General Development Obligations Sample Clauses

The General Development Obligations clause sets out the fundamental responsibilities and standards that parties must follow during the development phase of a project or product. Typically, it outlines requirements such as adhering to agreed timelines, meeting specified quality standards, and ensuring compliance with applicable laws and regulations. For example, it may require regular progress updates or mandate the use of certain development methodologies. The core function of this clause is to establish clear expectations and accountability, thereby reducing misunderstandings and ensuring that the development process proceeds smoothly and efficiently.
General Development Obligations. IPC shall use Commercially Reasonable Efforts to develop the Product in accordance with this Agreement. IPC's development responsibilities shall include, without limitation, the following:
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General Development Obligations. Spectrum shall use Commercially Reasonable Efforts to develop each Product, for all applicable dosage strengths and Packaging forms listed on Schedules 1.18, 1.19, 1.20 and 1.37. For future products, it is the intent of both Parties for Spectrum to develop all approved dosage strengths and Packaging forms, however, the Committee shall decide which dosage strengths and Packaging forms will be developed. Spectrum’s development responsibilities shall include, without limitation, the following: 2.1.1. Spectrum shall develop a stable final dosage form of each Product, which does not infringe any Third Party Intellectual Property that shall be Therapeutically Equivalent to the corresponding Reference Listed Drug. *** 2.1.2. Spectrum shall manufacture, or ensure that a Third Party manufactures, all supplies of the Products required for Regulatory Approval in facilities that meet the Applicable Laws. 2.1.3. Spectrum shall be responsible for, and maintain, materials, facilities and personnel reasonably necessary to fulfill its obligations under this Agreement. 2.1.4. Spectrum shall keep Par informed of the progress of the development of the Products and shall cooperate with Par and its legal counsel in assessing and avoiding infringement of Third Party Intellectual Property ***, including, but not limited to, providing Par and its legal Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. counsel with proposed and final formulations, results of all testing and analytical studies, API processing and synthesis information, manufacturing processes and access to Spectrum’s technical personnel involved in the development of a Product. 2.1.5. Spectrum shall conduct all reasonable testing and analytical studies required by the FDA to support an ANDA for each Product as applicable.
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General Development Obligations. Developers shall develop the Product in accordance with this Agreement with a regulatory filing target of the second half of 2011, Developer’s development responsibilities shall include the following: 2.1.1 Developers shall develop a stable final dosage form of the Product suitable for submission of an application for Regulatory Approval to the FDA for approval to market such Product in the Territory, such that the Product is Bioequivalent to the Reference Product as listed in the Orange Book, as expeditiously as reasonably practicable. 2.1.2 Except as provided in Section 2.5 below, Developers shall be solely responsible for all product development activities necessary to support the filing of the applicable application for Regulatory Approval for the Product, including development of appropriate analytical methods, development of a GMP compliant and commercially competitive manufacturing process; stability studies and other analytical testing; all manufacturing scale up activities; and all necessary preclinical and in vitro studies. 2.1.3 In carrying out its development responsibilities, Developers shall cooperate and coordinate with Stason, and Stason shall have final authority in establishing the final Product Specifications for the Territory. Developers shall cooperate with Stason and its legal counsel in assessing and avoiding infringement of third party Intellectual Property. 2.1.4 Developers, upon request by Stason, shall transfer to Stason all data, information and materials generated or obtained in connection with the Product for use in the Territory, including with respect to the components thereof, and all associated methods and analytical testing, within five (5) business days of completion or generation, of such data, information and materials, on an ongoing basis. 2.1.5 Developers will promptly complete timely requests for information from Stason relating to the development and manufacture of the Product. To the extent that Stason requests access to information or materials reasonably necessary or useful in preparing the applications for Regulatory Approval or necessary or useful in assessing any regulatory issues or Intellectual Property issues or concerns (collectively, the “Product Information”), such as formulation information, methods and processes, analytical and processing techniques, product and API samples, processing techniques and any other information, for these purposes, Developers will promptly disclose such Product Information ...
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General Development Obligations. Developers shall develop each Product in accordance with this Agreement, including the decisions of the Development Committee as described below. Unless otherwise decided by the Development Committee or expressly set forth in an applicable Additional Product Addendum as described below, Developer’s development responsibilities shall include, the following;” Section 2.1.1 of the Development Agreement is hereby deleted in its entirety and replaced with the following: 2.1.1 Developers shall develop a stable final dosage form of the Product suitable for submission of an application for Regulatory Approval for approval to market such Product in the Territory as expeditiously as reasonably practicable.” The introductory paragraph of Section 2.4 of the Development Agreement is hereby deleted in its entirety and replaced with the following:
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Related to General Development Obligations

  • Development Obligations 1. The College supports the development, production, and dissemination of copyrightable, trademarkable, patentable, and other intellectual properties by its employees. 2. It is understood that intellectual property developed by employees on or off College time, except for those materials for which the College had specifically contracted prior to June 9, 1998, shall remain the property of such employees, but shall continue to be used for the benefit of the College while the employee remains an employee of the College.

  • PROCUREMENT OBLIGATIONS Notwithstanding any other provisions of this Part B, where in this Part B the Customer accepts an obligation to procure that a Former Supplier does or does not do something, such obligation shall be limited so that it extends only to the extent that the Customer's contract with the Former Supplier contains a contractual right in that regard which the Customer may enforce, or otherwise so that it requires only that the Customer must use reasonable endeavours to procure that the Former Supplier does or does not act accordingly.

  • Local Church’s Payment Obligations At Closing or otherwise prior to or on the Disaffiliation Date, Local Church shall pay to the Annual Conference, in a manner specified by Annual Conference, the following: (a) Local Church shall have the right to retain its Real Property and Personal Property, tangible and intangible property without charge. Any costs relating to Local Church’s retention of its property will be borne by Local Church. (b) Any unpaid apportionments for the twelve (12) months immediately prior to the Disaffiliation Date, as calculated by Annual Conference, totaling Seven Thousand Nine Hundred Fifty-Two and 00/100 Dollars ($7,952.00) (for clarity, any amounts paid within the twelve (12) month period set out above shall be credited to the Local Church at Closing); (c) An additional twelve (12) months of apportionments, as calculated by Annual Conference, totaling Seven Thousand Nine Hundred Fifty-Two and 00/100 Dollars ($7,952.00); (d) An amount equal to Local Church’s pro rata share, as determined by Annual Conference, of Annual Conference’s unfunded pension obligations, based on the Annual Conference’s aggregate funding obligations as determined by the General Board of Pension and Health Benefits using market factors similar to a commercial annuity provider, totaling Nineteen Thousand Eight Hundred Thirty-Seven and 00/100 Dollars ($19,837.00); (e) If any clergy currently appointed to the Local Church will remain in The United Methodist Church after the Local Church disaffiliation, an amount equal to six (6) months salary, housing (if receiving a housing allowance), and pension/health benefits for the clergy, being Zero and 00/100 Dollars ($0.00). The intent of this provision is to provide salary and benefits to the clergy from January 1, 2024 through July 1, 2024, which is a period of time in which the clergy will not have an appointment to a church. (f) Any unpaid loans (secured or unsecured) owed to the Annual Conference or other United Methodist entities such as The United Methodist Foundation of Western North Carolina (unless those loans are assigned or transferred per Section 3.2 below), and any investment portfolio needs which require modifications or assignments; (g) The aggregate amount of any and all grants awarded and paid to Local Church by Annual Conference or any affiliate or subsidiary thereof within the prior ten (10) years; and, (h) All costs of the transfer of any assets involved hereunder and transactions set out herein, as well as the legal fees of the Annual Conference incurred in connection with this Agreement.

  • Nature of Participation and Reimbursement Obligations Each Lender’s obligation in accordance with this Agreement to make the Loans or Participation Revolving Loans as a result of a drawing under a Letter of Credit, and the obligations of the Borrowers to reimburse the Administrative Agent upon a draw under a Letter of Credit, shall be absolute, unconditional and irrevocable, and shall be performed strictly in accordance with the terms of this Section 2.03 under all circumstances, including the following circumstances: (i) any set-off, counterclaim, recoupment, defense or other right which such Lender may have against the Administrative Agent, the Borrowers or any other Person for any reason whatsoever; (ii) the failure of the Borrowers or any other Person to comply, in connection with a Letter of Credit Borrowing, with the conditions set forth in this Agreement for the making of a Loan, it being acknowledged that such conditions are not required for the making of a Letter of Credit Borrowing and the obligation of the Lenders to make Participation Revolving Loans under Section 2.03(d); (iii) any lack of validity or enforceability of any Letter of Credit; (iv) any claim of breach of warranty that might be made by any Borrower or any Lender against the beneficiary of a Letter of Credit, or the existence of any claim, set-off, recoupment, counterclaim, crossclaim, defense or other right which any Borrower or any Lender may have at any time against a beneficiary, any successor beneficiary or any transferee of any Letter of Credit or the proceeds thereof (or any Person for whom any such transferee may be acting), the Administrative Agent or any Lender or any other Person, whether in connection with this Agreement, such Letter of Credit, the transactions contemplated herein or any unrelated transactions (including any underlying transactions between the Borrowers or any other party and the beneficiary for which any Letter of Credit was procured); (v) the lack of power or authority of any signatory of (or any defect in or forgery of any signature or endorsement on) or the form of or lack of validity, sufficiency, accuracy, enforceability or genuineness of any draft, demand, instrument, certificate or other document presented under or in connection with any Letter of Credit, or any fraud or alleged fraud in connection with any Letter of Credit, or the transport of any property or provisions of services relating to a Letter of Credit, in each case even if the Administrative Agent or any of the Administrative Agent’s Affiliates has been notified thereof; (vi) except as provided in Section 2.03(g), any payment by the Administrative Agent under any Letter of Credit against presentation of a demand, draft or certificate or other document which does not comply with the terms of such Letter of Credit; (vii) the solvency of, or any acts or omissions by, any beneficiary of any Letter of Credit, or any other Person having a role in any transaction or obligation relating to a Letter of Credit, or the existence, nature, quality, quantity, condition, value or other characteristic of any property or services relating to a Letter of Credit; (viii) any failure by the Administrative Agent or any of the Administrative Agent’s Affiliates to issue any Letter of Credit in the form requested by the Borrowers, unless the Administrative Agent has received written notice from the Parent Borrower of such failure within three Business Days after the Administrative Agent shall have furnished Parent Borrower a copy of such Letter of Credit and such error is material and no drawing has been made thereon prior to receipt of such notice; (ix) any Material Adverse Effect on any Borrower or any Guarantor; (x) any breach of this Agreement or any Loan Document by any party thereto; (xi) the occurrence or continuance of a proceeding under any Debtor Relief Law with respect to any Borrower or any Guarantor; (xii) the fact that a Default or Event of Default shall have occurred and be continuing; (xiii) the fact that the Revolving Facility Maturity Date shall have expired or this Agreement or the Finance Obligations hereunder shall have been terminated; and (xiv) any other circumstance or happening whatsoever, whether or not similar to any of the foregoing. Nothing contained in this Section 2.03(h) shall be deemed to relieve the Administrative Agent or the L/C Issuer from any claim by the Borrowers for the gross negligence or willful misconduct of the Administrative Agent or the L/C Issuer, respectively, in respect of honoring or failing to honor any drawing under any Letter of Credit or otherwise in respect of any Letter of Credit, but any such claim may not be used as a defense to the reimbursement obligation for any such drawing.

  • Client Obligations 3.1 The Client warrants and represents that: 3.1.1 it shall co-operate with Centaur as required for the proper performance of the Services; 3.1.2 it shall provide, for Centaur, its agents, subcontractors, consultants and employees, in a timely manner and at no charge, access to the Client's premises during normal office hours (being Monday – Friday 8am – 6pm), office accommodation, data and other facilities as is reasonably required by Centaur or any of them for the proper performance of the Services; 3.1.3 all information it has provided to Centaur in relation to the Services as at the date of the Order Form is accurate, complete and is not misleading and it shall provide, in a timely manner, such further information and Client Material as Centaur may require for the proper performance of the Services, and ensure that such information and Client Material is accurate, complete and not misleading; 3.1.4 it shall be responsible (at its own cost) for preparing and maintaining the relevant premises for the supply of the Services; 3.1.5 it shall inform Centaur of all health and safety rules and regulations and any other reasonable security requirements that apply at any of the Client's premises; 3.1.6 it shall only use the Services for internal business purposes and, without prejudice to the foregoing, shall not use the Services, the Deliverables or any Centaur Materials to develop a product or service that competes with any of the products or services provided by Centaur; 3.1.7 the Client Materials shall not infringe any third party rights, including any third party Intellectual Property Rights; and 3.1.8 it shall obtain and maintain all necessary licences and consents and comply with all relevant legislation in relation to the Services, before the date on which the Services are to start. 3.2 If Centaur's performance of its obligations under this Agreement is prevented or delayed by any act or omission of the Client, its agents, subcontractors, consultants or employees, Centaur shall not be liable for any costs, charges or losses sustained or incurred by the Client that arise directly or indirectly from such prevention or delay.