Supply of Commercial Requirements Sample Clauses

Supply of Commercial Requirements. Except as provided in Sections 5, 6, 7 and 8 of this Article, GENENTECH, or Genentech Biopharmaceuticals Limited in the case of DNase as Vialed Product or Finished Product, or Genentech International Limited in the case of Genentech Products (except DNase) which are Vialed Product or Finished Product, shall supply ROCHE with ROCHE's Commercial Requirements pursuant to a mutually agreeable and reasonable production schedule for ROCHE's Commercial Requirements, and ROCHE agrees to purchase its Commercial Requirements from those entities. Those entities shall not be obligated to supply Commercial Requirements to ROCHE other than in accordance with the quantities mutually agreed to and at the approximate dates of delivery mutually agreed to. All transportation and packing and similar costs shall be borne by ROCHE. Title and risk of loss shall pass to ROCHE upon delivery by those entities to ROCHE, FOB origin. The Parties shall agree on specifications and procedures for the Commercial Requirements, and the Commercial Requirements delivered by those entities shall meet those specifications and procedures. Those entities shall not favor the supply of their own commercial requirements of Product to themselves or their other licensees over ROCHE's Commercial Requirements.
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Supply of Commercial Requirements for Trap-1 Product. (a) Novartis shall use Commercially Reasonable Efforts to provide an adequate and timely supply of properly forecast Commercial Requirements of the Trap-1 Product in the Territory during the applicable Term of this Agreement. Novartis shall also use Commercially Reasonable Efforts to provide an adequate supply of properly forecast Clinical Supply Requirements of the Trap-1 Product post first Launch in the Territory during the applicable Term of this Agreement at Novartis' Clinical Supply Cost for such product. For purposes of calculating the Target Profit Splits, Commercial Requirements of the Trap-1 Product shall be provided [*****************************************]: (i) [**********************************]; (ii) [*********************************]; (iii) [******************************]; and (iv) [****************************]; SCHEDULE 7 hereto sets forth a non-binding example of the cost pricing details for the processing of the Trap-1 using the above-referenced principles. The Parties agree that the Trap-1 cost pricing details set forth in SCHEDULE 7 are for illustrative purposes only and are not binding upon Novartis and have no legal effect whatsoever. If the Trap I Phase IIB Clinical Trial that is ongoing as of the Effective Date achieves the Trial Success Criteria, Novartis shall use Commercially Reasonable Efforts to constitute, equip, validate and license a manufacturing facility for the production of Trap-1, subject however to successful technology transfer with respect to the Trap-1 Product. Novartis shall use Commercially Reasonable Efforts to ensure that such production facility [**************************]. Novartis shall use Commercially Reasonable Efforts to ensure that such production facility shall [*****************************]. (b) Novartis shall be responsible for manufacturing Trap-1 Product in accordance with all applicable laws, including applicable Good Manufacturing Practices. Promptly following the execution of this Agreement, the Parties will enter into a separate Quality Agreement which shall specify certain additional responsibilities between the Parties. The Quality Agreement, which shall constitute an Ancillary Agreement for purposes hereof, shall be substantially in the form annexed hereto as Exhibit A, with such changes as are mutually agreed upon by the Parties. (c) Novartis shall notify Regeneron if it reasonably determines that it will not be able to supply, on a long term basis, the agreed upon...
Sample 1
Supply of Commercial Requirements. Unless the other Party exercises its Opt-out Option for a Drug Candidate or Product, the Responsible Party shall supply the other Party with the other Party's Commercial Requirements for that Product and the other Party agrees to purchase its Commercial Requirements for that Product from the Responsible Party. The other Party shall reimburse the Responsible Party for such Commercial Requirements at one hundred and twenty percent (120%) of the Responsible Party's Fully Burdened Manufacturing Cost. The supply and purchase of Commercial Requirements shall be pursuant to a Supply Agreement with terms and conditions to be negotiated, finalized and executed prior to the filing of the first Approval Application/Registration for that Product.
Sample 1
Supply of Commercial Requirements. The sales price of Product for commercial purposes shall be one hundred twenty percent (120%) of FBMC, invoiced in US Dollars and paid within thirty (30) days after shipment. Product supplied by a third party manufacturer shall be at cost. Product manufactured as qualification lots and supplied for commercial purposes shall only be charged to the extent not included in Development Costs.
Sample 1

Related to Supply of Commercial Requirements

  • Technical Requirements 2.7.4.1 The NID shall provide an accessible point of interconnection and shall maintain a connection to ground.

  • General Requirements The Contractor hereby agrees:

  • Financial Requirements A report of monthly and cumulative financial requirements; and

  • Procedural Requirements All holders of record of shares of Preferred Stock shall be sent written notice of the Mandatory Conversion Time and the place designated for mandatory conversion of all such shares of Preferred Stock pursuant to this Section 6. Such notice need not be sent in advance of the occurrence of the Mandatory Conversion Time. Upon receipt of such notice, each holder of shares of Preferred Stock shall surrender his, her or its certificate or certificates for all such shares (or, if such holder alleges that such certificate has been lost, stolen or destroyed, a lost certificate affidavit and agreement reasonably acceptable to the Corporation to indemnify the Corporation against any claim that may be made against the Corporation on account of the alleged loss, theft or destruction of such certificate) to the Corporation at the place designated in such notice. If so required by the Corporation, certificates surrendered for conversion shall be endorsed or accompanied by written instrument or instruments of transfer, in form satisfactory to the Corporation, duly executed by the registered holder or by his, her or its attorney duly authorized in writing. All rights with respect to the Preferred Stock converted pursuant to Section 6.1, including the rights, if any, to receive notices and vote (other than as a holder of Common Stock), will terminate at the Mandatory Conversion Time (notwithstanding the failure of the holder or holders thereof to surrender the certificates at or prior to such time), except only the rights of the holders thereof, upon surrender of their certificate or certificates (or lost certificate affidavit and agreement) therefor, to receive the items provided for in the next sentence of this Subsection 6.2. As soon as practicable after the Mandatory Conversion Time and the surrender of the certificate or certificates (or lost certificate affidavit and agreement) for Preferred Stock, the Corporation shall issue and deliver to such holder, or to his, her or its nominees, a certificate or certificates for the number of full shares of Common Stock issuable on such conversion in accordance with the provisions hereof, together with cash as provided in Subsection 5.2 in lieu of any fraction of a share of Common Stock otherwise issuable upon such conversion and the payment of any declared but unpaid dividends on the shares of Preferred Stock converted. Such converted Preferred Stock shall be retired and cancelled and may not be reissued as shares of such series, and the Corporation may thereafter take such appropriate action (without the need for stockholder action) as may be necessary to reduce the authorized number of shares of Preferred Stock accordingly.

  • Required Governmental Approvals All governmental authorizations, consents and approvals necessary for the valid consummation of the transactions contemplated hereby shall have been obtained and shall be in full force and effect. All applicable governmental pre-acquisition filing, information furnishing and waiting period requirements shall have been met or such compliance shall have been waived by the governmental authority having authority to grant such waivers.

  • Environmental Laws and Regulations (a) Except as set forth in Section 3.8 of the Company Disclosure Schedule or as would not have, individually or in the aggregate, a Company Material Adverse Effect: (i) no notice, notification, demand, request for information, citation, summons, complaint or order has been received, no penalty has been assessed, and no investigation, action, claim, suit, proceeding or review is pending or, to the knowledge of the Company, is threatened by any Governmental Entity or other person relating to the Company or any Subsidiary of the Company or against any person or entity whose liability the Company or any of its Subsidiaries has or may have retained or assumed either contractually or by operation of law, and relating to or arising out of any Environmental Law, (ii) the Company and its Subsidiaries are, and except for matters that have been fully resolved with the applicable Governmental Entity, since January 1, 2008 have been in compliance with all Environmental Laws (which compliance includes, but is not limited to, possession of all Company Permits and compliance with the terms and conditions thereof), (iii) the Company is not obligated to conduct or pay for, and is not conducting or paying for, any response, remedial, investigatory or corrective action under any Environmental Law at any location, (iv) there has been no release of Hazardous Materials at any real property currently owned, leased or operated by the Company or any Subsidiary of the Company or, to the knowledge of the Company, formerly owned, leased or operated by the Company or any Subsidiary of the Company or at any offsite disposal location used by the Company or any Subsidiary of the Company to dispose of any Hazardous Materials in concentrations or under circumstances that would require reporting or be reasonably likely to result in investigation, remediation or other corrective or response action by the Company or any Subsidiary of the Company or, to the knowledge of Company and its Subsidiaries, by any person or entity whose liability the Company or any of its Subsidiaries has or may have retained or assumed either contractually or by operation of law, under any Environmental Law, (v) the Company is not party to any order, judgment or decree that imposes any obligations under any Environmental Law, (vi) there have been no ruptures or explosions in the Company Systems resulting in personal injury, loss of life or material property damage, except to the extent any claims related to such ruptures have been resolved and (vii) there are no defects, corrosion or other damage to any of the Company Systems that could reasonably be expected to result in a pipeline integrity failure.

  • Functional Requirements Applications must implement controls that protect against known vulnerabilities and threats, including Open Web Application Security Project (OWASP) Top 10 Risks and denial of service (DDOS) attacks.

  • Compliance with Law; Governmental Approvals Each of the Borrower, the other Loan Parties and the other Subsidiaries is in compliance with each Governmental Approval and all other Applicable Laws relating to it except for noncompliances which, and Governmental Approvals the failure to possess which, could not, individually or in the aggregate, reasonably be expected to cause a Default or Event of Default or have a Material Adverse Effect.

  • General Requirement Any notice, election, demand, request, consent, approval, or other communication required or permitted to be given under this Contract shall be in writing signed by an officer or duly authorized representative of the party making same and shall be delivered personally or shall be sent by certified or statutory mail, postage prepaid, return receipt requested, shall be effective as of the date on which it is received or would have been received but for the refusal of the addressee to accept delivery, and shall be addressed as shown in the Contract. The persons and addresses to which notices should be given may be changed by notice given in accordance with this Article.

  • Compliance with Governmental Requirements Grantor shall comply promptly with all laws, ordinances, rules and regulations of all governmental authorities, now or hereafter in effect, applicable to the ownership, production, disposition, or use of the Collateral. Grantor may contest in good faith any such law, ordinance or regulation and withhold compliance during any proceeding, including appropriate appeals, so long as Lender's interest in the Collateral, in Lender's opinion, is not jeopardized.

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