Manufacture and Supply As between the Parties, Otsuka shall be responsible for, shall bear all costs associated with, and shall have all decision-making authority over, all Manufacturing Activities (subject to discussion of CMC matters with Acucela through the JDC or applicable Operating Team as discussed below); provided, that Otsuka shall supply Licensed Product to Acucela or its permitted subcontractors for use in clinical trials conducted in accordance with each Development Plan and, if applicable, Commercialization Plan (i.e., Phase 3b Clinical Trials or Post-Approval Studies, if any), free of charge and in such quantities as are agreed by the JDC or the JCC (as applicable) or are otherwise required to seek or obtain Regulatory Approval. In addition, if and after Acucela exercises an Opt-In Right under Section 3.1, Otsuka shall supply promotional samples of Licensed Product to Acucela for use in its performance of Co-Promotion, in such quantities and on such terms as are determined by the JCC. The cost of promotional samples of Licensed Product, which shall be included in Commercialization Costs, shall be established by the JCC based on Otsuka’s per-unit cost to manufacture such promotional samples (but, for the avoidance of doubt, Otsuka shall have no obligation to disclose any information relating to its manufacturing costs), but in no event shall such promotional sample cost exceed * per promotional sample unless mutually agreed otherwise by the Parties. Acucela’s and its permitted subcontractors’ obligations to conduct Development activities, and upon Acucela’s exercise of its Opt-in Right pursuant to Section 3.1, to conduct Development and Commercialization activities, shall be expressly conditioned upon Otsuka fulfilling its Licensed Product supply obligations as set forth in the Development Plan or the Commercialization Plan, as applicable. To the extent that Otsuka reasonably believes is necessary for performance of Development or Commercialization, Otsuka agrees to keep Acucela reasonably informed from time to time, through the JDC, JCC or applicable Operating Team, regarding the general status of Manufacturing Activities related to the Licensed Product (including Other Indication Product(s), as applicable) and from time to time shall update Acucela on any foreseeable delays and/or other material issues relating to Manufacturing the Licensed Product (including Other Indication Product(s), as applicable). Through the JDC or applicable Operating Team, Otsuka and Acucela shall confer and discuss CMC matters, and Otsuka agrees to consider suggestions of Acucela regarding CMC matters.
LICENSURE AND CERTIFICATION 25.1 The Employer will continue its current practices related to licensure and certification or comply with 25.2, 25.3 and 25.4, below, whichever provides the greater benefit to the employee.
NATURE AND SCOPE 4.1 This Agreement is an agreement under the terms and conditions of which the Supplier/Service Provider will arrange for the supply/provision to Transnet of the Goods/Services which meet the requirements and specifications of Transnet, the delivery of which is controlled by means of Purchase Orders to be issued by Transnet and executed by the Supplier/Service Provider in accordance with this Agreement. 4.2 Such Purchase Orders and deliveries to Transnet shall be agreed between the Parties from time to time, subject to the terms of the Schedule of Requirements/Work Order. 4.3 Each properly executed Purchase Order forms an inseparable part of this Agreement as if it were fully incorporated into the body of this Agreement. 4.4 During the period of this Agreement, both Parties can make written suggestions for amendments to the Schedule of Requirements/Work Orders in accordance with procedures set out in clause 35 [Amendment and Change Control]. A Party will advise the other Party within 14 [fourteen] Business Days, or such other period as mutually agreed, whether the amendment is acceptable. 4.5 Insofar as any term, provision or condition in the Schedule of Requirements/Work Order conflicts with a like term, provision or condition in this Agreement and/or a Purchase Order, the term or provision or condition in this Master Agreement shall prevail, unless such term or provision or condition in this Master Agreement has been specifically revoked or amended by mutual written agreement between the Parties. 4.6 Time will be of the essence and the Supplier/Service Provider will perform its obligations under this Agreement in accordance with the timeframe(s) [if any] set out in the relevant schedule, save that the Supplier/Service Provider will not be liable under this clause if it is unable to meet such obligation within the time required as a direct result of any act or omission by Transnet and it has used its best endeavours to advise Transnet of such act or omission. In the event of such delay, any time deadlines detailed in the relevant schedule shall be extended by a period equal to the period of that delay.
Nature and Purpose of Processing The Parties will Process Shared Personal Data only as necessary to perform under and pursuant to the Applicable Agreements, and subject to this Data Processing Addendum, including as further instructed by Data Subjects.
Cooperation on forestry matters and environmental protection 1. The aims of cooperation on forestry matters and environmental protection will be, but not limited to, as follows: (a) establishing bilateral cooperation relations in the forestry sector; (b) developing a training program and studies for sustainable management of forests; (c) improving the rehabilitation and sustainable management of forest with the aim of increasing carbon sinks and reduce the impact of climate change in the Asia-Pacific region; (d) cooperating on the execution of national projects, aimed at: improving the management of forest plantations for its transformation for industrial purposes and environmental protection; (e) elaborating studies on sustainable use of timber; (f) developing new technologies for the transformation and processing of timber and non-timber species; and (g) improving cooperation in agro-forestry technologies. 2. To achieve the objectives of the Article 149 (Objectives), the Parties may focus, as a means of cooperation and negotiations on concluding a bilateral agreement on forestry cooperation between the two Parties. Such collaboration will be as follows: (a) exchanges on science and technology as well as policies and laws relating the sustainable use of forest resources; (b) cooperation in training programs, internships, exchange of experts and projects advisory; (c) advice and technical assistance to public institutions and organizations of the Parties on sustainable use of forest resources and environmental protection; (d) facilitating forest policy dialogue and technical cooperation under the Network of Sustainable Forest Management and Forest Rehabilitation in Asia- Pacific Region, initiated at the 15th Asia Pacific Economic Cooperation (APEC) Meeting; (e) encouraging joint studies, working visits, exchange of experiences, among others; and (f) others activities mutually agreed.
Nature and Scope of Guaranty 1.1 The Guarantor, jointly and severally (if executed by more than one person), irrevocably, absolutely and unconditionally guarantees to the Lender, its successors and assigns, the payment of the Debt and the payment and performance of all the Obligations, subject to the recourse limitations of Paragraphs 8 and 9 of the Note. This Guaranty is a primary and absolute obligation of the Guarantor. 1.2 Guarantor will make all payments hereunder in lawful money of the United States of America in immediately available funds without set-off, counterclaim or defense. 1.3 Guarantor's liability hereunder shall remain unchanged irrespective of any invalidity, illegality or unenforceability of any other guaranty, pledge, assignment or other security for the Debt or Obligations, and without regard to any claim, counterclaim, set-off or defense which Borrower, any other guarantor, surety or obligor might be privileged to assert with respect to the validity, legality or enforceability of the Debt or Obligations and irrespective of any present or future law or order of any government or any agency thereof purporting to reduce, amend or otherwise affect any obligation of the Borrower or of any other guarantor, surety or other obligor or to vary the terms of payment of the Debt or the terms of any of the Obligations. If for any reason whatsoever (including but not limited to ultra xxxxx, lack of authority, illegality, force majeure, act of God or impossibility) the Debt or the Obligations cannot be enforced against Borrower, such unenforceability shall in no manner affect the liability of Guarantor hereunder and Guarantor shall be liable hereunder notwithstanding that Borrower may not be liable for such Debt or such Obligations. 1.4 The obligations of the Guarantor hereunder are independent of the obligations of the Borrower relative to the Debt and Obligations, and a separate action or actions for payment, damages or performance may be brought and prosecuted against Guarantor, or any of them should there be more than one, regardless of whether an action is or could be brought against Borrower, any security for the Debt and/or any of the Obligations or any other party obligated to pay the Debt and/or pay or perform any of the Obligations. Guarantor will not be privileged to assert, and hereby waives the right to assert, in any action(s) by Lender against Guarantor any defense, set-off or counterclaim which Borrower or any other obligor might then be privileged to assert. Guarantor acknowledges and agrees that, as between Guarantor and the Lender, the Debt and Obligations guaranteed hereunder may be declared to be due and payable for purposes of this Guaranty notwithstanding any stay, injunction or other prohibition arising from the filing of a voluntary or an involuntary bankruptcy petition by or against Borrower, or otherwise, which may prevent or delay any such declaration as against the Borrower. In addition, in the event that Borrower does not or is unable so to pay the Debt or perform the Obligations for any reason, including, without limitation, liquidation, dissolution, receivership, conservatorship, insolvency, bankruptcy, assignment for the benefit of creditors, sale of all or substantially all assets, reorganization, arrangement, composition, or readjustment of, or other similar proceedings affecting the status, composition, identity, existence, assets or obligations of Borrower, or the disaffirmance or termination of any of the Debt or Obligations in or as a result of any such proceeding, Guarantor shall pay the Debt and perform the Obligations and no such occurrence shall in any way affect Guarantor's obligations hereunder. 1.5 If any claim is ever made upon Lender for repayment or recovery of any amount received by Lender in payment or on account of the Debt and/or any of the Obligations by virtue of such amount having been a preference under applicable bankruptcy laws or for any other reason and Lender repays all or part of said amount pursuant to any judgment, decree or order of any court or administrative body having jurisdiction over Lender or any of its property or any settlement or compromise of any such claim effected by Lender with any such claimant (including but not limited to the Borrower or any other guarantor), then any such judgment, decree, order, settlement or compromise shall be binding upon the Guarantor, and, notwithstanding any prior satisfaction or cancellation of this Guaranty, of the Note or any other instrument evidencing the Debt and any of the Obligations, this Guaranty shall continue to be effective or shall be automatically reinstated, as the case may be, and the Guarantor shall be and remain liable to Lender hereunder for the amount so repaid or recovered to the same extent as if such amount had never originally been received by Lender. Such amount shall be paid by Guarantor to Lender on demand. 1.6 This Guaranty shall automatically remain in effect for a period of one hundred (100) days after the date on which all of the Debt and Obligations are last fully paid and performed, and, if no bankruptcy petition is filed against Borrower within ninety (90) days after such date, then, in that event this Guaranty shall be deemed to have been canceled as of the aforesaid date on which all of the Debt and Obligations were last fully paid and performed, subject to being automatically reinstated for the reasons stated in Subsection 1.5 above. If, however, a bankruptcy petition is filed by or against the Borrower during said ninety (90) day period, this Guaranty shall continue in effect unless and until a final, non-appealable decision by a court of competent jurisdiction has been rendered or an agreement has been entered or reached pursuant to which Lender shall be entitled to retain all monies paid by Borrower to Lender. If Lender is obligated to return to the Borrower, to the estate of the Borrower or to a bankruptcy trustee for the Borrower any monies previously paid by the Borrower, then this Guaranty shall continue in effect and Guarantor, as provided in Subsection 1.5 above, shall continue to be liable to Lender for repayment of such monies.
Procedure and Effect of Termination In the event of the termination of this Agreement and the abandonment of the transactions contemplated hereby pursuant to Section 7.1 hereof, written notice thereof shall forthwith be given by the parties so terminating to the other party and this Agreement shall terminate and the transactions contemplated hereby shall be abandoned, without further action by Seller, on the one hand, or Buyer and Parent, on the other hand. If this Agreement is terminated pursuant to Section 7.1 hereof: (a) Each party shall redeliver all documents, work papers and other materials of the other parties relating to the transactions contemplated hereby, whether obtained before or after the execution hereof, to the party furnishing the same, and all confidential information received by any party hereto with respect to the other party shall be treated in accordance with the Confidentiality Agreement and Section 5.2(c) hereof; (b) All filings, applications and other submissions made pursuant hereto shall, at the option of Seller, and to the extent practicable, be withdrawn from the agency or other person to which made; and (c) Each party's right of termination under Section 7.1 is in addition to any other rights it may have under this Agreement or otherwise, and the exercise of a right of termination will not be an election of remedies. If this Agreement is terminated pursuant to Section 7.1, all further obligations of the parties under this Agreement will terminate, except that the obligations in Section 5.5 and 9 will survive; provided, however, that if this Agreement is terminated by a party because of the breach of the Agreement by the other party or because one or more of the conditions to the terminating party's obligations under this Agreement is not satisfied as a result of the other party's failure to comply with its obligations under this Agreement, the terminating party's right to pursue all legal remedies, including the remedies set forth in Article VIII hereof, will survive such termination unimpaired.
OFFICE OF MANAGEMENT AND BUDGET (OMB) AUDIT REQUIREMENTS The parties shall comply with the requirements of the Single Audit Act of 1984, P.L. 98-502, ensuring that the single audit report includes the coverage stipulated in 2 CFR 200.
Disclosure and Use 20.2.1 Each Receiving Party agrees that, from and after the Effective Date: (a) all such Proprietary Information communicated or discovered, whether before, on or after the Effective Date, in connection with this Agreement shall be held in confidence to the same extent as such Receiving Party holds its own confidential information; provided, that such Receiving Party shall not use less than a reasonable standard of care in maintaining the confidentiality of such information; (b) it will not, and it will not permit any of its employees, contractors, consultants, agents or affiliates to disclose such Proprietary Information to any other third person; (c) it will disclose Proprietary Information only to those of its employees, contractors, consultants, agents and affiliates who have a need for it in connection with the use or provision of services required to fulfill this Agreement; (d) it will, and will cause each of its employees, contractors, consultants, agents and affiliates to use such Proprietary Information only to effectuate the terms and conditions of this Agreement and for no other purpose; (e) it will cause each of its affiliates to execute individual confidentiality agreements containing the same restrictions as this Article XX; and (f) it will, and will cause each of its employees, contractors, consultants, agents and affiliates, to use such Proprietary Information to create only that Derivative Information necessary for such Receiving Party's compliance with Applicable Law or its performance under the terms of this Agreement. 20.2.2 Any Receiving Party so disclosing Proprietary Information to its employees, contractors, consultants, agents or affiliates shall be responsible for any breach of this Agreement by any of its employees, contractors, consultants, agents or affiliates and such Receiving Party agrees to use its reasonable efforts to restrain its employees, contractors, consultants, agents or affiliates from any prohibited or unauthorized disclosure or use of the Proprietary Information and to assist the Disclosing Party in its efforts to protect such information from disclosure. Each Receiving Party making such disclosure shall notify the Disclosing Party as soon as possible if it has knowledge of a breach of this Agreement in any material respect. 20.2.3 Proprietary Information shall not be reproduced by any Receiving Party in any form except to the extent (i) necessary to comply with the provisions of Section 20.3 and (ii) reasonably necessary to perform its obligations under this Agreement. All such reproductions shall bear the same copyright and proprietary rights notices as are contained in or on the original.
SUPERVISION AND CONSTRUCTION PROCEDURES 4.3.1 The Contractor shall supervise and direct the Work, using his / her best skill and attention. The Contractor shall be solely responsible for all construction means, methods, techniques, sequences and procedures and for coordinating all portions of the Work under the Contract. All aspects of the Project shall be subject to the inspection and approval of the State. Contractor guarantees to repair, replace, re-execute or otherwise correct any defect in workmanship, materials, or the like that fails to conform to the requirements of this Contract or that appears during the progress of the Work or within one year of final acceptance by the State. 4.3.2 The Contractor shall be responsible to the State for the acts and omissions of his / her employees, Subcontractors and their agents and employees, and other persons performing any of the Work under a contract with the Contractor. 4.3.3 The Contractor shall not be relieved from his / her obligations to perform the Work in accordance with the Contract Documents either by the activities or duties of the Architect in his / her administration of the Contract, or by inspections, tests or approvals required or performed under Paragraph 7.7 by persons other than the Contractor. 4.3.4 The Contractor shall acquaint himself (herself / itself) with the limits of the property or right- of-way of the State and shall not trespass on other property. The Contractor shall adequately protect the project, adjacent property and the public, and shall be responsible for any damage or injury due to the Contractor’s act or neglect, and shall save the State harmless in respect thereto. 4.3.5 All work shall be done in such a manner as not to interfere with the State’s operating functions. Contractor and his employees shall familiarize themselves and comply with all rules and regulations applicable to the project. 4.3.6 The Contractor shall keep the premises free from liens arising out of or from the Project. Contractor shall obtain and submit waivers of liens with a request for a progress or final payment.
