“Q. You are saying that there was a reasonable likelihood that both drugs would be successful; yes? A. We set out with those drugs with a view that we felt at the time they could be developed successfully, that’s correct.”
“Q. It was extremely unlikely that both drugs would be successful, wasn’t it? A. Yes, there was a high risk of some of the drugs not working out, I accept that, yes.”
“In the light of these considerations, the best approach for a judge to adopt in the trial of a commercial case is, in my view, to place little if any reliance at all on witnesses’ recollections of what was said in meetings and conversations, and to base factual findings on inferences drawn from the documentary evidence and known or probable facts. This does not mean that oral testimony serves no useful purpose – though its utility is often disproportionate to its length. But its value lies largely, as I see it, in the opportunity which cross-examination affords to subject the documentary record to critical scrutiny and to gauge the personality, motivations and working practices of a witness, rather than in testimony of what the witness recalls of particular conversations and events. Above all, it is important to avoid the fallacy of supposing that, because a witness has confidence in his or her recollection and is honest, evidence based on that recollection provides any reliable guide to the truth.”
“… a proper awareness of the fallibility of memory does not relieve judges of the task of making findings of fact based upon all of the evidence. Heuristics or mental short cuts are no substitute for this essential judicial function. In particular, where a party’s sworn evidence is disbelieved, the court must say why that is; it cannot simply ignore the evidence.”
“… the whole thing is incentivised by the tax structure, there’s no question of that, I’m not denying that. But that can’t detract from the underlying substance which is research and development into clinical molecules, into you know medicines. That is the substance of what is happening here, and there’s no – to my mind subtracting away from that.”
“The Nemaura Group believes there is the potential for a wider range of drugs to be delivered using each of the Patches and has commenced testing on the compatibility of the technologies with a number of drugs. However, each drug will require extensive testing before it can be delivered commercially using a Patch. The Patches may also require customisation to work with different drugs. The Nemaura Group believes that significant research and development funding will therefore be needed to achieve the commercial potential of its Patch technology with a wider range of drugs. The Nemaura Group has indicated that it is willing to grant patent rights under [the] licence for research and development purposes for the [Patches] in connection with the drugs lidocaine and risperidone. The [LLP] intends to profit from the development of the Patent Rights to deliver the Molecules commercially to patients (the “Venture”).”
“The Venture described in this Information Memorandum is not suitable for everyone. Potential Members must rely on their own examination of the legal, taxation, financial and other consequences of participating, including the risks involved, and must consult their own independent financial advisers, including an adviser authorised under FSMA.”
“As the [LLP] itself does not currently have any employees, it expects that it will be necessary to sub-contract the provision of the majority (if not all) of the Research and Development to one or more Sub-Contractors. In order to provide the necessary commercial certainty that the Research and Development will be undertaken by the [LLP], it is the [LLP’s] intention to forward-purchase the necessary Research and Development from the relevant Sub-Contractors under Research and Development Sub-Contracts shortly after entering into the Licence Agreement. As such, the [LLP] expects to have to pay each Research and Development Sub-Contract price in full to the relevant Sub-Contractor on or shortly after entering into the relevant Research and Development Sub-Contract.”
“… on the assumption that the [LLP] raises the Maximum Total Capital and that following the early stages of the testing, [NPL] exercises their pre-emption right to acquire the Developed Technology covering those Molecules and milestone payments are paid by a pharmaceutical company with a view to the pharmaceutical company bringing the Product to market.”
“Financial illustrations and projections contained in this Information Memorandum are for illustrative purposes only. Nothing in this Information Memorandum should be construed so as to constitute a forecast return and none should be implied or inferred. …”
“Topical patches, Lidoderm (Endo Pharmaceuticals) and Synera (Galen US) have been approved for treatment of post herpetic neuralgia and local dermal analgesia respectively.”
“● The primary competition comes from other local anaesthetic drugs such as articaine, bupivacaine, mepivacaine and prilocaine. ● Apart from the competition from other APIs, topical patch (lidoderm patch 5%) also faces stiff competition from several generics that are available in various markets in and outside the US. ● In future, additional competition for lidocaine is likely to come from drugs which are currently under development for topical administration; examples include Fortacin, T2380, PeriZone PerioPatch etc.”
“… look to gain ~USD 10 million as upfront payments, ~USD 70 million as milestone payments in addition to royalty payments on future sales.”
“8.1 Methodology The approach, outlined below, is based on estimating the valuation (NPV) of a licensing deal for both [NPL] (licensor) and the partner (licensee). The extent of valuation shared between [NPL] and the partner will define the limits for upfront, milestone and royalty payments. However, each of these individually can be flexed to get to the same return for [NPL] under different scenarios. The NPV of the partner will be primarily hinged on the following two parameters: 1. Incremental Revenue, from delivery of drug via the new technology 2. Costs, which will come in three categories. a. Pre-launch R&D and marketing b. Ongoing CoGS, SG&A c. Payments made to [NPL] (Upfront, Milestone, Royalty) For [NPL], the NPV is based on the following: 3. Future Revenues, same as Point 2c above 4. Costs, which represents total money already spent on technology development. … 8.3 Cost Drivers In order to get the product in the market, additional expenses will be incurred on research & development, gaining market approval, pre-launch marketing etc. We have assumed that NPL’s partner will incur 100% of this expense as may be agreed in the terms of the deal. Post launch, ongoing CoGS and SG&A expenses will also have to be considered.”
“DISCLAIMER This report presents work done by analysts at Roots Analysis Private Limited. The views expressed in this report represent independent opinion of the analysts. These views are formed based on extensive business research and are published solely for guidance and information purposes. This report is not a substitute for tailored professional advice. These views shall not be misconstrued as a firm guideline for taking business decisions. We make no warranties as to the accuracy or completeness of information and opinions contained herein. This report may not be sold without the written consent of Roots Analysis.”
“… a whole host of documents, there were discussions, there were lab tours, there were demonstrations, there were a whole host of activities that were undertaken before even we as a company determined that we should pursue certain developments, because ultimately what are we – what was it we wanted after at the end of this? We wanted products to reach market and so that we could generate income.”
“● Due to the unmet need of self-administered injectables (resulting in in high non-compliance), the microneedle based product from [NPL] has the potential to capture moderate / high share of this market. In one particular scenario, at a 35% share of total pre-tax valuation, [NPL] could look to gain between USD 5-10 million as upfront payments, USD 20 - 30 million as milestone payments in addition to royalty payments on future sales.”
“Maintain or cause to be maintained for the purposes of any obligations under FSMA the [LLP’s] records and books of account and procure that such records and books of account are maintained to reflect the activities of the [LLP].”
“100% of Net Income, Net Losses, Capital Gains and Capital Losses to the Subscribing Members allocated by reference to their respective Subscription Proportions in the Contribution Period in which the Accounting Period falls.”
“11.1.2.1 As to 0.2% of Net Income, Net Losses, Capital Gains and Capital Losses to the Subscribing Members who are not, in respect of that Fundraising Accounting Period, Introducing Subscribing Members, in proportion to the cumulative total of each such Member's Subscriber Contributions as recorded in the Register of Capital Contributions 11.1.2.2 As to 99.8% of Net Income, Net Losses, Capital Gains and Capital Losses to the Introducing Subscribing Member or Introducing Subscribing Members and, if more than one, in proportion to their respective capital contributions made in that Accounting Period.”
“… is carried out on a “Partly Funded” basis where the R&D Firm has contracted to carry out Research and Development in relation to the use of the Technology to Deliver a Drug which is not Fully Funded.”
“3.1 At the request of the LLP [NPL] will draw up a strategy to enable an effective and profitable exploitation of the Technology as it relates to that Drug (“the Sales Strategy”). 3.2 The Sales Strategy shall be drawn up in a way which reflects the respective knowledge and expertise of the parties and the respective interests of the parties. 3.3 [NPL] shall have responsibility for implementation of the Sales Strategy. 3.4 [NPL] agrees not to undertake any sales or marketing programme which contravenes the laws of England or any other jurisdiction in which it operates. [NPL] will undertake its sales and marketing business in a legal and decent manner in accordance with the terms of this Agreement and in compliance with any codes of conduct appropriate to the industry. 3.5 The obligations under this clause shall not arise in relation to a Drug if [NPL] acquired the Developed Rights in relation to that Drug pursuant to the Pre-emption Deed. 3.6 If and to the extent that the LLP and/or [NPL] receives or is entitled to receive any amount as the result of exploitation of the Technology as it relates to that Drug, such amount shall be treated as if it were the proceeds of a Sales Strategy whether or not that is in fact the case and shall be shared as provided for in Clause 6.”
“… speculative and nothing in this Agreement gives any representation that the Research and Development shall deliver any particular results or data.”
“Each Task Order will provide a breakdown of the Research and Development services to be provided together with the fee agreed for this portion of the services to be provided. The cost of delivering the Research and Development (the “R&D Fee”) shall be the sum of fees for the services specified in the Task Order and shall be specified in the Task Order.”
“1. In this Task Order, capitalised terms shall have the meanings given to them in the [Framework Agreement] except to the extent specified herein. 2. It is agreed that pursuant to the [Framework Agreement], the LLP shall pay NPL-Sub and Initial Payment of£2,015,385 (being an Instalment of the R&D Fee) upon entering this Task Order. 3. If the Initial Payment is not equal to the R&D Fee, LLP shall pay Instalments up [to] the value of the outstanding value of the R&D Fee in accordance with the [Framework Agreement] and applicable Supplemental Services Agreement. 4. [NPL-Sub] shall deliver the following research and development services in respect of the Initial Pair in order to meet the Development Objectives specified in Schedule 1 of the [Framework Agreement].”
“Hi Faz, As mentioned today, we did get a number of responses back, attached. Parexel have reverted stating that their London base does not have the capacity. I went back asking for a ball park estimate for this being in SA and their latest response is querying the actual testing to be done for an injection based device. Likewise the response from MedPharm. The third company is yet to come back to me. Is there a high-level response you could provide to these emails or is this going to require much more substantial information being disclosed (which I assume we would want to avoid).”
“Parexel have provided a very competitive quote for Europe. The costs compare well ‐ and this is a good document to have on file. We’ve said about£1.2m – and they have quoted iro£1.3 -£1.4m for the clinical bridging study.”
“The attached [ie the breakdown of costs vs third party quotes] is what we have in terms of quotes. The only one we got directly was the Parexel quote, all the rest were details supplied by Faz [Dr Chowdhury]. The two other companies we approach said no or ignored us.”
“Hi Kin, I know we have approached and got quotes from other firms for doing the work for R&D. I’m not sure how may we have and the scope of the same. Can we please meet to review the same as it is quite an important factor in light of the Brain Disorders case.”
“All Intellectual Property Rights arising out of this Agreement (including those before the execution of this Agreement) shall be for the benefit of NDM and [NPL] shall at the direction of (NPL-Sub) assign such rights to NDM.”
“25% of any profits of the [LLP] once the Subscribing Members have received Distributions in an aggregate equal to their Application Amount (as stated in that Subscribing Member’s Application Form as the “Application Amount”).”
“Risperidone is a very complex formulation of microparticles with very specific drug release profile. We have thus far completed optimisation of the formation of the particles and this is being further optimised to achieve the requisite release properties, but due to the nature of the drug release measurements (over 2 weeks per study) the stages below have not as yet been completed We anticipate this project will require a further 3 months to complete this stage.”
“To date we have not as yet had to drop any drugs, although some have proven to be extremely challenging and requiring further development. Our reasons for not dropping even the most complex of drugs, thus far, is that firstly we are confident we can resolve the existing issues, and secondly the higher the challenge the greater the barrier to entry and therefore the higher asset value, thus in everyone’s interest. Given the structure of the LLP’s I am not sure how we go about addressing the point of potentially allowing everyone to benefit from ‘all’ molecules to some extend, so perhaps you can share you thoughts on this, as it is obviously not going to be possible through the potential EIS scheme.”
“… that given the track record of never producing anything either on time or of any meaning over the last six years, I would be very surprised if you provided anything either on time or [of] any substance.”
“111. … It is necessary to stand back and look at the whole picture and, having particular regard to what the taxpayer actually did, ask whether it constituted a trade. 112. The Income Tax Acts have never defined trade or trading further than to provide that (in the words of TA 1988, s 832(1) which was applicable to the relevant tax year) trade includes every trade, manufacture, adventure or concern in the nature of trade. As an ordinary word in the English language ‘trade’ has or has had a variety of meanings or shades of meaning. Its meaning in tax legislation is a matter of law. Whether or not a particular activity is a trade, within the meaning of the tax legislation, depends on the evaluation of the activity by the tribunal of fact. These propositions can be broken down into the following components. It is a matter of law whether some particular factual characteristic is capable of being an indication of trading activity. It is a matter of law whether a particular activity is capable of constituting a trade. Whether or not the particular activity in question constitutes a trade depends upon an evaluation of all the facts relating to it against the background of the applicable legal principles. To that extent the conclusion is one of fact, or, more accurately, it is an inference of fact from the primary facts found by the fact-finding tribunal.”
“… At the most basic level, it is now clear from Eclipse, if it was not clear before, that the question whether what the taxpayer actually did constitutes a trade has to be answered by standing back and looking at the whole picture: see [111]. Although it is a matter of law whether a particular activity is capable of constituting a trade, whether or not it does so in any given case ‘depends upon an evaluation of all the facts relating to it against the background of the applicable legal principles’: see [112]. It follows that it can never be appropriate to extract certain elements from the overall picture and treat them, viewed in isolation, as determinative of the issue. …”
“The research agreement, the sub-research contract (and the other documentation which implemented the ‘Scheme’) were all ‘commercial’ in the sense that they had as part of their objective research and development of a vaccine or vaccines which it was hoped would yield royalties and the royalties which might become due under the research sub-contract were clearly a ‘reward’ from PepTcell Ltd (which was, at the same time, the ‘Appointed Sub-Contractor’ under the research agreement, subject to an obligation to develop successful vaccines, and the Partnership’s ‘customer’ under that agreement, who paid for the right to exploit the patents and inventions held by the Partnership by agreeing to pay the royalties). The royalties were not income simply to be enjoyed by the Partnership qua owner of an income-producing asset. The Partnership had to fund the activities of PepTcell Ltd, via its arrangements to fund Numology Ltd, to carry out research and develop the vaccines into something which might ultimately prove to be marketable so as to generate an income. Nor did the royalties represent simply a form of capital appreciation, for the same reasons. The Partnership had to arrange for research and development activities to be funded and carried out in order to have any hope of a return on its assets. Accordingly, in the circumstances of this case, the Partnership’s activity could not be regarded as merely making an investment in an income-producing or capital-appreciating asset. The FTT was plainly entitled to consider the Partnership’s activity to be business or commercial activity, which did not have the character of investment activity; similarly, the FTT was plainly entitled to consider that the Partnership’s activity was trading activity.”
“… are not a comprehensive list and no single item is in any way decisive. I believe that in order to reach a proper factual assessment in each case it is necessary to stand back, having looked at those matters, and look at the whole picture and ask the question-and for this purpose it is no bad thing to go back to the words of the statute – was this an adventure in this an adventure in the nature of trade? In some cases perhaps more homely language might be appropriate by asking the question, was the taxpayer investing the money or was he doing a deal?”
“Although a one-off transaction is in law capable of being an adventure in the nature of trade, obviously the lack of repetition is a pointer which indicates there might not here be trade but something else.”
“one-off purchase of silver cutlery by a general dealer is much more likely to be a trade transaction than such a purchase by a retired colonel.”
“…If the money was borrowed that is some pointer towards an intention to buy the item with a view to its resale in the short term; a fair pointer towards trade.”
“…does not mean that the relationship is not one of partnership, so long as the enterprise is carried on with a view to profit in the future.”
“(1) The words for the purposes of the trade mean to serve the purposes of the trade. They do not mean for the purposes of the taxpayer but for the purposes of the trade, which is a different concept. A fortiori they do not mean for the benefit of the taxpayer. (2) To ascertain whether the payment was made for the purposes of the taxpayer’s trade it is necessary to discover his object in making the payment. Save in obvious cases which speak for themselves, this involves an inquiry into the taxpayer's subjective intentions at the time of the payment. (3) The object of the taxpayer in making the payment must be distinguished from the effect of the payment. A payment may be made exclusively for the purposes of the trade even though it also secures a private benefit. This will be the case if the securing of the private benefit was not the object of the payment but merely a consequential and incidental effect of the payment. (4) Although the taxpayer’s subjective intentions are determinative, these are not limited to the conscious motives which were in his mind at the time of the payment. Some consequences are so inevitably and inextricably involved in the payment that unless merely incidental they must be taken to be a purpose for which the payment was made.”
“… what is significant is the purpose of the payer, not what the recipient does with the money… But if the payer knows that the payee is going to use the money in a particular way, and intends that the payee should do so—indeed has been responsible for devising the transaction in such a way as to make it essential that the payee does use the money in that way—then it is wholly unrealistic to say that the payer does not intend the money to be used for that purpose. And if that is what the payer intends, it is very difficult to see that the payer can have had any other object in making the payment.”
“… the question of what, if any, monies were expended ‘on’ research and development is a ‘factual enquiry’ which is answered by examining ‘the circumstances of each case’ (Tower MCashback[2011] STC 1143 ). … The ‘factual enquiry’ must be conducted by reference to a realistic appraisal of the facts: BMBF[2005] STC 1 ,[2005] 1 AC 684 (at [36]–[38]); Tower MCashback (at [93]) per Lord Hope … Expenditure which ‘produces no economic activity’, but rather which goes ‘into a loop as part of a tax avoidance scheme’, is not expenditure ‘on’ the acquisition of software rights (Tower MCashback, paras [77]–[78] per Lord Walker).”
“Lord Clarke, giving the only judgment [in Autoclenz], with which the other Justices agreed, made clear that the well-established principles of interpretation of contracts continued to apply to ordinary contracts, particularly commercial contracts, but there was ‘a body of case law in the context of employment contracts in which a different approach has been taken’.”
“… critical that the relevant rights were not contractual rights but were created by legislation. The task for the tribunals was not to determine whether under the contracts Autoclenz had agreed to pay the valeters the minimum wage but to determine whether they ‘fell within the definition of “worker” in the relevant statutory provisions so as to qualify for these rights irrespective of what had been contractually agreed. In short, the primary question was one of statutory interpretation, not contractual interpretation’ ([69]).”