Invitation to Tender – supply of pharmaceuticals to DHB hospitals and/or to community pharmacies (text extract)

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Contents

Schedule 1: Definitions and interpretation ....................................................................... 4 1. 2. Definitions .................................................................................................................... 4 Interpretation.............................................................................................................. 10

Schedule 2: Products to be tendered .............................................................................. 12 1. 2. Information about Tender Items................................................................................ 12 List of Products.......................................................................................................... 15

Schedule 3: Tender Process ............................................................................................ 49 1. 2. 3. 4. 5. 6. 7. 8. 9. General ....................................................................................................................... 49 Information about submitting a Tender Bid ............................................................. 53 What to include in your Offer Letter and Tender Submission Form....................... 55 How to submit a Tender Bid ...................................................................................... 57 Evaluation................................................................................................................... 57 Conformity.................................................................................................................. 58 Decision...................................................................................................................... 59 Back-up supply .......................................................................................................... 60 Dealing with information ........................................................................................... 61

10. Miscellaneous ............................................................................................................ 61 Schedule 4: Offer Letter, Tender Submission Form Offer Letter................................... 63 1. 2. 3. Guidance for completing the Tender Submission Form ......................................... 63 Offer Letter, Tender Submission Form ..................................................................... 64 Tender Submission Form .......................................................................................... 66

Schedule 5: Contract terms for Hospital Supply Status ................................................ 68 1. 2. 3. 4. 5. 6. 7. 8. General ....................................................................................................................... 68 Effect of Hospital Supply Status ............................................................................... 68 Consents .................................................................................................................... 75 Price ............................................................................................................................ 75 Invoicing and Payment .............................................................................................. 76 Emergency and disaster supply ............................................................................... 77 Defective and short-dated Pharmaceuticals ............................................................ 77 Out-of-stock arrangements ....................................................................................... 78

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Termination, restrictions and Crown Direction........................................................ 81

10. Guarantee ................................................................................................................... 82 11. Audit............................................................................................................................ 82 12. Access by PHARMAC to price and volume data...................................................... 82 13. PCTs............................................................................................................................ 83 14. Miscellaneous ............................................................................................................ 84 Schedule 6: Contract terms for Sole Supply Status....................................................... 88 1. 2. 3. 4. 5. 6. 7. 8. 9. General ....................................................................................................................... 88 Effect of Sole Supply Status...................................................................................... 89 Consents .................................................................................................................... 91 Price ............................................................................................................................ 92 Shelf-life of Pharmaceutical ...................................................................................... 92 Out-of-stock arrangements ....................................................................................... 93 Termination, restrictions and Crown Direction........................................................ 95 Guarantee ................................................................................................................... 96 Miscellaneous ............................................................................................................ 96

Schedule 7: Additional contract terms for foreign exchange bid.................................. 99 1. 2. 3. 4. 5. Introduction ................................................................................................................ 99 Establishment of Base Price in New Zealand dollars. ............................................. 99 Exchange Rate Price Review................................................................................... 100 Reviewed Price......................................................................................................... 100 Dispute Over Price ................................................................................................... 101

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Schedule 1

Schedule 1: Definitions and interpretation

Definitions

In this Invitation: Aggregated Tender Bid means a Tender Bid for more than one Tender Item, which: (a) (b) PHARMAC is to consider in aggregate; and is specified to be an Aggregated Tender Bid,

and can include a Tender Bid for more than one Tender Item of the same Chemical Entity but not aggregation within a single Tender Item; Agreement means: (a) (b) in relation to a Pharmaceutical with Hospital Supply Status, Schedule Five; or in relation to a Pharmaceutical with Sole Supply Status, Schedule Six,

and includes, to the extent applicable, the other Schedules comprising the Invitation; Alternative Pharmaceutical means an alternative brand of a Pharmaceutical that PHARMAC, following consultation with HPAC, or PTAC or its sub-committees, considers to be an acceptable substitute for that Pharmaceutical; Back-up Supply Agreement means an alternative agreement or arrangement negotiated by PHARMAC, at its sole discretion, with a supplier other than the supplier with Sole Supply Status and/or Hospital Supply Status in respect of a particular Tender Item, to cover the contingency that Sole Supply Status and/or Hospital Supply Status is suspended or withdrawn under the terms of this Agreement in respect of that Tender Item, or that the Tender Item is otherwise out of stock or unavailable for supply; Base Exchange Rate means the average of the Reserve Bank Quote over 10 consecutive trading days ending: (a) in the case of an unconditional acceptance of your Tender Bid, 15 days prior to the date that PHARMAC’s board of directors (or chief executive, where applicable) determines to accept your Tender Bid; or in the case of acceptance of your Tender Bid being conditional on you obtaining market approval for the Pharmaceutical, on the date on which such market approval is notified in the New Zealand Gazette;

(b)

Base Price means, where your Foreign Exchange Bid has been accepted, the price exmanufacturer (exclusive of GST) for the Pharmaceutical, as calculated and notified to you by PHARMAC in accordance with clause 2 of Schedule Seven; Calculated Price is as defined in clause 3 of Schedule Seven; Chemical Entity means any pharmaceutical that contains, and is described generically according to, the relevant active ingredient specified in Schedule Two; Combined Community/Hospital Tender Bid means a Community Tender Bid and a Hospital Tender Bid that you submit in combination for the same Tender Item;

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Schedule 1 Community Tender Bid means a Tender Bid in relation to community supply; Confidential Information means all information exchanged between us under this Invitation or in relation to your Tender Bid, including during all negotiations relating to your Tender Bid; Consents means all consents, permits, licences and authorisations, whether statutory or otherwise, required for the supply of the Tender Item in New Zealand (including Ministry of Health market approval or, in respect of a Tender Item that is a Vitamin, approval by the Therapeutics Goods Administration as either a registrable (AUST R) good or a listable (AUST L) good); Contract Manufacturer means a manufacturer or a supplier that is a party to a contract with the relevant DHB Hospital to compound Pharmaceuticals, on request from that DHB Hospital; Crown Direction means any ministerial direction given to PHARMAC under section 103 of the Crown Entities Act 2004; Date of an Exchange Rate Price Review means 30 June 2007 and 30 June 2008; Deadline means 5 pm, Monday, 27 February 2006 (New Zealand time); Designated Delivery Point means at a DHB Hospital’s discretion: (a) (b) a delivery point agreed between you and the relevant DHB Hospital, to which delivery point you must supply the Pharmaceutical directly at the Price; and/or any delivery point designated by the relevant DHB Hospital or PHARMAC, such delivery point being within 30km of your national distribution centre;

DHB Hospital means a DHB, including its hospital or associated provider unit for which that DHB purchases pharmaceuticals; District Health Board (or DHB) has the same meaning as in the New Zealand Public Health and Disability Act 2000; DV Limit means, for a particular Pharmaceutical, the National DV Limit or the Individual DV Limit; DV Pharmaceutical means a discretionary variance Pharmaceutical, being an Alternative Pharmaceutical that does not have Hospital Supply Status, and includes a pharmaceutical which (unless PHARMAC specifies otherwise in Schedule Two of this Agreement, or we agree otherwise in writing): (a) is listed as a DV Pharmaceutical, in association with the relevant Pharmaceutical having Hospital Supply Status, in the then current Section H of the Pharmaceutical Schedule; or is the same Chemical Entity, at the same strength, and in the same or a similar presentation or form, as the relevant Pharmaceutical with Hospital Supply Status, but which is not yet listed as a DV Pharmaceutical.

(b)

For the avoidance of doubt, a pharmaceutical which: (c) is a different Chemical Entity from the Pharmaceutical with Hospital Supply Status; and

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Schedule 1 (d) is not listed as a DV Pharmaceutical in the then current Section H of the Pharmaceutical Schedule,

is not a DV Pharmaceutical; End Date means the last day of the Hospital Supply Status Period, or Sole Supply Period, as applicable; Evaluation Committee means a committee established by PHARMAC to evaluate Tender Bids; Exchange Rate Average means the average of the Reserve Bank Quote, over the period: (a) (b) for the first Exchange Rate Price Review, from the date on which the Base Exchange Rate is determined until the first occurring 30 June after that date; and for any subsequent Exchange Rate Price Review, from the date on which the last Exchange Rate Price Review occurred until the date of the next Exchange Rate Price Review;

Exchange Rate Price Review means the review of the Base Price or the Reviewed Price, as applicable, in accordance with clause 3 of Schedule Seven; Final Transition Period means, in respect of a Pharmaceutical with Sole Supply Status or Hospital Supply Status, as applicable, the period of three calendar months beginning on the day after the relevant End Date; First Transition Period means, in respect of a Pharmaceutical with Sole Supply Status or Hospital Supply Status, the period beginning on the first day of the month following the Market Notification Date and ending on the last day of the month following the month in which the Start Date occurs (or such different or longer period as PHARMAC determines under clause 1.2 of Schedule Three); Foreign Exchange Bid means a Tender Bid that specifies a price in a Permitted Currency; Funder means the body or bodies responsible, pursuant to the New Zealand Public Health and Disability Act 2000, for the funding of pharmaceuticals listed on the Pharmaceutical Schedule (which may be, without limitation, one or more District Health Boards and/or the Ministry of Health) and their successors; Hospital Pharmaceuticals Supplement means a supplement that clarifies the application of PHARMAC’s OPPs in respect of hospital pharmaceuticals; Hospital Supply Status means the status of being the brand of the relevant Pharmaceutical listed in Section H of the Pharmaceutical Schedule as having such status, which Pharmaceutical DHB Hospitals must purchase, subject to any DV Limit for that Pharmaceutical, for the Hospital Supply Status Period; Hospital Supply Status Period means the period beginning on the day after the end of the First Transition Period and ending on 30 June 2009; Hospital Tender Bid means a Tender Bid in relation to Hospital Supply; HPAC means the Hospital Pharmaceutical Advisory Committee; IMM means interchangeable multi-source medicine, as defined by the New Zealand Medicines and Medical Devices Safety Authority (Medsafe); Individual DV Limit means, for:

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Schedule 1 (a) (b) a particular Pharmaceutical; and a particular DHB Hospital,

the discretionary variance limit, being a percentage of the Individual Total Market Volume, which equals the percentage of the National DV Limit for that Pharmaceutical, up to which that DHB Hospital may purchase DV Pharmaceuticals of that Pharmaceutical. The Individual DV Limit is set: (c) (d) for the number of months during which the Hospital Supply Status Period applies during the period ending on 30 June 2007; and for the respective 12 month periods ending on 30 June 2008 and 2009;

Individual Total Market Volume means for: (a) (b) a particular Pharmaceutical; and a particular DHB Hospital,

in any given period, in accordance with data available to PHARMAC, the sum of: (c) (d) the total number of Units of the relevant Pharmaceutical with Hospital Supply Status purchased by the relevant DHB Hospital; and the total number of Units of all the relevant DV Pharmaceuticals, listed in Section H in association with that Pharmaceutical, purchased by that DHB Hospital;

Initial Period is as defined in clause 5 of Schedule Seven; Invitation means this invitation to tender and includes the cover letter and each of the Schedules; Lead Time means the length of time indicated on your Tender Bid that, if your Tender Bid is accepted, you would require following the Successful Tenderer Notification Date in order to source sufficient stock of your brand of the Tender Item to meet the market demand for the Tender Item, which must be at least one month; Market Notification Date means the date on which PHARMAC notifies the market that your Tender Bid, in respect of a particular Tender Item, has been accepted, being greater than one month prior to the Start Date; National DV Limit means, for a particular Pharmaceutical, the discretionary variance limit, being the specified percentage of the National Total Market Volume up to which all DHB Hospitals may collectively purchase DV Pharmaceuticals of that Pharmaceutical. The National DV Limit is set for DHB Hospitals nationally: (a) (b) for the number of months during which the Hospital Supply Status Period applies during the period ending on 30 June 2007; and for the respective 12 month periods ending on 30 June 2008 and 2009;

National Total Market Volume means, for a particular Pharmaceutical in any given period, in accordance with data available to PHARMAC, the sum of: (a) the total number of Units of the relevant Pharmaceutical with Hospital Supply Status purchased by all DHB Hospitals; and

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Schedule 1 (b) the total number of Units of all the relevant DV Pharmaceuticals, listed in Section H in association with that Pharmaceutical, purchased by all DHB Hospitals;

Offer Letter means the letter of offer to which your Tender Submission Form(s) must be attached, in the form set out in Schedule Four; OPPs means PHARMAC’s then current Operating Policies and Procedures and any relevant supplements, including the Hospital Pharmaceuticals Supplement, as applicable; PCT means a Tender Item for which a “PCT” is indicated in the list in clause 2 of Schedule Two; Permitted Currency means either United States dollars, the euro, pounds sterling, Australian dollars or Japanese yen; Pharmaceutical means the relevant Tender Item for which you have submitted, and PHARMAC has accepted on behalf of the Funder, a Tender Bid; Pharmacode means the unique six or seven digit identifier assigned to a pharmaceutical and notified to you by the Pharmacy Guild; Potential Out-of-Stock Event means: (a) in relation to community or hospital supply, your stock of the Pharmaceutical in New Zealand falls below two-thirds of your most recent three months’ total Unit sales of the Tender Item; or in relation to community or hospital supply, your forecast of sales demand in respect of the next two-month period is greater than your stock of the Pharmaceutical; or in relation to hospital supply, your stock of the Pharmaceutical in New Zealand falls below the average volume of stock of the Pharmaceutical required to supply the entire New Zealand DHB Hospital market for the Pharmaceutical for any given two-month period; or in relation to community supply, your stock of the Pharmaceutical in New Zealand falls below one-sixth of the Unit Volume.

(b) (c)

(d)

For the avoidance of doubt, references to your stock refer to stock physically held by you or on your behalf in New Zealand and do not include stock held in New Zealand by wholesalers or other parties; Price means the price (exclusive of GST) at which the Pharmaceutical is to be supplied, or made available for sale and supply, by you to: (a) in relation to community supply, wholesalers and other such distributors, and at which the Pharmaceutical is to be subsidised by the Funder, being the price specified in your successful Tender Submission Form, unless there has been a subsequent price change in accordance with the terms of the Invitation, in which case the Price will be the price notified to you by PHARMAC upon acceptance of your Tender Bid; in relation to hospital supply, at a DHB Hospital' discretion, any Designated Delivery s Points, and/or Contract Manufacturers (expressly for the purpose of compounding), being the price specified in your successful Tender Submission Form, unless there has been a subsequent price change in accordance with the terms of the Invitation, in which case the Price will be the price notified to you by PHARMAC upon acceptance of your Tender Bid; or

(b)

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Schedule 1 (c) in the case of a Foreign Exchange Bid, a price determined and notified in accordance with Schedule Seven;

PTAC means the Pharmacology and Therapeutics Advisory Committee; Reserve Bank Quote means the exchange rate between New Zealand dollars and the Permitted Currency in which you made the Foreign Exchange Bid, being the mid rate of the buy and sell quotes for that exchange rate quoted by the Reserve Bank of New Zealand on the days on which the New Zealand dollar and the Permitted Currency are traded, expressed as the value of one New Zealand dollar in Permitted Currency units (e.g. NZ$1.00 = US$[0.64]); Reviewed Price is as defined in clause 4 of Schedule Seven; Risk Sharing Percentage means, in respect of each Tender Item for which you submit a Foreign Exchange Bid, the percentage value of the exchange rate risk (between 1% and 100%) that you agree to share with PHARMAC for that Tender Item. For example, if you specify an 80% Risk Sharing Percentage, you agree that 80% of the price at which you supply the Tender Item may change in response to foreign exchange movement and 20% of the price will not change, in accordance with the terms in Schedule Seven; Second Transition Period means, in relation to community supply, the period of three calendar months beginning on the day after the expiry of the First Transition Period (or such different or longer period as PHARMAC determines under clause 1.2 of Schedule Three); Section H means the relevant section or sections of the Pharmaceutical Schedule relating to hospital pharmaceuticals; Sole Supply Period means the period beginning on the day after the expiry of the Second Transition Period and ending on 30 June 2009; Sole Supply Status means, in relation to community supply, the status of being the sole subsidised supplier of the particular Tender Item for the Sole Supply Period; Start Date means: (a) in relation to a Tender Item for which your Tender Bid has been accepted unconditionally, the first day of the month following the date that represents: (i) (ii) (b) the Successful Tenderer Notification Date; plus the Lead Time; or

in relation to a Tender Item for which your Tender Bid has received conditional acceptance, in terms of clause 7.4 of Schedule Three, the first day of the month following the date that represents: (i) (ii) the date that such acceptance ceases to be conditional; plus the Lead Time; or

(c)

such other date that is negotiated between you and PHARMAC under clause 1.6 of Schedule Three;

Successful Tenderer Notification Date means the date on which PHARMAC notifies you, in relation to a Tender Item for which you have submitted a Tender Bid, that your Tender Bid has been accepted;

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Schedule 1 Tender Bid means the Offer Letter together with the Tender Submission Form submitted for a particular Tender Item, including the Lead Time, and includes a Community Tender Bid, a Hospital Tender Bid and a Combined Community/Hospital Tender Bid; Tender Item means the form and strength of a Chemical Entity (or entities, if applicable) for which you may submit a Tender Bid; Tender Submission Form means the form on which you must submit your bid for each Tender Item and which is attached to the Offer Letter, as set out in Schedule Four; Transition Periods collectively refers to the First, and Second (if applicable), and Final Transition Periods; Unit means an individual unit of a Tender Item (e.g. tablet, 1ml of an oral liquid, ampoule, syringe); Unit Price means the relevant Price specified for a pack of that Tender Item in Section H of the Pharmaceutical Schedule, divided by the number of Units in the pack specified in the Pharmaceutical Schedule as being the listed pack size for that Tender Item (and where that Tender Item is not listed on the Pharmaceutical Schedule, the price and pack size in the most recent issue of the Pharmaceutical Schedule published prior to that Tender Item being delisted); Unit Subsidy means the subsidy specified for a pack of that Tender Item in sections A to G of the Pharmaceutical Schedule, divided by the number of Units in the pack specified in the Pharmaceutical Schedule as being the subsidised pack size for that Tender Item (and where that Tender Item is not listed on the Pharmaceutical Schedule, the subsidy and pack size specified in the most recent issue of the Pharmaceutical Schedule published prior to that Tender Item being delisted); Unit Volume means, in relation to community supply, the approximate number of Units of the Tender Item subsidised by PHARMAC, and claimed for by community pharmacies, in one year, as specified in Schedule Two; and Vitamin means a Tender Item for which a “V” is indicated in the list in clause 2 of Schedule Two.

Interpretation

In the construction of this Invitation, unless the context otherwise requires: (a) (b) a reference to a clause or a Schedule is a reference to a clause of, or a Schedule to, this Invitation; a reference to a statute or other law includes regulations and other instruments under it and consolidations, amendments, re-enactments or replacements of any of them (whether before or after the date of this Agreement); the singular includes the plural and vice versa; the word person includes an individual, a body corporate, an association of persons (whether corporate or not), a trust, a state and an agency of state, in each case, whether or not having a separate legal personality; a reference to a person includes a reference to the person’s executors, administrators, successors, substitutes, (including, but not limited to, persons taking by novation) and permitted assignees;

(e)

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Schedule 1 (f) (g) (h) words importing one gender include the other genders; headings in this Agreement are for convenience only and have no legal effect; and unless the context requires otherwise, references to the “listing” of a Pharmaceutical: (i) in relation to hospital supply, are to the listing of that Pharmaceutical in Section H of the Pharmaceutical Schedule and are deemed to include any written notification by PHARMAC of that Pharmaceutical being the subject of a national supply contract negotiated by PHARMAC on behalf of DHBs, where such written notification is in advance of the actual listing of that Pharmaceutical in Section H of the Pharmaceutical Schedule (and references to “list”, “listed”, “delisted”, and “delisting” are to be interpreted accordingly); in relation to community supply, are to the actual listing of that Pharmaceutical in sections A to G of the Pharmaceutical Schedule.

(ii)

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Schedule 2

Schedule 2: Products to be tendered

1.1

Information about Tender Items List of Tender Items

This Schedule sets out the Tender Items and information about the Tender Items. While PHARMAC has taken all reasonable care in preparing the information contained in this Schedule, it accepts no liability for any errors or omissions in the information.

1.2

Patents

(a) (b) (c) Where possible, PHARMAC has identified Tender Items that it understands may be the subject of a patent that it believes is due to expire after the Deadline. Where PHARMAC has been advised of the existence of a process patent prior to sending out this Invitation, it has shown this in the attached list by the use of a + symbol. However, PHARMAC makes no representation as to the patent status of the Tender Items and accepts no liability for any patent infringement that might occur as a result of this tender process or PHARMAC’s acceptance of a Tender Bid, including infringement of process patents.

1.3

Unit Volume and market value figures

(a) (b) Except where indicated otherwise the Unit Volume figures, in relation to community supply, are based on the year ending 30 June 2005. Market value figures, in relation to community supply, are expressed as the Unit Volume in the year ending 30 June 2005, multiplied by the Unit Subsidy as at 1 September 2005. The figures referred to in paragraphs (a) and (b): (i) are approximate and indicative only. PHARMAC makes no representation as to the accuracy of these figures or as to the level of sales or likely sales of any Tender Item. In particular, if these figures change at any time during the period from PHARMAC’s pre-tender consultation until decisions have been made about the acceptance of Tender Bids for all Tender Items, PHARMAC is not obliged to notify you of any such change; may not fully take into account any potential change in subsidised volumes as a result of some pharmaceuticals being dispensed in quantities providing for up to 90 consecutive days'treatment or, in the case of oral contraceptives, up to 180 consecutive days’ treatment (following the partial return to all at once dispensing); and do not include DHB Hospital volumes. For the avoidance of doubt, PHARMAC makes no representation as to the size of the DHB Hospital market for any Tender Item, in relation to hospital supply.

(c)

(ii)

(iii)

(d)

You acknowledge and agree that in submitting your Tender Bid you will rely on your own knowledge, skill and independent advice or assessment of the market size for any Tender Item and PHARMAC is to have no liability in that regard.

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Schedule 2

1.4

Special terms

Where there are any special terms relating to a particular Tender Item, those terms are indicated in the column entitled “Comments” in the list.

1.5

Subsidies

(a) (b) (c) The level at which each Tender Item, in relation to community supply, is specified in the attached list as being subsidised per Unit is as at 1 September 2005. Subsidies of Tender Items, in relation to community supply, may change before a Tender Bid is accepted. Where a * symbol is indicated next to the Unit Subsidy, there is no fully funded product available, in relation to community supply, for that Tender Item as at 1 September 2005.

1.6

DV Limits

Where there is a DV Limit relating to a particular Tender Item, in relation to hospital supply, that limit is indicated as a percentage amount in the column entitled “DV Limit” in the list.

1.7

Tender Items subject to sole supply arrangements

Where a Tender Item is underlined, that item is subject to a sole supply contract as at the date of this Invitation. Accordingly, the subsidy for those items is fixed until 30 June 2006 (unless otherwise indicated) and, for items that are the subject of a sole supply contract, the listing of a new brand, in relation to community supply, could only occur after that date.

1.8

Hospital only products

Where an H is indicated, you may submit a Tender Bid for Hospital Supply Status for that Tender Item.

1.9

Community only Products

Where a C is indicated, you may submit a Tender Bid for Sole Supply Status for that Tender Item.

1.10

Community and Hospital Products

Where a C and an H is indicated, you may submit a Tender Bid for Sole Supply Status and/or a Tender Bid for Hospital Supply Status for that Tender Item. You may also submit a Combined Community/Hospital Tender Bid in accordance with clause 2.5 of Schedule Three.

1.11

PCTs

Where a “PCT” is indicated, you may submit a Tender Bid for Hospital Supply Status for that Tender Item on the basis that, if PHARMAC accepts your Tender Bid, the Tender Item would be listed in Section H of the Pharmaceutical Schedule subject to clause 13 of Schedule Five.

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Schedule 2

1.12

IMM status

Where a symbol is indicated, your brand of the relevant Chemical Entity for which you submit a bid must have or be expected to gain IMM status.

1.13

Capsule and tablet form

Where a Tender Item specifies either: (a) (b) a capsule; or a tablet,

form of the Chemical Entity, your brand of the relevant Chemical Entity for which you submit a bid may be in either tablet or capsule form, provided that: (c) (d) your brand of the relevant Chemical Entity is the same strength as the Tender Item; and where the Tender Item specifies both the tablet and capsule form of that Chemical Entity as separate line items, you must submit a bid for the same form and strength as each line item in that Tender Item.

1.14

Pack size for use in DHB Hospitals

Where a Tender Item is specified as being available for a Tender Bid for Hospital Supply Status, it is the preference of DHB Hospitals that the pack size for such a Tender Item is: (a) (b) (c) 500 ml or less, where the Tender Item is in liquid form; 200 tablets or capsules, where the Tender Item is in tablet or capsule form; and 10 injections, where the Tender Item is in injection form.

Notwithstanding the preference of DHB Hospitals for Tender Items to be in pack sizes as specified in paragraphs (a) to (c) above, you may submit, and PHARMAC will consider and may accept, a Tender Bid for any pack size, including larger pack sizes, following its evaluation of Tender Bids under clause 5.2 of Schedule Three.

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Chemical Name Line Item Abacavir Sulphate Oral liq 20 mg per ml Tab 300 mg Acarbose Tab 50 mg Tab 100 mg Acebutolol Cap 100 mg Cap 200 mg Tab 400 mg Acetazolamide Sodium inj 500 mg

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

3,120 59,712

$1,300 $455,800

$0.4167 $7.6333

+ C H + C H

C H C H

1% 1%

398,135 125,544

$97,304 $43,237

$0.2444 $0.3444

1% 1%

97,700 145,063 36,476

$9,282 $23,123 $10,078

$0.0950 $0.1594 $0.2763

C H C H C H

1% 1% 1%

233

$3,250

$13.9500

C H

Acetic Acid with 1, 2- Propanediol Diacetate and Benzethonium Ear drops 2% with 1, 2-Propanediol diacetate 3 % and benzethonium chloride 0.02 % 85,540 $14,251 $0.1666 C H 1%

Acetic Acid with Boric Acid, Hydroxyquinoline and Ricinoleic Acid Jelly with boric acid 3%, hydroxyquinoline sulphate 0.025% and ricinoleic acid 0.75% with applicator Acetylcysteine Eye drops 5% Inj 200 mg per ml, 10 ml Aciclovir Tab 200 mg C H 1% Dispersible tablets need to

remain subsidised for patients who are unable to swallow tablets and the prescription is endorsed accordingly remain subsidised for patients who are unable to swallow tablets and the prescription is endorsed accordingly remain subsidised for patients who are unable to swallow tablets and the prescription is endorsed accordingly

345,300

$29,109

$0.0843

C H

H 142 $1,946 $13.7060 * C H

1% 1%

Tab 400 mg

C H

1% Dispersible tablets need to

Tab 800 mg

C H

1% Dispersible tablets need to

Tab dispersible 200 mg Tab dispersible 400 mg Tab dispersible 800 mg Inj 250 mg Inj 500 mg Eye oint 3% Adenosine Inj 3 mg per ml, 2 ml Alfacalcidol Cap 0.25 mcg Cap 1 mcg Oral drops 2 mcg per ml Alfentanil Inj 0.5 mg per ml, 2 ml

164,403 2,949,652 575,903

$16,440 $442,448 $153,766

$0.1000 $0.1500 $0.2670

C H C H C H H H

1% 1% 1% 1% 1% 1%

19,552

$163,064

$8.3400

C H

146,074 39,355 8,680

$38,447 $34,625 $26,335

$0.2632 $0.8798 $3.0340

C H C H C H

1% 1% 1%

1% 15

Chemical Name Line Item Allopurinol Inj 200 mg Alpha Tocopheryl Acetate

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

C H

Water solubilised soln 156 iu/ml, with calibrated dropper Alprostadil Inj 0.5 mg per ml, 1 ml Alteplase Inj 10 mg Inj 50 mg Amantadine Hydrochloride Cap 100 mg Amethocaine Gel 4% Amikacin Inj 5 mg per ml, 5 ml Inj 250 mg per ml, 2 ml Amiloride Tab 5 mg Amiodarone Hydrochloride Inj 50 mg per ml, 3 ml Amorolfine Nail soln 5% Amoxycillin Grans for oral liq 125 mg per 5 ml Grans for oral liq 250 mg per 5 ml Amphotericin B Inj 50 mg Lozenges 10 mg Amyl Nitrite Ampoule, 0.3 ml crushable Apomorphine Hydrochloride Inj 10 mg per ml, 1 ml Aprotinin Inj 10,000 mcg per ml 50 ml Arginine Inj 5%, 500 ml Ascorbic Acid Tab 100 mg Tab 250 mg Inj 500 mg Aspirin Tab 300 mg

75,900

$20,493

$0.2700

C H V

H H

1% 1%

365,088

$290,902

$0.7968

C H

H H

1% 1%

511

$3,109

$6.0840

C H

2,435

$18,438

$7.5720

C H

31,325,984 20,271,607

$338,321 $279,748

$0.0108 $0.0138

C H C H

1% 1%

H 181,116 $53,067 $0.2930 C H

1% 1%

160

$839

$5.2433

C H

3,574

$36,047

$10.0860

C H

545

$34,662

$63.6000

C H

1,047,625

$27,238

$0.0260 $0.0862

C H V C H V H

1% 1% 1%

724,173

$19,263

$0.0266

C H

1% Line item does not include

soluble 300 mg tablets

Chemical Name Line Item Aspirin Tab EC 300 mg Tab EC 650 mg Atenolol Tab 50 mg Tab 100 mg Atorvastatin Tab 10 mg Tab 20 mg Tab 40 mg Atropine Sulphate Eye drops 0.5% Inj 400 mcg, 1 ml Inj 600 mcg, 1 ml Inj 1200 mcg, 1 ml Auranofin Tab 3 mg Azithromycin Tab 500 mg Aztreonam Inj 500 mg Inj 1 g Baclofen Oral liq 5 mg per 5 ml Inj 2 mg per ml, 5 ml Beclomethasone Dipropionate

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

1,701,969 1,073

$123,393 $74

$0.0725 $0.0688

C H C

13,222,586 4,202,681

$198,339 $116,835

$0.0150 $0.0278

C H C H

1% 1%

987,970 2,641,586 5,547,366

$144,244 $561,865 $1,636,473

$0.1460 $0.2127 $0.2950

* * *

+ C + C + C

C H C H C H C H 1% Single dose presentation

would not be a DV Pharmaceutical

2,595 957 67,229 4,810

$695 $573 $32,270 $2,881

$0.2680 $0.5990 $0.4800 $0.5990

1% 1% 1%

18,926

$21,761

$1.1498

C H

54,892

$426,236

$7.7650

C H

H H

1% 1%

H H

1% 1%

Metered aqueous nasal spray, 50 mcg per dose Metered aqueous nasal spray, 100 mcg per dose Bendrofluazide Tab 1.25 mg Tab 2.5 mg Tab 5 mg Benztropine Mesylate Inj 1 mg per ml, 2 ml Tab 2 mg Benzylpenicillin Sodium Inj 600 mg Inj 1.2 g Inj 3 g Beractant Inj 25 mg per ml, 8 ml Betahistine Dihydrochloride Tab 8 mg

9,170,400 29,822,800

$98,123 $334,015

$0.0107 $0.0112

C H C H

1% 1%

C H 24,790,011 2,615,724 $669,330 $112,476 $0.0270 $0.0430 C H C H

1% 1% 1%

2,845 943,671

$20,683 $113,995

$7.2700 $0.1208

C H C H

1% 1%

13,127

$9,176

$0.6990

C H H H

1% 1% 1%

1% 17

Chemical Name Line Item Betamethasone Dipropionate Crm 0.05% Crm 0.05% in propylene glycol base Oint 0.05% Oint 0.05% in propylene glycol base

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

165,205 15,060 169,150 22,560

$32,595 $2,173 $33,373 $3,255

$0.1973 $0.1443 $0.1973 $0.1443

* * * *

C H C H C H C H

1% 1% 1% 1%

Betamethasone Sodium Phosphate with Betamethasone Acetate Inj 3.9 mg with betamethasone acetate 3 mg per ml, 1 ml Betamethasone Valerate Lotn 0.1% Scalp app 0.1% Betamethasone Valerate with Clioquinol Crm 0.1% with clioquinol 3% Oint 0.1% with clioquinol 3% Betamethasone Valerate with Fusidic Acid Crm 0.1% with fusidic acid 2% Bisacodyl Suppos 5 mg Suppos 10 mg Brinzolamide Eye Drops 1% Budesonide Metered aqueous nasal spray, 50 mcg per dose Metered aqueous nasal spray, 100 mcg per dose Nebuliser soln, 500 mcg per ml, 2 ml Bumetanide Inj 500 mcg per ml, 4 ml Tab 1 mg Bupivacaine hydrochloride Inf 0.125%, 100 ml Inf 0.125%, 100 ml Theatre pack Inf 0.125%, 200 ml Inf 0.125%, 200 ml Theatre pack Inj 0.25%, 20 ml Inj 0.25%, 20 ml Theatre pack Inf 0.25%, 100 ml Inf 0.25%, 100 ml Theatre pack Inj 0.375%, 20 ml Inj 0.375%, 20 ml Theatre pack Inj 0.5%, 4 ml Inj 0.5%, 4 ml Theatre pack Inj 0.5%, 10 ml Inj 0.5%, 10 ml Theatre pack Inj 0.5%, 20 ml Inj 0.5%, 20 ml Theatre pack H H H H H H H H H H H H H H H H 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 18 80 746,518 $127 $122,130 $1.5900 $0.1636 C H C H 1% 1% 4,395,400 17,919,200 1,410 $51,866 $232,950 $5,828 $0.0118 $0.0130 $4.1333 C H C H C 1% 1% 44,180 $86,328 $1.9540 C 11,886 $4,656 $0.3917 * C H H 1% 1% 389,880 $90,725 $0.2327 * C H 1% 96,165 26,760 $22,378 $6,227 $0.2327 $0.2327 * * C C 183,100 3,243,100 $36,803 $129,724 $0.2010 $0.0400 C H C H 1% 1% 741 $2,845 $3.8400 * C H 1%

Chemical Name Line Item Bupivacaine hydrochloride Inj 0.5%, 8% glucose, 4 ml

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

Bupivacaine hydrochloride with Adrenaline Inj 0.25% with 1:400,000 adrenaline, 10 ml Inj 0.25% with 1:400,000 adrenaline, 10 ml Theatre pack Inj 0.5% with 1:200,000 adrenaline, 10 ml Inj 0.5% with 1:200,000 adrenaline, 10 ml Theatre pack Inj 0.5% with 1:200,000 adrenaline, 20 ml Inj 0.5% with 1:200,000 adrenaline, 20 ml Theatre pack Buserelin Acetate Inj 1 mg per ml, 5.5 ml Caffeine Citrate Inj 10 mg per ml, 2.5 ml Oral liq 10 mg per ml Calamine Crm, aqueous, BP Lotn, BP Calcitonin Inj 100 iu per ml, 1 ml Calcitriol Cap 0.25 mcg Cap 0.5 mcg Oral liq 1 mcg per ml Calcium Polystyrene Sulphonate Powder Captopril Oral liq 5 mg per ml Carbachol Eye drops 1.5% Eye drops 3% Carbimazole Tab 5 mg Carboplatin Inj 10 mg per ml, 5 ml Inj 10 mg per ml, 15 ml Inj 10 mg per ml, 45 ml Inj 10 mg per ml, 100 ml Carmustine Inj 100 mg Carvedilol Tab 6.25 mg Tab 12.5 mg $0.7000 $0.9000 C C 19 H PCT 1% H PCT H PCT H PCT H PCT 1% 1% 1% 1% 1,929,703 $208,408 $0.1080 C H 1% 2,445 6,195 $1,112 $2,887 $0.4547 $0.4660 C H C H 1% 1% 183,255 $98,463 $0.5373 C 271,365 $128,030 $0.4718 C H 1% 4,026,344 492,529 10,170 $2,119,065 $433,327 $40,070 $0.5263 $0.8798 $3.9400 C H V C H V C H V 1% 1% 1% 1,725 $34,500 $20.0000 C H 1% 107,535 3,629,263 $3,678 $39,196 $0.0342 $0.0108 * * C H C H 1% 1% H H 1% 1% $97.5000 * C H 1% H H H H H H 1% 1% 1% 1% 1% 1%

Chemical Name Line Item Carvedilol Tab 25 mg Caspofungin Inj 50 mg Inj 70 mg Cefamandole Nafate Inj 500 mg Inj 1 g Inj 2 g Cefpirome Inj 1 g Inj 2 g Cephalexin Monohydrate Grans for oral liq 125 mg per 5 ml Grans for oral liq 250 mg per 5 ml Cephradine Cap 250 mg Cap 500 mg Inj 500 mg Inj 1 g Cetomacrogol Cream BP Crm (pack size 100 g or less) Crm (pack size greater than 100 g)

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

$1.1250

H H

1% 1%

$3.6000 $4.3000

C H C H H

1% 1% 1%

H H

1% 1%

75,922 110,548

$5,315 $10,502

$0.0700 $0.0950

C H C H

1% 1%

6,146 18,975 8 8

$3,713 $15,694 $27 $51

$0.6042 $0.8271 $3.3560 $6.3180

C H C H C H C H

1% 1% 1% 1%

5,472,566 5,472,566

$30,646 $30,646

$0.0056 $0.0056

* *

C H C H

1% Volume is aggregated for all

pack sizes of cetomacrogol cream pack sizes of cetomacrogol cream

1% Volume is aggregated for all

Charcoal Tab 300 mg Oral liq 50 g Charcoal with Sorbitol Oral liq 50 g Chloramphenicol Ear drops 0.5% Eye drops 0.5% Eye oint 1% Inj 1 g Chlorhexidine Crm 1% obstetric Mouthwash 0.2% Chlorhexidine Gluconate Handrub 0.5% - 1% with ethanol 70% 2,578,884 $29,399 $0.0114 C 1% Chlorhexidine strengths from

0.5% to 1% would be considered

57,178 135,300

$4,077 $8,930

$0.0713 $0.0660

C H C H

1% 1%

C H

16,160 1,110,390 293,132

$6,044 $113,260 $131,909

$0.3740 $0.1020 $0.4500

C H C H C H H

1% 1% Single dose presentation

would not be a DV Pharmaceutical

1% 1%

H 1,123,800 $15,508 $0.0138 * C

Chloroform BP Chloroform BP $0.0426 * C 1%

Chemical Name Line Item Chlorpheniramine Maleate Oral liq 2 mg per 5 ml Chlorpromazine Hydrochloride Tab 10 mg Tab 25 mg Tab 100 mg Oral liq 100 mg per 5 ml Inj 25 mg per ml, 2 ml Chlorthalidone Tab 25 mg Cholestyramine with Aspartame Sachets 4 g with aspartame Cidofovir Inj 75 mg per ml, 5 ml Cilazapril Tab 0.5 mg Tab 2.5 mg Tab 5 mg Cimetidine Tab 200 mg Tab 400 mg Ciprofloxacin Eye Drops 0.3% Ear drops 10 mg per ml Inj 2 mg per ml, 100 ml Oral liq 250 mg per 5 ml Oral liq 500 mg per 5 ml Clarithromycin Grans for oral liquid 125 mg per 5 ml Inj 500 mg Clobetasol Propionate Crm 0.05% Clobetasone Butyrate Crm 0.05% (pack size 30 g or less) Crm 0.05% (pack size greater than 30 g)

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

7,246,546

$54,349

$0.0075

149,179 1,124,883 399,772 323,824 2,941

$18,439 $146,460 $122,370 $48,574 $7,547

$0.1236 $0.1302 $0.3061 $0.1500 $2.5660

C H C H C H C H C H

1% 1% 1% 1% 1%

133,119

$17,838

$0.1340

C H

150,217

$57,834

$0.3850

8,703,354 12,271,968 11,429,807

$637,956 $1,795,389 $2,453,980

$0.0733 $0.1463 $0.2147

C C C

82,615 245,554

$4,131 $24,555

$0.0500 $0.1000

C H C H

1% 1%

10,360

$25,755

$2.4860

C H H H H H

1% 1% 1% 1% 1%

8,563

$2,828

$0.3303

C H H

1% 1%

1,769,880

$82,653

$0.0467

C H

682,970 672,827

$110,163 $108,527

$0.1613 $0.1613

* *

C H C H

1% Volume is aggregated for all

pack sizes of clobetasone butyrate cream pack sizes of clobetasone butyrate cream

1% Volume is aggregated for all

Clonazepam Inj 1 mg per ml, 1 ml Oral drops 2.5 mg per ml Clostridum botulinum Inj 100 iu Inj 500 u H H 1% 1% 11,968 71,630 $22,404 $52,863 $1.8720 $0.7380 C H C H 1% 1%

Chemical Name Line Item Clotrimazole Pessaries 100 mg with applicator Pessaries 500 mg with applicator Soln 1% Cocaine Soln 4%, 2 ml BP Paste 15% Codeine Phosphate Powder BP Oral liq 25 mg per 5 ml Colestipol Hydrochloride Sachets 5 g Colistin Sulphomethate Inj 150 mg Cortisone Acetate Tab 5 mg Tab 25 mg Co-Trimoxazole Inj 96 mg per ml, 5 ml Crotamiton Crm 10% Lotn 10% Cyclizine Hydrochloride Tab 50 mg Cyclopentolate Hydrochloride Eye drops 1%

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

12,019 3,952 11,340

$3,865 $7,627 $2,472

$0.3216 $1.9300 $0.2180 *

C H C H C

1% 1%

H H

1% 1%

$2.5236

C H H

1% 1%

128,724

$49,559

$0.3850

8,170

$404,742

$49.5400

C H

106,338 39,839

$8,603 $7,442

$0.0809 $0.1868

* *

C H C H

1% 1%

335,100 192,702

$71,376 $29,137

$0.2130 $0.1512

* *

C C

374,931

$47,241

$0.1260

C H

59,265

$34,611

$0.5840

C H

1% Single dose presentation

would not be a DV Pharmaceutical

Cyclophosphamide Inj 200 mg Inj 500 mg Inj 1 g Inj 2 g Tab 50 mg Cyproterone Acetate Tab 50 mg Tab 100 mg Cytarabine Inj 100 mg Inj 500 mg Inj 1 g Inj 2 g Dacarbazine Inj 200 mg H PCT 1% $16.0000 $67.0000 $118.0000 C H PCT C H PCT C H PCT H PCT 1% 1% 1% 1% 1,230,579 $664,513 $0.5400 C H C H 1% 1% 100,022 $51,431 $0.5142 H PCT H PCT C H PCT H PCT C H PCT 1% 1% 1% 1% 1%

Chemical Name Line Item Dalteparin Sodium Inj 2,500 iu per ml, 0.2 ml Inj 5,000 iu per ml, 0.2 ml Inj 7,500 iu per ml, 0.75 ml Inj 10,000 iu per ml, 0.4 ml Inj 10,000 iu per ml, 1 ml Inj 12,500 iu per ml, 0.5 ml Inj 15,000 iu per ml, 0.6 ml Inj 18,000 iu per ml, 0.72 ml Dantrolene Inj 1 mg per ml, 20 ml Dantrolene Sodium Cap 25 mg Cap 50 mg Daunorubicin Inj 20 mg Desferrioxamine Mesylate Inj 500 mg Inj 1 g Desipramine Hydrochloride Tab 25 mg Desmopressin Nasal drops 100 mcg per ml Tab 200 mcg Inj 4 mcg per ml, 1 ml Inj 15 mcg per ml, 1 ml Dexamethasone Eye drops 0.1 % Eye oint 0.1% Dexamethasone Sodium Phosphate Inj 4 mg per ml, 1 ml Inj 4 mg per ml, 2 ml

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

H H H H H H H H

1% 1% 1% 1% 1% 1% 1% 1%

138,642 59,695

$45,696 $30,862

$0.3296 $0.5170

* *

C H C H

1% 1%

H PCT

H C H

10% 10%

195,562

$126,411

$0.6464

C H

6,373 1,230 1,290

$99,495 $8,263 $8,666

$15.6120 $6.7180 $6.7180

C H C H C H C H

1% 1% 1% 1%

71,725 6,246

$64,553 $10,458

$0.9000 $1.6743

C H C H

1% 1%

18,308 45,010

$82,752 $293,465

$4.5200 $6.5200

C H C H

1% 1%

Dexamethasone with Framycetin and Gramicidin Ear/Eye drops 500 mcg with framycetin sulphate 5 mg and gramicidin 50 mcg per ml Ear/Eye oint 500 mcg with framycetin sulphate 5 mg and gramicidin 50 mcg per g 814,000 39,825 $457,875 $35,843 $0.5625 $0.9000 * * C H C H 1% 1%

Dexamethasone with Neomycin and Polymyxin B Sulphate Eye drops 0.1% with neomycin sulphate 0.35% and polymyxin B sulphate 6,000 u per ml Eye oint 0.1% with neomycin sulphate 0.35% and polymyxin B sulphate 6,000 u per g Dexamphetamine Sulphate Tab 5 mg Dextrochlorpheniramine Maleate Oral liq 2 mg per 5 ml 164,426 $2,910 $0.0177 * C 23 568,510 $108,017 $0.1900 C 106,050 9,366 $95,445 $14,424 $0.9000 $1.5400 C H C H 1% 1%

Chemical Name Line Item Dextrochlorpheniramine Maleate Tab 2 mg Tab long-acting 6 mg Dextrose Inj 50%, 10 ml Inj 50%, 50 ml Inj 50%, 90 ml Diazepam Rectal tubes 5 mg Rectal tubes 10 mg Diclofenac Sodium Eye drops 1 mg per ml Inj 25 mg per ml, 3 ml Suppos 12.5 mg Suppos 25 mg Suppos 50 mg Suppos 100 mg Tab EC 25 mg Tab EC 50 mg Tab 50 mg dispersible Tab long-acting 75 mg Tab long-acting 100 mg Dicloxacillin Cap 250 mg Cap 500 mg Grans for oral liq 125 mg per 5 ml Inj 500 mg Inj 1 g Dicobalt Edetate Inj 15 mg per ml, 20 ml Dicyclomine Hydrochloride Tab 10 mg Didanosine (ddI) Cap 125 mg Cap 200 mg Cap 250 mg Cap 400 mg Diflucortolone Valerate Crm 0.1% Fatty oint 0.1% Oint 0.1% Digoxin Inj 25 mcg per ml, 2 ml Inj 250 mcg per ml, 2 ml

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

121,269 462,152

$6,112 $62,391

$0.0504 $0.1350

* *

C C

2,910

$3,073

$1.0560

C H H H

1% 1% 1%

14,967 17,305

$79,325 $112,067

$5.3000 $6.4760

C H C H

1% 1%

18,900 24,660 5,721 11,867 70,929 183,672 434,748 2,835,341 1,062,339 16,306,696 3,689,008

$52,164 $59,184 $1,058 $2,634 $27,237 $116,815 $15,260 $154,810 $79,675 $875,670 $281,471

$2.7600 $2.4000 $0.1850 $0.2220 $0.3840 $0.6360 $0.0351 $0.0546 $0.0750 $0.0537 $0.0763 *

C H C H C H C H C H C H C H C H C H C H C H

1% Single dose presentation

would not be a DV Pharmaceutical

1% 1% 1% 1% 1% 1% 1% 1% 1% 1%

53,594 126,610 103,721 5 56

$5,515 $20,207 $3,682 $5 $84

$0.1029 $0.1596 $0.0355 $1.0900 $1.5080

* * *

C H C H C H C H C H

1% 1% 1% 1% 1%

682,516

$33,785

$0.0495

3,090 1,630 22,274

$11,850 $10,002 $273,347

$3.8350 $6.1360 $7.6700 $12.2720

C C C C

233,500 288,800 100,300

$41,890 $51,811 $17,994

$0.1794 $0.1794 $0.1794

* * *

C C C

H H

1% 1% 24

Chemical Name Line Item Digoxin Oral liq 50 mcg per ml Tab 62.5 mcg Tab 250 mcg Dinoprostone Gel 1 mg Gel 2 mg Pessary 10 mg Diphemanil Methylsulphate Powder 2% Dipivefrin Hydrochloride Eye drops 0.1% Dipyridamole Tab 25 mg Inj 5 mg per ml, 2 ml Inj 5 mg per ml, 10 ml Disopyramide Phosphate Cap 100 mg Cap 150 mg Disulfiram Tab 200 mg Dithranol Crm 1% Dobutamine Inj 12.5 mg per ml, 20 ml Docetaxel Inj 20 mg Inj 80 mg Docusate Sodium with Bisacodyl Suppos 100 mg with bisacodyl 10 mg Docusate Sodium with Sennosides Tab 50 mg with total sennosides 8 mg Domperidone Tab 10 mg Dopamine Inj 40 mg per ml, 5 ml Dornase Alfa Nebuliser soln 2.5 mg per 2.5 ml ampoule Dorzolamide Hydrochloride Eye drops 2%

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

26,065 10,344,208 2,566,564

$3,524 $268,949 $102,149

$0.1352 $0.0260 $0.0398

C H C H C H

1% 1% 1%

H H H

1% 1% 1%

26,750

$3,643

$0.1362

C H

670

$369

$0.5500

C H

335,494

$705

$0.0021

C H H H

1% 1% 1%

76,305 65,380

$11,446 $17,136

$0.1500 $0.2621

C C

144,132

$35,024

$0.2430

C H

98,850

$54,368

$0.5500

+ +

2,774 $1,637 $0.5900 * C

H PCT H PCT

1% 1%

4,982,810

$194,330

$0.0390

8,748

$429,089

$49.0500

C H

76,460

$149,403

$1.9540

Dorzolamide hydrochloride with timolol maleate Eye drops 2% with timolol maleate 0.5% 363,840 $1,742,794 $4.7900 C

Chemical Name Line Item Dothiepin Hydrochloride Cap 25 mg Tab 75 mg Doxepin Hydrochloride Cap 10 mg Cap 25 mg Cap 50 mg Cap 75 mg Doxorubicin Inj 10 mg Inj 20 mg Inj 50 mg Inj 100 mg Inj 200 mg Doxycycline Hydrochloride Tab 50 mg Inj 5 mg per ml, 2 ml Droperidol Inj 2.5 mg per ml, 1 ml Inj 5 mg per ml, 2 ml Drotrecogin Inj 5 mg Inj 20 mg Econazole Nitrate Crm 1% Foaming soln 1%, 10 ml sachets Pessaries 150 mg with applicators Vaginal crm 1 % with applicator(s) Efavirenz Cap 50 mg Cap 100 mg Cap 200 mg Tab 600 mg Enalapril Tab 5 mg Tab 10 mg Tab 20 mg Enalapril With Hydrochlorothiazide

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

4,798,190 1,690,279

$215,919 $147,899

$0.0450 $0.0875

C C

1,765,919 2,399,878 734,546 391,238

$88,119 $100,555 $51,345 $42,997

$0.0499 $0.0419 $0.0699 $0.1099 *

C C C C

H PCT H PCT H PCT H PCT H PCT

1% 1% 1% 1% 1%

811,894

$78,510

$0.0967

C H H

1% 1%

H H

1% 1%

H H

1% 1%

110,655 59,380 2,282 280

$7,414 $195,758 $2,092 $19

$0.0670 $3.2967 $0.9167 $0.0688

* * * *

C C C C

$5.2777 $5.2777 11,241 $59,327 $5.2777 $15.8330

C C C C

3,526,565 2,875,868 1,995,497

$85,696 $88,289 $81,616

$0.0243 $0.0307 $0.0409

C C C

Tab 20 mg with hydrochlorothiazide 12.5 mg Enoxaparin Sodium Inj 20 mg per 0.2 ml Inj 40 mg per 0.4 ml Inj 60 mg per 0.6 ml Inj 80 mg per 0.8 ml Inj 100 mg per ml

390,522

$43,231

$0.1107

H H H H H

1% 1% 1% 1% 1% 26

Chemical Name Line Item Enoxaparin Sodium Inj 120 mg per 0.8 ml Inj 150 mg per ml Ephedrine Inj 30 mg per ml, 1 ml Tab 30 mg Epirubicin Inj 2 mg per ml, 5 ml Inj 2 mg per ml, 10 ml Inj 2 mg per ml, 25 ml Inj 2 mg per ml, 50 ml Inj 2 mg per ml, 100 ml Eptifibatide Inj 0.75 mg per ml, 100 ml Inj 2 mg per ml, 10 ml Ergometrine Maleate Inj 500 mcg per ml, 1 ml Ergotamine Tartrate with Caffeine Tab 1 mg with caffeine 100 mg Erythromycin Ethyl Succinate Tab 400 mg Erythromycin Lactobionate Inj 1 g Erythromycin Stearate Tab 250 mg Tab 500 mg Esmolol Inj 10 mg per ml, 10 ml Inj 250 mg Ethinyloestradiol Tab 10 mcg Ethinyloestradiol with Gestodene

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

H H

1% 1%

H H

1% 1%

H PCT H PCT H PCT H PCT H PCT

1% 1% 1% 1% 1%

H H

1% 1%

2,329

$5,403

$2.3200

C H

524,621

$162,633

$0.3100

3,667,268

$549,723

$0.1499

C H

256

$1,664

$6.5000

C H

294,450 170,463

$44,020 $50,968

$0.1495 $0.2990

* *

C H C H

1% 1%

H H

1% 1%

358,432

$59,213

$0.1652

Tab 20 mcg with gestodene 75 mcg and 7 inert tab Ethinyloestradiol with Levonorgestrel Tab 20 mcg with levonorgestrel 100 mcg and 7 inert tab Tab 30 mcg with levonorgestrel 150 mcg Tab 30 mcg with levonorgestrel 150 mcg and 7 inert tab Tab 50 mcg with levonorgestrel 125 mcg and 7 inert tab Tab ethinyloestradiol 30 mcg with levonorgestrel 50 mcg (6) and ethinyloestradiol 40 mcg with levonorgestrel 75 mcg (5), and ethinyloestradiol 30 mcg with levonorgestrel 125 mcg (10) and 7 inert tab

29,988

$2,366

$0.0789

9,372,387 584,935 27,000,977 530,957 3,623,857

$738,544 $61,477 $2,127,677 $59,733 $285,560

$0.0788 $0.1051 $0.0788 $0.1125 $0.0788

* *

C C C C

Chemical Name Line Item Ethinyloestradiol with Norethisterone Tab 35 mcg with norethisterone 1 mg

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

65,347 673,620 84,420 53,312

$6,868 $53,081 $8,873 $4,201

$0.1051 $0.0788 $0.1051 $0.0788

* * * *

C C C C

Tab 35 mcg with norethisterone 1 mg and 7 inert tab Tab 35 mcg with norethisterone 500 mcg Tab ethinyloestradiol 35 mcg with norethisterone 500 mcg (7) and tab ethinyloestradiol 35 mcg with norethisterone 1 mg (9) and tab ethinyloestradiol 35 mcg with norethisterone 500 mcg (5) and 7 inert Ethynodiol Diacetate Tab 500 mcg Etidronate Disodium Tab 200 mg Etoposide Cap 50 mg Cap 100 mg Etoposide Phosphate Inj 113.6 mg Inj 568 mg Inj 1,136 mg Fentanyl Inj 50 mcg per ml, 2 ml Inj 50 mcg per ml, 10 ml Inj 50 mcg per ml, 20 ml Transdermal patch 2.5 mg, 25 mcg per hour Transdermal patch 5 mg, 50 mcg per hour Transdermal patch 7.5 mg, 75 mcg per hour Transdermal patch 10 mg, 100 mcg per hour Ferrous Sulphate with Folic Acid Tab long-acting 325 mg with folic acid 350 mcg Fexofenadine Hydrochloride Tab 60 mg Tab 120 mg Tab 180 mg Filgrastim Inj 0.3 mg per ml, 1 ml Inj 0.6 mg per ml, 0.5 ml Flecainide Acetate Tab 50 mg Tab 100 mg Cap long-acting 100 mg Cap long-acting 200 mg Inj 10 mg per ml, 15 ml Flucloxacillin Cap 250 mg

8,348,441

$657,857

$0.0788

2,226,417

$846,038

$0.3800

C H

6,962 424

$118,608 $14,447

$17.0365 $34.0730

C H PCT C H PCT

1% 1%

H PCT H PCT H PCT

1% 1% 1%

H H H H H H H

1% 1% 1% 1% 1% 1% 1%

1,339,145

$80,349

$0.0600

97,701 152,147

$21,201 $72,118

$0.2170 $0.4740

* *

C H C H H

1% 1% 1%

H H

1% 1%

260,780 309,209 561,276 408,740 261

$186,119 $389,758 $801,109 $1,030,434 $2,559

$0.7137 $1.2605 $1.4273 $2.5210 $9.8040

C H C H C H C H C H

1% 1% 1% 1% 1%

1,125,121

$91,810

$0.0816

C H

Chemical Name Line Item Flucloxacillin Cap 500 mg Grans for oral liq 125 mg per 5 ml Grans for oral liq 250 mg per 5 ml Inj 250 mg Inj 500 mg Inj 1 g Fluconazole Inj 2 mg per ml, 50 ml Oral liq 10 mg per ml Fludrocortisone Acetate Tab 100 mcg Flumazenil Inj 0.1 mg per ml, 5 ml Flumetasone Pivalate Ear drops 0.02% with clioquinol 1% Fluorometholone Eye drops 0.1% Fluorouracil Sodium Crm 5% Inj 25 mg per ml, 100 ml Inj 50 mg per ml, 10 ml Inj 250 mg per 10 ml Inj 500 mg per 10 ml Inj 500 mg per 20 ml Flupenthixol Decanoate Inj 20 mg per ml, 1 ml Inj 20 mg per ml, 2 ml Inj 100 mg per ml, 1 ml Folic Acid Inj 15 mg per ml, 1 ml Tab 0.8 mg Tab 5 mg Framycetin Sulphate Ear/Eye drops 0.5% Ear/Eye oint 0.5% Frusemide Inj 10 mg per ml, 2 ml Inj 20 mg per ml, 2 ml Inf 10 mg per ml, 25 ml Oral liq 10 mg per ml Fusidic Acid Eye drops 1% Inj 500 mg sodium fusidate per 10 ml

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

4,798,296 4,590,778 5,072,788 528 2,848 39,635

$657,367 $117,065 $169,938 $492 $3,104 $59,770

$0.1370 $0.0255 $0.0335 $0.9320 $1.0900 $1.5080

C H C H C H C C C

1% 1% 1%

H H

1% 1%

727,974

$55,472

$0.0762

C H

101,089

$60,118

$0.5947

57,820

$50,766

$0.8780

C H

233,040

$278,366

$1.1945

C H PCT H PCT H PCT

1% 1% 1% 1% 1% 1%

$3.6480 74 568 $426 $3,158 $5.7500 $5.5600

C H PCT C H PCT C H PCT

10,189 10,877 11,426

$26,777 $45,466 $93,396

$2.6280 $4.1800 $8.1740

C H C H C H

1% 1% 1%

H 1,088,795 4,769,637 $17,965 $62,959 $0.0165 $0.0132 C H V C H V

1% 1% 1%

74,216 19,190

$38,310 $14,009

$0.5162 $0.7300

C C

H H 12 100,440 $116 $35,686 $9.6280 $0.3553 C H C H

1% 1% 1% 1%

261,545

$235,391

$0.9000 $12.8700

* *

C H C H

1% 1%

Chemical Name Line Item Fusidic Acid Tab 250 mg Gamma Benzene Hexachloride Crm 1% Ganciclovir Cap 250 mg Inj 500 mg Gatifloxacin Tab 200 mg Tab 400 mg Inj 200 mg per 20 ml Inj 200 mg per 100 ml Inj 400 mg per 200 ml Gentamicin Sulphate Eye drops 0.3% Inj 10 mg per ml, 2 ml Inj 40 mg per ml, 1 ml Inj 40 mg per ml, 2 ml Gestrinone Cap 2.5 mg Glibenclamide Tab 2.5 mg Tab 5 mg Glycerol Liquid BP Suppos 3 g or less Glyceryl Trinitrate Inj 1 mg per ml, 5 ml Inj 1 mg per ml, 50 ml Inj 5 mg per ml, 1 ml Inj 5 mg per ml, 10 ml Tab 600 mcg Glycopyrronium Inj 0.2 mg per ml, 1 ml Haloperidol Inj 5 mg per ml, 1 ml Heparin Sodium Inj 1,000 iu per ml, 1 ml Inj 1,000 iu per ml, 5 ml Inj 5,000 iu per ml, 5 ml Inj 25,000 iu per ml, 0.2 ml Heparinised Saline Inj 10 iu per ml, 5 ml

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

40,811

$117,332

$2.8750

C H

162,400

$10,394

$0.0640

H H

1% 1%

H H H H H

1% 1% 1% 1% 1%

525 70 6,587

$1,197 $224 $3,755

$2.2800 $3.2000 $0.5700

C H C H C H C H

1% Single dose presentation

would not be a DV Pharmaceutical

1% 1% 1%

10,477

$133,412

$12.7338

411,070 1,943,433

$8,139 $40,812

$0.0198 $0.0210

C C

15,000 61,644

$186 $16,027

$0.0124 $0.2600

C H C

H H H H 187,696 $6,194 $0.0330 C H

1% 1% 1% 1% 1%

30,528

$45,242

$1.4820

C H

H 655 15,452 7,519 $875 $42,802 $11,279 $1.3360 $2.7700 $1.5000 * * C H C H C H

1% 1% 1% 1%

24,981

$9,992

$0.4000

C H

1% 30

Chemical Name Line Item Hyaluronidase Inj 1,500 iu per ml Hydralazine Inj 20 mg per ml, 1 ml Hydrocortisone Tab 5 mg Tab 20 mg Oral liq Inj 50 mg per ml, 2 ml Hydrocortisone Acetate Rectal foam 10 %, CFC-free Hydroxychloroquine Sulphate Tab 200 mg Hydroxyurea Cap 500 mg Ibuprofen Tab 400 mg Tab 600 mg Tab long-acting 800 mg Idarubicin Cap 5 mg Cap 10 mg Inj 5 mg Inj 10 mg Ifosfamide Inj 1 g Inj 2 g Imipenem with Cilastatin Inj 500 mg Imipramine Hydrochloride Tab 10 mg Tab 25 mg Indapamide Tab 2.5 mg Indinavir Cap 200 mg Cap 400 mg Indomethacin Cap long-acting 75 mg Suppos 100 mg Infliximab Inj 100 mg Irinotecan Inj 20 mg per ml, 2 ml

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

1,130

$2,070

$1.8320

C H

137

$836

$6.1000

C H

1,906,062 108,611 9,477

$151,532 $15,499 $35,254

$0.0795 $0.1427 $3.7200

C H C H C H C H

1% 1% 1% 1%

244,725

$221,060

$0.9033

C H

1,691,418

$477,995

$0.2826

636,074

$202,017

$0.3176

C H

1,087,638 241,352 2,894,851

$38,720 $12,840 $145,322

$0.0356 $0.0532 $0.0502

* * *

C H C H C H

1% 1% 1%

H PCT H PCT H PCT H PCT

1% 1% 1% 1%

H PCT H PCT

1% 1%

530,032 1,837,460

$52,791 $293,994

$0.0996 $0.1600

C H C H

1% 1%

2,186,771

$73,694

$0.0337

C H

9,930 108,330

$14,337 $312,803

$1.4438 $2.8875

+ C H + C H

C C

1% 1%

700,929 61,113

$87,616 $24,445

$0.1250 $0.4000

H PCT

1% 31

Chemical Name Line Item Irinotecan Inj 20 mg per ml, 5 ml Isoniazid Tab 100 mg Tab 100 mg with rifampicin 150 mg Tab 150 mg with rifampicin 300 mg Isoprenaline Hydrochloride Inj 200 mcg per ml, 1 ml Inj 200 mcg per ml, 5 ml Isosorbide Mononitrate Tab 20 mg Tab long-acting 40 mg Tab long-acting 60 mg Isotretinoin Cap 10 mg Cap 20 mg Cap 40 mg

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

H PCT

323,669 27,750 111,074

$67,970 $24,986 $199,456

$0.2100 $0.9004 $1.7957

C C C

433

$637

$1.4720

C H H

1% 1%

693,452 926,987 12,602,714

$124,821 $458,580 $609,971

$0.1800 $0.4947 $0.0484

C H C H C H

1% 1% 1%

919,941 2,089,869

$367,976 $1,253,921

$0.4000 $0.6000

C H C H C H

1% Information on appropriate use

should be available on a website should be available on a website should be available on a website

1% Information on appropriate use 1% Information on appropriate use

Ketamine Inj 100 mg per ml, 2 ml Ketoprofen Cap 100 mg Cap long-acting 100 mg Cap long-acting 200 mg Ketotifen Oral liq 1 mg per 5 ml Labetalol Inj 5 mg per ml, 20 ml Lamivudine Oral liq 5 mg per ml Oral liq 10 mg per ml Tab 100 mg Tab 150 mg Levobunolol Eye drops 0.25% Eye drops 0.5 % Levocabastine Eye drops 0.5 mg per ml Levodopa with Benserazide Tab dispersible 50 mg with benserazide 12.5 mg Cap 50 mg with benserazide 12.5 mg Cap long-acting 100 mg with benserazide 25 mg 557,056 1,072,722 767,270 $55,706 $85,818 $130,436 $0.1000 $0.0800 $0.1700 C H C H C H 1% 1% 1% 106,288 $231,442 $2.1775 * C 40,785 38,160 $57,099 $53,424 $1.4000 $1.4000 C H C H 1% 1% 660 78,240 203,081 92,718 $248 $32,603 $1,037,155 $474,716 $0.3750 $0.4167 $5.1071 $5.1200 1,043 $12,320 $11.8120 * C H 1% 5,661,484 $138,706 $0.0245 * C 2,356 253,642 278,298 $158 $17,045 $37,403 $0.0672 $0.0672 $0.1344 * * * C C C H 1%

+ C H + C H + C H + C H

1% 1% 1% 1%

Chemical Name Line Item Levodopa with Benserazide Cap 100 mg with benserazide 25 mg Cap 200 mg with benserazide 50 mg Levonorgestrel Tab 30 mcg Tab 750 mcg Lignocaine Gel 2% Lignocaine Hydrochloride Inj 0.5%, 5 ml Inj 0.5%, 5 ml Theatre pack Inj 1%, 2 ml Inj 1%, 2 ml Theatre pack Inj 1%, 5 ml Inj 1%, 5 ml Theatre pack Inj 1%, 20 ml Inj 1%, 20 ml Theatre pack Inj 2%, 2 ml Inj 2%, 2 ml Theatre pack Inj 2%, 5 ml Inj 2%, 5 ml Theatre pack Inj 2%, 20 ml Inj 2%, 20 ml Theatre pack Inj twin pack 100 mg per 5 ml Pump spray 10%, 50 ml CFC-free

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

1,028,842 144,663

$128,605 $36,166

$0.1250 $0.2500

C H C H

1% 1%

946,524 147,760

$74,586 $627,980

$0.0788 $4.2500

C C

H H H H H H H H H H H H H H 1,090 $4,633 $4.2500 * C H

1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1%

Lignocaine hydrochloride with adrenaline Inj 1% with 1:100,000 adrenaline, 5 ml Inj 1% with 1:100,000 adrenaline, 5 ml Theatre pack Inj 1% with 1:200,000 adrenaline, 20 ml Inj 1% with 1:200,000 adrenaline, 20 ml Theatre pack Inj 2% with 1:200,000 adrenaline, 20 ml Inj 2% with 1:200,000 adrenaline, 20 ml Theatre pack Lignocaine with Chlorhexidine Gel 2% with 0.05% chlorhexidine Lignocaine with Prilocaine Hydrochloride Crm 5%, 5 g Crm 5%, 30 g Patch 5% Linezolid Inf 2 mg per ml, 300 ml Oral liq 20 mg per ml Tab 600 mg H H H 1% 1% 1% H 1% H H H H H H 1% 1% 1% 1% 1% 1%

H H H

1% 1% 1%

Chemical Name Line Item Liposomal Amphotericin Inj 50 mg Lisinopril Tab 5 mg Tab 10 mg Tab 20 mg Lisuride Hydrogen Maleate Tab 200 mcg Lodoxamide trometamol Eye drops 0.1% Lomustine Cap 10 mg Cap 40 mg Lorazepam Tab 0.5 mg Tab 1 mg Tab 2.5 mg Tab sublingal 1 mg Inj 4 mg per ml, 1 ml Magnesium Sulphate Inj 49.3% Paste Maprotiline Hydrochloride Tab 25 mg Tab 75 mg Medroxyprogesterone Acetate Tab 2.5 mg Tab 5 mg Tab 10 mg Tab 100 mg Tab 200 mg Tab 500 mg Mercaptopurine Tab 10 mg Tab 50 mg Meropenem Inj 500 mg Inj 1 g Mesalazine Enema 1 g per 100 ml Metaraminol Tartrate Inj 10 mg per ml, 1 ml Metformin Hydrochloride Tab 500 mg

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

494,577 518,488 510,390

$80,962 $123,400 $171,848

$0.1637 $0.2380 $0.3367

C C C

164,675

$150,958

$0.9167

143,420

$124,919

$0.8710

H H

1% 1%

H 3,420,506 263,431 $55,412 $10,326 $0.0162 $0.0392 C H C H H H

1% 1% 1% 1% 1%

11,416 164,331

$36,851 $6,113

$3.2280 $0.0372 *

C H C H

1% 1%

105,433 30,618

$35,721 $29,047

$0.3388 $0.9487

* *

C C

163,635 582,609 716,772 58,791 2,724

$11,291 $80,109 $180,842 $61,295 $7,087

$0.0690 $0.1375 $0.2523 $1.0426 $2.6018 $3.7800 *

C H C H C H C H C H C H

1% 1% 1% 1% 1% 1%

C H 124,016 $233,448 $1.8824 C H

1% 1%

H H

1% 1%

38,458

$303,818

$7.9000

C H

41,619,757

$978,064

$0.0235

C H

1% 34

Chemical Name Line Item Metformin Hydrochloride Tab 850 mg Methadone Hydrochloride Powder Methotrexate Tab 2.5 mg Tab 10 mg Methotrimeprazine Inj 25 mg per ml, 1 ml Tab 25 mg Tab 100 mg Methoxsalen Cap 10 mg Methyl Hydroxybenzoate Powder Methylphenidate Hydrochloride Tab 5 mg Tab 10 mg Tab 20 mg Tab long-acting 20 mg Methylprednisolone Tab 4 mg Tab 100 mg Methylprednisolone aceponate Crm 0.1% Oint 0.1% Methylprednisolone Sodium Succinate Inj 40 mg per ml, 1 ml Inj 62.5 mg per ml, 2 ml Inj 500 mg Inj 1 g Metoclopramide Hydrochloride Inj 5 mg per ml, 2 ml Oral liq 5 mg per 5 ml

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

10,966,489

$361,894

$0.0330

C H

221

$1,845

$8.3500

Pharmacopoeia standard must be specified with Tender Bid

1,519,542 139,471

$293,727 $114,171

$0.1933 $0.8186

C H C H

1% 1%

17,314 441,036 82,633

$127,570 $74,667 $36,325

$7.3680 $0.1693 $0.4396

C H C H C H

1% 1% 1%

25,669

$11,972

$0.4664

$0.6248

C H 2,474,234 2,557,081 $490,641 $1,917,811 $0.1983 $0.7500 C H C H C H

1% 1% 1% 1%

32,997 12,112

$16,027 $100,845

$0.4857 $8.3260

C H C H

1% 1%

319,425 297,375

$105,410 $98,134

$0.3300 $0.3300

C H C H

1% 1%

765 714 163 200

$4,633 $11,784 $6,383 $14,190

$6.0560 $16.5036 $39.1600 $70.9500

C H C H C C

1% 1%

H 784,637 $21,499 $0.0274 * C

Metoclopramide Hydrochloride with Paracetamol Tab 5 mg with paracetamol 500 mg Metolazone Tab 5 mg Metoprolol Tartrate Tab 50 mg Tab 100 mg Tab long-acting 200 mg Inj 1 mg per ml 5 ml 443,852 261,559 110,841 1,635 $66,578 $95,024 $89,859 $7,874 $0.1500 $0.3633 $0.8107 $4.8160 * * C H C H C H C H 1% 1% 1% 1% H 1% 988,244 $53,563 $0.0542 C

Chemical Name Line Item Metronidazole Oral liq benzoate 200 mg per 5 ml Suppos 500 mg Suppos 1 g Metyrapone Cap 250 mg Mianserin Hydrochloride Tab 30 mg Miconazole Nitrate Lotn 2% Powder 2% Tincture 2% Vaginal crm 2% with applicator Midodrine Tab 2.5 mg Tab 5 mg Mifepristone Tab 200 mg Milrinone Inj 1 mg per ml, 10 ml Minoxidil Tab 2.5 mg Tab 5 mg Tab 10 mg Misoprostol Tab 200 mcg Mitozantrone Inj 2 mg per ml, 5 ml Inj 2 mg per ml, 10 ml Moclobemide Tab 150 mg Tab 300 mg Mometasone Furoate Oint 0.1% (pack size 30 g or less) Oint 0.1% (pack size greater than 30 g) Crm 0.1% (pack size 30 g or less) Crm 0.1% (pack size greater than 30 g)

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

216,594 3,164 2,286

$38,575 $7,040 $6,922

$0.1781 $2.2250 $3.0280

C H C H C H

1% 1% 1%

8,981

$38,992

$4.3416

62,477

$60,915

$0.9750

17,430 31,110 438,080

$2,533 $4,520 $30,140

$0.1453 $0.1453 $0.0688

* * *

C H H C H C H

1% 1% 1% 1%

59,189 70,423

$31,370 $55,634

$0.5300 $0.7900

C C

H H H

1% 1% 1%

117,737

$51,710

$0.4392

H PCT H PCT

1% 1%

1,786,504 406,847

$164,358 $106,228

$0.0920 $0.2611

C C

1,772,685 1,757,835 2,278,695 2,239,380

$446,717 $442,974 $574,231 $564,324

$0.2520 $0.2520 $0.2520 $0.2520

+ C + C + C + C

Volume is aggregated for all pack sizes of mometasone furoate ointment Volume is aggregated for all pack sizes of mometasone furoate ointment Volume is aggregated for all pack sizes of mometasone furoate cream Volume is aggregated for all pack sizes of mometasone furoate cream

Morphine Hydrochloride Oral liq 1 mg per ml Oral liq 2 mg per ml 5,204,748 925,833 $199,862 $37,774 $0.0384 $0.0408 C H C H 1% 1%

Chemical Name Line Item Morphine Hydrochloride Oral liq 5 mg per ml Oral liq 10 mg per ml Morphine Sulphate Inj 5 mg per ml, 1 ml Inj 15 mg per ml, 1 ml Tab immediate release 10 mg Tab immediate release 20 mg Cap long-acting 10 mg Cap long-acting 30 mg Cap long-acting 60 mg Cap long-acting 100 mg Cap long-acting 200 mg Tab long-acting 10 mg Tab long-acting 30 mg Tab long-acting 60 mg Tab long-acting 100 mg Tab long-acting 200 mg Suppos 5 mg Suppos 10 mg Suppos 20 mg Suppos 30 mg Morphine Tartrate Inj 80 mg per ml, 1.5 ml Inj 80 mg per ml, 5 ml Moxifloxacin Inj 1.6 mg per ml, 250 ml Tab 400 mg Mucilaginous Laxatives Dry-original flavour, regular texture only Sugar Free Mucilaginous Laxatives with Stimulants Dry Mupirocin Oint 2% Nafarelin Acetate Nasal soln 2 mg per ml Naloxone Hydrochloride Inj 20 mcg per ml, 2 ml Inj 400 mcg per ml, 1 ml Naltrexone hydrochloride Tab 50 mg Nandrolone Decanoate Inj 50 mg per ml, 1 ml

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

889,721 597,172

$40,838 $35,711

$0.0459 $0.0598

C H C H

1% 1%

13,327 13,397 905,877 464,422 2,975,554

$13,780 $12,593 $239,152 $236,855 $535,600

$1.0340 $0.9400 $0.2640 $0.5100 $0.1800 $0.3600 $0.7200

C H C H C H C H C H C H C H C H C H * * * C H C H C H C H C H C H C H C H C H

1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1%

355,079 543,029 269,074 168,223 199,609 389 244 5,623 1,392

$301,817 $97,745 $96,867 $121,121 $169,668 $575 $389 $9,517 $3,641

$0.8500 $1.7000 $0.1800 $0.3600 $0.7200 $0.8500 $1.4783 $1.5950 $1.6925 $2.6158

29,919 2,529

$120,873 $34,076

$4.0400 $13.4740

C H C H

1% 1%

H H

1% 1%

15,815,856 702,625

$278,359 $12,366

$0.0176 $0.0176

* *

C H C H

1% 1%

8,647,900

$152,203

$0.0176

C H

1,482,870

$652,463

$0.4400

C H

200

$5,540

$27.7000

245 8,619

$1,468 $46,543

$5.9900 $5.4000

C C H

Min-I-Jet would not be DV Pharmaceutical

1% Min-I-Jet would not be DV

Pharmaceutical

$6.0000

C H

699

$14,784

$21.1500

C H

1% 37

Chemical Name Line Item Naproxen Oral liq 125 mg per 5 ml Tab 250 mg Tab 500 mg Naproxen Sodium Tab 275 mg Tab 550 mg Nedocromil Aerosol Inhaler, 2 mg per dose CFC-free Nefopam Hydrochloride Inj 20 mg per ml, 1 ml Tab 30 mg Nelfinavir Powder 50 mg per g Tab 250 mg Neostigmine methylsulphate Inj 2.5 mg per ml, 1 ml Nevirapine Oral suspension 50 mg per 5 ml Tab 200 mg Nicotinic Acid Tab 25 mg Tab 50 mg Tab 100 mg Tab 500 mg Nifedipine Tab long-acting 10 mg Tab long-acting 20 mg Nimodipine Inj 0.2 mg per ml, 50 ml Nitrazepam Tab 5 mg Nitrofurantoin Tab 50 mg Tab 100 mg Oral liq 25 mg per 5 ml Noradrenaline Inj 1 mg per ml, 2 ml Norethisterone Tab 350 mcg Norethisterone with Mestranol Tab 1 mg with mestranol 50 mcg

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

C 1,105,811 2,595,827 $58,608 $275,158 $0.0530 $0.1060 C C

1,345,244 2,809,823

$86,096 $359,657

$0.0640 $0.1280

C C

1,079,792

$223,625

$0.2071

33 1,176,071

$60 $305,778

$1.8200 $0.2600

C H C H

1% 1%

16,560 151,044

$6,376 $335,650

$0.3850 $2.2222

+ C + C H

H 1%

+ C H

89,258 $475,745 $5.3300

1% 1%

+ C H

C C C C V V V

229,542 231,837 330,263 636,998

$6,083 $11,105 $23,019 $102,875

$0.0265 $0.0479 $0.0697 $0.1615

262,176 759,123

$74,982 $52,759

$0.2860 $0.0695

C H C H

1% 1%

895,655

$17,913

$0.0200

1,421,442 202,309

$224,588 $56,040

$0.1580 $0.2770

C H C H C H

1% 1% 1%

2,158,005

$183,646

$0.0851

13,851 80,010

$1,456 $6,305

$0.1051 $0.0788

* *

C C

Tab 1 mg with mestranol 50 mcg and 7 inert tab

Chemical Name Line Item Nystatin Pastilles 100,000 u Pessary 100,000 iu

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

296,240 87,375

$66,654 $5,129

$0.2250 $0.0587

* *

C H H C

1% 1%

Vaginal crm 100,000 u per 5 g with applicator(s) Oestradiol Tab 2 mg Oestradiol valerate Tab 1 mg Tab 2 mg Oestradiol with levonorgestrel Tab 2 mg with 75 mcg levonorgestrel tab (12) and 2 mg oestradiol tab (16) Oestradiol with norethisterone Tab 1 mg with 0.5 mg norethisterone acetate Tab 2 mg with 1 mg norethisterone acetate Tab 2 mg with 1 mg norethisterone acetate (10), and 2 mg oestradiol tab (12) and 1 mg oestradiol tab (6) Oestriol Crm 1 mg per g with applicator Pessaries 500 mcg Tab 2 mg Oestrogens Conjugated, equine tab 1.25 mg Conjugated, equine tab 300 mcg Conjugated, equine tab 625 mcg Oestrogens with medroxyprogesterone Tab 625 mcg conjugated equine (14) and 5 mg medroxyprogesterone acetate tab (14) Tab 625 mcg conjugated equine (28) and 10 mg medroxyprogesterone acetate tab (14) Tab 625 mcg conjugated equine (28) and 2.5 mg medroxyprogesterone acetate tab (28) Tab 625 mcg conjugated equine (28) and 5 mg medroxyprogesterone acetate tab (28) Tab 625 mcg conjugated equine and 5 mg medroxyprogesterone acetate tab (28) Oily Phenol Inj 5%, 5 ml Olsalazine Cap 250 mg Tab 500 mg Ornidazole Tab 500 mg Orphenadrine Citrate Inj 30 mg per ml, 2 ml Tab 100 mg

671,888

$129,607

$0.1929

191,471 255,065

$28,165 $49,202

$0.1471 $0.1929

C C

99,354

$19,165

$0.1929

987,196 614,320 386,120

$190,430 $118,502 $74,483

$0.1929 $0.1929 $0.1929

* * *

C C C

1,181,070 226,677 199,565

$551,205 $109,553 $46,559

$0.4667 $0.4833 $0.2333

C H C H C H

1% 1% 1%

459,940 1,711,771 1,393,001

$115,813 $184,015 $204,910

$0.2518 $0.1075 $0.1471

C C C

191,492 13,440 419,468 1,120 520,800

$36,939 $1,728 $80,915 $108 $100,462

$0.1929 $0.1286 $0.1929 $0.0964 $0.1929

* * * * *

C C C C C

580

$8,318

$14.3420

C H

233,195 174,230

$73,480 $104,294

$0.3151 $0.5986

C C

130,138

$161,111

$1.2380

90 1,060,568

$288 $196,629

$3.2000 $0.1854

C H C H

1% 1%

Chemical Name Line Item Orphenadrine Hydrochloride Tab 50 mg Oxazepam Tab 10 mg Tab 15 mg Oxypentifylline Tab 400 mg Oxytocin Inj 5 iu per ml, 1 ml

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

473,370

$60,449

$0.1277

C H

1,111,190 485,729

$22,002 $11,900

$0.0198 $0.0245

* *

C C

51,991

$38,411

$0.7388

C H

1,150 2,103 3,263

$1,136 $3,533 $4,033

$0.9880 $1.6800 $1.2360

C H C H C H

1% 1% 1%

Inj 5 iu with ergometrine maleate 500 mcg per ml, 1 ml Inj 10 iu per ml, 1 ml Pancuronium bromide Inj 2 mg per ml, 2 ml Pantoprazole Inj 40 mg Tab 20 mg Tab 40 mg Paracetamol Suppos 25 mg Suppos 50 mg Paraffin White soft or yellow soft (pack size 30 g or less) White soft or yellow soft (pack size 100 g or more) Liquid BP Paraffin Liquid with Soft White Paraffin Eye oint with soft white paraffin Paraffin Liquid with Wool Fat Liquid Eye oint 3% with wool fat liq 3% Penicillamine Tab 125 mg Tab 250 mg Pentastarch Plasma Expander Inj 6%, 500 ml Perhexiline Maleate Tab 100 mg Pericyazine Tab 2.5 mg Tab 10 mg Phenindione Tab 10 mg Tab 25 mg Tab 50 mg

H 4,936,086 8,309,706 $899,848 $1,930,345 $0.1823 $0.2323 * * C H C H

1% 1% 1%

H H

1% 1%

H * C H H

1% 1% 1% Sterile 5 g preparation would

not be a DV Pharmaceutical

76,550

$79,390

$1.0371

25,844

$26,803

$1.0371

40,863 78,014

$23,006 $70,197

$0.5630 $0.8998

* *

C C

324,141

$169,915

$0.5242

C H

197,989 92,220

$24,729 $40,992

$0.1249 $0.4445

C H C H

1% 1%

H H H

1% 1% 1% 40

Chemical Name Line Item Phenoxybenzamine Cap 10 mg Phenoxymethylpenicillin (Penicillin V) Cap 250 mg Cap 500 mg Phenylephrine Inj 1%, 1 ml Phenylephrine Hydrochloride Eye drops 0.12%

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

78,615

$20,479

$0.2605

C H

494,793 1,419,952

$42,453 $231,452

$0.0858 $0.1630

C C

31,470

$6,820

$0.2167

C H

Phenylephrine Hydrochloride with Zinc Sulphate Eye drops 0.12% with zinc sulphate 0.25% Physostigmine Salicylate Inj 500 mcg per ml, 2 ml Phytomenadione Inj 2 mg per 0.2 ml Inj 10 mg per ml, 1 ml Tab 10 mg Piperacillin with Tazobactam Inj 2.25 g Inj 4.5 g Pipothiazine Palmitate Inj 50 mg per ml, 1 ml Inj 50 mg per ml, 2 ml Pizotifen Tab 500 mcg Podophyllotoxin Soln 0.5% Polyethylene glycol with sodium sulphate Powder, sachets Polyvinyl Alcohol Eye drops 1.4% Eye drops 3% Polyvinyl Alcohol with Povidone Eye drops 1.4% with povidone 0.6% Potassium Bicarbonate Tab 315 mg with sodium acid phosphate 1.937 g and sodium bicarbonate 350 mg, effervescent Potassium Chloride Tab 548 mg (14 m eq) with chloride 285 mg (8 m eq) effervescent Tab long-acting 600 mg Povidone Iodine Alcohol skin preparation 10% Antiseptic Soln 10% 530,000 1,433,317 $8,639 $18,346 $0.0163 $0.0128 * * C C 41 362,423 12,979,763 $31,784 $319,302 $0.0877 $0.0246 * C C H 1% 51,902 $38,927 $0.7500 C 326,925 $78,887 $0.2413 C 240,675 58,350 $58,075 $15,095 $0.2413 $0.2587 C H C H 1% 1% H 1% 18,802 $171,905 $9.1429 C H 1% 1,731,826 $365,415 $0.2110 * C 3,641 1,509 $64,985 $53,316 $17.8480 $35.3320 C H C H 1% 1% H H 1% 1% 7,044 3,215 28,983 $11,270 $5,922 $16,230 $1.6000 $1.8420 $0.5600 C H C H C H 1% 1% 1% $11.0400 C H 1% 19,470 $5,855 $0.3007 C H 1%

Chemical Name Line Item Povidone Iodine Oint 10% Prednisolone Acetate Eye drops 0.12% Eye drops 1% Pregnancy Tests - HCG Urine Urine diagnostic test Prilocaine hydrochloride Inj 0.5%, 50 ml Inj 1%, 5 ml Inj 2%, 5 ml Probenecid Tab 500 mg Prochlorperazine Inj 12.5 mg per ml, 1 ml Suppos 5 mg Suppos 25 mg Tab 3 mg buccal Procyclidine Hydrochloride Tab 5 mg Promethazine Hydrochloride Inj 25 mg per ml, 1 ml Oral liq 5 mg per 5 ml Promethazine Theoclate Tab 25 mg Propafenone Hydrochloride Tab 150 mg Protamine Sulphate Inj 10 mg per ml, 5 ml Pyrazinamide Tab 500 mg Pyridostigmine Bromide Tab 60 mg Pyridoxine Hydrochloride Tab 25 mg Tab 50 mg Tab 100 mg Quinine Sulphate Tab 200 mg Tab 300 mg Rasburicase Inj 1.5 mg

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

198,150

$21,598

$0.1090

34,820 137,530

$31,338 $123,777

$0.9000 $0.9000

* *

C H C H

1% 1%

380,600

$449,108

$1.1800

H H H

1% 1% 1%

229,851

$126,418

$0.5500

35,011 7,744 15,359 246,206

$52,201 $14,737 $38,520 $29,397

$1.4910 $1.9030 $2.5080 $0.1194

* * * *

C H C H C H C H

1% PSO Maximum pack size is 5

injections

1% 1% 1%

723,276

$53,522

$0.0740

C H

20,819 5,761,734

$26,398 $203,389

$1.2680 $0.0353

* *

C H C H

1% 1%

4,336

$520

$0.1200

90,917

$74,370

$0.8180

5,726

$12,826

$2.2400

C H

107,360

$63,342

$0.5900

315,126

$90,126

$0.2860

456,762 689,398 324,402

$15,530 $17,373 $17,453

$0.0340 $0.0252 $0.0538

* * *

C H V C H V C H V

1% 1% 1%

1,494,528 3,411,548

$98,639 $238,808

$0.0660 $0.0700

C H C H

1% 1%

Chemical Name Line Item Rifabutin Cap 150 mg Rifampicin Inj 600 mg Oral liq 100 mg per 5 ml Cap 150 mg Cap 300 mg Tab 600 mg Ritonavir Cap 100 mg Oral liq 80 mg per ml Rocuronium Inj 10 mg per ml, 5 ml Inj 10 mg per ml, 10 ml Ropivacaine hydrochloride Inj 2 mg per ml, 10 ml Inj 2 mg per ml, 10 ml Theatre pack Inj 2 mg per ml, 20 ml Inj 2 mg per ml, 20 ml Theatre pack Inj 2 mg per ml, 100 ml Inj 2 mg per ml, 100 ml Theatre pack Inj 2 mg per ml, 200 ml Inj 2 mg per ml, 200 ml Theatre pack Inj 7.5 mg per ml, 10 ml Inj 7.5 mg per ml, 10 ml Theatre pack Inj 7.5 mg per ml, 20 ml Inj 7.5 mg per ml, 20 ml Theatre pack Inj 10 mg per ml, 10 ml Inj 10 mg per ml, 10 ml Theatre pack Inj 10 mg per ml, 20 ml Inj 10 mg per ml, 20 ml Theatre pack Ropivacaine hydrochloride with Fentanyl Inj 2 mg with 2 mcg fentanyl per ml, 100 ml Inj 2 mg with 2 mcg fentanyl per ml, 100 ml Theatre pack Inj 2 mg with 2 mcg fentanyl per ml, 200 ml Inj 2 mg with 2 mcg fentanyl per ml, 200 ml Theatre pack Roxithromycin Tab 150 mg Tab 300 mg Salbutamol Inf 1 mg per ml, 5 ml Inj 500 mcg per ml, 1 ml Nebuliser soln, 1 mg per ml, 2.5 ml Nebuliser soln, 2 mg per ml, 2.5 ml

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

8,318

$59,110

$7.1063

H 103,679 53,925 85,679 15,335 $21,876 $31,632 $104,837 $58,477 $0.2110 $0.5866 $1.2236 $3.8133 C H C H C H C H

1% 1% 1% 1% 1%

88,705

$128,072

$1.4438 $1.1553

+ C H + C H

H H

1% 1%

H H H H H H H H H H H H H H H H

1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1%

H H H H

1% 1% 1% 1%

1,097,398 433,276

$328,122 $259,099

$0.2990 $0.5980

C H C H

1% 1%

H 2,771 411,382 1,061,712 $7,149 $99,349 $270,737 $2.5800 $0.2415 $0.2550 C H C H C H

1% 1% 1% 1% 43

Chemical Name Line Item Salbutamol with Ipratropium Bromide

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

Nebuliser soln, 2.5 mg with ipratropium bromide 0.5 mg per 2.5 ml vial Saquinavir Cap 200 mg Selegiline Hydrochloride Tab 5 mg Sertraline Tab 50 mg Tab 100 mg Sodium Acid Phosphate Enema 16% with sodium phosphate 8% Sodium Aurothiomalate Inj 10 mg per 0.5 ml Inj 20 mg per 0.5 ml Inj 50 mg per 0.5 ml Sodium Bicarbonate Inj 8.4%, 10 ml Sodium Calcium Edetate Inj 200 mg per ml, 5 ml Sodium Chloride Inj 0.9%, 5 ml Inj 0.9%, 10 ml Inj 0.9%, 20 ml Inj 20%, 10 ml Inj 4 mmol per ml, 20 ml

1,980,899

$1,035,020

$0.5225

58,446

$87,990

$1.5055

+ C

198,457

$33,559

$0.1691

H H

1% 1%

30,361

$75,903

$2.5000

C H

126 213 3,652

$969 $2,411 $79,332

$7.6870 $11.3170 $21.7230

C H C H C H

1% Small pack sizes preferred 1% Small pack sizes preferred 1% Small pack sizes preferred

811

$1,632

$2.0120

C H

$8.8850

C H

103,337 367,619 77,586 1,345

$33,068 $158,444 $4,032

$0.3200 $0.4310 * $2.9976

C H C H C H C H H

1% 1% 1% 1% 1%

Sodium Citrate with Sodium Lauryl Sulphoacetate Enema 90 mg with sodium lauryl sulphoacetate 9 mg per ml, 5 ml Sodium Citro-Tartrate Grans effervescent 4 g sachets Sodium Cromoglycate Cap 100 mg Nasal spray, 4% Sodium Hyaluronate Inj 3% with 4% chondroitin sulphate, 0.35 ml Inj 3% with 4% chondroitin sulphate, 0.5 ml Ophthalmic inj 14 mg per ml Ophthalmic soln 10 mg per ml Sodium Hypochlorite Soln Sodium Polystyrene Sulphonate Powder 175,889 $34,826 $0.1980 C H 1% 68,750 $76 $0.0011 C H H H H 1% 1% 1% 1% 94,255 82,896 $84,085 $60,589 $0.8921 $0.7309 * C C H 1% 329,446 $200,402 $0.6083 C H 1%

Chemical Name Line Item Sodium Tetradecyl Sulphate Inj 0.5% 2 ml Inj 1% 2 ml Inj 3% 2 ml Sotalol Inj 10 mg per ml, 4 ml Spironolactone Tab 25 mg Tab 100 mg Sulindac Tab 100 mg Tab 200 mg Sulphacetamide Sodium Eye drops 10% Sulphasalazine Enema 3 g per 100 ml Tab 500 mg Tab EC 500 mg Suxamethonium Inj 100 mg per 2 ml Teicoplanin Inj 400 mg Tenoxicam Inj 10 mg per ml, 2 ml Inj 20 mg per ml, 2 ml Suppos 20 mg Tab 20 mg Testosterone Cypionate Inj long-acting 100 mg per ml, 10 ml Testosterone Enanthate Inj long-acting 250 mg - prefilled syringe Testosterone Undecanoate Cap 40 mg Tetrabenazine Tab 25 mg Tetracosactrin Inj 250 mcg Inj 1 mg per ml, 1 ml Inj 1 mg per ml, 2 ml Theophylline Tab long-acting 250 mg Tab long-acting 350 mg Thiamine Hydrochloride Inj 100 mg per ml, 2 ml

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

15 36 219

$70 $180 $1,248

$4.6400 $5.0000 $5.7000

* * *

C H C H C H

1% 1% 1%

664

$5,490

$8.2680

C H

4,995,982 1,209,484

$424,658 $262,458

$0.0850 $0.2170

C H C H

1% 1%

177,562 232,155

$9,446 $15,601

$0.0532 $0.0672

* *

C C

43,274

$12,679

$0.2930

$5.3429 302,368 6,036,554 $26,790 $600,033 $0.0886 $0.0994

C C C

64,073 13,941 2,297,020 $128,146 $7,389 $545,542 $2.0000 $0.5300 $0.2375

C H C H C H C H

1% 1% 1% 1%

410

$25,178

$61.4100

C H

4,012

$60,180

$15.0000

C H

727,302

$735,884

$1.0118

C H

105,494

$228,880

$2.1696

310 408

$5,493 $10,967

$17.7180 $26.8800

C H C H H

1% 1% 1%

1,442,342 379,436

$310,248 $111,099

$0.2151 $0.2928

C C

C H

1% 45

Chemical Name Line Item Thiamine Hydrochloride Tab 10 mg Tab 25 mg Tab 50 mg Tab 100 mg Thioridazine Hydrochloride Tab 10 mg Tab 25 mg Tab 50 mg Tab 100 mg Tab long-acting 200 mg Thrombin Inj 5,000 iu Thyroxine Tab 50 mcg Tab 100 mcg Tiaprofenic Acid Tab 300 mg Cap long-acting 300 mg Timolol Tab 10 mg Timolol Maleate Eye drops 0.25%, gel forming Eye drops 0.5%, gel forming Timolol Maleate with Pilocarpine Eye drops 0.5% with pilocarpine 2% Eye drops 0.5% with pilocarpine 4% Tinazaparin Sodium Inj 3,500 anti-Xa IU per 0.35 ml Inj 4,500 anti-Xa IU per 0.45 ml Inj 10,000 anti-Xa IU per 0.5 ml Inj 14,000 anti-Xa IU per 0.7 ml Inj 18,000 anti-Xa IU per 0.9 ml Inj 20,000 anti-Xa IU per 2 ml Tinidazole Tab 500 mg Tirofiban Inj 0.25 mg per ml, 50 ml Tobramycin Eye drops 0.3% Eye oint 0.3% Inj 40 mg per ml, 1 ml Tolbutamide Tab 500 mg

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

52,711 215,084 1,246,563

$1,771 $8,388 $52,106

$0.0336 $0.0390 $0.0418

* *

C H V C H V C H V C H V

1% 1% 1% 1%

361,048 467,045 235,385 124,190 14,400

$27,584 $40,726 $27,870 $23,646 $6,480

$0.0764 $0.0872 $0.1184 $0.1904 $0.4500

C H C H C H C H C

1% 1% 1% 1%

22,115,465 9,261,109

$751,926 $351,922

$0.0340 $0.0380

C C

95,525 394,571

$6,419 $26,555

$0.0672 $0.0673

* *

C C

274,182

$30,462

$0.1111

24,423 52,403

$78,154 $178,170

$3.2000 $3.4000

C C

25,360 9,305

$70,754 $25,961

$2.7900 $2.7900

C C

H H H H H H

1% 1% 1% 1% 1% 1%

30,179

$31,437

$1.0417

C H

5,255 1,571

$12,065 $4,691

$2.2960 $2.9857

C H C H C H

1% 1% 1%

170,976

$20,517

$0.1200

C H

1% 46

Chemical Name Line Item Tolcapone Tab 100 mg Tranexamic Acid Inj 100 mg per ml, 5 ml Tranylcypromine Sulphate Tab 10 mg Triamcinolone Acetonide Inj 10 mg per ml, 1 ml Inj 10 mg per ml, 5 ml Inj 40 mg per ml, 1 ml

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

202,757

$261,050

$1.2875

251,009

$115,163

$0.4588

4,206 126 52,950

$9,346 $1,299 $297,473

$2.2220 $10.3100 $5.6180

C H C H C H

1% 1% 1%

Triamcinolone Acetonide with Gramicidin, Neomycin and Nystatin Crm 1 mg with nystatin 100,000 u, neomycin sulphate 2.5 mg and gramicidin 250 mcg per g Ear drops 1 mg with nystatin 100,000 u, neomycin sulphate 2.5 mg and gramicidin 250 mcg per g Trifluoperazine Hydrochloride Cap long acting 15 mg Oral liq 1 mg per ml Tab 1 mg Tab 2 mg Tab 5 mg Trimeprazine Tartrate Oral liq 30 mg per 5 ml Trimethoprim Tab 100 mg Oral liq 50 mg per 5 ml Tropicamide Eye drops 0.5% Eye drops 1% 945 2,820 $450 $1,628 $0.4767 $0.5773 C H C H 1% Single dose presentation

would not be a DV Pharmaceutical would not be a DV Pharmaceutical

495,090 111,967

$115,207 $38,371

$0.2327 $0.3427

C C H

1% 1%

C H 16,446 280,600 299,013 521,585 $1,230 $27,583 $40,755 $82,358 $0.0748 $0.0983 $0.1363 $0.1579 * * * C H C H C H C H

1% 1% 1% 1% 1%

372,665

$10,397

$0.0279

C H C H

1% 1%

1% Single dose presentation

Tropisetron Inj 1 mg per ml, 2 ml Cap 5 mg Tyloxapol Eye drops 0.25% Urokinase Inj 10,000 iu Inj 100,000 iu Inj 500,000 iu Vancomycin Hydrochloride Inj 500 mg Vasopressin Inj 20 iu per ml, 1 ml H 1% 47 1,720 $11,008 $6.4000 C H 1% H H H 1% 1% 1% 6,180 $3,555 $0.5753 C H H 1% 1%

Chemical Name Line Item Vecuronium Inj 4 mg Inj 10 mg Verapamil Hydrochloride Inj 2.5 mg per ml, 2 ml Vincristine Sulphate Inj 1 mg per ml, 1 ml Inj 1 mg per ml, 2 ml Inj 1 mg per ml, 5 ml Vinorelbine Inj 10 mg per ml, 1 ml Inj 10 mg per ml, 5 ml Vitamin A with Vitamins D and C

SCHEDULE TWO: PRODUCTS TO BE TENDERED

Units Cost Unit Subsidy DV Limit Comments

H H

1% 1%

996

$1,502

$1.5080

C H

$26.6000 $53.2400

C H PCT C H PCT C H PCT

1% 1% 1%

H PCT H PCT

1% 1%

Soln 1,000 u with Vitamin D 400 u and ascorbic acid 30 mg per 10 drops Vitamin B Complex Tab Vitamins Tab (BPC cap strength ) Water for Injection Purified for inj 5 ml Purified for inj 10 ml Purified for inj 20 ml Zidovudine (AZT) Cap 100 mg Inj 200 mg per 20 ml Oral liq 10 mg per ml Zidovudine (AZT) with Lamivudine Tab 300 mg with lamivudine 150 mg Zinc and Castor Oil Oint (pack size 30 g or less) Oint (pack size 100 g or more)

167,120

$73,199

$0.4380

1,077,436

$26,074

$0.0242

23,772,766

$370,855

$0.0156

H H 19,904 $13,933 $0.7000 C H

1% 1% 1%

34,719 171,400

$100,685 $49,706

$2.9000 $0.2900

+ C H +

1% 1% 1%

+ C H + C H

H H

296,484

$3,296,902

$11.1200

1% 1%

Schedule 3

Schedule 3: Tender Process

1.1

General Sole Supply Period and Hospital Supply Status Period

(a) Hospital Tender Bids are to be submitted on the basis that if your Hospital Tender Bid is accepted, you will have Hospital Supply Status for the particular Tender Item for the Hospital Supply Status Period. Community Tender Bids are to be submitted on the basis that if your Community Tender Bid is accepted, you will have Sole Supply Status for the particular Tender Item for the Sole Supply Period. Combined Community/Hospital Tender Bids are to be submitted on the basis that if your Combined Community/Hospital Tender Bid is accepted, you will have Hospital Supply Status for the particular Tender Item for the Hospital Supply Status Period and Sole Supply Status for the particular Tender Item for the Sole Supply Period.

(b)

(c)

1.2

Transition Periods

(a) In relation to hospital supply: (i) there will be two Transition Periods (the First Transition Period and the Final Transition Period) during which the successful tenderer’s brand is to be available for supply and purchased by DHB Hospitals; the First Transition Period is intended to allow for an orderly transition to the arrangements that will apply during the Hospital Supply Status Period; the Final Transition Period is intended to allow for an orderly transition to any new arrangements following the end of the Hospital Supply Status Period; DHB Hospitals may purchase DV Pharmaceuticals at any time within the First Transition Period and Final Transition Period without any requirement to comply with the DV Limit.

(ii) (iii) (iv)

(b)

Subject to paragraph (d) below, in relation to community supply: (i) there will be three Transition Periods (the First Transition Period, the Second Transition Period and the Final Transition Period) during which the successful tenderer’s brand is to be available for supply and subsidised, but may not be the sole subsidised brand of that Tender Item; the First Transition Period and Second Transition Period are intended to allow for an orderly transition to the arrangements that will apply during the Sole Supply Period; the Final Transition Period is intended to allow for an orderly transition to any new arrangements following the end of the Sole Supply Period.

(ii)

(iii) (c)

In relation to community and/or hospital supply, PHARMAC may, in its sole discretion: (i) determine a different commencement date for the First Transition Period and/or Second Transition Period, as applicable, including where it considers that a

R33-4-0 #94186

Schedule 3 different commencement date is necessary to ensure appropriate stock management or appropriate supply of the Tender Item; and/or (ii) extend the period of the First Transition Period and/or Second Transition Period, as applicable, by determining a different end date, and may do so before or after the commencement date of the relevant First Transition Period or Second Transition Period. For the avoidance of doubt, in the event that PHARMAC extends the Second Transition Period under this clause 1.2(c)(ii): (A) the delisting of all other brands of that form and strength of the Chemical Entity is to be deferred until the actual commencement date of the Sole Supply Period, notwithstanding any date previously notified to suppliers by PHARMAC as being the intended date of delisting; all other brands of that form and strength of the Chemical Entity are to remain listed in accordance with the terms of any existing contract between PHARMAC and the particular pharmaceutical supplier in respect of the relevant brand(s) until such time as that supplier’s brand of that form and strength of the Chemical Entity is actually delisted.

(B)

(d)

In relation to community supply, if the successful tenderer’s brand is the only brand of the Tender Item listed on the Pharmaceutical Schedule as at the time PHARMAC notifies the market that a Tender has been accepted for a Tender Item, then the First Transition Period and clause 2.1(a) of Schedule Six will not apply and, subject to paragraph (c) above, the Second Transition Period is to begin on the first day of the second month following the date of such notification. For the avoidance of doubt, any notification by PHARMAC of the delisting of all other brands of that form and strength of the Chemical Entity on the first day of the Sole Supply Period operates solely as advance notice of the intended delisting of those pharmaceuticals and does not constitute a notice of termination of any existing contract for the supply of those other brands.

(e)

1.3

Contract

If PHARMAC accepts your: (a) Community Tender Bid, then a contract on the terms and conditions set out in: (i) (ii) (iii) your Tender Bid (incorporating any variations as a result of negotiations or discussions under clause 1.6 of this Schedule); and Schedule Six; and if PHARMAC accepts a Foreign Exchange Bid from you, Schedule Seven,

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your Tender Bid (incorporating any variations as a result of negotiations or discussions under clause 1.6 of this Schedule); and Schedule Five; and if PHARMAC accepts a Foreign Exchange Bid from you, Schedule Seven,

Schedule 3 will be deemed to have been entered into between you and PHARMAC for Hospital Supply Status for the relevant Pharmaceutical and, where applicable, its listing on the Pharmaceutical Schedule; (c) Combined Community/Hospital Tender Bid, then: (i) a contract on the terms and conditions set out in: (A) your Tender Bid, to the extent applicable (incorporating any variations as a result of negotiations or discussions under clause 1.6 of this Schedule); and for the Hospital Tender Bid element of that Combined Community/Hospital Tender Bid, Schedule Five; and if PHARMAC accepts a Foreign Exchange Bid from you, Schedule Seven,

(B) (C)

will be deemed to have been entered into between you and PHARMAC for Hospital Supply Status for the relevant Pharmaceutical and, where applicable, its listing on the Pharmaceutical Schedule; and (ii) a separate contract on the terms and conditions set out in: (A) your Tender Bid, to the extent applicable (incorporating any variations as a result of negotiations or discussions under clause 1.6 of this Schedule); and for the Community Tender Bid element of Community/Hospital Tender Bid, Schedule Six; and that Combined

(B) (C)

if PHARMAC accepts a Foreign Exchange Bid from you, Schedule Seven,

will be deemed to have been entered into between you and PHARMAC for Sole Supply Status for the relevant Pharmaceutical and, where applicable, its listing on the Pharmaceutical Schedule. For the avoidance of doubt, the terms and conditions specified in Schedule Five, Schedule Six and Schedule Seven, as applicable, apply from the date when PHARMAC notifies you in accordance with clause 7.2 of this Schedule of its acceptance of your Tender Bid, and do not apply solely for the Sole Supply Period or Hospital Supply Status Period, as applicable.

1.4

Extension of Hospital Supply Status to include Sole Supply Status

(a) You acknowledge and agree that if your Hospital Tender Bid is for a Tender Item that is specified in the product list in clause 2 of Schedule Two as being a Tender Item for which you may submit a Tender Bid for Hospital Supply Status, you may agree (such consent not to be unreasonably withheld), if so requested by PHARMAC: (i) (ii) if PHARMAC has not yet accepted a Hospital Tender Bid for the particular Tender Item, to extend your Tender Bid to cover community supply; or if PHARMAC has accepted your Hospital Tender Bid for the particular Tender Item, to supply the Tender Item for use in the community under Sole Supply Status as soon as practicable after such requirement is notified to you, and in any case no later than three months after that notification, under a separate contract for Sole Supply Status.

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Schedule 3 (b) The Community Tender Bid referred to in paragraph (a)(i) above and the contract for Sole Supply Status referred to in paragraph (a)(ii) above will be: (i) (ii) at a price that is equal to the Price specified for that Pharmaceutical in your Hospital Tender Bid; and on the other terms and conditions set out in your Hospital Tender Bid (incorporating any variations as a result of negotiations or discussions under clause 1.6 of this Schedule), as applicable; and for supply in accordance with Schedule Six; and for such quantities of the Pharmaceutical as are required for use in the community.

(iii) (iv) (c)

This clause confers a benefit on, and is enforceable by, the Funder in accordance with the Contracts (Privity) Act 1982.

1.5

Extension of Sole Supply Status to include Hospital Supply Status

(a) You acknowledge and agree that if your Community Tender Bid is for a Tender Item that is specified in the product list in clause 2 of Schedule Two as being a Tender Item for which you may submit a Tender Bid for Sole Supply Status, you may agree (such consent not to be unreasonably withheld), if so required by PHARMAC: (i) (ii) if PHARMAC has not yet accepted a Community Tender Bid for the particular Tender Item, to extend your Tender Bid to cover hospital supply; or if PHARMAC has accepted your Community Tender Bid for the particular Tender Item, to supply the Tender Item for use in DHB Hospitals under Hospital Supply Status as soon as practicable after such requirement is notified to you, and in any case no later than three months after that notification, under a separate contract for Hospital Supply Status.

(b)

The Hospital Tender Bid referred to in paragraph (a)(i) above and the contract for Hospital Supply Status referred to in paragraph (a)(ii) above will be: (i) (ii) at a price that is equal to the Price specified for that Pharmaceutical in your Community Tender Bid; and on the other terms and conditions set out in your Community Tender Bid (incorporating any variations as a result of negotiations or discussions under clause 1.6 of this Schedule), as applicable; and for supply in accordance with Schedule Five; and for such quantities of the Pharmaceutical as are required for use in DHB Hospitals.

(iii) (iv) (c)

This clause confers a benefit on, and is enforceable by, DHB Hospitals in accordance with the Contracts (Privity) Act 1982.

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Schedule 3

1.6

PHARMAC may initiate limited negotiations

(a) Notwithstanding clause 2.7 of this Schedule, PHARMAC may, in its sole discretion, initiate negotiations or discussions with you in relation to your Tender Bid about: (i) (ii) (iii) (iv) any of the terms and conditions to apply if your Tender Bid is accepted; the proposed packaging or pack size of the Tender Item; your ability to ensure continued availability of the Tender Item throughout the Hospital Supply Status Period and/or Sole Supply Period, as applicable; the price of the Tender Item, but only where PHARMAC determines, in its sole discretion, that an increased price for the Tender Item may be necessary for practicality of supply of the Tender Item (for example, because of particular packaging requirements); DV Limits and/or DV Pharmaceuticals, in relation to hospital supply; the Lead Time and/or the Start Date; or any other matter that PHARMAC considers necessary or appropriate.

(v) (vi) (vii) (b)

If PHARMAC initiates negotiations or discussions with you under paragraph (a), and as a result there is a change to any of the terms and conditions relating to the supply of a Tender Item, PHARMAC is not obliged to inform the other tenderers of that change, nor give those tenderers an opportunity to amend their bid for that Tender Item. The initiation and pursuit of any negotiations or discussions under this clause shall not constitute a counter-offer and your original Tender Bid will remain open for acceptance in accordance with clause 4.2(b) of this Schedule in the absence of agreement on any variation to that Tender Bid.

(c)

1.7

Termination and amendment of Invitation

PHARMAC may: (a) (b) amend this Invitation at any time up to five business days before the Deadline; and/or terminate this Invitation at any time before the acceptance of any Tender Bid by giving five business days’ written notice.

2.1

Information about submitting a Tender Bid Choice of forms and strengths

Where a Tender Item includes different forms and strengths of a Chemical Entity or entities, your Tender Bid may, but does not need to, include all of the forms and strengths of the Chemical Entity or entities contained in that Tender Item.

2.2

Consents not yet held

You may submit a Tender Bid for a Tender Item where your brand of the Tender Item is yet to obtain all necessary Consents. In those circumstances, you may be required to demonstrate your ability to obtain those consents within a time frame acceptable to PHARMAC. For example, you may be required to demonstrate that you have the dossier for that brand of the

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Schedule 3 Tender Item ready to submit to Medsafe within one month of such a request being made by PHARMAC.

2.3

Individual Tender Bids

You may submit more than one bid for a Tender Item (for example, you may submit separate bids for different pack sizes of a Tender Item) provided that each bid is submitted on a separate Tender Submission Form.

2.4

Aggregated Tender Bids

(a) You may, in addition to submitting a separate Tender Bid for each Tender Item, submit an Aggregated Tender Bid, provided that: (i) (ii) (iii) (b) each brand contained in an Aggregated Tender Bid is only a different form and strength of the same Chemical Entity; you may not aggregate within a single Tender Item; you must also submit a separate Community Tender Bid and/or Hospital Tender Bid, as applicable, for each particular Tender Item.

Where a Tender Item includes different forms and strengths of a Chemical Entity or different entities and you bid for the whole Tender Item, that is not an Aggregated Tender Bid. You must clearly indicate on your Tender Submission Form if your Tender Bid is an Aggregated Tender Bid.

(c)

2.5

Combined Community/Hospital Tender Bids

(a) You may submit a Combined Community/Hospital Tender Bid, provided that you must also submit a separate Community Tender Bid and a separate Hospital Tender Bid for each Tender Item in respect of which you submit a Combined Community/Hospital Tender Bid. You must clearly indicate on your Tender Submission Form if your Tender Bid is a Combined Community/Hospital Tender Bid.

(b)

2.6

Aggregated Combined Community/Hospital Tender Bids

You may submit a Tender Bid that is both an Aggregated Tender Bid and a Combined Community/Hospital Tender Bid, provided that you comply with clauses 2.4 and 2.5 above.

2.7

No conditions

You cannot make a conditional Tender Bid nor qualify a Tender Bid in any way.

2.8

Separate offers

PHARMAC will treat each Tender Bid as a separate offer.

2.9

Tender Bid prices

You must:

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Schedule 3 (a) (b) submit, for each Tender Bid, a single price in New Zealand dollars (exclusive of GST), which will be the Price at which you will supply the Tender Item; not submit a Tender Bid that contains only a price in foreign currency.

3.1

What to include in your Offer Letter and Tender Submission Form Compulsory use of Offer Letter and Tender Submission Form

(a) You must submit your Tender Bid by completing and signing the Offer Letter and completing a separate Tender Submission Form for each Tender Item for which you wish to submit a bid. An electronic version of these forms is available on disc from PHARMAC or on PHARMAC’s website at <www.pharmac.govt.nz>.

(b)

3.2

Information that must be supplied about you

In the Offer Letter, you must supply the following information about you: (a) (b) (c) (d) (e) (f) (g) (h) your company structure; your management and technical skills; your financial resources; your (or your supplier’s) existing supply commitments; your (or your supplier’s) previous supply performance; your quality assurance processes, where applicable; for any Hospital Tender Bids, your drug information and interaction support services; and for any Hospital Tender Bids, any other benefits to PHARMAC and DHB Hospitals in selecting you as the supplier of a Tender Item, including details of how you have added value to your customers’ business in the past.

3.3

Information that must be supplied about the Tender Item

In your Tender Submission Form, you must supply the following information about the Tender Item: (a) (b) the chemical, form, strength, brand name, pack size and type of packaging; a single price in New Zealand dollars (exclusive of GST) at which you will supply the Tender Item: (i) (ii) to wholesalers and other distributors during the Sole Supply Period in respect of a Community Tender Bid; or to, at a DHB Hospital’s discretion, Designated Delivery Points, and/or Contract Manufacturers (expressly for the purpose of compounding), in respect of a Hospital Tender Bid;

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Schedule 3 (c) (d) (e) (f) whether it has all necessary Consents (and if not, what the status of registration is); whether it has IMM status, and if so, to which brand and presentation; the Lead Time for supply of the Tender Item; the name and location of: (i) (ii) (iii) (g) (h) the manufacturer(s) of the finished product (and name and location of the packaging site, if different); and the manufacturer(s) of the active ingredients; and alternative manufacturers of the finished product and active ingredients (if any);

for any Hospital Tender Bids, the Pharmacode for your brand of that Tender Item, if available; and for any Community Tender Bids, your proposed distribution and supply arrangements for the Tender Item.

3.4

Foreign Exchange Bid

(a) In addition to specifying prices in New Zealand dollars, Tender Bids may also specify prices in a Permitted Currency. If PHARMAC accepts your Tender Bid, PHARMAC will, in its sole discretion, decide whether to accept the Foreign Exchange Bid or whether to accept the price for the Tender Item submitted in New Zealand dollars. If you submit a Foreign Exchange Bid, you must supply the following additional information: (i) (ii) the price in the Permitted Currency; and your Risk Sharing Percentage.

(b)

3.5

PHARMAC may request further information

(a) PHARMAC may request such further information as it considers necessary from or about you for the purposes of clarifying or evaluating your Tender Bid, including (but not limited to): (i) (ii) information about your credit status; information on the price of a Tender Item, but only where PHARMAC requires clarification to confirm the exact price being offered, or where PHARMAC initiates negotiations with you under clause 1.6 of this Schedule; where a Tender Item is a controlled drug, information about the form in which the Tender Item will be supplied, in which case you must supply that information within 10 business days of PHARMAC requesting the information; and a sample pack or container of the Tender Item (and if you intend supplying it in a different form from that sample pack or container, information about the form in which it will be supplied), in which case you must supply that sample pack or container or information within 10 business days of PHARMAC requesting it.

(iii)

(iv)

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Schedule 3 (b) If PHARMAC requests further information from or about you it is not obliged to request the same or any other information from or about any other party.

4.1

How to submit a Tender Bid Submission of Tender Bids

As this tender is a closed tender, no Tender Bids will be opened until after the Deadline. Therefore, it is important that all Tender Bids must: (a) be contained in a sealed envelope marked “TENDER FOR THE SUPPLY OF CERTAIN PHARMACEUTICALS - COMMERCIAL IN CONFIDENCE”, and, if you wish to be notified of the receipt of the Tender Bid immediately, the sealed envelope must have your return address stated clearly on the outside of the envelope and be marked “FOR IMMEDIATE NOTIFICATION OF RECEIPT”; and be delivered in the specially marked envelope either in person, by courier or by post (and not by facsimile or email) to: The Chief Executive c/- Legal Counsel Pharmaceutical Management Agency Level 14, Cigna House 40 Mercer Street PO Box 10-254 WELLINGTON

(b)

4.2

Key dates

Your Tender Bid must: (a) (b) be received by PHARMAC no later than the Deadline; and be irrevocable and remain open for acceptance by PHARMAC until, as applicable: (i) (ii) (iii) Friday, 1 September 2006; the date specified for a Tender Item in Schedule Two (if any); or if PHARMAC so requests at any time, such later date as you agree in writing.

5.1

Evaluation Process of evaluation

The Evaluation Committee, taking such regulatory, legal, medical and other advice as it considers appropriate, will evaluate all conforming Tender Bids that have been checked for conformity under clause 6(a) of this Schedule, and any non-conforming Tender Bids that are admitted for consideration under clause 6(b) of this Schedule.

5.2

Matters for evaluation

The matters to be taken into account by the Evaluation Committee, the weight to be attached to them, and the basis on which it will evaluate Tender Bids, are all to be determined by the Evaluation Committee in its sole discretion. The matters taken into account by the Evaluation Committee will, however, include:

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Schedule 3 (a) your ability to ensure continued availability of the Tender Item throughout the Sole Supply Period and/or Hospital Supply Status Period and each of the Transition Periods, as applicable, taking into account each of the following separate points: (i) (ii) (iii) (iv) (v) (vi) (vii) (viii) (b) (c) (d) your financial resources; your management and technical skills; your, or your supplier’s, existing supply commitments; your, or your supplier’s, previous supply performance; your quality assurance processes, where applicable; the site of manufacture and packaging of the Pharmaceutical, and site of manufacture of the active ingredient; your proposed distribution and supply arrangements for the Tender Item; and the Lead Time for supply of the Tender Item;

the pack size of the Tender Item and the type of packaging; the price of the Tender Item (including the price in a Permitted Currency if a Foreign Exchange Bid is submitted); the amount and timing of savings, including non-pharmaceutical savings accruing to the Funder or PHARMAC during the Hospital Supply Status Period and/or the Second Transition Period and the Sole Supply Period, as applicable; either: (i) (ii) evidence that you have obtained, and still have, market approval for your brand of the Tender Item, and all necessary Consents; or evidence that will enable the Evaluation Committee to form a view on the likelihood and timing of your brand of the Tender Item gaining all necessary Consents;

(e)

(f) (g) (h)

whether your brand of the Tender Item has IMM status, or is likely to gain IMM status; the name and location of the manufacturer of the finished product and active ingredients of the Tender Item; and any other benefits to the Funder of selecting you as the supplier of the Tender Item.

Conformity

(a) PHARMAC may, in its sole discretion, check your Tender Bid for conformity with this Invitation. If PHARMAC does elect to check your Tender Bid, it is not obliged to check all or any other Tender Bids for conformity. A Tender Bid will conform if it: (i) (ii) is received by the Deadline; is submitted on the Tender Submission Form and attached to the Offer Letter;

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Schedule 3 (iii) (iv) (v) (b) has no conditions or qualifications attached; includes all information required under clauses 3.2 and 3.3, and if applicable clause 3.4, of this Schedule; and otherwise complies, both as to form and substance, with the requirements of this Invitation.

PHARMAC may, in its sole discretion: (i) (ii) exclude any non-conforming Tender Bid from consideration; or consider, and accept, any non-conforming Tender Bid.

7.1

Decision Decision on acceptance of Tender Bid

(a) The Evaluation Committee will make a recommendation as to which Tender Bid should be accepted to PHARMAC’s board of directors (or chief executive acting under delegated authority pursuant to section 73 of the Crown Entities Act 2004, where applicable). PHARMAC’s board of directors (or chief executive, where applicable) will have the sole discretion to decide whether or not to accept a Tender Bid for any Tender Item. PHARMAC’s board of directors (or chief executive, where applicable): (i) will use the decision criteria in PHARMAC’s then current OPPs, including the Hospital Pharmaceuticals Supplement, as applicable, in deciding whether or not to accept a Tender Bid for any Tender Item; and is not obliged to act in accordance with any recommendation of the Evaluation Committee.

(b) (c)

(ii)

7.2

Notification of acceptance

(a) Once PHARMAC’s board of directors (or chief executive, where applicable) has decided under clause 7.1 above which Tender Bid (if any) to accept for a Tender Item, PHARMAC will, within a reasonable period of time, notify the successful tenderer in writing that it has been successful and in addition: (i) subject to paragraph (b) below, if the successful Tender Bid is unconditionally accepted, PHARMAC will, within a reasonable period of time, notify each unsuccessful tenderer in writing of the identity of the successful tenderer; or subject to paragraph (b) below, if the successful Tender Bid is conditionally accepted, PHARMAC will, within a reasonable period of time of that tender becoming unconditionally accepted, notify each unsuccessful tenderer in writing of the identity of the successful tenderer.

(ii)

(b)

If for any reason you do not receive written notification from PHARMAC in accordance with paragraph (a) above, you will be deemed to have received the required notification on the date that each Tender Item you bid for is notified in the Pharmaceutical Schedule.

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Schedule 3

7.3

PHARMAC’s rights reserved

(a) (b) PHARMAC reserves the right to accept or reject any Tender Bid, and is not obliged to give reasons for its decision. While it is PHARMAC’s current intention, unless specified otherwise in Schedule Two, to enter into an agreement to award Hospital Supply Status and/or Sole Supply Status for each Tender Item, PHARMAC will not in any circumstances be bound to accept any or all Tender Bids and, in particular, PHARMAC will not be bound to accept the lowest or any other Tender Bid for a Tender Item. Acceptance only occurs if, and when, PHARMAC’s board of directors (or chief executive, where applicable) resolves to accept a Tender Bid and this acceptance is notified to the successful tenderer. PHARMAC may take any action, including making any adjustments to the tender process that it considers appropriate, or do anything, that is incidental to the process described in this Invitation, at any time during the process, except to the extent that such action is explicitly precluded by this Invitation.

(c)

(d)

7.4

Conditional acceptance

(a) Where the successful tenderer’s brand of a Tender Item is yet to receive all necessary Consents: (i) (ii) the contract referred to in clause 1.3 of Schedule Three will be conditional upon such Consents being received within a time period specified by PHARMAC; and PHARMAC may terminate the contract if such Consents have not been obtained, or in PHARMAC’s view are unlikely to be obtained, within the period specified by PHARMAC.

(b)

Acceptance of a Tender Bid by PHARMAC’s board of directors (or chief executive, where applicable), and the contract referred to in clause 1.3 of Schedule Three, may be conditional upon you satisfying PHARMAC that you will have sufficient stock of the Tender Item available to commence supply as at a date reasonably determined by PHARMAC.

Back-up supply Back-up Supply Agreements

(a) (b) PHARMAC may at any time negotiate a Back-up Supply Agreement with another supplier for any Tender Item. PHARMAC may, at its sole discretion, seek proposals for Back-up Supply Agreements under a separate process to this Invitation to Tender. PHARMAC does not seek submissions for Back-up Supply Agreements in response to this Invitation to Tender and is not obliged to consider proposals or bids for back-up supply submitted as part of the tender process.

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Schedule 3

9.1

Dealing with information Confidentiality

Subject to clause 9.2 below, all Confidential Information is confidential to us and our employees, legal advisers and other consultants (including HPAC, PTAC and its subcommittees), the Ministry of Health, DHBs and the Funder. You acknowledge that it may be necessary or appropriate for PHARMAC to disclose Confidential Information: (a) (b) (c) pursuant to the Official Information Act 1982; or in publicly notifying any acceptance of your Tender Bid; or otherwise pursuant to PHARMAC’s public law or any other legal obligations.

PHARMAC may consult with you before deciding whether to disclose Confidential Information for the purposes described in paragraphs (a) and (c) above, in order to ascertain any objections you may have to the disclosure of any of the Confidential Information. You acknowledge, however, that it is for PHARMAC to decide, in its absolute discretion, whether it is necessary or appropriate to disclose information for any of the above purposes, provided that PHARMAC shall act in good faith in disclosing any Confidential Information. Outside the circumstances described in paragraphs (a) and (c) above, Confidential Information must not be disclosed by either of us (or by our employees, legal advisers and other consultants) unless: (d) (e) the information is publicly available without any cause attributable to the disclosing party; or the other party has been reasonably informed prior to disclosure, and the disclosure is: (i) (ii) (iii) for the purposes of this Agreement; or required by law; or in a form, and of content, agreed to by us.

For the avoidance of doubt, information released by PHARMAC in accordance with paragraphs (a) to (c) above ceases to be Confidential Information and you agree that PHARMAC may release that information again at any time in future without consulting with you or obtaining your prior agreement.

9.2

Use of information

Generalised aggregated information regarding your Tender Bid that does not identify you or that can not reasonably be expected to identify you or lead to the connection of you with your Tender Bid is not Confidential Information and PHARMAC may use and publish such information as it sees fit.

10.

10.1

Miscellaneous Costs

PHARMAC is not liable for any direct or indirect costs incurred, or loss sustained, by you in respect, or arising out, of this tendering process or the obtaining or granting of Hospital Supply Status and/or Sole Supply Status, as applicable, for your supply of the Tender Item including, without limitation, costs of obtaining all necessary Consents for any Tender Item.

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Schedule 3

10.2

No reliance

Your Tender Bid is submitted in reliance on your own knowledge, skill and independent advice, and not in reliance on any representations made by PHARMAC (including for these purposes the sales and market information (if any) provided in Schedule Two).

10.3

No further liability

PHARMAC’s liability (if any) under, or in relation to, the tendering process is limited to the obligations expressly contained in this Invitation, and no further private law liability exists in relation to the process.

10.4

No lobbying

(a) You are not to initiate any communication with PHARMAC, the Minister of Health (or any Associate Ministers), the Ministry of Health, or a District Health Board or any of their officers or directors, at any time with a view to influencing the outcome of the tendering process. Failure to comply with this clause will entitle PHARMAC, in its sole discretion, to disqualify you from this tendering process.

(b)

10.5

Enquiries

If you have any enquiries about this Invitation you should contact Mike Bignall or Andrew Davies at PHARMAC. Any additional information that PHARMAC gives to you as a result of your enquiry will also be given by PHARMAC to other potential tenderers, if PHARMAC determines that such information is material.

10.6

Jurisdiction and governing law

We each submit to the exclusive jurisdiction of the New Zealand courts and agree that this Invitation is governed by New Zealand law.

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Schedule 4

Schedule 4: Offer Letter, Tender Submission Form Offer Letter

1. 1.1 Guidance for completing the Tender Submission Form Markets

In the box labelled “Market(s) bidding for” please tick: (a) Community Tender Bid if you are bidding for a Tender Item or Tender Items listed in Schedule Two that are being tendered for community supply. If you tick this box then you need to supply a price in the bottom table on that page in the column labelled “Pack Price ($NZ) for community bid”; or Hospital Tender Bid if you are bidding for a Tender Items or Tender Items listed in Schedule Two that are being tendered for hospital supply. If you tick this box then you need to supply a price in the bottom table on that page in the column labelled “Pack Price ($NZ) for hospital bid”; or Combined Community/Hospital Tender Bid if you are bidding for a Tender Items or Tender Items listed in Schedule Two that are being tendered both for community and hospital supply. If you tick this box then you need to supply a price in the bottom table on that page in the columns labelled “Pack Price ($NZ) for community bid”, “Pack Price ($NZ) for hospital bid” and “Pack Price ($NZ) for combined bid”. A Combined Community/Hospital Tender Bid must be accompanied by individual Tender Bids for each of community and hospital supply. Please note that these three prices do not need to be the same.

(b)

(c)

1.2

Aggregated Tender Bid

In the box labelled Aggregated Tender Bid please tick This is an Aggregated Bid if you are submitting a Tender Bid for more than one Tender Item of the same Chemical Entity. If you tick this box then you need to supply an individual price in the bottom table on that page for each Chemical Entity (for either a Community Tender Bid and/or Hospital Tender Bid and/or Combined Community/Hospital Tender Bid) and an aggregated price. Please refer to clause 2.4 of Schedule Three for more information on how to submit an Aggregated Tender Bid.

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Schedule 4

Offer Letter, Tender Submission Form

<Insert today’s date> Chief Executive c/- Legal Counsel PHARMAC PO Box 10-254 or for courier delivery: Level 14, Cigna House 40 Mercer Street) Wellington New Zealand Dear Sir/Madam Tender for the supply of certain pharmaceuticals - commercial in confidence In response to your invitation to tender dated 22 December 2005, we offer to provide the tender items specified in the attached form(s), in the presentations and strengths set out in the attached form(s), on the terms and conditions contained in the invitation. Set out below (or, where applicable, attached to this offer letter) is further information in support of our tender bid. (a) information about our company structure:

(b)

information about our management and technical skills:

(c)

information about our financial resources:

(d)

information about our, or our supplier’s, existing supply commitments:

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Schedule 4 (e) information about our, or our supplier’s, previous supply performance:

(f)

information about our quality assurance processes (where applicable):

(g)

our contact details (i.e., who communications relating to the attached bid(s) should be made to):

Name Title Address Phone Facsimile Email address

Signed for and on behalf of <insert name of tenderer> by

____________________ <Insert name> <Insert designation> Please find attached <insert number> Tender Submission Forms.

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Schedule 4

Tender Submission Form

Note: Please attach all Tender Submission Forms to one completed Offer Letter. Supplier’s name

Market(s) bidding for (tick as applicable) Community Tender Bid Hospital Tender Bid Combined Community/Hospital Tender Bid

Aggregated Tender Bid This is an Aggregated Bid (If an Aggregated Tender Bid, please complete the below rows as often as necessary in the same Tender Submission Form)

Tender Item(s) Chemical Name Market Approval (yes/no)

Tender Item Strength

(as per Schedule Two)

Pack size

Unit type/ form and packaging type

Product name (brand name)

Pharma code

Pack Price ($NZ) for community bid

(if applicable)

Pack Price ($NZ) for hospital bid

(if applicable)

Pack Price ($NZ) for combined bid

(if applicable)

Pack Price for aggregate bid (if

applicable)

Permitted Currency and Pack Price in Permitted Currency (if

applicable)

Risk Sharing Percentage

(if applicable)

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Schedule 4 Product approval status (please complete only one of the following four options) Date of market approval (please attach copy of Medsafe Gazette notice or Therapeutic Database Report) OR if Tender Item is a Vitamin, AUSTR or AUSTL number OR Date of submission of dossier (please attach confirmation from Medsafe that dossier has been submitted) OR Expected date submission to Medsafe of dossier

Miscellaneous IMM status (if so, interchangeability with which brand and presentation) Lead Time for supply (on the basis of your assessment of the size of the market for the Tender Item) – for Hospital Tender Bids only Lead Time for supply (on the basis of your assessment of the size of the market for the Tender Item) – for Community Tender Bids only

Name and location of manufacture Name and location of manufacturer(s) of finished product Name and location of packaging site (if different) Name and location of manufacturer(s) of active ingredients Alternative name and location of manufacturer(s) of finished product (if any) Alternative name and location of manufacturer(s) of active ingredients (if any)

Proposed supply and distribution arrangements for the Tender Item

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Schedule 5

Schedule 5: Contract terms for Hospital Supply Status

1.1

General Operating Policies and Procedures

(a) You acknowledge that: (i) PHARMAC is required to pursue the objectives, carry out the functions, and otherwise comply with the statutory obligations, prescribed for PHARMAC in the New Zealand Public Health and Disability Act 2000; PHARMAC is subject to other statutory and public law obligations, which govern PHARMAC’s decision-making processes; PHARMAC has OPPs, as supplemented by the Hospital Pharmaceuticals Supplement, which provide guidance on the way in which PHARMAC carries out its statutory responsibilities in relation to the management of the Pharmaceutical Schedule; PHARMAC’s OPPs may be amended or updated from time to time, following consultation with relevant groups; the actions which PHARMAC may take under its OPPs include (without limitation): (A) (B) (C) (vi) (b) listing new pharmaceuticals; changing guidelines pharmaceuticals; or restrictions on the purchasing of listed

(ii) (iii)

(iv) (v)

changing the market dynamics for pharmaceuticals as a result of PHARMAC adopting one of the strategies set out in the OPPs;

any action taken by PHARMAC pursuant to its OPPs may impact on the listing of the Pharmaceutical.

PHARMAC agrees not to apply, amend or update its OPPs in order to avoid any of PHARMAC’s obligations under Schedule Five of this Agreement.

1.2

Amendments to Pharmaceutical Schedule

PHARMAC will consult with you before amending Section H of the Pharmaceutical Schedule if a proposed amendment would have a material adverse effect on the listing of the Pharmaceutical.

2.1

Effect of Hospital Supply Status Pricing arrangements

(a) Subject to PHARMAC’s other rights under this Agreement and clause 4.1 of this Schedule, on and from the Start Date, during the remainder of the First Transition Period and during the Hospital Supply Status Period, the Pharmaceutical is to be: (i) listed at the Price set out in Section H of the Pharmaceutical Schedule;

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Schedule 5 (ii) sold by you to, at a DHB Hospital' discretion, any Designated Delivery Points, s and/or Contract Manufacturers (expressly for the purpose of compounding), at the Price.

(b)

Subject to PHARMAC’s other rights under this Agreement in relation to the Pharmaceutical (including under clause 2.6 of this Schedule), and provided that there are no Alternative Pharmaceuticals listed in Section H of the Pharmaceutical Schedule at the start of the Final Transition Period, the Pharmaceutical: (i) (ii) is to continue to be listed, sold and purchased at the Price referred to in clauses 2.1(a)(i) and (ii) above during the Final Transition Period and beyond; and is not to be delisted during the Final Transition Period.

2.2

Supplier for Hospital Supply Status Period

(a) Subject to: (i) (ii) PHARMAC’s other rights under this Agreement in relation to the Pharmaceutical; and clauses 2.4 and 2.5 of this Schedule relating to the DV Limit for the Pharmaceutical,

your brand of the Pharmaceutical will be the brand listed in Section H of the Pharmaceutical Schedule, and purchased by DHB Hospitals at any time during the Hospital Supply Status Period, as the brand having Hospital Supply Status. (b) This clause does not prohibit PHARMAC (on behalf of DHB Hospitals) from entering into negotiations or arrangements with, or inviting tenders from, other suppliers to be the supplier of any forms and strengths of the particular Pharmaceutical with Hospital Supply Status, or a relevant Alternative Pharmaceutical having a status equivalent to Hospital Supply Status, if notification of such an arrangement (once finalised) occurs, and such supply commences, after the end of the Hospital Supply Status Period.

2.3

DV Pharmaceuticals

(a) PHARMAC may amend the relevant list of DV Pharmaceuticals specified in Section H of the Pharmaceutical Schedule, from time to time, in accordance with this clause 2.3, whereby: (i) PHARMAC is only to remove a pharmaceutical listed as a DV Pharmaceutical if PHARMAC: (A) (B) (ii) has first obtained your agreement; or has a direction from Medsafe or its successor, or a recommendation from HPAC, PTAC or its sub-committees, based on a significant clinical issue;

PHARMAC may add a pharmaceutical to the relevant list of DV Pharmaceuticals specified in Section H of the Pharmaceutical Schedule if such pharmaceutical is identified as a DV Pharmaceutical during the Hospital Supply Status Period or the First Transition Period by PHARMAC following a recommendation from HPAC, PTAC or its sub-committees.

(b)

PHARMAC must consult with you prior to the addition or removal of any pharmaceutical from the relevant list of DV Pharmaceuticals specified in Section H of the Pharmaceutical Schedule.

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Schedule 5

2.4

DV Limit

(a) PHARMAC may, from time to time during the Hospital Supply Status Period or the First Transition Period, amend the DV Limit of the Pharmaceutical following what PHARMAC considers to be appropriate consultation with HPAC, PTAC or its sub-committees, provided that PHARMAC may only increase the DV Limit without your prior agreement if it has a direction from Medsafe or its successor, or a recommendation from HPAC, PTAC or its sub-committees, based on a significant clinical issue. Subject to clause 2.5 of this Schedule you acknowledge and agree that while you have Hospital Supply Status: (i) DHB Hospitals may purchase DV Pharmaceuticals at any time within the First Transition Period and Final Transition Period without any requirement to comply with the DV Limit; provided that DHB Hospitals collectively do not exceed the National DV Limit for the relevant Pharmaceutical, a DHB Hospital may purchase DV Pharmaceuticals at any time within the Hospital Supply Status Period; without derogating from any other rights available to PHARMAC or DHB Hospitals under this Agreement or otherwise, if you fail to supply the Pharmaceutical in accordance with this Agreement (other than for a reason PHARMAC considers to be wholly outside your control) within the Hospital Supply Status Period, then the relevant DHB Hospital is not required to comply with the DV Limit for the Pharmaceutical during that period of non-supply and the calendar month during which that non-supply occurred will be excluded in any review of the DV Limit in accordance with clause 2.5 below; if a DHB Hospital’s usage of any DV Pharmaceuticals, in percentage terms, reaches or exceeds the percentage at which the Individual DV Limit is set for the relevant Pharmaceutical, that DHB Hospital may negotiate with you to agree to vary the application of the Individual DV Limit to the DHB Hospital in respect of particular patients with exceptional needs.

(b)

(ii)

(iii)

(iv)

2.5

DV Limit Compliance

(a) For the purposes of this clause 2.5: (i) “Relevant Period” means: (A) (B) (C) the initial period starting on the day that the Hospital Supply Status Period begins up to and including 30 June 2007; or the period commencing on 1 July 2007 and ending on 30 June 2008; or the period commencing on 1 July 2008 and ending on 30 June 2009,

provided that for the purposes of carrying out the calculations in this clause 2.5 any calendar months that fall within those periods when there is any failure to supply the Pharmaceutical in accordance with this Agreement will be excluded. (ii) “Actual National DV Limit Indicator” means, for a particular Pharmaceutical in any Relevant Period, such sum, expressed as a percentage, as is equal to: (Total DV Pharmaceuticals Volume ÷ (Total DV Pharmaceuticals Volume + Total Pharmaceutical Volume)) x 100;

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Schedule 5 (iii) “Total DV Pharmaceuticals Volume” means, for a particular Pharmaceutical in any Relevant Period, the total number of Units of all DV Pharmaceuticals of the relevant Pharmaceutical with Hospital Supply Status purchased by DHB Hospitals, as calculated by PHARMAC, following your request in accordance with clause 2.5(b) below, on the basis of the data extracted by PHARMAC from the electronic records used by it; and “Total Pharmaceutical Volume” means, for a particular Pharmaceutical with Hospital Supply Status in any Relevant Period, the total number of Units of that Pharmaceutical purchased by DHB Hospitals, as calculated by PHARMAC following your request in accordance with clause 2.5(b) below, on the basis of the data extracted by PHARMAC from the electronic records used by it.

(iv)

(b)

If you reasonably believe that DHB Hospitals’ percentage usage of DV Pharmaceuticals collectively exceeds the National DV Limit for a particular Pharmaceutical, you may at any time, but not more often than three-monthly, request that PHARMAC carry out calculations in accordance with the procedure set out in this clause 2.5 for the proportion of the Relevant Period that has passed to the date of your request, and PHARMAC may, in its discretion, agree to carry out the calculations for the Total DV Pharmaceuticals Volume, the Total Pharmaceutical Volume and the Actual National DV Limit Indicator, provided that if PHARMAC refuses to carry out such calculations, it will provide you with the reasons for refusing to do so. It is acknowledged, for the avoidance of doubt, that if the Actual National DV Limit Indicator is less than the National DV Limit specified for the relevant Chemical Entity in Schedule Two then, regardless of whether an individual DHB Hospital’s percentage usage of DV Pharmaceuticals has exceeded the Individual DV Limit percentage for that Pharmaceutical, PHARMAC may decide, in its sole discretion, not to take any further action. If the Actual National DV Limit Indicator is greater than the National DV Limit, PHARMAC will use its best endeavours to identify which individual DHB Hospitals’ percentage usage of DV Pharmaceuticals have exceeded the Individual DV Limit percentage for that Pharmaceutical. You acknowledge that if PHARMAC cannot do this on the basis of information held by it, it may be necessary to obtain any further information you can provide. If neither of us can establish or quantify non-compliance by an individual DHB Hospital with the Individual DV Limit, then you acknowledge that PHARMAC may not be able to calculate for you, and you may not be able to obtain, financial compensation under clause 2.5(f)(ii) below. In that event you acknowledge, for the avoidance of doubt, that PHARMAC is not liable to pay any financial compensation on behalf of the relevant DHB. If an individual DHB Hospital’s percentage usage of DV Pharmaceuticals has exceeded the Individual DV Limit percentage for that Pharmaceutical as a result of DV Pharmaceutical usage that has been agreed to by you in accordance with clause 2.4(b)(iv) above then PHARMAC will not take any further action. Subject to paragraph (e) above, PHARMAC will address the issue of non-compliance with any individual DHB Hospital or DHB Hospitals identified in accordance with paragraph (d) above by: (i) using its best endeavours to ensure that the relevant DHB Hospital complies with the DV Limit for that Pharmaceutical in the remainder of that Relevant Period (if applicable) and in any subsequent Relevant Period or Relevant Periods; and/or following the end of a Relevant Period, and only once in respect of any Relevant Period, determining what financial compensation is payable by that DHB for its contribution towards exceeding the National DV Limit (where PHARMAC is able to quantify this based on the information available to it), being the greater amount of $5,000 or such sum as is equal to:

(c)

(d)

(e)

(f)

(ii)

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Schedule 5 DHB Deviation x Adjusted Price where: (A) (B) “Adjusted Price” means the Unit Price, for a particular Pharmaceutical in any Relevant Period, divided by two; “DHB Deviation” is equal to: (Total Contribution for DHBx ÷ Total Contribution for Exceeding DHBs) x Total DV Pharmaceuticals Volume in Excess of DV Limit where: “Total Contribution for DHBx” means, for: (a) (b) a particular Pharmaceutical; and a particular DHB Hospital,

in any Relevant Period, the total number of Units of all DV Pharmaceuticals of the relevant Pharmaceutical with Hospital Supply Status purchased by that DHB Hospital minus the number of Units of DV Pharmaceuticals that corresponds to the percentage of the Individual Total Market Volume represented by the Individual DV Limit percentage for that Pharmaceutical, as calculated by PHARMAC for such Relevant Period on the basis of the data extracted by PHARMAC from the electronic records used by it; “Total Contribution for Exceeding DHBs” means, for a particular Pharmaceutical in any Relevant Period, the sum of the Total Contribution for DHBx for each DHB Hospital identified by PHARMAC in accordance with paragraph (d) above as exceeding the Individual DV Limit for that Relevant Period, as calculated by PHARMAC for such Relevant Period on the basis of the data extracted by PHARMAC from the electronic records used by it; “Total DV Pharmaceuticals Volume in Excess of DV Limit” means, for a particular Pharmaceutical in any Relevant Period, the total number of Units of all DV Pharmaceuticals of the relevant Pharmaceutical with Hospital Supply Status purchased by DHB Hospitals in excess of the National DV Limit for that Relevant Period, as calculated by PHARMAC on the basis of the data extracted by PHARMAC from the electronic records used by it; (iii) PHARMAC will notify you and the relevant DHB in writing of any DV Limit compensation payable in accordance with clause 2.5(f)(ii) above. You may then invoice the relevant DHB for the amount of DV Limit compensation payable, as calculated and notified to you by PHARMAC. You must provide to PHARMAC a copy of any such invoice, and evidence of any payment received from the DHB in respect of that invoice, within 10 business days of sending such invoice or receiving such payment, respectively. If you have not received the amount of any DV Limit compensation payable in accordance with clause 2.5(f)(ii) above from the DHB within 60 business days of invoicing the DHB for the amount owing, then you may take such further actions (other than ceasing to supply) directly with the DHB as you consider appropriate to recover the amount owing to you. In that event you acknowledge, for the avoidance of doubt, that PHARMAC is not liable to pay any financial compensation on behalf of the relevant DHB.

(iv)

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Schedule 5 (v) For the avoidance of doubt, for the purposes of calculating the Total DV Pharmaceuticals Volume, the Total Contribution for DHBx and the Total DV Pharmaceuticals Volume in Excess of DV Limit in this clause 2.5, if a pharmaceutical is added to, or removed from, the list of DV Pharmaceuticals during the Relevant Period in accordance with clause 2.3 of this Schedule, then only the number of Units of that pharmaceutical purchased by DHB Hospitals during the portion of the Relevant Period in which that pharmaceutical was a DV Pharmaceutical are to be included in those calculations.

2.6

Supply arrangements after the End Date

(a) Subject to paragraphs (b) and (c) below, the Pharmaceutical is to continue to be the subject of a listing agreement between you and PHARMAC with effect from the End Date, and accordingly: (i) (ii) you will cease to have Hospital Supply Status for that form and strength of the Pharmaceutical; the Pharmaceutical will remain listed in Section H of the Pharmaceutical Schedule subject to PHARMAC’s standard terms of supply for pharmaceuticals used in DHB Hospitals (as recorded in the then current Annex Three of PHARMAC’s standard hospital contract template); you may increase the price (exclusive of GST) at which you supply the Pharmaceutical to, at a DHB Hospital’s discretion, any Designated Delivery Points, and/or Contract Manufacturers (expressly for the purpose of compounding), on giving PHARMAC six months’ written notice of that price increase. You may provide PHARMAC with this written notice at any time after, but not before, the End Date; you may withdraw the Pharmaceutical from supply on not less than two years’ prior written notice (except where the withdrawal is for reasons that PHARMAC considers to be wholly outside of your control, in which case you must first provide to PHARMAC such information as it may require from you in order to satisfy it, in its sole discretion, that you are required to withdraw supply); and if at the time of providing notice under paragraph (a)(iii) above, you advise PHARMAC that you are required to purchase a significant quantity of extra stock of the Pharmaceutical to enable you to continue to supply for the two-year period, and you advise PHARMAC of the total cost of that stock, PHARMAC will either: (A) (B) (b) use reasonable endeavours to enter into an agreement to reimburse you for stock that remains unsold at the end of that two-year period; or release you from your obligations to supply under this paragraph (a).

(iii)

(iv)

(v)

PHARMAC may, at its sole discretion, with effect from the End Date: (i) require that the Pharmaceutical does not continue to be the subject of a listing agreement, in which case PHARMAC will give you written notice not less than three months prior to the End Date; and/or apply any of the strategies under PHARMAC’s then current OPPs to the Pharmaceutical (including delisting the Pharmaceutical after the Final Transition Period).

(ii)

(c)

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In the event PHARMAC applies any of the strategies described in paragraph (b)(ii) above, you may withdraw the Pharmaceutical from supply on not less than six months’

Schedule 5 prior written notice. You may provide PHARMAC with this written notice at any time after, but not before, the date that the particular strategy takes effect in the Pharmaceutical Schedule.

2.7

Withdrawal of Hospital Supply Status

(a) PHARMAC may withdraw Hospital Supply Status in relation to your supply of the Pharmaceutical (in which case clauses 2.1, 2.2 and 2.3 of this Schedule will no longer apply), by written notice to you at any time during the Hospital Supply Status Period or (in anticipation) during the First Transition Period if: (i) (ii) you have failed to notify PHARMAC as required under clause 8.1 of this Schedule; you fail, for a period of 30 days, to supply the Pharmaceutical in accordance with this Agreement to any of the DHB Hospitals including to, at a DHB Hospital’s discretion, any Designated Delivery Points, and/or Contract Manufacturers (expressly for the purpose of compounding); any Consent for the Pharmaceutical required under clause 3 of this Schedule is withdrawn; you have failed to comply with clause 7 of this Schedule on more than one occasion; clause 4(d)(i) of Schedule Seven applies; or you otherwise fail to supply the Pharmaceutical in accordance with this Agreement.

(iii) (iv) (v) (vi) (b)

Any withdrawal of Hospital Supply Status is without prejudice to PHARMAC’s rights under clauses 8.2 and 8.3 of this Schedule.

2.8

Suspension of Hospital Supply Status

(a) If, at any time during the Hospital Supply Status Period or (in anticipation) during the First Transition Period, you are unable to meet demand for the Pharmaceutical, or you notify PHARMAC under clause 8.1 of this Schedule of a Potential Out-of-Stock Event, or you otherwise fail to supply the Pharmaceutical in accordance with this Agreement, then: (i) (ii) PHARMAC may suspend Hospital Supply Status in relation to your supply of the Pharmaceutical for the period of such inability; and DHB Hospitals may purchase DV Pharmaceuticals during the period when Hospital Supply Status is suspended without the requirement to comply with the DV Limit for the relevant Pharmaceutical.

(b) (c)

Any suspension of Hospital Supply Status is without prejudice to PHARMAC’s rights under clauses 8.2 and 8.3 of this Schedule. PHARMAC may, at any time, in its sole discretion, notify you of the date on which the suspension of Hospital Supply Status under this clause 2.8 ceases and on which date: (i) Hospital Supply Status is to be re-implemented in respect of the Pharmaceutical; or

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Schedule 5 (ii) Hospital Supply Status is to be withdrawn in accordance with clause 2.7 of this Schedule.

3.1

Consents Warranty and indemnity that Consents are held

You warrant that you have, and will maintain, all necessary Consents. If a Consent is not held by you or is withdrawn or the Pharmaceutical is no longer approved for the treatment of any indication for which it is listed in Section H of the Pharmaceutical Schedule, then: (a) (b) PHARMAC is entitled to terminate this Agreement by 14 days’ written notice to you; and whether or not PHARMAC terminates this Agreement under paragraph (a) above, you are to indemnify the Funder for any additional costs incurred by it (or by PHARMAC on its behalf) as a result of that failure to hold all necessary Consents. This clause confers a benefit on (and is enforceable by) the Funder in accordance with the Contracts (Privity) Act 1982.

3.2

Changed medicine notification

If the Ministry of Health approves any changed medicine notification for the Pharmaceutical, or for a variant of the Pharmaceutical: (a) (b) you must immediately notify PHARMAC; and PHARMAC may take such action as it considers appropriate in relation to that Pharmaceutical or variant of the Pharmaceutical including (but not limited to): (i) (ii) (iii) withdrawing Hospital Supply Status for the Pharmaceutical; reviewing the terms of listing of that Pharmaceutical; and determining the extent to which DHB Hospitals may purchase the variant of that Pharmaceutical.

3.3

Pharmacode

You agree to obtain and notify PHARMAC of the Pharmacode for the Pharmaceutical as soon as the Pharmacode is notified to you, and in any event before the date on which the Pharmaceutical is listed in Section H of the Pharmaceutical Schedule.

4.1

Price Price change

You must change the price at which you supply the Pharmaceutical to, at a DHB Hospital’s discretion, any Designated Delivery Points, and/or Contract Manufacturers (expressly for the purpose of compounding), to the Price with effect from the 12th day of the month prior to the Start Date. If your brand of the Pharmaceutical is not listed on the Pharmaceutical Schedule at the beginning of the First Transition Period, you must supply it at the Price on and from the th 12 day of the month prior to the Start Date.

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Schedule 5

4.2

Supply price

Subject to clause 4.1 of this Schedule, during each of the First Transition Period, the Hospital Supply Status Period and the Final Transition Period, if applicable in accordance with clause 2.1(b) of this Schedule, the price at which the Pharmaceutical is supplied by you to, at a DHB Hospital’s discretion, any Designated Delivery Points, and/or Contract Manufacturers (expressly for the purpose of compounding), must not exceed the Price.

4.3

Warranty that not less than cost price

You warrant that the Price at which you are required to supply the Pharmaceutical under this Agreement is greater than the cost price of the Pharmaceutical (including, without limitation, the costs of manufacturing the Pharmaceutical and of supplying it to you for supply in New Zealand).

5.1

Invoicing and Payment Invoice

You are to invoice DHB Hospitals at the end of each month, but no later than the tenth day following the month to which the invoice in respect of the Pharmaceutical relates, specifying for the Pharmaceutical supplied during that month: (a) (b) (c) (d) your delivery note reference number; the particular DHB’s purchase order reference number (if applicable); the net amount payable in respect of the Pharmaceutical supplied to that DHB in accordance with this Agreement; full details in respect of the Pharmaceutical supplied to that DHB in accordance with this Agreement, including the: (i) (ii) (iii) (iv) (e) DHB’s item codes; quantity of the Pharmaceutical supplied; price of the Pharmaceutical; total cost for the total amount of the Pharmaceutical supplied; and

any other information that DHB Hospital requires you to supply.

5.2

Payment

Provided that the Pharmaceutical has been supplied in accordance with this Agreement, and the particular DHB receives an invoice in accordance with clause 5.1 above, payment by the DHB Hospital to you of the amount required to be paid by it is expected to occur: (a) (b) by electronic funds transfer or such other method of payment as is designated by that DHB Hospital; on the 20 day of the month following the month to which the invoice for the th Pharmaceutical relates, or, if the 20 day of the month is not a business day, then on the next business day following the 20th of the month.

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Schedule 5

5.3

Future payment

(a) A particular DHB Hospital’s failure to dispute any invoice prior to payment does not prejudice that DHB Hospital’s right subsequently to dispute the correctness of such an invoice, nor its ability to recover any amount of overpayment from you. A DHB Hospital may withhold, deduct or set off the amount of any overpayment or any amount recoverable by that DHB Hospital from you under this Agreement from any future amount owing to you.

(b)

5.4

Contracts Privity

This clause 5 confers a benefit on (and is enforceable by) DHB Hospitals in accordance with the Contracts (Privity) Act 1982.

Emergency and disaster supply

In the event of an emergency or disaster affecting any DHB Hospital, or an emergency or disaster on a national level, you will use your best endeavours to provide such quantities of the Pharmaceutical as are required by the relevant DHB Hospital(s). Your obligations under this clause include, but are not limited to, using your best endeavours to: (a) (b) source the Pharmaceutical from other suppliers and distributors within New Zealand; and source the Pharmaceutical or a pharmaceutical that is the same brand as the Pharmaceutical from any overseas manufacturer, supplier or distributor, and airfreighting that stock to New Zealand (for which the relevant DHB Hospital will meet all reasonable costs) for supply, either under Medsafe’s explicit consent to import, sell or distribute the Pharmaceutical or under section 29 of the Medicines Act 1981, to DHB Hospitals.

7.1

Defective and short-dated Pharmaceuticals Pharmaceutical recall

(a) In the event that you are required by the Ministry of Health or any other authorities to recall the Pharmaceutical or a particular batch of the Pharmaceutical, you will notify PHARMAC and the relevant DHB Hospitals immediately you become aware of the need to recall the Pharmaceutical or that batch of the Pharmaceutical. You will use your best endeavours to provide replacement Pharmaceuticals to DHB Hospitals as soon as possible. If you fail to provide replacement Pharmaceuticals or an Alternative Pharmaceutical within what DHBs consider to be a reasonable time frame, then DHB Hospital(s) may purchase an Alternative Pharmaceutical elsewhere. Any reasonable additional costs incurred by DHB Hospital(s) in purchasing such an Alternative Pharmaceutical will be met by you on demand by PHARMAC or the DHB Hospital(s) and will be recoverable from you as a debt due to PHARMAC and to the DHB Hospital(s), as applicable. In the event that the Pharmaceutical or a particular batch of the Pharmaceutical is recalled as contemplated by paragraph (a) above, you shall immediately refund to the relevant DHB Hospitals all money paid by them to you for or on account of the Pharmaceutical or that batch of the Pharmaceutical and such money will be recoverable from you as a debt due to the relevant DHB Hospitals, unless you have provided a replacement Pharmaceutical to the relevant DHB Hospitals’ satisfaction.

(b) (c)

(d)

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Schedule 5 (e) This clause confers a benefit on (and is enforceable by) DHB Hospitals in accordance with the Contracts (Privity) Act 1982.

7.2

Shelf-life of Pharmaceutical

(a) You will not supply the Pharmaceutical if: (i) (ii) the remaining shelf-life of the Pharmaceutical is less than six months; or where the total shelf-life of the Pharmaceutical is less than six months, the remaining shelf-life is less than 75% of the Pharmaceutical’s total shelf-life,

without prior agreement from the relevant DHB Hospital. (b) If you have an agreement with the relevant DHB Hospital to supply the Pharmaceutical, where the total shelf-life of the Pharmaceutical is less than six months and the remaining shelf-life is less than 75% of the Pharmaceutical’s total shelf-life, and that DHB Hospital does not use the Pharmaceutical before its expiry or use-by date, you agree to allow that DHB Hospital to return the Pharmaceutical to you and to provide that DHB Hospital with a credit for the Pharmaceutical. This clause confers a benefit on (and is enforceable by) DHB Hospitals in accordance with the Contracts (Privity) Act 1982.

(c)

8.1

Out-of-stock arrangements Notification of Potential Out-of-Stock Event and supply of Alternative Pharmaceutical

(a) You must notify PHARMAC in writing as soon as you have reasonable cause to believe at any time that you will fail to supply the Pharmaceutical in accordance with this Agreement and, in any event, you must notify PHARMAC and the relevant DHB Hospitals if at any time a Potential Out-of-Stock Event occurs, including during the Hospital Supply Period or the First Transition Period. If a Potential Out-of-Stock Event occurs, or your failure to supply the Pharmaceutical in accordance with this Agreement will result in insufficient stock of the Pharmaceutical being available, then at PHARMAC’s option: (i) (ii) PHARMAC may implement an arrangement with another supplier to supply an Alternative Pharmaceutical (including an arrangement for back-up supply); and/or you must use your best endeavours to procure, as soon as practicable, an Alternative Pharmaceutical for supply to, at a DHB Hospital’s discretion, any Designated Delivery Points, and/or Contract Manufacturers (expressly for the purpose of compounding), at the Price, and if you are unable to do so you will pay to DHB Hospitals any additional costs incurred by DHB Hospitals as a result of the purchase price for the Alternative Pharmaceutical being higher than the Price.

(b)

8.2

General indemnity

You agree to indemnify DHB Hospitals and PHARMAC if you fail to supply the Pharmaceutical in accordance with this Agreement (other than for reasons that PHARMAC considers to be wholly outside your control) whether as a result of: (a) your inability to meet demand for supply of the Pharmaceutical;

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Schedule 5 (b) (c) (d) (e) your withdrawal of the Pharmaceutical from supply; any failure to have and maintain a Consent as specified in clause 3 of this Schedule; any failure to notify PHARMAC in accordance with clause 8.1 above; or for any other reason.

This indemnity: (f) covers all additional costs, including without limitation all costs (if any) incurred in securing and purchasing an Alternative Pharmaceutical, incurred by DHB Hospitals (or by PHARMAC on their behalf) as a result of your failure that are additional to any costs specified in clause 8.3; and confers a benefit on (and is enforceable by) DHB Hospitals in accordance with the Contracts (Privity) Act 1982.

(g)

8.3

Liquidated damages

(a) If you fail to supply the Pharmaceutical in accordance with this Agreement (other than for reasons that PHARMAC considers to be wholly outside your control) and: (i) you have not notified PHARMAC and the relevant DHB Hospitals under clause 8.1 of this Schedule, then without prejudice to PHARMAC’s and the relevant DHB Hospitals’ rights under clause 8.2 above you must pay to PHARMAC (for the benefit of PHARMAC and DHB Hospitals) liquidated damages for the administrative and/or operational costs incurred by PHARMAC and DHB Hospitals as a result of your failure to supply in the amount of $50,000 per Pharmaceutical in respect of which you failed to notify PHARMAC; or you have notified PHARMAC and the relevant DHB Hospitals under clause 8.1 of this Schedule, then without prejudice to PHARMAC’s and the relevant DHB Hospitals’ rights under clause 8.2 above you must pay to PHARMAC (for the benefit of PHARMAC and DHB Hospitals) liquidated damages for the administrative and/or operational costs incurred by PHARMAC and DHB Hospitals as a result of your failure to supply in the amount of $5,000 per Pharmaceutical in respect of which you notified PHARMAC.

(ii)

(b)

If, having notified PHARMAC and the relevant DHB Hospitals under clause 8.1 of this Schedule, you remain able to, and you continue to, supply the Pharmaceutical, or an Alternative Pharmaceutical in accordance with clause 8.1(b)(ii) of this Schedule, such that there is no interruption to supply of the Pharmaceutical or of the Alternative Pharmaceutical in accordance with this Agreement, you will not be liable for any costs unless PHARMAC, in its sole discretion, has considered it necessary to enter into an arrangement with an alternative supplier under which PHARMAC or the relevant DHB Hospitals have agreed to make a payment to that supplier to ensure continuity of supply, in which case you must indemnify the relevant DHB Hospitals and PHARMAC for that payment. Such indemnity will be limited to an amount of $10,000 per Pharmaceutical. You acknowledge and agree that: (i) subject to paragraph (d) below the amounts of liquidated damages in this clause represent a reasonable estimate of the administrative and operational costs incurred by PHARMAC and DHB Hospitals (including the use of staff and loss of opportunity as a result of use of staff time, and communication costs), the estimate being based on PHARMAC’s and DHB Hospitals’ previous experience; and

(c)

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Schedule 5 (ii) the amounts referred to as liquidated damages are not intended to include any penalty element nor any amount for costs relating to the securing of an Alternative Pharmaceutical, or the purchasing of an Alternative Pharmaceutical,

provided that PHARMAC may, in its sole discretion, require you to pay less than the amount specified as liquidated damages if it is satisfied that the actual costs in the particular circumstances are less than the relevant amount so specified. (d) Where you notify PHARMAC under clause 8.1 above of a Potential Out-of-Stock Event or that you will fail to supply the Pharmaceutical in accordance with this Agreement, PHARMAC agrees to recover as liquidated damages under clause 8.3(a)(ii) of this Schedule only the amounts specified in paragraphs (a)(ii) and (b) of this clause, which represent only a portion of PHARMAC’s and DHB Hospitals’ costs actually incurred. All amounts referred to in this clause are plus GST.

(e)

8.4

Failure to supply

References in this clause 8 and elsewhere in this Schedule to your failure or inability to supply the Pharmaceutical in accordance with this Agreement, or your inability to meet demand for supply of the Pharmaceutical, or insufficient stock of the Pharmaceutical being available, include, but are not limited to, circumstances where: (a) (b) no stock of the Pharmaceutical is physically held by you or on your behalf in New Zealand; the only stock of the Pharmaceutical physically held by you or on your behalf in New Zealand is stock to which clause 7.2(a)(i) or (ii) of this Schedule applies and no agreement has been reached with the relevant DHB Hospital in terms of clause 7.2(a) of this Schedule; you fail, directly or indirectly, to ensure that all orders for the Pharmaceutical are filled, including in particular where not all patients for whom the Pharmaceutical is prescribed receive the full amount of the Pharmaceutical they require, or to which they are entitled, under their prescriptions, without delay; you fail to supply the Pharmaceutical on and from the Start Date.

(c)

(d)

8.5

Default interest and recovery costs

If payment of any amount required to be paid by you under this clause 8 is not made by you, in full, by the due date for payment of that amount as notified to you in writing by PHARMAC, then: (a) interest will accrue in such sum as remains unpaid at a rate per annum equal to the business base rate of ASB Bank Limited plus five percentage points, calculated and compounded on a daily basis, from the due date until such time as the sum due (including interest) is paid in full. This obligation to pay default interest is to arise without the need for a notice or demand from PHARMAC for such default interest; and PHARMAC may take any action, including legal action, without first needing to implement the dispute resolution procedure contained in clause 14.2 of this Schedule, to recover that amount and you agree to pay to PHARMAC actual enforcement costs incurred in relation to that action.

(b)

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Schedule 5

9.1

Termination, restrictions and Crown Direction Termination and restrictions for clinical reasons

PHARMAC reserves the right, but only after consultation with you and a relevant medical adviser (being either the Ministry of Health, HPAC, PTAC, or a sub-committee of HPAC or PTAC), to: (a) terminate this Agreement at any time during the Hospital Supply Status Period or the First Transition Period if the medical adviser determines for clinical reasons that it is no longer appropriate to have either: (i) any Pharmaceutical, including the Pharmaceutical or any relevant Alternative Pharmaceutical, having Hospital Supply Status of that form and strength of the Pharmaceutical with Hospital Supply Status; or the Pharmaceutical as the brand having Hospital Supply Status; and/or

(ii) (b)

impose at any time during the Hospital Supply Status Period or the Transition Periods restrictions on the prescribing or dispensing of a Pharmaceutical if those restrictions are necessary for clinical reasons.

9.2

Crown Direction

(a) (b) You acknowledge that PHARMAC must comply with any Crown Direction. PHARMAC may terminate or amend the Agreement, or impose restrictions on the prescribing or dispensing of a Pharmaceutical, at any time during the Hospital Supply Status Period or the Transition Periods, if the termination, amendment or imposition of restrictions is required to give effect to a Crown Direction. In the event that a Crown Direction is issued to PHARMAC that requires an amendment to be made to this Agreement to give effect to that direction: (i) PHARMAC will give you as much notice as practicable of the Crown Direction and of any amendments to this Agreement that are required to give effect to that direction; the Agreement will be deemed to be amended so as to give effect to the Crown Direction from the date when such direction is due to take effect; and you may terminate this Agreement on not less than six months’ written notice to PHARMAC where the effect of the amendment required under sub-paragraph (ii) above is such that it is no longer viable, financially or otherwise, for you to continue supplying the Pharmaceutical or to perform your obligations under this Agreement.

(c)

(ii) (iii)

9.3

Termination following an audit

PHARMAC may terminate the Agreement, or withdraw Hospital Supply Status in relation to, or revise DV Limits for, a Pharmaceutical, at any time during the Hospital Supply Status Period or the Transition Periods, if you fail to remedy any area of non-compliance in accordance with clause 11(b) of this Schedule.

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Schedule 5

10.

Guarantee

(a) PHARMAC may require an entity acceptable to it to provide a guarantee (in a form satisfactory to PHARMAC) of your performance obligations under clauses 8.2 and 8.3 of this Schedule including, without limitation, the payment of any sum payable under the indemnity or as liquidated damages pursuant to those clauses for any failure to supply the Pharmaceutical in accordance with this Agreement during the Hospital Supply Status Period. The guarantor’s liability under such a guarantee will be limited to a total of $100,000 per Pharmaceutical for all claims made by PHARMAC under the guarantee.

(b)

11.

Audit

(a) PHARMAC may, from time to time, review your records and any other information you hold that relates to this Agreement with regard to stock levels, registration information and supply issues, for the purposes of auditing your compliance with this Agreement. In these circumstances, PHARMAC, in consultation with you, will determine the terms and manner of any such audit, which as a minimum, must include the following: (i) (ii) the audit will be conducted by an auditor authorised by PHARMAC; you agree to co-operate fully with PHARMAC and provide PHARMAC and the auditor with all reasonable assistance to ensure that any audit conducted under this clause is fully and properly completed to PHARMAC’s satisfaction, including: (A) allowing the auditor access to your premises, records and other information you hold that relates to this Agreement with regard to stock levels, registration information and supply issues for the purposes of, and during the course of, conducting the audit; answering promptly any questions from PHARMAC or the auditor concerning any aspect of your compliance with this Agreement;

(B) (iii)

PHARMAC will give you 10 business days’ notice of its intention to conduct an audit under this clause and will ensure that the conduct of any such audit, and access in terms of sub-paragraph (A) above, does not unreasonably disrupt your business operations.

(b)

PHARMAC will notify you in writing if an audit under this clause reveals any noncompliance with this Agreement. You agree to remedy any non-compliance within 10 business days of receiving such notice from PHARMAC. PHARMAC will use its best endeavours to audit compliance by DHB Hospitals with the DV Limits and related requirements set out under this Agreement.

(c)

12.

Access by PHARMAC to price and volume data

(a) You acknowledge that PHARMAC and its agents will require access to price and volume data held by you and DHB Hospitals in respect of the Pharmaceutical covered by this Agreement to assist PHARMAC to carry out its statutory function in relation to managing the purchasing of hospital pharmaceuticals on behalf of DHBs. Notwithstanding any other provisions in this Agreement, including clauses 9.1 and 9.2 of Schedule Three regarding confidential information, you agree that where the circumstances in this clause apply, a DHB Hospital may provide PHARMAC and its agents with any price and volume data held by that DHB Hospital in respect of a

(b)

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Schedule 5 Pharmaceutical covered by this Agreement and PHARMAC and its agents may provide such data on DHBs. (c) You agree that within 10 business days following any request from PHARMAC, you will provide PHARMAC with volume data in respect of the Pharmaceutical covered by this Agreement for each month of the period specified in that request.

13.

13.1

PCTs Listing in Section B of the Pharmaceutical Schedule

(a) Where the Pharmaceutical is a PCT, you acknowledge and agree that PHARMAC may list the Pharmaceutical in Section B of the Pharmaceutical Schedule: (i) (ii) (b) at a price that is equal to (or subject to your agreement, less than) the Price; subject to the rules and restrictions applying to PCTs in Sections A to G of the Pharmaceutical Schedule.

If PHARMAC lists the Pharmaceutical in Section B of the Pharmaceutical Schedule pursuant to paragraph (a) above, you acknowledge and agree that: (i) such listing will be for reasons relating to claiming and will not, unless otherwise advised in writing by PHARMAC, enable you to supply the Pharmaceutical for use in the community; listing of the Pharmaceutical in Section B will, at PHARMAC’s option, be additional to or instead of listing in Part II of Section H; references to the “listing” of the Pharmaceutical will, where applicable, be to the listing of the Pharmaceutical in Section B of the Pharmaceutical Schedule (and references to “list”, “listed”, “delist”, “delisted”, and “delisting” are to be interpreted accordingly); and the standard terms of listing of the Pharmaceutical in Section B of the Pharmaceutical Schedule will, except to the extent otherwise advised in writing by PHARMAC, be the terms set out in this Schedule Five, and for that purpose all references in Schedule Five to “Section H” will be deemed to be references to “Section B”.

(ii) (iii)

(iv)

(c)

This clause confers a benefit on (and is enforceable by) DHB Hospitals in accordance with the Contracts (Privity) Act 1982.

13.2

Transitional Budget Arrangements

(a) You acknowledge that DHBs and PHARMAC are in the process of transferring responsibility for a notional PCT budget to PHARMAC and that this is expected to take place in two phases with the following approximate dates: (i) the “Data Collection Phase” is expected to run from 1 July 2005 until 30 June 2007, unless notified otherwise by PHARMAC, during which time DHB Hospitals will still have responsibility for the PCTs’ budget; and the “Budget Transfer” is expected to occur on 1 July 2007, unless notified otherwise by PHARMAC, at which point PHARMAC will have responsibility for the PCTs budget.

(ii)

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Schedule 5 (b) You agree that, from the date of the Budget Transfer, which will occur on 1 July 2007 unless notified otherwise to you by PHARMAC, clause 8.1 of this Schedule will be deleted and replaced by the following:

8.1 Notification of Potential Out-of-Stock Event and supply of Alternative Pharmaceutical. (a) You must notify PHARMAC in writing as soon as you have reasonable cause to believe that you will fail to supply a Pharmaceutical in accordance with this Agreement and, in any event, you must notify PHARMAC and the relevant DHB Hospitals if at any time a Potential Out-of-Stock Event occurs, including during the Hospital Supply Period or the First Transaction Period. If you fail to supply a Pharmaceutical in accordance with this Agreement for more than 1 business day to any DHB Hospital, then: (i) you must use your best endeavours to procure, within what the relevant DHB Hospitals consider to be a reasonable period of time, an Alternative Pharmaceutical for supply to, at a DHB Hospital' s discretion, any Designated Delivery Points, and/or Contract Manufacturers (expressly for the purpose of compounding) at the Price; and if you fail to procure an Alternative Pharmaceutical at the Price in accordance with sub-clause (i) above (other than for reasons that PHARMAC considers to be wholly outside your control) then, at PHARMAC’s option: (A) you must pay to PHARMAC (for the benefit of PHARMAC and DHB Hospitals) any additional costs that PHARMAC incurs or that the relevant DHB Hospitals incur as a result of the purchase of the Alternative Pharmaceutical; or PHARMAC may implement an arrangement with another supplier to supply an Alternative Pharmaceutical (including an arrangement for back-up supply), and you must pay to PHARMAC (for the benefit of PHARMAC and DHB Hospitals) any additional costs that PHARMAC incurs or that the relevant DHB Hospitals incur as a result of the purchase of the Alternative Pharmaceutical.

(b)

(ii)

(B)

(c)

This clause confers a benefit on (and is enforceable by) DHB Hospitals in accordance with the Contracts (Privity) Act 1982.

14.

14.1

Miscellaneous Litigation support

If this Agreement or its terms (including the basis on which the Pharmaceutical is listed): (a) (b) give rise to proceedings being issued against PHARMAC; or result in PHARMAC being made a party to any proceedings issued by a third party,

you will give PHARMAC all assistance it reasonably requires to gather evidence (including expert medical and clinical evidence) for the purpose of those proceedings.

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Schedule 5

14.2

Dispute resolution

If there is a dispute between us arising out of, or in connection with, this Agreement, neither of us is to commence any proceedings relating to that dispute until the following procedure has been complied with: (a) (b) (c) the party claiming a dispute has arisen must give written notice to the other party specifying the nature of the dispute; we will endeavour, in good faith, to resolve the dispute referred to in the notice by using informal dispute resolution techniques; if we do not agree on a dispute resolution technique within 14 days after the date notice of a dispute was given, the dispute is to be mediated according to the standard mediation agreement of LEADR New Zealand Incorporated (Lawyers Engaged in Alternative Dispute Resolution), and the Chair of LEADR (or the Chair’s nominee) will select the mediator and determine the mediator’s remuneration; a party seeking urgent interlocutory relief may, by notice to the other party, elect not to comply with the provisions of this clause, but only to the extent of the relief sought, and only for the period required to dispose of the application for interlocutory relief; and pending resolution of the dispute, this Agreement will remain in full effect without prejudicing our respective rights and remedies.

(d)

(e)

For the avoidance of doubt you acknowledge and agree that PHARMAC may elect to involve any relevant DHB in any part, or all, of the above procedure.

14.3

Advertising

You must not procure, or in any way participate or assist in, the publishing of any Advertisement that: (a) (b) is aimed at consumers of pharmaceuticals; and which breaches any applicable: (i) (ii) statute or regulation, including the Fair Trading Act 1986, Medicines Act 1981 and Medicines Regulations 1984; or industry standard, including the Advertising Standards Authority Codes of Practice and the Researched Medicines Industry Code of Practice.

For the purposes of this clause: (c) "Advertisement" means any words, whether written, printed or spoken, any pictorial representation or design, any sounds or visual images, or combination of sounds and visual images, or any other form of communication used or appearing to be used to promote: (i) (ii) (d) the sale of a Pharmaceutical; or the use of a method of treatment involving a Pharmaceutical; and

references to a statute, regulation or industry standard include that statute, regulation or industry standard as amended or replaced from time to time.

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Schedule 5

14.4

No derogation

For the avoidance of doubt, the express provision of a remedy for, or consequence of, breach of any term of this Agreement does not derogate from any other legal right or remedy available to PHARMAC under this Agreement or otherwise in respect of such breach.

14.5

No waiver

A failure or delay by either of us to exercise any right arising under this Agreement is not a waiver of that right, and a waiver of a breach of this Agreement is not a waiver of any other breach.

14.6

Agreement prevails

Where any of your terms of supply, whether recorded on your invoices or in credit arrangements entered into or elsewhere, conflict with or detract from any of the terms of this Agreement, the terms of this Agreement will prevail and will apply to the exclusion of any of your terms or documentation.

14.7

Entire agreement

This Agreement: (a) is the entire agreement between us regarding the terms on which the Pharmaceutical is listed in Section H of the Pharmaceutical Schedule and purchased by DHB Hospitals; and supersedes and extinguishes, from the Start Date, all prior agreements and understandings between us, and between you and any District Health Board regarding supply of the Pharmaceutical to DHB Hospitals.

(b)

14.8

Amendments

Amendments to this Agreement are only effective if in writing and signed by both of us.

14.9

Assignment

You will not permit any part of this Agreement to be transferred, assigned or sub-contracted (either directly or due to a change of ownership or control) without PHARMAC’s prior written consent (such consent not to be unreasonably withheld). Any such consent may be given subject to such reasonable conditions as PHARMAC sees fit but no such consent will relieve you from any liability or obligation under the terms of the Agreement, and you will continue to be responsible for the acts, defaults and neglects of your transferee, assignee or subcontractor.

14.10

Further assurances

We both agree to execute any further documents and do any further acts within our power as may be reasonably necessary from time to time to give effect to the terms and intentions of this Agreement.

14.11

Contracts Privity

(a) For the purposes of the Contracts (Privity) Act 1982, we both acknowledge that your obligations in this Agreement constitute promises which confer or are intended to confer a benefit on DHB Hospitals and related persons, and are enforceable at the suit of any such DHB Hospitals or persons.

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Schedule 5 (b) Except as expressly provided in paragraph (a) above, the parties do not intend to create rights in, or grant remedies to, any third party as a beneficiary of this Agreement, and all the provisions of this Agreement shall be for the sole and exclusive benefit of the parties. For the avoidance of doubt, you acknowledge that PHARMAC may pursue damages or any other claim (including injunctive or other such relief) under this Agreement on its own account and/or on behalf of the Funder, in respect of any form of loss or damage incurred by PHARMAC and/or the Funder.

(c)

14.12

Jurisdiction and governing law

We each submit to the exclusive jurisdiction of the New Zealand courts and agree that this Agreement is governed by New Zealand law.

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Schedule 6

Schedule 6: Contract terms for Sole Supply Status

1.1

General Operating Policies and Procedures

(a) You acknowledge that: (i) PHARMAC is required to pursue the objectives, carry out the functions, and otherwise comply with the statutory obligations, prescribed for PHARMAC in the New Zealand Public Health and Disability Act 2000; PHARMAC is subject to other statutory and public law obligations, which govern PHARMAC’s decision-making processes; PHARMAC has OPPs, which provide guidance on the way in which PHARMAC carries out its statutory responsibilities in relation to the management of the Pharmaceutical Schedule; PHARMAC’s OPPs may be amended or updated from time to time, following consultation with relevant groups; the actions which PHARMAC may take under its OPPs include (without limitation): (A) (B) (C) (D) (E) (vi) (b) listing new pharmaceuticals; changing guidelines or restrictions on the prescribing and dispensing of listed pharmaceuticals; changing the subsidy levels for pharmaceuticals as a result of PHARMAC adopting one of the strategies set out in the OPPs or by any other means; amending the basis on which pharmaceuticals are classified into therapeutic groups and sub-groups; and delisting pharmaceuticals, or delisting all or part of a therapeutic group or sub-group; and

(ii) (iii)

(iv) (v)

any action taken by PHARMAC pursuant to its OPPs may impact on the listing of each Pharmaceutical.

PHARMAC agrees not to apply, amend or update its OPPs in order to avoid any of PHARMAC’s obligations under Schedule Six of this Agreement.

1.2

Amendments to Pharmaceutical Schedule

PHARMAC will consult with you before amending the Pharmaceutical Schedule if a proposed amendment would have a material adverse effect on the listing of the Pharmaceutical.

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Schedule 6

2.1

Effect of Sole Supply Status Subsidy arrangements

(a) Subject to clause 4.1 of this Schedule, the Pharmaceutical will be subsidised, and you must supply it, during the First Transition Period at the Price. If another brand of the Chemical Entity is listed on the Pharmaceutical Schedule, that brand will continue to be subsidised for the First Transition Period at the subsidy applicable to it immediately before the commencement of the First Transition Period. The subsidy payable for all other brands of that form and strength of the Chemical Entity that are listed will be changed to the Price on the first day of the Second Transition Period. All other brands of that form and strength of the Chemical Entity will be delisted on the first day of the Sole Supply Period, with the result that you will have Sole Supply Status for that form and strength of the Chemical Entity during the Sole Supply Period. The Pharmaceutical will continue to be fully subsidised, and you must continue to supply it, at the Price throughout the Second Transition Period and, subject to PHARMAC’s other rights under this Agreement in relation to the Pharmaceutical, throughout the Sole Supply Period. Subject to PHARMAC’s other rights under this Agreement in relation to the Pharmaceutical, the Pharmaceutical will not be delisted during the Final Transition Period.

(b)

(c)

(d)

(e)

2.2

Exclusivity for the Sole Supply Period

(a) Subject to PHARMAC’s other rights under this Agreement in relation to the Pharmaceutical, PHARMAC will not subsidise another supplier’s brand of the Pharmaceutical on the Pharmaceutical Schedule at any time during the Sole Supply Period. This clause does not prohibit PHARMAC from entering into negotiations or arrangements with, or inviting tenders from, other suppliers to be the sole subsidised supplier of any forms and strengths of the Chemical Entity, if such supply commences after the end of the Sole Supply Period. For the avoidance of doubt, PHARMAC may lower the subsidy applicable to a Pharmaceutical during the Final Transition Period as it sees fit, including lowering the subsidy of a Pharmaceutical as a result of the implementation of new tender arrangements.

(b)

(c)

2.3

Withdrawal of Sole Supply Status

(a) PHARMAC may withdraw Sole Supply Status in relation to your supply of the Pharmaceutical (in which case clauses 2.1 and 2.2 of this Schedule will no longer apply), by written notice to you at any time during the Sole Supply Period or (in anticipation) during the First Transition Period or the Second Transition Period if: (i) (ii) (iii) you have failed to notify PHARMAC as required under clause 6.1 of this Schedule; you are unable to supply the Pharmaceutical in accordance with this Agreement for a period of 30 days; any Consent for the Pharmaceutical is withdrawn; or

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Schedule 6 (iv) (b) clause 4(d)(i) of Schedule Seven applies.

Any withdrawal of Sole Supply Status is without prejudice to PHARMAC’s rights under clauses 6.2 and 6.3 of this Schedule.

2.4

Suspension of Sole Supply Status

(a) If, at any time during the Sole Supply Period or (in anticipation) during the First Transition Period or the Second Transition Period, you are unable to meet demand for the Pharmaceutical, or you notify PHARMAC under clause 6.1 of this Schedule of a Potential Out-of-Stock Event, or you otherwise fail to supply the Pharmaceutical in accordance with this Agreement, PHARMAC may suspend Sole Supply Status in relation to your supply of the Pharmaceutical for the period of such inability. Any suspension of Sole Supply Status is without prejudice to PHARMAC’s rights under clauses 6.2 and 6.3 of this Schedule. PHARMAC may, at any time, in its sole discretion, notify you of the date on which the suspension of Sole Supply Status under this clause 2.4 ceases and on which date: (i) (ii) Sole Supply Status is to be re-implemented in respect of the Pharmaceutical; or Sole Supply Status is to be withdrawn in accordance with clause 2.3 of Schedule Six.

(b) (c)

2.5

Subsidy arrangements after the End Date

(a) Subject to paragraphs (b) and (c) below, the Pharmaceutical is to continue to be the subject of a listing agreement between you and PHARMAC with effect from the End Date, and accordingly: (i) (ii) you will cease to have Sole Supply Status for that form and strength of the Chemical Entity; the Pharmaceutical will remain listed in Section B of the Pharmaceutical Schedule subject to PHARMAC’s standard terms of supply for pharmaceuticals used in the community (as recorded in the then current Annex Three of PHARMAC’s standard community contract template); you may increase the price ex-manufacturer (exclusive of GST) at which you supply the Pharmaceutical to wholesalers and other such distributors on giving PHARMAC six months’ written notice of that price increase. You may provide PHARMAC with this written notice at any time after, but not before, the End Date; if PHARMAC does not increase the subsidy for the Pharmaceutical to the new price notified under paragraph (a)(iii) above, you may withdraw the Pharmaceutical from supply on not less than six months’ prior written notice; if PHARMAC does increase the subsidy for the Pharmaceutical to the new price notified under paragraph (a)(iii) above, you may withdraw the Pharmaceutical from supply on not less than two years’ prior written notice (except where the withdrawal is for reasons that PHARMAC considers to be wholly outside of your control, in which case you must first provide to PHARMAC such information as it may require from you in order to satisfy it, in its sole discretion, that you are required to withdraw supply); and if at the time of providing notice under paragraph (a)(iii) above, you advise PHARMAC that you are required to purchase a significant quantity of extra stock

(iii)

(iv)

(v)

(vi)

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Schedule 6 of the Pharmaceutical to enable you to continue to supply for the two-year period, and you advise PHARMAC of the total cost of that stock, PHARMAC will either: (A) use reasonable endeavours to enter into an agreement to reimburse you for stock that remains unsold at the end of that two-year period; or

release you from your obligations to supply under this paragraph (a). (b) PHARMAC may at its sole discretion, with effect from the End Date: (i) require that the Pharmaceutical does not continue to be the subject of a listing agreement, in which case PHARMAC will give you written notice not less than three months prior to the End Date; and/or apply any of the strategies under PHARMAC’s then current OPPs to the Pharmaceutical (including delisting the Pharmaceutical after the Final Transition Period).

(ii)

(c)

In the event PHARMAC applies any of the strategies described in paragraph (b)(ii) above, you may withdraw the Pharmaceutical from supply on not less than six months’ prior written notice. You may provide PHARMAC with this written notice at any time after, but not before, the date that the particular strategy takes effect in the Pharmaceutical Schedule.

3.1

Consents Warranty and indemnity that Consents are held

You warrant that you have, and will maintain, all necessary Consents. If a Consent is not held by you or is withdrawn or the Pharmaceutical is no longer approved for the treatment of any indication for which it is subsidised, then: (a) (b) PHARMAC is entitled to terminate this Agreement by 14 days’ written notice to you; and whether or not PHARMAC terminates this Agreement under paragraph (a) above, you are to indemnify the Funder for any additional costs incurred by it (or by PHARMAC on its behalf) as a result of that failure to hold all necessary Consents. This clause confers a benefit on (and is enforceable by) the Funder in accordance with the Contracts (Privity) Act 1982.

3.2

Changed medicine notification

If the Ministry of Health approves any changed medicine notification for the Pharmaceutical, or for a variant of the Pharmaceutical: (a) (b) you must immediately notify PHARMAC; and PHARMAC may take such action as it considers appropriate in relation to that Pharmaceutical or variant of the Pharmaceutical including (but not limited to): (i) (ii) withdrawing Sole Supply Status for the Pharmaceutical; and delisting the Pharmaceutical.

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Schedule 6

4.1

Price Price change

You must change the price at which you supply day of the month prior to the Start Date. If your the Pharmaceutical Schedule at the beginning th available at the Price from the 12 day of the subsidised at the Price from the Start Date. the Pharmaceutical to the Price on the 12 brand of the Pharmaceutical is not listed on of the First Transition Period, it must be month prior to the Start Date, and will be

4.2

Supply price

During each of the Second Transition Period, the Sole Supply Period and the Final Transition Period, the price at which the Pharmaceutical is supplied by you must not exceed the Price.

4.3

Warranty that not less than cost price

You warrant that the price at which you are required to supply the Pharmaceutical under this Agreement is greater than the cost price of the Pharmaceutical (including, without limitation, the costs of manufacturing the Pharmaceutical and of supplying it to you for supply in New Zealand).

4.4

No reference pricing during Sole Supply Period

The subsidy payable for the Pharmaceutical will not be reduced as a result of a reduction in the reference price for the therapeutic sub-group of which it is a member during the Sole Supply Period. For the avoidance of doubt, PHARMAC will not be prevented from applying its reference pricing mechanisms to the Pharmaceutical to reduce the subsidy payable for it from the End Date.

Shelf-life of Pharmaceutical

(a) You will not supply the Pharmaceutical to wholesalers, or other such distributors, or pharmacies if: (i) (ii) the remaining shelf-life of the Pharmaceutical is less than six months; or where the total shelf-life of the Pharmaceutical is less than six months, the remaining shelf-life is less than 75% of the Pharmaceutical’s total shelf-life,

without prior written agreement from PHARMAC. (b) If you have an agreement with PHARMAC to supply the Pharmaceutical, where the total shelf-life of the Pharmaceutical is less than six months and the remaining shelf-life is less than 75% of the Pharmaceutical’s total shelf-life, and a particular wholesaler, or other such distributor, or pharmacy does not distribute or dispense that Pharmaceutical before its expiry or use-by date, you agree to allow that wholesaler, or other such distributor, or pharmacy to return the Pharmaceutical to you and to provide that wholesaler, or other such distributor, or pharmacy with a credit for the Pharmaceutical.

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Schedule 6

6.1

Out-of-stock arrangements Notification of Potential Out-of-Stock Event and supply of Alternative Pharmaceutical

(a) You must notify PHARMAC in writing as soon as you have reasonable cause to believe at any time that you will fail to supply the Pharmaceutical in accordance with this Agreement and, in any event, you must notify PHARMAC if at any time a Potential Outof-Stock Event occurs, including during the Sole Supply Period or the First Transition Period or the Second Transition Period, in which case PHARMAC may suspend Sole Supply Status in relation to your supply of the Pharmaceutical. If a Potential Out-of-Stock Event occurs, or your failure to supply the Pharmaceutical in accordance with this Agreement will result in insufficient stock of the Pharmaceutical being available, then at PHARMAC’s option: (i) (ii) PHARMAC may implement an arrangement with another supplier to supply an Alternative Pharmaceutical (including an arrangement for back-up supply); or you must use your best endeavours to procure wholesalers and other such distributors to supply, as soon as practicable, an Alternative Pharmaceutical to pharmacies at the Price, and PHARMAC will subsidise the Alternative Pharmaceutical at the Price.

(b)

6.2

General indemnity

You agree to indemnify the Funder if you fail to supply the Pharmaceutical in accordance with this Agreement (other than for reasons that PHARMAC considers to be wholly outside your control). This indemnity: (a) covers all additional costs, including without limitation all costs (if any) incurred in securing and subsidising an Alternative Pharmaceutical, incurred by the Funder (or by PHARMAC on its behalf) as a result of your failure to supply the Pharmaceutical in accordance with this Agreement that are additional to any costs specified in clause 6.3; and confers a benefit on (and is enforceable by) the Funder in accordance with the Contracts (Privity) Act 1982.

(b)

6.3

Liquidated damages

(a) If you fail to supply the Pharmaceutical in accordance with this Agreement (other than for reasons that PHARMAC considers to be wholly outside your control) and: (i) you have not notified PHARMAC under clause 6.1 of this Schedule, then without prejudice to PHARMAC’s rights under clause 6.2: (A) you must pay to PHARMAC (for the benefit of PHARMAC and the Funder) liquidated damages for the administrative and/or operational costs incurred by PHARMAC as a result of your failure to supply in the amount of $50,000 per Chemical Entity; and PHARMAC may withdraw Sole Supply Status in relation to your supply of the Pharmaceutical under clause 2.3 of this Schedule; or

(B) (ii)

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you have notified PHARMAC under clause 6.1 of this Schedule, then without prejudice to PHARMAC’s rights under clause 6.2:

Schedule 6 (A) you must pay to PHARMAC (for the benefit of PHARMAC and the Funder) liquidated damages for the administrative and/or operational costs incurred by PHARMAC as a result of your failure to supply in the amount of $5,000 per Chemical Entity; and if you fail to supply the Pharmaceutical in accordance with this Agreement for more than 30 days, PHARMAC may withdraw Sole Supply Status in relation to your supply of the Pharmaceutical under clause 2.3 of this Schedule.

(B)

(b)

If, having notified PHARMAC under clause 6.1 of this Schedule, you remain able to, and you continue to supply, the Pharmaceutical, or an Alternative Pharmaceutical in accordance with clause 6.1(b)(ii) of this Schedule, such that there is no interruption to supply of the Pharmaceutical or of the Alternative Pharmaceutical in accordance with this Agreement, you will not be liable for any costs unless PHARMAC, in its sole discretion, has considered it necessary to enter into an arrangement with an alternative supplier under which PHARMAC has agreed to make a payment to that supplier to ensure continuity of supply, in which case you must indemnify the Funder or PHARMAC for that payment. Such indemnity will be limited to an amount of $10,000. You acknowledge and agree that: (i) subject to paragraph (d) below the amounts of liquidated damages in this clause represent a reasonable estimate of the administrative and operational costs incurred by PHARMAC (including the use of staff and loss of opportunity as a result of use of staff time, and communication costs), the estimate being based on PHARMAC’s previous experience; and the amounts referred to as liquidated damages are not intended to include any penalty element nor any amount for costs relating to the securing of an Alternative Pharmaceutical, or the subsidisation of an Alternative Pharmaceutical,

(c)

(ii)

provided that PHARMAC may, in its sole discretion, require you to pay less than the amount specified as liquidated damages if it is satisfied that the actual costs in the particular circumstances are less than the relevant amount so specified. (d) Where you notify PHARMAC under clause 6.1 above of a Potential Out-of-Stock Event or that you will fail to supply the Pharmaceutical in accordance with this Agreement, PHARMAC agrees to recover as liquidated damages under clause 6.3(a)(ii) of this Schedule only the amounts specified in paragraphs (a)(ii) and (b) of this clause, which represent only a portion of PHARMAC’s costs actually incurred. All amounts referred to in this clause are plus GST.

(e)

6.4

Failure to supply

References in this clause 6 and elsewhere in this Schedule to your failure or inability to supply the Pharmaceutical in accordance with this Agreement, or your inability to meet demand for the Pharmaceutical, or insufficient stock of the Pharmaceutical being available, include, but are not limited to, circumstances where: (a) (b) no stock of the Pharmaceutical is physically held by you or on your behalf in New Zealand; the only stock of the Pharmaceutical physically held by you or on your behalf in New Zealand is stock to which clause 5(a)(i) or (ii) of this Schedule applies and no agreement has been reached with PHARMAC in terms of clause 5(a) of this Schedule;

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Schedule 6 (c) you fail, directly or indirectly, to ensure that all orders for the Pharmaceutical are filled, including in particular where, for reasons attributable (wholly or partly) to you, not all patients for whom the Pharmaceutical is prescribed receive the full amount of the Pharmaceutical they require, or to which they are entitled, under their prescriptions, within the required time frames for dispensing under the then current contract, or notice under section 88 of the New Zealand Public Health and Disability Act 2000, in respect of pharmacy services; you fail to supply the Pharmaceutical on and from the Start Date.

(d)

6.5

Default interest and recovery costs

If payment of any amount required to be paid by you under this clause 6 is not made by you, in full, by the due date for payment of that amount as notified to you in writing by PHARMAC, then: (a) interest will accrue in such sum as remains unpaid at a rate per annum equal to the business base rate of ASB Bank Limited plus five percentage points, calculated and compounded on a daily basis, from the due date until such time as the sum due (including interest) is paid in full. This obligation to pay default interest is to arise without the need for a notice or demand from PHARMAC for such default interest; and PHARMAC may take any action, including legal action, without first needing to implement the dispute resolution procedure contained in clause 9.2 of this Schedule, to recover that amount and you agree to pay to PHARMAC actual enforcement costs incurred in relation to that action.

(b)

7.1

Termination, restrictions and Crown Direction Termination and restrictions for clinical reasons

PHARMAC reserves the right, but only after consultation with you and a relevant medical adviser (being either the Ministry of Health, PTAC or its sub-committees), to: (a) terminate this Agreement at any time during the Sole Supply Period or the First Transition Period or the Second Transition Period if the medical adviser determines for clinical reasons that it is no longer appropriate to have either: (i) (ii) (b) a sole subsidised supplier of that form and strength of the Chemical Entity; or the Pharmaceutical as the sole subsidised brand; and/or

impose at any time during the Sole Supply Period or the Transition Periods restrictions on the prescribing or dispensing of a Pharmaceutical if those restrictions are necessary for clinical reasons.

7.2

Crown Direction

(c)

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Schedule 6 (i) PHARMAC will give you as much notice as practicable of the Crown Direction and of any amendments to this Agreement that are required to give effect to that direction; the Agreement will be deemed to be amended so as to give effect to the Crown Direction from the date when such direction is due to take effect; and you may terminate this Agreement on not less than six months’ written notice to PHARMAC where the effect of the amendment required under sub-paragraph (ii) above is such that it is no longer viable, financially or otherwise, for you to continue supplying the Pharmaceutical or to perform your obligations under this Agreement.

(ii) (iii)

Guarantee

(a) PHARMAC may require an entity acceptable to it to provide a guarantee (in a form satisfactory to PHARMAC) of your performance obligations under clauses 6.2 and 6.3 of this Schedule including, without limitation, the payment of any sum payable under the indemnity or as liquidated damages pursuant to those clauses for any failure to supply the Pharmaceutical in accordance with this Agreement during the Sole Supply Period. The guarantor’s liability under such a guarantee will be limited to a total of $100,000 per Chemical Entity for all claims made by PHARMAC under the guarantee.

(b)

9.1

Miscellaneous Litigation support

you will give PHARMAC all assistance it reasonably requires to gather evidence (including expert medical and clinical evidence) for the purpose of those proceedings.

9.2

Dispute resolution

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Schedule 6 (d) a party seeking urgent interlocutory relief may, by notice to the other party, elect not to comply with the provisions of this clause, but only to the extent of the relief sought, and only for the period required to dispose of the application for interlocutory relief; and pending resolution of the dispute, this Agreement will remain in full effect without prejudicing our respective rights and remedies.

(e)

9.3

Advertising

references to a statute, regulation or industry standard include that statute, regulation or industry standard as amended or replaced from time to time.

9.4

No derogation

9.5

No waiver

A failure or delay by either of us to exercise any right arising under this Agreement is not a waiver of that right, and a waiver of a breach of this Agreement is not a waiver of any other breach.

9.6

Entire agreement

This Agreement and, to the extent applicable, the Invitation: (a) constitute the entire agreement between us regarding the terms on which the Pharmaceutical is listed and subsidised by the Funder; and

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Schedule 6 (b) supersede and extinguish, from the Start Date, all prior agreements and understandings between us regarding the Pharmaceutical.

9.7

Amendments

Amendments to this Agreement are only effective if in writing and signed by both of us.

9.8

Assignment

You will not permit any part of this Agreement to be transferred, assigned or sub-contracted (either directly or due to a change of ownership or control) without PHARMAC’s prior written consent (such consent not to be unreasonably withheld). Any such consent may be given subject to such reasonable conditions as PHARMAC sees fit but no such consent will relieve you from liability or obligation under the terms of the Agreement, and you will continue to be responsible for the acts, defaults and neglects of your transferee, assignee or sub-contractor.

9.9

Further assurances

We both agree to execute any further documents and do any further acts within our power as may be reasonably necessary from time to time to give effect to the terms and intentions of this Agreement.

9.10

Contracts Privity

(a) For the purpose of the Contracts (Privity) Act 1982, we both acknowledge that your obligations in this Agreement constitute promises which confer or are intended to confer a benefit on the Funder and related persons, and are enforceable at the suit of the Funder and any such persons. Except as expressly provided in paragraph (a) above, the parties do not intend to create rights in, or grant remedies to, any third party as a beneficiary to this Agreement, and all the provisions of this Agreement shall be for the sole and exclusive benefit of the parties. For the avoidance of doubt, you acknowledge that PHARMAC may pursue damages or any other claim (including injunctive or other such relief) under this Agreement on its own account and/or on behalf of the Funder, in respect of any form of loss or damage incurred by PHARMAC and/or the Funder.

(b)

(c)

9.11

Jurisdiction and governing law

We each submit to the exclusive jurisdiction of the New Zealand courts and agree that this Agreement is governed by New Zealand law.

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Schedule 7

Schedule 7: Additional contract terms for foreign exchange bid

Introduction

This Schedule sets out terms that will apply to your Tender Bid if you have submitted a Foreign Exchange Bid. The provisions in this Schedule are intended to operate as follows: (a) (b) (c) Your Foreign Exchange Bid will be converted into New Zealand dollars in order to establish an initial or base price. The timing of this conversion is described in clause 2(a) of this Schedule and depends on whether or not your Tender Bid is accepted conditional on market approval. The formula for calculating the base price is set out in clause 2(b) of this Schedule and is based on an average exchange rate over the period shortly before the base price is calculated. The base price will be the initial Price under the Agreement. The Price will be reviewed periodically under the Agreement. The first review of the base price will occur on 30 June 2007. After the review on 30 June 2007, a subsequent review will be held on 30 June 2008. At each review date, an exchange rate average for the preceding period will be determined. The exchange rate average forms part of the formula described in clause 3(a) of this Schedule for calculating a new price. If the calculated new price is between 95% and 105% of the price just preceding the review, there will be no change to the Price. If the calculated new price is below 95% or above 105% of the Price, then you may supply the Pharmaceutical at a reviewed price that must be less than or equal to the price calculated under the formula. PHARMAC will subsidise the pharmaceutical at the level of that reviewed price unless the reviewed price is greater than 120% of the base price. In this case, your Sole Supply Status, or Hospital Supply Status, as applicable, is no longer guaranteed and PHARMAC may apply any of the strategies under its OPPs, and/or it may choose to subsidise the Pharmaceutical with Sole Supply Status at a level that is no more than 120% of the base price, and/or it may review the terms of listing of, and the extent to which DHB Hospitals may purchase a variant of, a pharmaceutical with Hospital Supply Status. A reviewed price (if any) will apply until the next review date, at which time the same process will occur to determine another reviewed price (if any), except that the provisions relating to the subsidy cap of 120% will always be based on the base price. There is provision in clause 5 of this Schedule for you and PHARMAC to appoint an independent expert to determine any disputed calculation.

(d) (e) (f) (g) (h) (i) (j) (k)

(l)

(m)

Establishment of Base Price in New Zealand dollars.

(a) PHARMAC will determine the Base Price in New Zealand dollars as soon as practicable after:

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Schedule 7 (i) in the case of an unconditional acceptance of your Tender Bid, the date which is 15 days prior to the date that PHARMAC’s board of directors (or chief executive, where applicable) determines to accept your Tender Bid; or in the case of acceptance of your Tender Bid being conditional on you obtaining market approval for the Pharmaceutical, the date on which such market approval is notified in the New Zealand Gazette.

(ii)

(b)

The Base Price will be determined according to the following formula: Base Price = Price in Permitted Currency / Base Exchange Rate.

PHARMAC will notify you of the Base Price as soon as practicable after making the calculation. If there is a dispute between PHARMAC and you over the calculation of the Base Price, then that dispute will be resolved in accordance with clause 5 of this Schedule. Once the Base Price is determined under this clause, it will be the Price under the Agreement until the first Exchange Rate Price Review.

Exchange Rate Price Review

(a) As soon as practicable after the Date of an Exchange Rate Price Review and, in any case, no later than two weeks after that date, you are to: (i) calculate a price for the Pharmaceutical in accordance with the following formula:

Calculated Price = Base Price × 1 +

Risk Sharing Percentage Base Exchange Rate × −1 100 Exchange Rate Average

(ii)

notify PHARMAC of the price calculated under sub-clause (a)(i) above (the Calculated Price), and provide PHARMAC with a copy of the calculations used to derive the Calculated Price.

(b)

PHARMAC will advise you, as soon as practicable after receiving your notification under paragraph (a)(ii) above, whether it agrees with the Calculated Price. If PHARMAC disputes the Calculated Price, then the price will be determined in accordance with clause 5 below.

Reviewed Price

(a) Subject to paragraph (c) below, you must notify PHARMAC in writing, on the 7th day of the month following agreement on (or determination of) the Calculated Price, of the price (exclusive of GST) at which you will supply the Pharmaceutical until the next Exchange Rate Price Review, such price being a price that is less than or equal to the Calculated Price (the Reviewed Price). The Reviewed Price will become the new Price under the Agreement from the first day of the month following the date on which you notify PHARMAC of the Reviewed Price. th Therefore, that price must be effective in the market from the 12 day of the month on which you notify PHARMAC of the Reviewed Price. If the Calculated Price is between 95% and 105% of the Base Price (or, if there has been an Exchange Rate Price Review, of the Reviewed Price), then you are to continue

100

(b)

(c)

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Schedule 7 to supply the Pharmaceutical at the Base Price, or, if applicable, the Reviewed Price until the next Exchange Rate Price Review, or the end of the Sole Supply Period or the Hospital Supply Status Period, as applicable (whichever is earlier). (d) If the Reviewed Price is greater than 120% of the Base Price, then PHARMAC may: (i) withdraw your Sole Supply Status or Hospital Supply Status, as applicable, in which case PHARMAC may, at its sole discretion, require the Pharmaceutical to remain listed subject to the terms of this Agreement, as applicable, from the date on which Sole Supply Status, or Hospital Supply Status, as applicable is withdrawn; and/or apply any of the strategies under PHARMAC’s OPPs to the Pharmaceutical, which may include: (A) entering into negotiations or arrangements with other suppliers for the listing of other brands of the Pharmaceutical at any time on the Pharmaceutical Schedule; and calling for a further tender of the Pharmaceutical, which may result in the delisting of your brand of the Pharmaceutical; and/or

(ii)

(B) (iii) (iv)

in relation to community supply, subsidise the Pharmaceutical at a subsidy that is no greater than 120% of the Base Price; and/or in relation to hospital supply, review the terms of listing of, and the extent to which DHB Hospitals purchase that Pharmaceutical.

Dispute Over Price

(a) If there is a dispute between PHARMAC and you over any price calculation, which you and PHARMAC cannot resolve within five days of the dispute arising (the Initial Period), then, as soon as possible following the expiry of that Initial Period, PHARMAC and you are to appoint an appropriately qualified independent person to determine the price. If there is no agreement on a mutually acceptable person within 15 days of the end of the Initial Period, then the price is to be determined by an appropriately qualified independent person appointed for that purpose by the President for the time being of the Institute of Chartered Accountants of New Zealand. The independent person is to calculate the disputed price and, in doing so, is to be considered as acting as an expert and not an arbitrator. As soon as practicable after the date of the independent person’s appointment, and in any case no later than three days after that appointment, we shall both submit our calculations, in writing, to the independent person, together with any documentation supporting our calculations. The independent person is to provide us with a written determination of the price, including the calculations used to derive that price, no later than 14 days from the date of his or her appointment under paragraph (a) above unless we agree otherwise. The independent person’s determination of the price is to be final and binding on both of us. The costs incurred by the independent person in completing his or her determination are to be shared equally by us, irrespective of the outcome of the determination.

(b) (c)

(d)

(e)

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101

Metadata

Title

Invitation to Tender – supply of pharmaceuticals to DHB hospitals and/or to community pharmacies

Abstract

Page 1

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