicing Advance Reimbursement Amounts" and together with Advance Reimbursement Amounts, "Reimbursement Amounts") (in each case to the extent such type of Reimbursement Amount is included in the Advance Facility), as applicable, pursuant to this Agreement, then the Master Servicer shall identify such Reimbursement Amounts consistent with the reimbursement rights set forth in Section 3.10(a)(ii) and (vii) and remit such Reimbursement Amounts in accordance with this Section 3.22 or otherwise in accordance with the documentation establishing the Advance Facility to such Advancing Person or to a trustee, agent or custodian (an "Advance Facility Trustee") designated by such Advancing Person in an Advance Facility Notice described below in Section 3.22(b). Notwithstanding the foregoing, if so required pursuant to the terms of the Advance Facility, the Master Servicer may direct, and if so directed in writing the Trustee is hereby authorized to and shall pay to the Advance Facility Trustee the Reimbursement Amounts identified pursuant to the preceding sentence. An Advancing Person whose obligations hereunder are limited to the funding of Advances and/or Servicing Advances shall not be required to meet the qualifications of a Master Servicer or a Subservicer pursuant to Section 3.02(a) or 6.02(c) hereof and shall not be deemed to be a Subservicer under this Agreement. Notwithstanding anything to the contrary herein, in no event shall Advance Reimbursement Amounts or Servicing Advance Reimbursement Amounts be included in the Available Distribution Amount or distributed to Certificateholders.

  • Technology Access Fee In consideration of the licenses and rights granted to Regado herein, Regado shall, as of the date immediately preceding the closing (the “Closing”) of the first equity financing of Regado in which Regado is assigned a pre-money valuation of not less than [***] dollars ($[***]), issue to Archemix fully-paid and non-assessable shares of common stock of Regado equal to [***] percent ([***]%) of the total number of equity shares of Regado, on a fully diluted basis, immediately prior to the issuance of shares at the Closing. Regado shall deliver written notice of the Closing to Archemix at least [***] business days prior to such Closing in accordance with the notice provisions contained in Section 14.1 of this Agreement. Archemix and Regado shall enter into such agreements relating to the issuance of the common stock as are customary under such circumstances. For the purpose of this Agreement, “fully diluted basis” shall mean the aggregate of (a) the number of shares of common stock issued and outstanding on the determination date, (b) the number of shares of common stock issuable upon exercise, exchange or conversion of all exercisable, exchangeable or convertible securities outstanding on the determination date, assuming such securities were exercised, exchanged or converted on the determination date (without regard to whether such securities are actually exercisable, exchangeable or convertible on the determination date) and (c) the number of shares of common stock issuable pursuant to any other obligation or agreement of, or right granted by, Regado, whether vested or unvested, contingent or otherwise.

  • Assignment; Sales; Advance Facilities (a) The Servicer is hereby authorized to enter into a financing or other facility (any such arrangement, an "Advance Facility"), the documentation for which complies with Section 10.14(e) below, under which (1) the Servicer assigns or pledges its rights under this Agreement to be reimbursed for any or all Advances and/or Servicing Advances to (i) a Person, which may be a special-purpose bankruptcy-remote entity (an "SPV"), (ii) a Person, which may simultaneously assign or pledge such rights to an SPV or (iii) a lender (a "Lender"), which, in the case of any Person or SPV of the type described in either of the preceding clauses (i) or (ii), may directly or through other assignees and/or pledgees, assign or pledge such rights to a Person, which may include a trustee acting on behalf of holders of debt instruments (any such Person or any such Lender, an "Advance Financing Person"), and/or (2) an Advance Financing Person agrees to fund all the Advances and/or Servicing Advances required to be made by the Servicer pursuant to this Agreement. No consent of the Trustee, Certificateholders or any other party shall be required before the Servicer may enter into an Advance Facility nor shall the Trustee or the Certificateholders be a third party beneficiary of any obligation of an Advance Financing Person to the Servicer. Notwithstanding the existence of any Advance Facility under which an Advance Financing Person agrees to fund Advances and/or Servicing Advances, (A) the Servicer (i) shall remain obligated pursuant to this Agreement to make Advances and/or Servicing Advances pursuant to and as required by this Agreement and (ii) shall not be relieved of such obligations by virtue of such Advance Facility and (B) neither the Advance Financing Person nor any Servicer's Assignee (as hereinafter defined) shall have any right to proceed against or otherwise contact any Mortgagor for the purpose of collecting any payment that may be due with respect to any related Mortgage Loan or enforcing any covenant of such Mortgagor under the related Mortgage Loan documents.

  • Development Agreement That certain Development Agreement dated of even date herewith by and between the Company and Developer providing for the development of the Project on the Property, a copy of which is attached hereto as Exhibit C and incorporated herein by reference. Development Fee. As described in Section 6.8.

  • Software License Agreement McDATA agrees that all Licensed Software will be distributed to Customers subject to a Software License Agreement (including warranty statement), along with a McDATA Manual, in a manner which is (a) no less protective of BROCADE's Intellectual Property Rights in the Licensed Software than the form attached hereto as Exhibit D, and (b) legally enforceable in the jurisdictions in which the Licensed Software, as incorporated into the McDATA Products, is distributed.

  • Site Access The Buyer agrees to RELEASE, INDEMNIFY AND HOLD HARMLESS the Seller Indemnitees from and against the entirety of any Adverse Consequences that are suffered by the Seller Indemnitees arising out of, resulting from or relating to any field visit or other due diligence activities relating to any performance of the Diligence Activities to the extent caused by acts or omissions of any Buyer Party or Buyer Diligence Representative, even if such Adverse Consequences arise out of or result from, solely or in part, the sole, active, passive, concurrent or comparative negligence, strict liability or other fault or violation of Law of or by the Seller Indemnitees, except Adverse Consequences to the extent resulting from the gross negligence or willful misconduct of the Seller Indemnitees.

  • Network Access Control The VISION Web Site and the Distribution Support Services Web Site (the “DST Web Sites”) are protected through multiple levels of network controls. The first defense is a border router which exists at the boundary between the DST Web Sites and the Internet Service Provider. The border router provides basic protections including anti-spoofing controls. Next is a highly available pair of stateful firewalls that allow only HTTPS traffic destined to the DST Web Sites. The third network control is a highly available pair of load balancers that terminate the HTTPS connections and then forward the traffic on to one of several available web servers. In addition, a second highly available pair of stateful firewalls enforce network controls between the web servers and any back-end application servers. No Internet traffic is allowed directly to the back-end application servers. The DST Web Sites equipment is located and administered at DST’s Winchester data center. Changes to the systems residing on this computer are submitted through the DST change control process. All services and functions within the DST Web Sites are deactivated with the exception of services and functions which support the transfer of files. All ports on the DST Web Sites are disabled, except those ports required to transfer files. All “listeners,” other than listeners required for inbound connections from the load balancers, are deactivated. Directory structures are “hidden” from the user. Services which provide directory information are also deactivated.

  • Information Systems Acquisition Development and Maintenance a. Client Data – Client Data will only be used by State Street for the purposes specified in this Agreement.

  • Facility Prudential is willing to consider, in its sole discretion and within limits which may be authorized for purchase by Prudential Affiliates from time to time, the purchase of Shelf Notes pursuant to this Agreement. The willingness of Prudential to consider such purchase of Shelf Notes is herein called the “Facility”. At any time, the aggregate principal amount of Shelf Notes stated in Section 1.2, minus the aggregate principal amount of Shelf Notes purchased and sold pursuant to this Agreement prior to such time, minus the aggregate principal amount of Accepted Notes (as hereinafter defined) which have not yet been purchased and sold hereunder prior to such time, is herein called the “Available Facility Amount” at such time. NOTWITHSTANDING THE WILLINGNESS OF PRUDENTIAL TO CONSIDER PURCHASES OF SHELF NOTES BY PRUDENTIAL AFFILIATES, THIS AGREEMENT IS ENTERED INTO ON THE EXPRESS UNDERSTANDING THAT NEITHER PRUDENTIAL NOR ANY PRUDENTIAL AFFILIATE SHALL BE OBLIGATED TO MAKE OR ACCEPT OFFERS TO PURCHASE SHELF NOTES, OR TO QUOTE RATES, SPREADS OR OTHER TERMS WITH RESPECT TO SPECIFIC PURCHASES OF SHELF NOTES, AND THE FACILITY SHALL IN NO WAY BE CONSTRUED AS A COMMITMENT BY PRUDENTIAL OR ANY PRUDENTIAL AFFILIATE.

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