Second Source Facility Sample Clauses

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.
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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.
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 period of employment, Executive shall have his office where the Corporation’s principal executive offices are located from time to time, which currently are at 3000 Xxxx Xxxxxxxxxx Xxxxxx, Xxxxx Xxxxx, Xxxxx Xxxxxx, and the Corporation shall furnish Executive with office facilities reasonably suitable to his position at such location.

  • First Source Hiring Program Contractor must comply with all of the provisions of the First Source Hiring Program, Chapter 83 of the San Francisco Administrative Code, that apply to this Agreement, and Contractor is subject to the enforcement and penalty provisions in Chapter 83.

  • Entrance Facility The facilities between a Party's designated premises and the Central Office serving that designated premises.

  • 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. (b) If the Master Servicer enters into an Advance Facility and makes the election set forth in Section 3.22(a), the Master Servicer and the related Advancing Person shall deliver to the Certificate Insurer and the Trustee a written notice and payment instruction (an "Advance Facility Notice"), providing the Trustee with written payment instructions as to where to remit Advance Reimbursement Amounts and/or Servicing Advance Reimbursement Amounts (each to the extent such type of Reimbursement Amount is included within the Advance Facility) on subsequent Distribution Dates. The payment instruction shall require the applicable Reimbursement Amounts to be distributed to the Advancing Person or to an Advance Facility Trustee designated in the Advance Facility Notice. An Advance Facility Notice may only be terminated by the joint written direction of the Master Servicer and the related Advancing Person (and any related Advance Facility Trustee). The Master Servicer shall provide the Certificate Insurer, if any, with notice of any termination of any Advance Facility pursuant to this Section 3.22(b). (c) Reimbursement Amounts shall consist solely of amounts in respect of Advances and/or Servicing Advances made with respect to the Mortgage Loans for which the Master Servicer would be permitted to reimburse itself in accordance with Section 3.10(a)(ii) and (vii) hereof, assuming the Master Servicer or the Advancing Person had made the related Advance(s) and/or Servicing Advance(s). Notwithstanding the foregoing, except with respect to reimbursement of Nonrecoverable Advances as set forth in Section 3.10(c) of this Agreement, no Person shall be entitled to reimbursement from funds held in the Collection Account for future distribution to Certificateholders pursuant to this Agreement. Neither the Company nor the Trustee shall have any duty or liability with respect to the calculation of any Reimbursement Amount, nor shall the Company or the Trustee have any responsibility to track or monitor the administration of the Advance Facility or have any responsibility to track, monitor or verify the payment of Reimbursement Amounts to the related Advancing Person or Advance Facility Trustee. The Master Servicer shall maintain and provide to any Successor Master Servicer a detailed accounting on a loan-by-loan basis as to amounts advanced by, sold, pledged or assigned to, and reimbursed to any Advancing Person. The Successor Master Servicer shall be entitled to rely on any such information provided by the Master Servicer and the Successor Master Servicer shall not be liable for any errors in such information. (d) Upon the direction of and at the expense of the Master Servicer, the Trustee agrees to execute such acknowledgments, certificates and other documents reasonably satisfactory to the Trustee provided by the Master Servicer recognizing the interests of any Advancing Person or Advance Facility Trustee in such Reimbursement Amounts as the Master Servicer may cause to be made subject to Advance Facilities pursuant to this Section 3.22. (e) Reimbursement Amounts collected with respect to each Mortgage Loan shall be allocated to outstanding unreimbursed Advances or Servicing Advances (as the case may be) made with respect to that Mortgage Loan on a "first-in, first out" ("FIFO") basis, subject to the qualifications set forth below: (i) Any successor Master Servicer to Residential Funding (a "Successor Master Servicer") and the Advancing Person or Advance Facility Trustee shall be required to apply all amounts available in accordance with this Section 3.22(e) to the reimbursement of Advances and Servicing Advances in the manner provided for herein; provided, however, that after the succession of a Successor Master Servicer, (A) to the extent that any Advances or Servicing Advances with respect to any particular Mortgage Loan are reimbursed from payments or recoveries, if any, from the related Mortgagor, and Liquidation Proceeds or Insurance Proceeds, if any, with respect to that Mortgage Loan, reimbursement shall be made, first, to the Advancing Person or Advance Facility Trustee in respect of Advances and/or Servicing Advances related to that Mortgage Loan to the extent of the interest of the Advancing Person or Advance Facility Trustee in such Advances and/or Servicing Advances, second to the Master Servicer in respect of Advances and/or Servicing Advances related to that Mortgage Loan in excess of those in which the Advancing Person or Advance Facility Trustee Person has an interest, and third, to the Successor Master Servicer in respect of any other Advances and/or Servicing Advances related to that Mortgage Loan, from such sources as and when collected, and (B) reimbursements of Advances and Servicing Advances that are Nonrecoverable Advances shall be made pro rata to the Advancing Person or Advance Facility Trustee, on the one hand, and any such Successor Master Servicer, on the other hand, on the basis of the respective aggregate outstanding unreimbursed Advances and Servicing Advances that are Nonrecoverable Advances owed to the Advancing Person, Advance Facility Trustee or Master Servicer pursuant to this Agreement, on the one hand, and any such Successor Master Servicer, on the other hand, and without regard to the date on which any such Advances or Servicing Advances shall have been made. In the event that, as a result of the FIFO allocation made pursuant to this Section 3.22(e), some or all of a Reimbursement Amount paid to the Advancing Person or Advance Facility Trustee relates to Advances or Servicing Advances that were made by a Person other than Residential Funding or the Advancing Person or Advance Facility Trustee, then the Advancing Person or Advance Facility Trustee shall be required to remit any portion of such Reimbursement Amount to the Person entitled to such portion of such Reimbursement Amount. Without limiting the generality of the foregoing, Residential Funding shall remain entitled to be reimbursed by the Advancing Person or Advance Facility Trustee for all Advances and Servicing Advances funded by Residential Funding to the extent the related Reimbursement Amount(s) have not been assigned or pledged to an Advancing Person or Advance Facility Trustee. The documentation establishing any Advance Facility shall require Residential Funding to provide to the related Advancing Person or Advance Facility Trustee loan by loan information with respect to each Reimbursement Amount distributed to such Advancing Person or Advance Facility Trustee on each date of remittance thereof to such Advancing Person or Advance Facility Trustee, to enable the Advancing Person or Advance Facility Trustee to make the FIFO allocation of each Reimbursement Amount with respect to each Mortgage Loan. (ii) By way of illustration, and not by way of limiting the generality of the foregoing, if the Master Servicer resigns or is terminated at a time when the Master Servicer is a party to an Advance Facility, and is replaced by a Successor Master Servicer, and the Successor Master Servicer directly funds Advances or Servicing Advances with respect to a Mortgage Loan and does not assign or pledge the related Reimbursement Amounts to the related Advancing Person or Advance Facility Trustee, then all payments and recoveries received from the related Mortgagor or received in the form of Liquidation Proceeds with respect to such Mortgage Loan (including Insurance Proceeds collected in connection with a liquidation of such Mortgage Loan) will be allocated first to the Advancing Person or Advance Facility Trustee until the related Reimbursement Amounts attributable to such Mortgage Loan that are owed to the Master Servicer and the Advancing Person, which were made prior to any Advances or Servicing Advances made by the Successor Master Servicer, have been reimbursed in full, at which point the Successor Master Servicer shall be entitled to retain all related Reimbursement Amounts subsequently collected with respect to that Mortgage Loan pursuant to Section 3.10 of this Agreement. To the extent that the Advances or Servicing Advances are Nonrecoverable Advances to be reimbursed on an aggregate basis pursuant to Section 3.10 of this Agreement, the reimbursement paid in this manner will be made pro rata to the Advancing Person or Advance Facility Trustee, on the one hand, and the Successor Master Servicer, on the other hand, as described in clause (i)(B) above. (f) The Master Servicer shall remain entitled to be reimbursed for all Advances and Servicing Advances funded by the Master Servicer to the extent the related rights to be reimbursed therefor have not been sold, assigned or pledged to an Advancing Person. (g) Any amendment to this Section 3.22 or to any other provision of this Agreement that may be necessary or appropriate to effect the terms of an Advance Facility as described generally in this Section 3.22, including amendments to add provisions relating to a successor Master Servicer, may be entered into by the Trustee, the Certificate Insurer, Company and the Master Servicer without the consent of any Certificateholder, with written confirmation from each Rating Agency that the amendment will not result in the reduction of the ratings on any class of the Certificates below the lesser of the then current or original ratings on such Certificates, and an opinion of counsel as required by Section 11.01(c), notwithstanding anything to the contrary in Section 11.01 of or elsewhere in this Agreement. (h) Any rights of set-off that the Trust Fund, the Trustee, the Company, any Successor Master Servicer or any other Person might otherwise have against the Master Servicer under this Agreement shall not attach to any rights to be reimbursed for Advances or Servicing Advances that have been sold, transferred, pledged, conveyed or assigned to any Advancing Person. (i) At any time when an Advancing Person shall have ceased funding Advances and/or Servicing Advances (as the case may be) and the Advancing Person or related Advance Facility Trustee shall have received Reimbursement Amounts sufficient in the aggregate to reimburse all Advances and/or Servicing Advances (as the case may be) the right to reimbursement for which were assigned to the Advancing Person, then upon the delivery of a written notice signed by the Advancing Person and the Master Servicer or its successor or assign) to the Trustee terminating the Advance Facility Notice (the "Notice of Facility Termination"), the Master Servicer or its Successor Master Servicer shall again be entitled to withdraw and retain the related Reimbursement Amounts from the Custodial Account pursuant to Section 3.10. (j) After delivery of any Advance Facility Notice, and until any such Advance Facility Notice has been terminated by a Notice of Facility Termination, this Section 3.22 may not be amended or otherwise modified without the prior written consent of the related Advancing Person.

  • PROPOSED MOBILITY PROGRAMME The proposed mobility programme includes the indicative start and end months of the agreed study programme that the student will carry out abroad. The Learning Agreement must include all the educational components to be carried out by the student at the receiving institution (in table A) and it must contain as well the group of educational components that will be replaced in his/her degree by the sending institution (in table B) upon successful completion of the study programme abroad. Additional rows can be added as needed to tables A and B. Additional columns can also be added, for example, to specify the study cycle-level of the educational component. The presentation of this document may also be adapted by the institutions according to their specific needs. However, in every case, the two tables A and B must be kept separated, i.e. they cannot be merged. The objective is to make clear that there needs to be no one to one correspondence between the courses followed abroad and the ones replaced at the sending institutions. The aim is rather that a group of learning outcomes achieved abroad replaces a group of learning outcomes at the sending institution, without having a one to one correspondence between particular modules or courses. A normal academic year of full-time study is normally made up of educational components totalling 60 ECTS* credits. It is recommended that for mobility periods shorter than a full academic year, the educational components selected should equate to a roughly proportionate number of credits. In case the student follows additional educational components beyond those required for his/her degree programme, these additional credits must also be listed in the study programme outlined in table A. When mobility windows are embedded in the curriculum, it will be enough to fill in table B with a single line as described below: Component code (if any) Component title (as indicated in the course catalogue) at the sending institution Semester [autumn / spring] [or term] Number of ECTS* credits Mobility window … Total: 30 Otherwise, the group of components will be included in Table B as follows: Component code (if any) Component title (as indicated in the course catalogue) at the sending institution Semester [autumn / spring] [or term] Number of ECTS* credits Course x … 10 Module y … 10 Laboratory work … 10 Total: 30 The sending institution must fully recognise the number of ECTS* credits contained in table A if there are no changes to the study programme abroad and the student successfully completes it. Any exception to this rule should be clearly stated in an annex of the Learning Agreement and agreed by all parties. Example of justification for non-recognition: the student has already accumulated the number of credits required for his/her degree and does not need some of the credits gained abroad. Since the recognition will be granted to a group of components and it does not need to be based on a one to one correspondence between single educational components, the sending institution must foresee which provisions will apply if the student does not successfully complete some of the educational components from his study programme abroad. A web link towards these provisions should be provided in the Learning Agreement. The student will commit to reach a certain level of language competence in the main language of instruction by the start of the study period. The level of the student will be assessed after his/her selection with the Erasmus+ online assessment tool when available (the results will be sent to the sending institution) or else by any other mean to be decided by the sending institution. A recommended level has been agreed between the sending and receiving institutions in the inter-institutional agreement. In case the student would not already have this level when he/she signs the Learning Agreement, he/she commits to reach it with the support to be provided by the sending or receiving institution (either with courses that can be funded by the organisational support grant or with the Erasmus+ online tutored courses). All parties must sign the document; however, it is not compulsory to circulate papers with original signatures, scanned copies of signatures or digital signatures may be accepted, depending on the national legislation. * In countries where the "ECTS" system it is not in place, in particular for institutions located in partner countries not participating in the Bologna process, "ECTS" needs to be replaced in all tables by the name of the equivalent system that is used and a weblink to an explanation to the system should be added. The section to be completed during the mobility is needed only if changes have to be introduced into the original Learning Agreement. In that case, the section to be completed before the mobility should be kept unchanged and changes should be described in this section. Changes to the mobility study programme should be exceptional, as the three parties have already agreed on a group of educational components that will be taken abroad, in the light of the course catalogue that the receiving institution has committed to publish well in advance of the mobility periods and to update regularly as ECHE holder. However, introducing changes might be unavoidable due to, for example, timetable conflicts. Other reasons for a change can be the request for an extension of the duration of the mobility programme abroad. Such a request can be made by the student at the latest one month before the foreseen end date. These changes to the mobility study programme should be agreed by all parties within four to seven weeks (after the start of each semester). Any party can request changes within the first two to five-week period after regular classes/educational components have started for a given semester. The exact deadline has to be decided by the institutions. The shorter the planned mobility period, the shorter should be the window for changes. All these changes have to be agreed by the three parties within a two-week period following the request. In case of changes due to an extension of the duration of the mobility period, changes should be made as timely as possible as well. Changes to the study programme abroad should be listed in table C and, once they are agreed by all parties, the sending institution commits to fully recognise the number of ECTS credits as presented in table C. Any exception to this rule should be documented in an annex of the Learning Agreement and agreed by all parties. Only if the changes described in table C affect the group of educational components in the student's degree (table B) that will be replaced at the sending institution upon successful completion of the study programme abroad, a revised version should be inserted and labelled as "Table D: Revised group of educational components in the student's degree that will be replaced at sending institution". Additional rows and columns can be added as needed to tables C and D. All parties must confirm that the proposed amendments to the Learning Agreement are approved. For this specific section, original or scanned signatures are not mandatory and an approval by email may be enough. The procedure has to be decided by the sending institution, depending on the national legislation.

  • Loop Provisioning Involving Integrated Digital Loop Carriers 2.6.1 Where Xxxx has requested an Unbundled Loop and BellSouth uses IDLC systems to provide the local service to the End User and BellSouth has a suitable alternate facility available, BellSouth will make such alternative facilities available to Xxxx. If a suitable alternative facility is not available, then to the extent it is technically feasible, BellSouth will implement one of the following alternative arrangements for Xxxx (e.g. hairpinning): 1. Roll the circuit(s) from the IDLC to any spare copper that exists to the customer premises. 2. Roll the circuit(s) from the IDLC to an existing DLC that is not integrated. 3. If capacity exists, provide "side-door" porting through the switch. 4. If capacity exists, provide "Digital Access Cross Connect System (DACS)- door" porting (if the IDLC routes through a DACS prior to integration into the switch). 2.6.2 Arrangements 3 and 4 above require the use of a designed circuit. Therefore, non- designed Loops such as the SL1 voice grade and UCL-ND may not be ordered in these cases. 2.6.3 If no alternate facility is available, and upon request from Xxxx, and if agreed to by both Parties, BellSouth may utilize its Special Construction (SC) process to determine the additional costs required to provision facilities. Xxxx will then have the option of paying the one-time SC rates to place the Loop.

  • Access Toll Connecting Trunk Group Architecture 9.2.1 If CSTC chooses to subtend a Verizon access Tandem, CSTC’s NPA/NXX must be assigned by CSTC to subtend the same Verizon access Tandem that a Verizon NPA/NXX serving the same Rate Center Area subtends as identified in the LERG. 9.2.2 CSTC shall establish Access Toll Connecting Trunks pursuant to applicable access Tariffs by which it will provide Switched Exchange Access Services to Interexchange Carriers to enable such Interexchange Carriers to originate and terminate traffic to and from CSTC’s Customers. 9.2.3 The Access Toll Connecting Trunks shall be two-way trunks. Such trunks shall connect the End Office CSTC utilizes to provide Telephone Exchange Service and Switched Exchange Access to its Customers in a given LATA to the access Tandem(s) Verizon utilizes to provide Exchange Access in such LATA. 9.2.4 Access Toll Connecting Trunks shall be used solely for the transmission and routing of Exchange Access to allow CSTC’s Customers to connect to or be connected to the interexchange trunks of any Interexchange Carrier which is connected to a Verizon access Tandem.

  • Originating Switched Access Detail Usage Data A category 1101XX record as defined in the EMI Telcordia Practice BR-010-200- 010.

  • Interconnection Facilities Engineering Procurement and Construction Interconnection Facilities, Network Upgrades, and Distribution Upgrades shall be studied, designed, and constructed pursuant to Good Utility Practice. Such studies, design and construction shall be based on the assumed accuracy and completeness of all technical information received by the Participating TO and the CAISO from the Interconnection Customer associated with interconnecting the Large Generating Facility.

  • Developer Attachment Facilities Developer shall design, procure, construct, install, own and/or control the Developer Attachment Facilities described in Appendix A hereto, at its sole expense.

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