Supply Matters Sample Clauses

Supply Matters. Any Excipients supplied by AEGIS will be done so in accordance with the Supply Agreement.
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Supply Matters. During the Pediatrician Promotion Period, Forest shall keep Replidyne advised of matters regarding the supply of the Oral Suspension in the Territory and shall consult with Replidyne on strategic decisions to be made with respect thereto.
Supply Matters. (a) Any Enhancement Agents supplied by Aegis will be done so in accordance with Section 3.4 of this Agreement and the Supply Agreement.
Supply Matters. 4.1. Transfer of Bulk Compound to TMC. ASTRAZENECA undertakes to supply to TMC [**] approximately ten (10) kilograms of bulk Compound no later than ninety (90) days after the License Agreement Effective Date. The transport of such entire quantity of bulk Compound shall be entirely at TMC's risk and expense. It is explicitly understood that this quantity of Compound was manufactured by ASTRAZENECA at an earlier date, and was not made for the purpose of the supply now stated, and that ASTRAZENECA gives no guarantee whatsoever as to the characteristics of the Compound or the Compound's fitness for any particular purpose.
Supply Matters. Local materials that are adequate in quality and available in sufficient quantity shall be used for the Project as practical as possible. During implementation of the Project, quality of the locally procured materials shall be examined in a proper manner with sufficient frequency in order to confirm that they satisfy the requirements of the technical specifications of the Project.
Supply Matters. Aegis covenants that it will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended under 21 U.S.C. §335(a) or (b). Aegis will not hire, as an officer or an employee any person who has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the United States Food, Drug and Cosmetic Act.
Supply Matters. 4.1. TRANSFER OF BULK COMPOUND TO TMC. ASTRAZENECA undertakes to supply to TMC [**] approximately [**] kilograms of bulk Compound no later than ninety (90) days after the Effective Date. The transport of such entire quantity of bulk Compound shall be entirely at TMC's risk and expense. It is explicitly understood that this quantity of Compound was License Agreement - The Medicines Company manufactured by ASTRAZENECA at an earlier date, and was not made for the purpose of the supply now stated, and that ASTRAZENECA gives no guarantee whatsoever as to the characteristics of the Compound or the Compound's fitness for any particular purpose. It is explicitly understood and agreed by the Parties that ASTRAZENECA shall have no obligations whatsoever to transfer or supply, other than as explicitly provided under this Article 4.1, any quantity of Compound or Product to TMC. 4.2. SUPPLY OF COMPOUND AND PRODUCT BY TMC. 4.2.1. TMC undertakes to supply ASTRAZENECA and/or any of its Affiliates, at TMC's [**] ASTRAZENECA's and/or its Affiliates entire need of Product for clinical trials, sale, promotion and marketing in the Excluded Countries, pursuant to the Supply Agreement between TMC and ASTRAZENECA, attached hereto, subject to what is stated in Article 4.2.3, as Schedule F. In addition ASTRAZENECA will reimburse TMC for costs specifically pertaining to the development of a formulation necessary only for the purpose of enabling ASTRAZENECA to obtain NDA Approval in one or more of the Excluded Countries. 4.2.2. TMC further undertakes to supply ASTRAZENECA, subject to Article 15.1 (i), at [**] and otherwise under terms to be as consistent as possible with those under the Supply Agreement, ASTRAZENECA's entire need of Product for clinical trials, sale, promotion and marketing in any country where the license granted under Article 2 has been terminated pursuant to Article 3.8; provided always that such TMC's obligation shall not become effective unless and until TMC has Launched the Product in at least one (1) country of the Territory. 4.2.3. The Supply Agreement has not been entered into on the Effective Date due to the Parties' desire to expeditiously enter into this Agreement, not delaying such procedure by awaiting the completion of the Supply Agreement. The parties acknowledge the substantial need for License Agreement - The Medicines Company ASTRAZENECA to rely on TMC for its supply of the Product for the countries mentioned in Articles 4.2.1 and 4.2.2 and that en...
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Supply Matters. 6.1. The Supply Addendum (Exhibit C to the Agreement) shall continue to apply by its terms except to the extent set forth below: (a) The provisions of Section 4.4 of this Amendment Agreement shall supersede the provisions for payments to Mylan for Compound set forth in Section 3.2(b) of the Supply Addendum. (b) Section 4.5 of the Supply Addendum is hereby deleted in its entirety. (c) Mylan shall not have the rights of inspection and audit provided by Section 6.7 of the Supply Addendum, provided that such rights shall continue to be extended to Xxxxxxx to the extent required by the Xxxxxxx Agreement or any Quality Agreement (each a "Quality Agreement") between Mylan and Xxxxxxx or between Forest and Xxxxxxx from time to time in effect. (d) Except to the extent required by the Xxxxxxx Agreement or any Quality Agreement, Forest shall not be obligated to notify Mylan of any audit or inspection by the FDA or other Regulatory Authority of Forest’s facilities used in the manufacture of the Product.

Related to Supply Matters

  • UCC Matters Such Seller shall not change its state of organization or incorporation or its name, identity or corporate structure such that any financing statement filed to perfect the Purchaser’s interests under this Agreement would become seriously misleading, unless such Seller shall have given the Purchaser not less than thirty (30) days’ prior written notice of such change.

  • FDA Matters (a) The Corporation has (i) complied in all material respects with all applicable laws, regulations and specifications with respect to the manufacture, design, sale, storing, labeling, testing, distribution, inspection, promotion and marketing of all of the Corporation’s products and product candidates and the operation of manufacturing facilities promulgated by the U.S. Food and Drug Administration (the “FDA”) or any corollary entity in any other jurisdiction and (ii) conducted, and in the case of any clinical trials conducted on its behalf, caused to be conducted, all of its clinical trials with reasonable care and in compliance in all material respects with all applicable laws and the stated protocols for such clinical trials. (b) All of the Corporation’s submissions to the FDA and any corollary entity in any other jurisdiction, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made, and remain true, accurate and complete in all material respects and do not misstate any of the statements or information included therein, or omit to state a fact necessary to make the statements therein not materially misleading. (c) The Corporation has not committed any act, made any statement or failed to make any statement that would breach the FDA’s policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar laws, rules or regulations, whether under the jurisdiction of the FDA or a corollary entity in any other jurisdiction, and any amendments or other modifications thereto. Neither the Corporation nor, to the Corporation’s Knowledge, any officer, employee or agent of the Corporation has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar state or foreign law or regulation or (ii) exclusion under 42 U.S.C. Section 1320a 7 or any similar state or foreign law or regulation, and neither the Corporation nor, to the Corporation’s Knowledge, any such person has been so debarred or excluded. (d) The Corporation has not sold or marketed any products prior to receiving any required or necessary approvals or consents from any federal or state governmental authority, including but not limited to the FDA under the Food, Drug & Cosmetics Act of 1976, as amended, and the regulations promulgated thereunder, or any corollary entity in any jurisdiction. The Corporation has not received any notice of, nor is the Corporation aware of any, actions, citations, warning letters or Section 305 notices from the FDA or any corollary entity.

  • Environmental, Health and Safety Matters (a) Comply in all material respects with all applicable Environmental Laws, including, without limitation, obtaining and complying with and maintaining any and all licenses, approvals, notifications, registrations or permits required by applicable Environmental Laws. For purposes of this Section 5.12(a), material noncompliance by the Company, any of its Subsidiaries or any tenant or subtenant, with any applicable Environmental Law shall be deemed not to constitute a breach of this covenant provided that, upon learning of any actual or suspected material noncompliance, the Company and the relevant Subsidiaries shall promptly undertake all reasonable efforts to achieve material compliance (or contest in good faith by appropriate proceedings the alleged violation or applicable Environmental Law at issue and (to the extent required by GAAP) provide on the books of the Company or any of its Subsidiaries, as the case may be, reserves in accordance with GAAP with respect thereto), and provided further that, in any case, such noncompliance, and any other noncompliance with applicable Environmental Law, individually or in the aggregate, could not reasonably be expected to have a Material Adverse Effect. (b) Promptly comply in all material respects with all lawful orders and directives of all Governmental Authorities regarding applicable Environmental Laws, except to the extent that the validity thereof is currently being contested in good faith by appropriate proceedings and (to the extent required by GAAP) reserves in accordance with GAAP with respect thereto have been provided on the books of the Company or any of its Subsidiaries, as the case may be. (c) Defend, indemnify and hold harmless the Administrative Agent and the Lenders, and their respective parents, subsidiaries, affiliates, employees, agents, officers and directors, from and against any claims, demands, penalties, fines, liabilities, settlements, damages, costs and expenses of whatever kind or nature, known or unknown, contingent or otherwise, arising out of, or in any way relating to the violation of, noncompliance with or liability under any Environmental Laws applicable to the Company or any of its Subsidiaries or any of their respective operations or properties, or any orders, requirements or demands of Governmental Authorities related thereto, including, without limitation, attorney’s and consultant’s fees, investigation and laboratory fees, response costs, court costs and litigation expenses, except to the extent that any of the foregoing arise out of the gross negligence or willful misconduct of (or, as determined pursuant to a claim initiated by the Company, breach in bad faith of its express obligations under the applicable Loan Documents by) the party seeking indemnification therefor, in each case, as determined by a final non-appealable judgment by a court of competent jurisdiction. This indemnity shall continue in full force and effect regardless of the termination of this Agreement.

  • Personnel Matters 7.1 Verbal or written complaints regarding an employee made to any member of the Administration by any parent, student or other person which is to be placed in any personnel file or which may be used to evaluate or discipline an employee shall be promptly investigated. The employee shall be given prompt notice of such complaint and shall be given the opportunity to respond to the complaint. Unsubstantiated complaints shall not be placed in an employee’s file. 7.2 Each employee shall be entitled to access to his/her personnel file. This review shall take place during an agreed upon time; requests to examine the file need to be made to the Superintendent or his/her designee at least 24 hours prior and shall not be unreasonably withheld. The employee may, if he/she wishes, have a representative of the Association accompany him/her during such review. 7.3 The employee shall have the right to make a response to any material contained in his/her personnel file and such response shall be made a part of said employee’s file. Reproductions of such material may be made by hand or copying machine, if available. 7.4 No disciplinary material will be placed in an employee's personnel file without written or electronic notification to the employee. 7.5 The Board agrees to maintain, as part of its general policy manual, job descriptions for members of the bargaining unit; said policy manual to be made available to each member of the bargaining unit and any new employee. Whenever the District contemplates any changes in job description, the District will notify the Association on the planned action and convene the Job Description Team per the Memorandum of Understanding included in Exhibit 1.

  • Transition Matters (a) Prior to the Closing, each party shall use its commercially reasonable efforts to negotiate in good faith the schedules to, and Provider Fees provided for in, the Transition Services Agreement in accordance with the terms thereof. To the extent that the Parties are unable to reach such agreement, the applicable provisions of the Transition Services Agreement shall control from and after the Closing, subject to amendment in accordance with the terms of the Transition Services Agreement. The Parties acknowledge and agree that if there are any disputes with respect to the Transition Services Agreement prior to the Closing, such disputes shall not affect the obligations of the Parties to effect the Closing and shall be resolved in accordance with the terms of the Transition Services Agreement. (b) Acquiror acknowledges that Seller has the absolute and exclusive proprietary right to the trademark “OPTIMUM”, other “OPTIMUM” inclusive trademarks and designs and logos associated therewith currently used by the Business (collectively, the “Names”) and that none of the rights thereto or goodwill represented thereby or pertaining thereto are being transferred hereby or in connection herewith. Notwithstanding the foregoing, for a period of 360 days following the Closing, the Company and the Subsidiaries may continue to operate the Systems using the Names, including (i) use of the phrase “Optimum is now Charter,” (ii) use of any Name affixed to vehicles, signage or other equipment which are used by any of them in Business as of the Closing Date, (iii) use of any printed purchase orders or sales, maintenance or license agreements that bear a Name (as limited by any existing agreements the Seller or any of its Affiliates may have with third parties) until the supplies thereof existing on the Closing Date have been exhausted, and (iv) use of any printed billing statements that bear a Name (such billing statements and purchase orders and sales, maintenance and license agreements are collectively referred to herein as “Forms”); provided, however, that notwithstanding the foregoing with respect to any advertising, marketing, packaging, displays, merchandise or other promotional materials (“Promotional Materials”) which are used by the Company or any Subsidiary in the Business as of the Closing Date the Company and the Subsidiaries shall have the right to use such Promotional Materials only: (i) for a period of 60 days following the Closing with respect to mass marketing Promotional Materials (such as television advertising and mass mailings) and 180 days for all other Promotional Materials, (ii) in the exact form as such Promotional Materials exist on the Closing Date, (iii) to the extent that the Company or Subsidiary using such Promotional Materials has not modified the products or services of the Business in any way which would render the use of such Promotional Materials inaccurate or misleading in any respect, and (iv) provided the Company and the Subsidiaries shall xxxx such materials as necessary in order to indicate clearly and prominently to indicate that neither the Acquiror nor any of its Affiliates is affiliated with the Seller or any of its Affiliates. With respect to Forms, within 60 days after the Closing Date the Company and the Subsidiaries shall sticker or otherwise xxxx such documents as necessary in order to indicate clearly that neither the Seller nor any of its Affiliates are a party to such documents or affiliated with the Seller or any of its Affiliates. From and after the expiration of the period for use applicable to Promotional Materials or Forms, the Company and the Subsidiaries shall cease to use any such Promotional Materials or Forms. With respect to the other uses of the Names permitted above, from and after the 360-day period permitted above the Company and the Subsidiaries shall delete or cover (as by stickering) any Name from any item included in inventory that bears Name and take such other actions as may be necessary or advisable clearly and prominently to indicate that neither the Acquiror nor any of its Affiliates is affiliated with the Seller or any of its Affiliates. If Acquiror determines that it wishes the Company and the Subsidiaries to use any Promotional Materials or Forms to which the applicable period provided above applies for a duration longer than such period or to use any other Promotional Materials or Forms or to create new Promotional Materials or Forms incorporating the Names in a manner exceeding the scope of the rights granted herein, Acquiror shall notify Seller and the parties shall negotiate in good faith the terms of a trademark license granting to the Company and the Subsidiaries such rights for an agreed-upon term and otherwise on terms and conditions mutually acceptable to Acquiror and Seller. For the avoidance of doubt, the execution and delivery of any such trademark license shall not be a condition to Closing or otherwise affect the obligations of the parties to consummate the Transaction. Notwithstanding the foregoing, nothing in this Section 5.11(b) shall require the Acquiror to remove or discontinue using any Name that is affixed as of the Closing Date to converters or other items in or to be used in consumer homes or properties, or as are used in a similar fashion making such removal or discontinuation impracticable.

  • Labour Matters No material work stoppage, strike, lock-out, labour disruption, dispute grievance, arbitration, proceeding or other conflict with the employees of the Corporation or the Subsidiaries currently exists or, to the knowledge of the Corporation, is imminent or pending and the Corporation and the Subsidiaries are in material compliance with all provisions of all federal, national, regional, provincial and local laws and regulations respecting employment and employment practices, terms and conditions of employment and wages and hours.

  • Transitional Matters (a) Each of the parties acknowledges and agrees that the transition of the Business from the Selling Companies to Buyer will require that certain transactions and relationships will need to be entered into, restructured and reorganized in connection with the transition of the Business from the Selling Companies to Buyer. The parties agree that prior to the Closing Date, the parties shall cooperate with each other to identify all such transactions and relationships and negotiate in good faith to enter into a mutually acceptable Transitional Agreement effective as of the Closing Date, which agreement shall provide for all such transactions and relationships as are reasonably necessary to provide, (i) for (A) the operation of the Business and use of the Purchased Assets by Buyer, (B) the operation and use of the Excluded Assets by Sellers and the Selling Subsidiaries and (C) the separation of the Business, the Purchased Assets and the Assumed Liabilities from Parent and its Affiliates (including the Selling Companies), in each case during the period commencing on and after the Closing Date and ending no later than the one year anniversary of the Closing Date or such longer period as the parties may agree, including the following: (1) the transitioning of the financial systems, assets and hedging valuation systems, asset management systems, payroll and employee benefits systems and any other applicable business operating systems; (2) the provision of rights of access (provided that access to the ALSS Platform shall be governed and limited by the Intellectual Property Rights Agreement and the Services Agreement) to the Parent and its Affiliates to Intellectual Property currently owned (or licensed) by the Selling Companies (and included in the Purchased Assets) and used by Parent or the Selling Companies in the ordinary course of their business, or required by the Selling Companies for the operation and use of the Excluded Assets or Excluded Liabilities; provided, that access to the ALSS Platform and other Software shall be governed solely by the Intellectual Property Rights Agreement and the Services Agreement and, provided further, anything foregoing to the contrary notwithstanding, Buyer shall not be required to disclose or deliver trade secret or confidential information regarding the ALSS Platform, Software or Acquired Intellectual Property unless required by the Intellectual Property Rights Agreement, the Services Agreement or required by law or legal proceedings and under the type of protective provisions in the Intellectual Property Rights Agreement. (3) the provision of rights of access (to the extent not covered by the Intellectual Property Rights Agreement) to Buyer to Intellectual Property currently owned (or licensed) by Parent (or the Selling Companies) and used by the Selling Companies in connection with the Purchased Assets or Assumed Liabilities; (4) moving corporate records related to the Selling Companies; and (5) the provision of office space, computer equipment and supplies sufficient to enable the Selling Companies to complete any transition services; and (ii) for such services and facilities as Sellers and Selling Subsidiaries may require to monitor compliance with, and implementation of the Subservicing Agreement, during its term, including the provision of office space, computer equipment and supplies sufficient to enable Sellers to monitor compliance with the Retained Portfolio Subservicing Agreement throughout its term. (b) In addition to the matters to be identified pursuant to paragraph (a) of this Section 5.12, the Transition Agreement shall specifically provide for the transactions and matters outlined in Section 5.12 of Sellers' Disclosure Schedule. (c) For the purpose of facilitating the transition of the financial system, on or prior to the 15th day prior to the Closing Date, the Selling Companies shall create on their general ledger, a separate general ledger company ("GL Company"), as well as accounts for such GL Company ("Buyer GL Accounts"), which accounts shall be duplicative of the Selling Companies' own accounts ("Seller GL Accounts") and are intended to be used by the Buyer in the operation of the Business, the Purchased Assets and the Assumed Liabilities from and after the Closing Date. From and after the creation of the Buyer GL Accounts, until Closing, the Selling Companies shall maintain such accounts (as duplicate entries on the books of the Selling Companies in the name of the GL Company). From and after Closing until the completion of the transition of the financial system of the Selling Companies, the Buyer shall operate the Business by recording entries using the Buyer GL Accounts, and shall maintain on behalf of the Selling Companies, the Seller GL Accounts on its general ledger. (d) The party receiving service under the Transitional Agreement shall pay to the party providing service the costs incurred by such providing party. Services provided under the Transitional Agreement shall be performed at the same standard as the providing party performs such service for its own account.

  • Environmental and Safety Matters (a) The Company and its Subsidiaries have at all times complied in all material respects with all applicable Environmental and Safety Requirements, which compliance has included obtaining and complying in all material respects at all times with all material permits, licenses and other authorizations required pursuant to Environmental and Safety Requirements for the occupation of their facilities and the operation of their respective businesses. (b) Except as set forth in Section 4.27(b) of the Disclosure Schedule, since February 19, 2008, neither the Company nor any of its Subsidiaries has received any notice, report, order, or directive regarding any, and is not subject to any litigation, proceedings or order regarding any, actual or alleged violation of Environmental and Safety Requirements, or any liability or potential liability arising under Environmental and Safety Requirements, in effect prior to and as of the date of the applicable Closing, relating to the business, the Owned Real Property or Leased Real Property. (c) Except as set forth in Section 4.27(c) of the Disclosure Schedule, neither the Company nor any of its Subsidiaries has treated, stored, disposed of, arranged for or permitted the disposal of, transported, handled, released, or exposed any Person to, any substance (including without limitation any hazardous substance), owned or operated any property or facility which is or has been contaminated by any substance, so as to give rise to any current or future liabilities under any Environmental and Safety Requirements in effect at the time of such treatment, storage, disposal, transportation, handling, release or exposure. (d) Except as set forth in Section 4.27(d) of the Disclosure Schedule, neither the Company nor any of its Subsidiaries has assumed, undertaken, or provided any indemnity with respect to, any liability of any other Person relating to Environmental and Safety Requirements. (e) The Company has furnished to Investor true and correct copies of all environmental audits, reports, assessments and all other documents materially bearing on environmental, health or safety liabilities relating to the past or current operations or facilities of the Company and all of its Subsidiaries, in each case which are in its possession or under its reasonable control.

  • Regulatory Matters (a) VFL and Purchaser shall cooperate and use commercially reasonable efforts to obtain all consents, approvals and agreements of, and to give and make all notices and filings with, any Governmental Entity necessary to authorize, approve or permit the consummation of the transactions contemplated by this Agreement, the Related Agreements and any other agreements contemplated hereby or thereby, including, without limitation, as set forth on Schedule 3.04 and Schedule 4.04. Purchaser and VFL will provide each other and their counsel the opportunity to review in advance and comment on all such filings with any Governmental Entity. Purchaser and VFL will keep each other informed of the status of matters relating to obtaining the regulatory approvals specified in Schedule 3.04 and Schedule 4.04. It is expressly understood by the parties hereto that each party hereto shall use commercially reasonable efforts to ensure that representatives of both Purchaser and VFL shall have the right to attend and participate in any hearing, proceeding, meeting, conference or similar event before or with a Governmental Entity or other organization relating to this Agreement or a Related Agreement. In furtherance of the foregoing, Purchaser and VFL shall provide each other reasonable advance notice of any such hearing, proceeding, meeting, conference or similar event. The notice required to be given under this Section 5.04 shall be given to representatives of VFL or Purchaser entitled to receive notices hereunder. (b) VFL and Purchaser shall cooperate and use commercially reasonable efforts to obtain all other approvals and consents to the transactions contemplated by this Agreement and the Related Agreements, including the consents of third parties under Assigned Contracts. In the event and to the extent that VFL is unable to obtain any required approval or consent of non-governmental authorities to any agreement to be assigned to Purchaser hereunder, (i) VFL shall use commercially reasonable efforts in cooperation with Purchaser to (A) provide or cause to be provided to Purchaser the benefits of any such agreement, (B) cooperate in any arrangement, reasonable and lawful as to VFL and Purchaser, designed to provide such benefits to Purchaser and (C) enforce for the account of Purchaser any rights of VFL arising from such agreements, including the right to elect to terminate in accordance with the terms thereof on the advice of Purchaser and (ii) Purchaser shall use commercially reasonable efforts to perform the obligations of VFL arising under such agreements and licenses, to the extent that, by reason of the transactions consummated pursuant to this Agreement or otherwise, Purchaser has control over the resources necessary to perform such obligations. If and when any such approval or consent shall be obtained or such agreement or license shall otherwise become assignable, VFL shall promptly assign all of its rights and obligations thereunder to Purchaser without the payment of further consideration and Purchaser shall, without the payment of any further consideration therefor, assume such rights and obligations and VFL shall be relieved of any and all obligation or liability hereunder.

  • Intellectual Property Matters A. Definitions

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